Molnupiravir for COVID-19: real-time analysis of 125 studies

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Molnupiravir for COVID-19

54 studies with >180,000 patients

Serious outcome risk

Molnupiravir

Control

Potential risks include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity. Multiple analyses have identified variants potentially created by molnupiravir.

COVID-19 Molnupiravir studies · October 2026

Outcome (studies)

Improvement

Relative risk · 95% CI

All studies (54)5%

With exclusions (50)10%

Mortality (29)9%

Hospitalization (25)0%

Recovery (13)6%

Cases (1)24%

Viral clearance (16)19%

RCTs (19)16%

RCT mortality (6)1%

Prophylaxis (1)24%

Early (44)4%

Late (9)11%

00.511.5+

← Molnupiravir
reduces riskIncreased
risk →

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Potential risks include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-15. Multiple analyses have identified variants potentially created by molnupiravir16-20. There is substantial publication bias. Multiple trials have not reported results and did not respond to requests21. Studies show significantly increased risk of acute kidney injury22, cardiovascular toxocity23, and neurological symptoms22. Treatment may increase viral rebound24,25. Molnupiravir was adopted in 47 countries. Recent:

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	Covid Analysis	Meta-analysis of molnupiravir studies
	Meta-analysis of molnupiravir studies
Jun 3	Khoo et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkag180	A randomized controlled Phase I de-escalation trial of molnupiravir and nirmatrelvir/ritonavir combination for mild-moderate SARS-CoV-2 infection
	Phase I RCT of 24 outpatients (16 combination therapy, 8 standard of care) showing that molnupiravir (800 mg twice daily) combined with nirmatrelvir/ritonavir (300/100 mg twice daily) for 5 days was safe and well-tolerated in mild-to-mode..
May 29	Liu et al., Medicine, doi:10.1097/MD.0000000000049099	Independent mortality predictors in older COVID-19 patients with delayed hospitalization: A retrospective study from Eastern China, 2023
	Retrospective 300 elderly hospitalized COVID-19 patients in China, showing no mortality benefit with antivirals (paxlovid and molnupiravir) in multivariable analysis, OR 1.15 [0.28-4.74], without statistical significance.
Apr 17	Fang et al., Medicine, doi:10.1097/md.0000000000048378	Effectiveness of oral antivirals in reducing adverse outcomes in asthmatic patients with non-severe COVID-19: A multi-institutional retrospective cohort study
	TriNetX retrospective 29,143 matched pairs of asthmatic non-hospitalized adults with COVID-19 showing lower mortality, hospitalization, and mechanical ventilation with oral antiviral treatment (nirmatrelvir/ritonavir or molnupiravir). Thi..
Apr 16	Şimşek-Yavuz et al., Scientific Reports, doi:10.1038/s41598-026-44971-x	Effectiveness and safety of molnupiravir among patients with mild to moderate COVID-19: a prospective, observational, cohort study
	200% higher progression (p=0.34), 41% worse viral clearance (p=0.32), and 1% lower long COVID (p=0.93). PSM prospective observational cohort study of 844 mild COVID-19 patients (402 molnupiravir, 442 no antiviral) in Turkey showing higher progression to hospitalization, death, or new oxygen requirement within 28 days, without statistical si..
Mar 17	Guo et al., BMC Medicine, doi:10.1186/s12916-026-04791-2	Effectiveness of nirmatrelvir/ritonavir and molnupiravir on post-COVID diabetes risk among an older adult cohort: a target trial emulation study
	Retrospective analysis finding lower risk of post-COVID diabetes with nirmatrelvir/ritonavir but not molnupiravir. The effect may be entirely due to confounding. Authors excluded only 8% of non-diabetic patients for nirmatrelvir/ritonavir..
Jan 14	Ozhan et al., Scientific Reports, doi:10.1038/s41598-025-31048-4	Evaluation of the cardiopulmonary effects of repurposed COVID-19 therapeutics in healthy rats
	Animal study analyzing potential cardiopulmonary harm with molnupiravir (MOL), favipiravir (FAVI), hydroxychloroquine (HCQL), and dexamethasone (DEX) in healthy Wistar albino rats. In summary: Data suggests molnupiravir may have the highe..
Jan 11	Siby et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofaf695.1825	Temporal Trends in Serious Adverse Events Associated with Oral Antivirals During the COVID-19 Pandemic: Insights from the FAERS Database (2020–2023)
	Retrospective 11,547 serious adverse event reports from the FDA database (2020-2023) showing significant safety signals with oral COVID-19 antivirals. Paxlovid showed the strongest signals for drug-drug interactions (ROR: 4.83) and liver ..
Jan 11	Hong Choi et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofaf695.1812	Comparative Effectiveness of Combination Therapy with Nirmatrelvir-Ritonavir and Molnupiravir versus Monotherapy with Molnupiravir or Nirmatrelvir-Ritonavir in Hospitalised COVID-19 Patients: A Target Trial Emulation Study
	61% higher mortality (p<0.0001), 12% higher ventilation (p=0.66), and 28% higher ICU admission (p=0.44). IPTW retrospective target trial emulation of 28,355 hospitalized COVID-19 patients in Hong Kong showing no benefit and potential harm (higher mortality) with combined nirmatrelvir-ritonavir and molnupiravir compared to nirmatrelvir-ritona..
Jan 10	Prager et al., Virology Journal, doi:10.1186/s12985-025-03057-2	Viral kinetics in adults with Covid-19 treated with nirmatrelvir-ritonavir or molnupiravir: a population-based, observational cohort study
	12% worse viral clearance (p<0.0001). Observational cohort study of 113,399 COVID-19 outpatients in Vienna showing viral kinetics patterns with nirmatrelvir-ritonavir and molnupiravir treatment. Both antivirals showed improved viral clearance at 7 days, but worse viral cleara..
Jan 9	Shah et al., The Lancet Microbe, doi:10.1016/j.lanmic.2025.101227	SARS-CoV-2 infectious shedding and rebound among adults with and without oral antiviral use: two case-ascertained prospective household studies
	218% worse results (p=0.01). Prospective study of 160 non-hospitalized adults at high risk for severe COVID-19 showing paxlovid or molnupiravir associated with increased risk of viral rebound with infectious virus. Among treated participants, 25% experienced culture ..
Jan 8	Lin et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiag026	Incidence and Severity of Postacute Sequelae of SARS-CoV-2 Infection in the Omicron Era: A Prospective Cohort Study
	Prospective study of 2,960 nonhospitalized adults in the USA showing no significant difference in long-COVID with antiviral therapy using paxlovid or molnupiravir, aHR 1.02, 95% CI 0.87-1.21.
Nov 11 2025	Aggunna et al., Drugs and Drug Candidates, doi:10.3390/ddc4040050	In Silico Evaluation of Structural Consequences in the Human CYP3A4 Caused by Molnupiravir-Induced Mutations During COVID-19 Treatment
	In silico study showing potential harm from molnupiravir-induced mutations in human CYP3A4 enzyme during COVID-19 treatment. Authors identified six hotspot amino acids (R105, W126, R130, R375, S437, R440) in the CYP3A4 active site that co..
Oct 28 2025	Tatz et al., Cochrane Database of Systematic Reviews, doi:10.1002/14651858.CD015381.pub2	Molnupiravir for treating COVID-19
	Systematic review and meta-analysis of 11 RCTs with 31,272 participants showing little to no difference in mortality, hospitalization, or symptom resolution with molnupiravir, though it did increase viral clearance at day 5. Authors note ..
Sep 29 2025	Ikeuchi et al., BMC Infectious Diseases, doi:10.1186/s12879-025-11651-6	Comparative effectiveness of antiviral treatment on household transmission of SARS-CoV-2: a retrospective cohort study using administrative data
	Retrospective 5,398 married couples in Japan showing no significant difference in household transmission rates between molnupiravir, ensitrelvir, and paxlovid. Hospitalized patients receiving antivirals showed a trend toward lower transmi..
Sep 2 2025	Horby et al., medRxiv, doi:10.1101/2025.08.29.25334732	Long-term follow-up of treatment comparisons in RECOVERY: a randomised, open-label, platform trial for patients hospitalised with COVID-19
	6-month followup of RECOVERY patients. Results are reported within the respective trials for each treatment.
Jul 22 2025	Huntsman et al., Toxicological Sciences, doi:10.1093/toxsci/kfaf093	Detection of developmental toxicity of the anti-COVID-19 drug molnupiravir using gastruloid-based in vitro assays
	In vitro study showing developmental toxicity with N4-hydroxycytidine (NHC), the active metabolite of molnupiravir, in mouse and human gastruloid models. Authors exposed P19C5 mouse embryonic-stem-cell gastruloids to 20 µM NHC, which seve..
Jun 26 2025	Shen et al., Pharmaceutics, doi:10.3390/pharmaceutics17070832	Carboxylesterase Factors Influencing the Therapeutic Activity of Common Antiviral Medications Used for SARS-CoV-2 Infection
	Review of how carboxylesterase (CES) enzymes influence the activity of certain COVID-19 antivirals, focusing on remdesivir, molnupiravir, nirmatrelvir, and favipiravir. Authors highlight that remdesivir requires activation by CES1, while ..
May 8 2025	Tawfiq et al., Health Expectations, doi:10.1111/hex.70273	Long Covid Symptom Clusters, Correlates and Predictors in a Highly Vaccinated Australian Population in 2023
	Retrospective 1,205 adults in Australa showing 20% reported long COVID symptoms during an Omicron-predominant period. In multivariable analysis, paxlovid and molnupiravir use showed higher risk of long COVID, without statistical significa..
May 2 2025	Khoo et al., medRxiv, doi:10.1101/2025.05.01.25326797	A randomised-controlled Phase I de-escalation trial of Molnupiravir and Nirmatrelvir/Ritonavir combination for mild-moderate SARS-CoV-2 infection
	1% worse viral clearance (p=0.94). Randomized open-label phase I trial of 24 outpatients with mild-moderate COVID-19 showing safety and tolerability of combined molnupiravir and paxlovid therapy. Supplemental Table 2 shows greater decline of viral load in the control group..
Apr 4 2025	Nishimura et al., Biomedical Research, doi:10.2220/biomedres.46.37	Possible involvement of neuropeptide Y sub-receptor 1 (NPY-Y1) in the anti-viral response of SARS-CoV-2 infection in Syrian hamster
	Animal study showing that molnupiravir and remdesivir co-administration reduces SARS-CoV-2 viral load and inflammatory responses in Syrian hamsters, with involvement of neuropeptide Y sub-receptor 1 (NPY-Y1). Authors found that SARS-CoV-2..
Mar 15 2025	Zou et al., BMC Pulmonary Medicine, doi:10.1186/s12890-025-03524-0	Risk prediction and early intervention strategies for persistent SARS-CoV-2 infection in patients with non-Hodgkin lymphoma: a retrospective cohort study
	32% worse viral clearance (p=0.18). Retrospective 660 patients with non-Hodgkin lymphoma (NHL) and SARS-CoV-2 infection, identifying risk factors for persistent COVID-19. There was no significant difference in persistent SARS-CoV-2 infection with paxlovid, molnupiravir, or ..
Feb 20 2025	Mori et al., Free Radical Research, doi:10.1080/10715762.2025.2469738	Reactive oxygen species-mediated cytotoxic and DNA-damaging mechanism of N4-hydroxycytidine, a metabolite of the COVID-19 therapeutic drug molnupiravir
	In vitro study showing that molnupiravir may have cytotoxic and mutagenic effects in host cells via hydroxylamine production from N4-hydroxycytidine (NHC) by cytidine deaminase (CDA). Molnupiravir metabolite NHC may induce cytotoxicity an..
Feb 18 2025	Wei et al., Emerging Microbes & Infections, doi:10.1080/22221751.2025.2469648	Effectiveness of nirmatrelvir/ritonavir and molnupiravir on post-COVID-19 outcomes among outpatients: a target trial emulation investigation
	3% lower mortality (p=0.77) and 8% higher hospitalization (p=0.001). Retrospective target trial emulation of outpatients in Hong Kong showing reduced post-acute mortality and hospitalization with paxlovid, but no significant long-term benefit with molnupiravir. Figure 1 shows only 0.08% of patients were ex..
Jan 29 2025	Jorda et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofae631.2173	Nirmatrelvir-ritonavir and molnupiravir for the outpatient treatment of Covid-19: a population-based cohort study
	27% higher mortality (p=0.5) and 1% higher hospitalization (p=0.93). Retrospective 113,399 outpatients in Austria showing lower hospitalization and mortality with paxlovid treatment in patients over 60, but no significant differences with molnupiravir. Viral rebound was observed after treatment with both a..
Dec 20 2024	Rahman, M.	Elucidation of the DNA repair mechanisms involved in the repair of DNA damage caused by the Arabinosides and Anti-COVID-19 drugs
	In vitro study showing potential genotoxic side effects of remdesivir and molnupiravir linked to DNA repair pathway deficiencies. Remdesivir incorporation into nascent DNA caused replication fork stalling and acute S-phase arrest in FEN1-..
Dec 18 2024	Frederick et al., Toxicological Sciences, doi:10.1093/toxsci/kfae156	Reader Comment on: “Comprehensive genotoxicity and carcinogenicity assessment of molnupiravir”
	Commentary on [Escobar] regarding the genotoxicity and carcinogenicity of molnupiravir, raising concerns that the study did not adequately address the potential for molnupiravir's active metabolite to be incorporated into cellular DNA an..
Nov 27 2024	Mishra et al., ACS Pharmacology & Translational Science, doi:10.1021/acsptsci.4c00535	Effective, but Safe? Physiologically Based Pharmacokinetic (PBPK)-Modeling-Based Dosing Study of Molnupiravir for Risk Assessment in Pediatric Subpopulations
	In silico physiologically based pharmacokinetic (PBPK) modeling study suggesting that effective doses of molnupiravir for pediatric COVID-19 treatment pose a bone and cartilage toxicity risk.
Nov 12 2024	Kim et al., Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043	Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study
	FAERS adverse event analysis for remdesivir, bebtelovimab, molnupiravir, and paxlovid. Top 10 signals for serious adverse drug reactions for remdesivir included death and acute kidney injury, for paxlovid: disease recurrence and rebound, ..
Nov 8 2024	Wang et al., Journal of Global Health, doi:10.7189/jogh.14.05032	Low antiviral uptake of nirmatrelvir/ritonavir and molnupiravir in adult patients with COVID-19 in Taiwan in 2022
	Retrospective 96,398 adult COVID-19 patients in Taiwan showing very low use of approved antivirals nirmatrelvir/ritonavir (5.1%) and molnupiravir (1.9%) in 2022, especially in moderate-to-high risk groups eligible for treatment per WHO gu..
Nov 8 2024	Focosi et al., Intervirology, doi:10.1159/000540282	The fitness of molnupiravir-signed SARS-CoV-2 variants: imputation analysis based on prescription counts and GISAID analyses by country
	Analysis of GISAID SARS-CoV-2 sequences showing a strong correlation between molnupiravir prescriptions and putative molnupiravir-generated variants by country. Authors identify 1,094 sequences with a molnupiravir mutational signature, pr..
Oct 3 2024	Quinlan et al., MMWR. Morbidity and Mortality Weekly Report, doi:10.15585/mmwr.mm7339a3	Differences in COVID-19 Outpatient Antiviral Treatment Among Adults Aged ≥65 Years by Age Group — National Patient-Centered Clinical Research Network, United States, April 2022–September 2023
	Retrospective 393,390 COVID-19 patients aged ≥65 years showing underutilization of antiviral treatment, with lower use for older patients at higher risk for severe outcomes.
Sep 27 2024	Zabek, M., Electronic Thesis and Dissertation Repository, 10427	The Transfer of Molnupiravir and Nirmatrelvir Across the Human Placenta and Prediction of Drug Safety in Pregnancy
	Ex vivo study showing placental transfer of molnupiravir (NHC) and nirmatrelvir in human placentas. Author used a placental perfusion model to assess drug transfer across the human placental barrier. Both compounds readily crossed the pla..
Sep 20 2024	Escobar et al., Toxicological Sciences, doi:10.1093/toxsci/kfae112	Comprehensive genotoxicity and carcinogenicity assessment of molnupiravir
	Merck study finding that Merck's molnupiravir does not present a genotoxicity or carcinogenicity risk. Authors found molnupiravir was negative for mutagenicity in somatic and germ cells in transgenic rat models and did not increase tumor ..
Sep 19 2024	Kumar et al., Antiviral Research, doi:10.1016/j.antiviral.2024.106006	Identification of antibody-resistant SARS-CoV-2 mutants via N4-Hydroxycytidine mutagenesis
	In vitro selection study identifying SARS-CoV-2 spike mutations that confer resistance to therapeutic antibodies. Using a Wuhan-like strain and omicron B.1.1.529, the authors used sequential mutagenesis with the molnupiravir active compou..
Sep 9 2024	Harris et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00431-6	Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial
	27% higher mortality (p=0.5), 7% lower hospitalization (p=1), 1% improved recovery (p<0.0001), and 14% worse results (p=0.01). PRINCIPLE molnupiravir long-term followup showing improvements in time off work, healthcare use, severe symptoms, and quality of life over 6 months, however there was higher mortality (without statistical significance) and no difference i..
Sep 9 2024	Gentile et al., Microorganisms, doi:10.3390/microorganisms13030669 (date from preprint)	Efficacy of Molnupiravir in Reducing the Risk of Severe Outcomes in Patients with SARS-CoV-2 Infection: A Real-Life Full-Matched Case–Control Study (SAVALO Study)
	4% lower mortality (p=0.79), 26% lower hospitalization (p=0.74), and 65% lower progression (p=0.01). PSM retrospective case-control study with 1,382 SARS-CoV-2 positive outpatients in Italy, showing lower risk for a composite outcome of hospitalization, ICU admission, or death with molnupiravir, but no significant difference for mortalit..
Aug 23 2024	Chen et al., Biomedical Chromatography, doi:10.1002/bmc.5996	Mass spectrometry‐based metabolomics reveals metabolism of molnupiravir may lead to metabolic disorders and hepatotoxicity
	Analysis of molnupiravir induced liver injury. Molnupiravir treatment may disrupt metabolic homeostasis and cause liver injury by increasing levels of certain metabolites and activating inflammatory pathways.
Aug 20 2024	Yen et al., BMC Infectious Diseases, doi:10.1186/s12879-024-09654-w	Predictors for cause-specific and timing of deaths in patients with COVID-19: a cohort study in Taiwan
	18% lower mortality (p=0.43). Retrospective 2,196 COVID-19 patients in Taiwan (49% mild cases, 44% moderate, 7% severe) showing lower mortality with molnupiravir, without statistical significance. Authors report that all infected patients were hospitalized at the time..
Aug 14 2024	Lai et al., Age and Ageing, doi:10.1093/ageing/afae180	Efficacy of COVID-19 Oral antivirals in hospitalised oldest-old with high morbidity burden: a target trial emulation study
	10% lower mortality (p=0.007). Target trial emulation study of 13,642 (molnupiravir) and 9,553 (paxlovid) elderly hospitalized patients in Hong Kong showing lower mortality with treatment.
Aug 3 2024	Shen, Y., Doctoral dissertation, University of Cincinnati	Hydrolytic Activation and Drug-Drug Interactions of COVID-19 Therapeutics Remdesivir and Molnupiravir: The Role of CES2 Covalent Inhibition and the Impact of Genetic Polymorphism
	In vitro and ex vivo study showing significant potential drug-drug interactions between remdesivir and molnupiravir. Author found that remdesivir irreversibly inhibits CES2, an enzyme crucial for activating molnupiravir in the body, which..
Jul 30 2024	Shum, C., The University of Hong Kong, PhD Thesis	An investigational study into the drug-associated mutational signature in SARS-CoV-2 viruses
	In vitro and hamster study of drug associated SARS-CoV-2 mutations with several drugs including molnupiravir and favipiravir. Next-generation sequencing was used to identify de novo mutational spectra and single base substitution mutation..
Jul 26 2024	Shiraki et al., Heliyon, doi:10.1016/j.heliyon.2024.e35331	Convenient screening of the reproductive toxicity of favipiravir and antiviral drugs in Caenorhabditis elegans
	Reproductive toxicity analysis of antiviral drugs in C. elegans, showing increased incidence of arrested embryos with molnupiravir, favipiravir, ribavirin, acyclovir, ganciclovir, zidovudine, and thalidomide compared to controls. Authors ..
Jul 4 2024	Razia et al., Frontiers in Transplantation, doi:10.3389/frtra.2024.1408289	Remdesivir and molnupiravir had comparable efficacy in lung transplant recipients with mild-to-moderate COVID-19: a single center experience
	272% higher mortality (p=0.28) and 28% lower hospitalization (p=0.58). Retrospective 113 lung transplant recipients with mild-to-moderate COVID-19 showing higher mortality with remdesivir and molnupiravir in unadjusted analysis, with statistical significance for remdesivir. mAb PrEP and treatment and the dom..
Jun 24 2024	Lv et al., Journal of Zhejiang University - SCIENCE B (Biomedicine & Biotechnology, doi:10.1631/jzus.B2300538	Clinical characteristics and outcomes of hospitalized kidney transplant recipients with COVID-19 infection in China during the Omicron wave: a single-center cohort study
	53% higher mortality (p=0.22). Retrospective 324 hospitalized kidney transplant recipients with COVID-19 showing no significant benefit with molnupiravir, paxlovid, or azvudine. The study was conducted during the omicron wave in China between December 2022 and January ..
Jun 3 2024	Verma et al., bioRxiv, doi:10.1101/2024.06.02.596989	Persistent Neurological Deficits in Mouse PASC Reveal Antiviral Drug Limitations
	Mouse study showing persistent neurological deficits after SARS-CoV-2 infection, and failure of nirmatrelvir and molnupiravir to prevent neurological damage. Authors found decreased tyrosine hydroxylase expression in the olfactory bulb an..
May 24 2024	Horby et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(25)00093-3 (date from preprint)	Molnupiravir or nirmatrelvir-ritonavir versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
	11% higher mortality (p=0.55), 43% higher ventilation (p=0.59), 9% lower hospital discharge (p=0.46), and 12% improved viral clearance (p<0.0001). RECOVERY RCT showing no significant differences in mortality, ventilation, or discharge with either molnupiravir (923 patients) or paxlovid (137 patients). Viral load was improved with treatment but did not translate into clinical benefit..
Sep 17 2024	Lieber et al., Journal of Virology, doi:10.1128/jvi.00905-24 (date from preprint)	Efficacy of late-onset antiviral treatment in immunocompromised hosts with persistent SARS-CoV-2 infection
	Mouse study showing that late-onset treatment with paxlovid, molnupiravir, or 4'-FlU significantly reduced persistent SARS-CoV-2 infection in immunocompromised mice, with 4'-FlU being most effective. Authors used a CD4+ and CD8+ T cell-de..
May 13 2024	Pakotiprapha et al., ASPET 2024 Annual Meeting Abstract - Toxicology, doi:10.1124/jpet.212.937140	Molnupiravir Active Metabolite–N4 hydroxycytidine causes Cytotoxicity to Mammalian Cells In Vitro
	In vitro study showing cytotoxicity of N4-hydroxycytidine (NHC), the active metabolite of molnupiravir, at concentrations relevant to therapeutic doses of molnupiravir in COR-L23 and HepG2 cancer cell lines, and compared with cytotoxicity..
May 6 2024	Gruber et al., Journal of Medical Virology, doi:10.1002/jmv.29642	Molnupiravir increases SARS‐CoV‐2 genome diversity and complexity: A case‐control cohort study
	Analysis of 38 COVID-19 outpatients treated with molnupiravir showing significantly increased SARS-CoV-2 genetic diversity and complexity compared to 17 patients treated with tixagevimab/cilgavimab. Molnupiravir increased the mutation rat..
Apr 25 2024	Bessi et al., ACS Central Science, doi:10.1021/acscentsci.4c00146	The Tautomeric State of N4-Hydroxycytidine within Base-Paired RNA
	In vitro study showing that NHC, the active form of molnupiravir, can base pair with both G and A in two different tautomeric forms. This ambiguous base pairing enables NHC to induce mutations in the viral RNA. However, it raises the poss..
Apr 23 2024	Amani et al., Immunity, Inflammation and Disease, doi:10.1002/iid3.1262	Comparison of effectiveness and safety of molnupiravir versus sotrovimab for COVID‐19: A systematic review and meta‐analysis
	Meta analysis of 13 studies involving 16,166 patients showing higher mortality and higher incidence of adverse events with molnupiravir compared with sotrovimab.
Mar 31 2024	Choe et al., Pharmacoepidemiology and Risk Management, doi:10.56142/perm.24.0006	Safety Monitoring of Oral Antiviral COVID-19 Treatment Using Korea Adverse Event Reporting System (KAERS) Database
	Safety analysis of paxlovid and molnupiravir. Disproportionality analysis found significant signals for paxlovid with sensory abnormalities, interactions, fecal abnormalities, and signals not on the label including olfactory nerve disorde..
Mar 25 2024	Özdemir et al., Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, doi:10.34087/cbusbed.1423523	COVID-19 enfeksi̇yonunda molnupiravi̇r tedavi̇si̇ alan hastalarin değerlendi̇ri̇lmesi̇
	50% higher mortality (p=1) and no change in ICU admission (p=1). Retrospective study of 78 hospitalized COVID-19 patients in Turkey showing no significant difference in mortality or discharge rates with molnupiravir treatment.
Mar 22 2024	Fountain-Jones et al., The Lancet Microbe, doi:10.1016/S2666-5247(23)00393-2	Effect of molnupiravir on SARS-CoV-2 evolution in immunocompromised patients: a retrospective observational study
	Analysis of immunocompromised COVID-19 showing rapid creation of new variants with molnupiravir. Some mutations became fixed in the viral population and the distinctive mutational pattern, dominated by G-to-A and C-to-T transitions, persi..
Mar 2 2024	Schreiber et al., Antiviral Research, doi:10.1016/j.antiviral.2024.105840	The host-targeted antiviral drug Zapnometinib exhibits a high barrier to the development of SARS-CoV-2 resistance
	In vitro study showing that molnupiravir and paxlovid induced resistant variants in SARS-CoV-2 during serial passaging, while the host-directed antiviral zapnometinib did not. Authors found that molnupiravir did not lead to abrogated vira..
Feb 23 2024	Standing et al., Nature Communications, doi:10.1038/s41467-024-45641-0	Randomized controlled trial of molnupiravir SARS-CoV-2 viral and antibody response in at-risk adult outpatients
	103% worse viral clearance (p=0.33). PANORAMIC virology-sub-study showing increased viral persistence with molnupiravir treatment. Molnupiravir 800mg twice daily for 5 days led to faster initial viral decline but 86% still had detectable virus by day 5. By day 14, molnupirav..
Feb 9 2024	Chen et al., Scientific Reports, doi:10.1038/s41598-024-53862-y	Comparison of azvudine, molnupiravir, and nirmatrelvir/ritonavir in adult patients with mild-to-moderate COVID-19: a retrospective cohort study
	Retrospective 157 hospitalized mild-to-moderate COVID-19 patients showing no significant differences between azvudine, molnupiravir, and paxlovid for time to viral clearance and length of hospitalization.
Feb 9 2024	Cheng et al., Kidney International Reports, doi:10.1016/j.ekir.2024.02.009	Effectiveness of molnupiravir and nirmatrelvir–ritonavir in CKD patients with COVID-19
	15% lower mortality (p=0.003), no change in oxygen therapy (p=1), and 12% lower ICU admission (p=0.52). Retrospective emulated target trial of hospitalized COVID-19 patients with chronic kidney disease in Hong Kong showing lower mortality with molnupiravir and paxlovid treatment. No significant reduction was found in ICU admission or ventil..
Feb 6 2024	Yoshida et al., Cureus, doi:10.7759/cureus.61048 (date from preprint)	Real-World Efficacy of Ensitrelvir in Hospitalized Patients With COVID-19 in Japan: A Retrospective Observational Study
	Retrospective 154 hospitalized COVID-19 patients in Japan showing faster viral clearance and shorter hospitalization with ensitrelvir treatment compared to remdesivir or molnupiravir. There was no significant difference for fever resoluti..
Jan 26 2024	Wilcock et al., JAMA Health Forum, doi:10.1001/jamahealthforum.2023.5044	Clinical Risk and Outpatient Therapy Utilization for COVID-19 in the Medicare Population
	Analysis of Medicare beneficiaries in 2022 showing that outpatient COVID-19 treatments like antivirals and monoclonal antibodies were disproportionately used by patients at lower risk of severe infection and outcomes. Retrospective studie..
Jan 24 2024	Guermazi et al., Research Square, doi:10.21203/rs.3.rs-3876022/v1	Oral antivirals for COVID-19 among patients with cancer
	Retrospective 67 cancer outpatients treated with nirmatrelvir/ritonavir or molnupiravir, compared to 56 untreated concurrent controls, reporting lower mortality with treatment. However, Figure 3 shows the opposite results for invasive mec..
Jan 4 2024	Illingworth et al., Virus Evolution, doi:10.1093/ve/veae001	Genetic consequences of effective and suboptimal dosing with mutagenic drugs in a hamster model of SARS-CoV-2 infection
	Syrian hamster study showing that short-term treatment with the mutagenic antiviral drugs favipiravir and molnupiravir led to increased genetic variation in SARS-CoV-2 viral populations. Treatment with effective antiviral doses resulted i..
Dec 28 2023	Chamod et al., Asian Medical Journal and Alternative Medicine, 23:3	Molnupiravir Metabolite--N4-hydroxycytidine Causes Cytotoxicity and DNA Damage in Mammalian Cells in vitro: N4-hydroxycytidine Induced Cytotoxicity DNA Damage
	In vitro study showing concentration-dependent cytotoxicity and DNA damage in human skin and lung cell lines with NHC, the active metabolite of molnupiravir, at concentrations spanning the therapeutic range. The genotoxic effects raise co..
Dec 19 2023	Lombardo et al., Microorganisms, doi:10.3390/microorganisms12010002	Assessing Genomic Mutations in SARS-CoV-2: Potential Resistance to Antiviral Drugs in Viral Populations from Untreated COVID-19 Patients
	Analysis of naturally occurring SARS-CoV-2 mutations in genomic regions targeted by remdesivir, molnupiravir, and paxlovid in 4,155 antiviral-naive COVID-19 patients. Authors identified 84 amino-acid substitutions in Nsp12 (RdRp; target o..
Dec 6 2023	Bacigalupo et al., Frontiers in Medicine, doi:10.3389/fmed.2023.1287542	Unveiling patenting strategies of therapeutics and vaccines: evergreening in the context of COVID-19 pandemic
	Review of the patenting activity and evergreening approaches for three major COVID-19 antiviral medications - remdesivir, molnupiravir, and favipiravir. Authors found extensive primary and secondary patent filing, with 29 applications cov..
Nov 30 2023	Xu et al., Clinical Interventions in Aging, doi:10.2147/cia.s431271	Factors Affecting Mortality in Elderly Hypertensive Hospitalized Patients with COVID-19: A Retrospective Study
	232% higher mortality (p=0.006). Retrospective 748 elderly hospitalized COVID-19 patients in China showing increased risk of death with paxlovid/molnupiravir. Multivariate analysis showed that paxlovid/molnupiravir was independently associated with higher in-hospital mor..
Nov 30 2023	Uraki et al., iScience, doi:10.1016/j.isci.2023.108147	Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate
	In vitro and animal study showing that the SARS-CoV-2 omicron subvariant XBB.1.9.1 has similar antigenicity, antiviral susceptibility, and replicative ability compared to XBB.1.5. Casirivimab, imdevimab, tixagevimab, cilgavimab, sotrovima..
Nov 23 2023	Strizki et al., Infectious Diseases and Therapy, doi:10.1007/s40121-023-00891-1	Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial
	Virological outcomes for the MOVe-OUT trial. Results are shown with the main paper [Jayk Bernal].
Nov 22 2023	Park et al., Infection & Chemotherapy, doi:10.3947/ic.2023.0087	Effectiveness of Molnupiravir Treatment in Patients with COVID-19 in Korea: A Propensity Score Matched Study
	25% lower mortality (p<0.0001) and 29% lower progression (p<0.0001). PSM retrospective 190,692 COVID-19 patients treated with molnupiravir and 762,768 matched controls, showing lower mortality and combined severe/critical illness and mortality with treatment.
Nov 20 2023	Tare et al., BJGP Open, doi:10.3399/bjgpo.2023.0109	The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice
	83% worse recovery (p=0.36). Very small early terminated RCT with 8 molnupiravir and 17 placebo patients showing worse recovery with molnupiravir, without statistical significance.
Nov 11 2023	Xu et al., Nucleic Acids Research, doi:10.1093/nar/gkad1002	Uridine–cytidine kinase 2 potentiates the mutagenic influence of the antiviral β-d-N4-hydroxycytidine
	In vitro study showing that molnupiravir increased mutation rates in mouse blood cancer cell lines. The mutagenic effects were enhanced by overexpression of the enzyme uridine-cytidine kinase 2 (Uck2), and lessened in Uck2 knockout cells...
Nov 4 2023	Tanbek et al., Archives of Pharmacology and Therapeutics, doi:10.33696/Pharmacol.4.044	Dose-dependent Oxidative Damage of Molnupiravir (Antiviral Drug for Treatment of COVID-19) in Lung, Liver, Heart, and Kidney Tissues in Rats
	Rat study showing dose-dependent oxidative damage with molnupiravir in lung, liver, heart, and kidney tissues. Authors found that molnupiravir decreased SOD activity and increased MDA, TOS, and OSI levels in multiple tissues, indicating o..
Oct 31 2023	Winyupakorn et al., Research Square, doi:10.21203/rs.3.rs-3484296/v1	Liver injury in non-severe COVID-19 with various pandemic phases: a real-world study
	Prospective study of 300 patients with mild to moderate COVID-19 in Thailand, showing the highest risk of liver injury with molnupiravir treatment, OR 3.4 (p = 0.06).
Oct 24 2023	Kosakovsky Pond et al., Nature, doi:10.1038/d41586-023-03248-3	Anti-COVID drug accelerates viral evolution
	Discussion of the creation of new COVID-19 variants via treatment with molnupiravir. Sanderson et al. [Sanderson] showed that thousands of viruses with many mutations - sometimes more than 100 - survived molnupiravir treatment, and that m..
Oct 23 2023	Fung et al., JAMA Internal Medicine, doi:10.1001/jamainternmed.2023.5099	Nirmatrelvir and Molnupiravir and Post–COVID-19 Condition in Older Patients
	4% lower long COVID (p=0.001). Retrospective 8,089 molnupiravir patients in the USA showing a small reduction in long COVID with treatment. Confounding is likely significant as below, and may eliminate the benefit. Results specific to the COVID-19 code should be closer..
Sep 25 2023	Sanderson et al., Nature, doi:10.1038/s41586-023-06649-6	A molnupiravir-associated mutational signature in global SARS-CoV-2 genomes
	Identification of SARS-CoV-2 variants created by molnupiravir treatment, including cases of onwards transmission. Authors find a class of long phylogenetic branches almost exclusively matching the time period, location, and age groups of ..
Sep 23 2023	Marikawa et al., Reproductive Toxicology, doi:10.1016/j.reprotox.2023.108475	An active metabolite of the anti-COVID-19 drug molnupiravir impairs mouse preimplantation embryos at clinically relevant concentrations
	Analysis of molnupiravir active metabolite N4-hydroxycytidine's effects on mouse preimplantation embryos in vitro, showing embryotoxicity at clinically relevant concentrations. The researchers found that N4-hydroxycytidine impaired blasto..
Sep 8 2023	Alpizar et al., Journal of Infection, doi:10.1016/j.jinf.2023.08.016	Molnupiravir for Intra-Household Prevention of COVID-19: the MOVe-AHEAD Randomized, Placebo-Controlled Trial
	24% fewer symptomatic cases (p=0.06). PEP RCT 1,527 patients showing lower COVID-19 cases with molnupiravir, without statistical significance.
Aug 31 2023	Zibat et al., iScience, doi:10.1016/j.isci.2023.107786	N4-hydroxycytidine, the active compound of Molnupiravir, promotes SARS-CoV-2 mutagenesis and escape from a neutralizing nanobody
	In vitro study showing that NHC, the active compound molnupiravir, can promote rapid selection of immune escape mutants. NHC treatment enabled selection of nanobody-resistant mutants much faster than without NHC. While an in vitro model w..
Aug 7 2023	Gbinigie et al., BMJ Open, doi:10.1136/bmjopen-2022-069176	Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease
	PANORAMIC protocol paper, published over 9 months after publication of the molnupiravir arm [Butler].
Aug 7 2023	Shiau et al., Virology, doi:10.1016/j.virol.2023.109865	Molnupiravir, a ribonucleoside antiviral prodrug against SARS-CoV-2, alters the voltage-gated sodium current and causes adverse events
	In vitro study showing that molnupiravir inhibited sodium channel currents by altering channel gating kinetics, which may explain some of the neurological and gastrointestinal side effects.
Jul 19 2023	Guan et al., Clinical Infectious Diseases, doi:10.1093/cid/ciad409	Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial
	Symptom recovery details for the MOVe-OUT trial. Results are shown with the main paper [Jayk Bernal].
Jun 1 2023	Butt et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiad195	Molnupiravir Use and 30-Day Hospitalizations or Death in Previously Uninfected Non-hospitalized High-risk Population with COVID-19
	9% higher combined mortality/hospitalization (p=0.75). Retrospective 65,010 veterans in the USA, showing no significant difference in hospitalization/death with molnupiravir treatment. 1,729 patients received molnupiravir. Authors emulate a target trial closely matching the MOVe-OUT RCT and u..
May 16 2023	Tazare et al., medRxiv, doi:10.1101/2023.05.12.23289914	Effectiveness of Sotrovimab and Molnupiravir in community settings in England across the Omicron BA.1 and BA.2 sublineages: emulated target trials using the OpenSAFELY platform
	9% higher combined mortality/hospitalization (p=0.28). OpenSAFELY retrospective 75,048 outpatients in the UK, using the clone-censor-weight approach to address immortal time bias, showing no significant difference in combined mortality/hospitalization with molnupiravir treatment.
May 10 2023	Torti et al., Elsevier BV, doi:10.2139/ssrn.4444431	Real-Life Comparison of Mortality in Non-Hospitalised Patients with SARS-CoV-2 Infection at Risk for Clinical Progression Treated with Molnupiravir or Nirmatrevir Plus Ritonavir During the Omicron Era in Italy: A Nationwide, Observational Study
	47% higher mortality (p=0.0001). Prospective study of 17,977 outpatients treated with molnupiravir and 11,576 treated with paxlovid, showing significant mortality with both treatments, and lower mortality with paxlovid.
Apr 30 2023	Wan et al., Annals of Internal Medicine, doi:10.7326/M22-3057	Effectiveness of Molnupiravir and Nirmatrelvir–Ritonavir in Hospitalized Patients With COVID-19
	13% lower mortality (p<0.0001), 7% higher ventilation (p=0.49), and 2% higher ICU admission (p=0.9). Target trial emulation retrospective with 16,495 patients in Hong Kong, showing lower mortality with molnupiravir, but no significant difference for ventilation and ICU admission. See also [acpjournals.org], [acpjournals.org].
Mar 15 2023	Goodwin et al., PLOS ONE, doi:10.1371/journal.pone.0281915	Evaluation of outpatient treatment for non-hospitalised patients with COVID-19: The experience of a regional centre in the UK
	110% higher mortality (p=0.47) and 58% lower hospitalization (p=0.7). Retrospective 604 outpatients in the UK, showing lower risk of hospitalization with molnupiravir treatment, without statistical significance due to the small number of hospitalizations.
Feb 24 2023	European Medicines Agency, EMA/82948/2023	Refusal of the marketing authorisation for Lagevrio (molnupiravir)
	The European Medicines Agency has recommended the refusal of the marketing authorisation of molnupiravir.
Feb 22 2023	Wan et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.029	Molnupiravir and nirmatrelvir-ritonavir reduce mortality risk during post-acute COVID-19 phase
	11% lower mortality (p=0.02), 1% lower hospitalization (p=0.76), and 4% higher progression (p=0.18). Retrospective 30,040 hospitalized patients in Hong Kong, showing lower mortality with molnupiravir treatment.
Feb 21 2023	Merck, Press Release	Merck Provides Update on Phase 3 MOVe-AHEAD Trial Evaluating LAGEVRIO™ (molnupiravir) for Post-exposure Prophylaxis for Prevention of COVID-19
	MOVe-AHEAD PEP RCT reporting no significant difference in cases. Limited information is available. There were 23.6% fewer cases with treatment, but the number of cases and confidence interval are not provided.
Feb 8 2023	Boretti, A., Clinical and Experimental Medicine, doi:10.1007/s10238-023-01010-7	On the choice of Molnupiravir and Paxlovid as the only antivirals permitted for COVID-19 infection in Australia
	Letter to the editor discussing the choice of molnupiravir and paxlovid as the only approved COVID-19 antiviral therapies in Australia in 2022, despite other therapies showing higher efficacy and lower cost in clinical trials. The author ..
Feb 1 2023	Service, R., Science, doi:10.1126/science.adg9677	Could a popular COVID-19 antiviral supercharge the pandemic?
	Coverage of [Fountain-Jones, Sanderson] which show evidence for molnupiravir creating new variants. The quote "Right now, it’s much ado about nothing" is from Emory University, where Molnupiravir was invented..
Jan 25 2023	Evans et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.012	Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study
	51% lower combined mortality/hospitalization (p=0.008). Retrospective high risk outpatients in the UK, showing lower hospitalization/death with molnupiravir treatment. Residual confounding is likely with adjustments having no detail on specific comorbidities.
Jan 22 2023	Zheng et al., medRxiv, doi:10.1101/2023.01.20.23284849	Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised patients: observational cohort study using the OpenSAFELY platform
	285% higher combined mortality/hospitalization (p=0.004). OpenSAFELY retrospective 5,638 outpatients in the UK, showing significantly higher hospitalization/death for molnupiravir compared with paxlovid.
Jan 15 2023	Inaba et al., Research Square, doi:10.21203/rs.3.rs-2451986/v1	Real-world data concerning the efficacy of molnupiravir in patients vaccinated against COVID-19 during the Omicron surge in Japan
	127% higher combined mortality/hospitalization (p=0.22) and 127% higher hospitalization (p=0.22). Retrospective 294 consecutive patients in Japan, showing higher risk of hospitalization/death with molnupiravir, without statistical significance.
Dec 21 2022	Santi Laurini et al., Journal of Clinical Medicine, doi:10.3390/jcm12010034	Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data
	Safety analysis of molnupiravir reporting an unexpectedly high rate of serious adverse reactions.
Dec 6 2022	Bajema et al., medRxiv, doi:10.1101/2022.12.05.22283134	Effectiveness of COVID-19 treatment with nirmatrelvir-ritonavir or molnupiravir among U.S. Veterans: target trial emulation studies with one-month and six-month outcomes
	18% lower mortality (p=0.4), 1% lower ICU admission (p=1), and 30% higher hospitalization (p=0.04). Retrospective 112,380 high-risk patients in the USA, showing significantly higher acute or long-term care admission at 180 days with molnupiravir treatment, and no significant difference for other outcomes. The title and headers of Table ..
Nov 16 2022	Zheng et al., BMJ, doi:10.1136/bmj-2022-071932	Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform
	100% higher combined mortality/hospitalization (p=0.005). Retrospective 3,331 sotrovimab and 2,689 molnupiravir patients in the UK, showing higher risk of combined hospitalization/death with molnupiravir.
Nov 14 2022	Sinha et al., Cureus, doi:10.7759/cureus.31508	Efficacy and Safety of Molnupiravir in Mild COVID-19 Patients in India
	65% lower hospitalization (p=0.005), 53% greater improvement (p=0.01), and 48% improved viral clearance (p<0.0001). RCT 1,218 outpatients in India, showing lower hospitalization, better clinical improvement, and improved viral clearance with molnupiravir.
Oct 30 2022	Liu et al., Infectious Diseases and Therapy, doi:10.1007/s40121-022-00716-7	Disease Progression of Hospitalized Elderly Patients with Omicron BA.2 Treated with Molnupiravir
	18% shorter hospitalization (p=0.14) and 21% faster viral clearance (p=0.1). Retrospective 42 elderly patients in China showing faster viral clearance with molnupiravir.
Oct 8 2022	Wong et al., The Lancet, doi:10.1016/S0140-6736(22)01586-0	Real-world effectiveness of molnupiravir and nirmatrelvir plus ritonavir against mortality, hospitalisation, and in-hospital outcomes among community-dwelling, ambulatory patients with confirmed SARS-CoV-2 infection during the omicron wave in Hong Kong: an observational study
	24% lower mortality (p=0.01), 60% lower ventilation (p=0.02), 26% lower ICU admission (p=0.24), and 2% lower hospitalization (p=0.58). PSM retrospective 1,074,856 outpatients in Hong Kong, showing lower mortality with molnupiravir.
Oct 7 2022	Mazzotta et al., Journal of Medical Virology, doi:10.1002/jmv.28186	Viral load decrease in SARS‐CoV‐2 BA.1 and BA.2 Omicron sublineages infection after treatment with monoclonal antibodies and direct antiviral agents
	Observational study of 521 outpatients with mild-to-moderate COVID-19 showing paxlovid had stronger viral load reduction against Omicron BA.1 and BA.2 variants compared to sotrovimab, molnupiravir, and remdesivir, with the exception of co..
Oct 6 2022	Butler et al., The Lancet, doi:10.1016/S0140-6736(22)02597-1 (date from preprint)	Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial
	27% higher mortality (p=0.5), 6% higher combined mortality/hospitalization (p=0.69), 7% higher hospitalization (p=0.67), and 2% lower transmission (p=0.88). 26,411 patient RCT in the UK, showing faster recovery but no significant difference in hospitalization/death or transmission. Improved recovery may be in part due to the open label design with self-reported symptomatic data. Viral load in..
Oct 6 2022	Alteri et al., Research Square, doi:10.21203/rs.3.rs-2105569/v1	Genomic Evolution of Sars-Cov-2 in Molnupiravir-Treated Patients Compared to Paxlovid-Treated and Drug-Naïve Patients: A Proof-of-Concept Study
	Mutation analysis showing over 5x greater within-host genetic diversity with molnupiravir compared to paxlovid or no treatment.
Oct 6 2022	Brown et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac527	Demographics and outcomes of initial phase of COVID-19 Medicines Delivery Units across 4 UK centres during peak B1.1.529 omicron epidemic: a service evaluation
	101% higher hospitalization (p=0.51). Retrospective 442 patients in the UK treated with molnupiravir, and 222 eligible but declining treatment, showing no significant difference in hospitalization. No group details are provided and the results are subject to confounding by in..
Oct 5 2022	Suzuki et al., Clinical and Experimental Medicine, doi:10.1007/s10238-022-00949-3 (date from preprint)	Real-world clinical outcomes of treatment with molnupiravir for patients with mild-to-moderate coronavirus disease 2019 during the Omicron variant pandemic
	53% lower progression (p=0.04). Retrospective 1,921 patients in Japan, showing lower progression with molnupiravir use.
Oct 1 2022	Miranda et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22510	Evaluation of the mutagenic effects of Molnupiravir and N4-hydroxycytidine in bacterial and mammalian cells by HiFi sequencing
	In vitro genotoxocity study of molnupiravir showing dose dependent increased genome-wide mutation frequencies with mouse lymphoma L5178Y and human lymphoblastoid TK6 cells.
Sep 29 2022	Arbel et al., Research Square, doi:10.21203/rs.3.rs-2115769/v1	Molnupiravir Use and Severe Covid-19 Outcomes During the Omicron Surge
	74% lower mortality (p=0.008) and 45% lower hospitalization (p=0.01). Retrospective 19,868 patients eligible for molnupiravir treatment in Israel with 1,069 treated, showing lower mortality and hospitalization with treatment for the subgroup of patients ≥65, and higher mortality for patients 40-64. Authors ..
Sep 20 2022	Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac781	Effectiveness of Molnupiravir in High Risk Patients: a Propensity Score Matched Analysis
	19% lower mortality (p=0.48), 17% lower progression (p=0.34), and 25% lower severe cases (p=0.15). PSM retrospective 2,661 molnupiravir patients in Israel, showing lower mortality and severe COVID-19, without statistical significance. Significant benefit was seen in some subgroups, and significant harm was seen in the <75 subgroup.
Sep 9 2022	Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8	Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
	15% higher severe cases (p=0.71). Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early molnupiravir use.
Aug 2 2022	Lawrence et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac440 (date from preprint)	Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13,694 patients with meta-analysis
	Meta analysis of molnupiravir trials showing 12 registered RCTs in India with only one presented at a conference, and two issuing press releases suggesting failure. Authors find that ~90% of the global data on molnupiravir has not been pu..
Jul 29 2022	Lieber et al., Nature Communications, doi:10.1038/s41467-022-32045-1	SARS-CoV-2 VOC type and biological sex affect molnupiravir efficacy in severe COVID-19 dwarf hamster model
	Roborovski dwarf hamster and in vitro study finding molnupiravir efficacy varied significantly by SARS-CoV-2 variant in the hamster model, in contrast to no significant difference seen in cultured cells and human organoids. Efficacy for o..
Jul 24 2022	Khoo et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00644-2 (date from preprint)	Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial
	89% lower hospitalization (p=0.12), 12% worse recovery (p=0.74), and 23% improved viral clearance (p=0.07). RCT 90 molnupiravir and 90 placebo patients, showing faster viral clearance with treatment, not reaching the pre-defined threshold for superiority and recommendation as a candidate for large scale evaluation.
Jul 6 2022	Flisiak et al., Pharmacological Reports, doi:10.1007/s43440-022-00408-6 (date from preprint)	Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance
	39% lower mortality (p=0.03), 5% lower ventilation (p=1), and 1% longer hospitalization (p=0.97). Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.
Jun 15 2022	Zou et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.939573	Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial
	29% faster recovery (p=0.5) and 10% faster viral clearance (p=0.009). RCT 116 mild/moderate COVID-19 patients in China, showing improved viral clearance with treatment.
May 24 2022	Yip et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac687 (date from preprint)	Impact of the use of oral antiviral agents on the risk of hospitalization in community COVID-19 patients
	12% higher combined mortality/ICU admission (p=0.66) and 17% higher hospitalization (p=0.06). Propensity score weighted retrospective of 93,883 outpatients in Hong Kong, 5,808 treated with molnupiravir and 4,921 treated with paxlovid, showing higher hospitalization and higher combined mortality/mechanical ventilation/ICU admission..
May 20 2022	Wong et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00507-2 (date from preprint)	Real-world effectiveness of early molnupiravir or nirmatrelvir–ritonavir in hospitalised patients with COVID-19 without supplemental oxygen requirement on admission during Hong Kong's omicron BA.2 wave: a retrospective cohort study
	52% lower mortality (p<0.0001), 58% lower ventilation (p=0.06), 40% lower progression (p<0.0001), and 6% shorter hospitalization (p=0.03). PSM retrospective 40,776 patients in Hong Kong, showing lower mortality and lower combined mortality, ventilation, ICU, and oxygen therapy with molnupiravir treatment.
May 17 2022	Rosenke et al., JCI Insight, doi:10.1172/jci.insight.160108	Molnupiravir inhibits SARS-CoV-2 variants including Omicron in the hamster model
	Syrian hamster study showing efficacy of molnupiravir for multiple variants including omicron.
May 3 2022	Gleeson et al., medRxiv, doi:10.1101/2022.05.03.22274524	Kidney Transplant Recipients and Omicron: Outcomes, effect of vaccines and the efficacy and safety of novel treatments
	129% higher mortality (p=0.52), 129% higher ICU admission (p=0.52), and 31% lower hospitalization (p=0.74). Retrospective 116 kidney transplant recipients diagnosed with COVID-19 in the community during the Omicron era in the UK, showing lower hospitalization with sotrovimab, but no significant difference with molnupiravir. Two molnupiravir-tre..
Apr 18 2022	Hadj Hassine et al., Viruses, doi:10.3390/v14040841	Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity
	Review of lethal mutagenesis for RNA viruses, as used by molnupiravir, favipiravir, and ribavirin. Authors note the potential for permanently modifying the genomes of patients while causing teratogenicity or embryotoxicity, and the potent..
Apr 8 2022	Lee, T.	PANORAMIC recruitment analysis
	Analysis of the PANORAMIC trial recuitment suggesting that if the trial shows efficacy, the NNT will be >200.
Mar 11 2022	Thorlund et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339	Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
	Discussion of concerns with the MOVe-OUT trial, including the reversal of the treatment effect post-interim analysis.
Feb 24 2022	Tippabhotla et al., SSRN Electronic Journal, doi:10.2139/ssrn.4042673	Efficacy and Safety of Molnupiravir for the Treatment of Non-Hospitalized Adults With Mild COVID-19: A Randomized, Open-Label, Parallel-Group Phase 3 Trial
	46% lower hospitalization (p=0.26), 46% greater improvement (p<0.0001), and 59% improved viral clearance (p<0.0001). RCT 1,220 patients in India, showing lower risk of hospitalization and improved recovery with treatment. CTRI/2021/07/034588.
Feb 7 2022	Schultz et al., Nature, doi:10.1038/s41586-022-04482-x	Pyrimidine inhibitors synergize with nucleoside analogues to block SARS-CoV-2
	In vitro and mouse study showing synergistic antiviral effects when combining pyrimidine biosynthesis inhibitors with antiviral nucleoside analogues against SARS-CoV-2. Authors screened 18 thousand drugs and validated 122 with antiviral a..
Feb 3 2022	Swanstrom et al., Science, doi:10.1126/science.abn0048	Lethal mutagenesis as an antiviral strategy
	Review of the unknown long-term cancer, reproductive, and escape variant creation risks of molnupiravir. For more discussion see [twitter.com, twitter.com, twitter.com].
Jan 28 2022	Waters et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22471	Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir
	Review of antiviral nucleoside analog drugs that induce lethal mutagenesis, including molnupiravir and favipiravir, and the potential mutagenic risks to human DNA and human mitochondrial DNA. Author recommends monitoring for mutagenicity,..
Jan 25 2022	Caraco et al., NEJM Evidence, doi:10.1056/EVIDoa2100043	Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults
	22% worse recovery (p=0.63). Phase 2 RCT of 302 nonhospitalized adults showing possible benefit with molnupiravir (200, 400, or 800 mg twice daily for 5 days) for treatment of mild-to-moderate COVID-19.
Dec 16 2021	Arribas et al., NEJM Evidence, doi:10.1056/EVIDoa2100044	Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19
	282% higher mortality (p=0.31), 1% improved recovery (p=0.96), and 12% improved viral clearance (p=0.57). RCT 304 hospitalized patients, 218 treated with molnupiravir, showing no significant differences. MOVe-IN MK-4482-001. NCT04575584.
Dec 16 2021	Jayk Bernal et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116044	Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
	89% lower mortality (p=0.01), 30% lower combined mortality/hospitalization (p=0.05), 15% faster recovery (p=0.02), and 4% improved viral clearance (p=0.2). MOVe-OUT RCT, showing significantly lower risk of hospitalization or death. In subgroup analysis efficacy was much lower with the delta variant.
Dec 3 2021	Anonymous, Authorea, doi:10.22541/au.163854323.34557301/v1	Treating a Pandemic Respiratory Disease with a Mutagen is a Doomsday Scenario
	Review of molnupiravir's mutagenic mechanism of action, and analysis of the increased probability of creating dangerous variants.
Nov 6 2021	Goldstein, L., TrialSite News	Molnupiravir: mutagenic, carcinogenic, authorized in the UK
	Discussion of concerns with molnupiravir and the MOVe-OUT trial. Author notes that results showing bone marrow toxicity in dogs were mentioned in this preprint [medrxiv.org], but removed from the journal version [journals.asm.org]. Some a..
Oct 28 2021	Optimus, Press Release	Optimus announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
	75% lower hospitalization (p=0.22), 15% worse recovery (p=0.03), and 41% improved viral clearance (p<0.0001). RCT 1,202 patients showing improved viral clearance, but no significant differences in clinical outcomes. Only interim results were reported by the manufacturer, the final results are from [pmc.ncbi.nlm.nih.gov]. Some results are provided..
Oct 9 2021	Reuters, 10/8	Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
	no change in recovery (p=1). Trial CTRI/2021/08/035424 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].
Oct 9 2021	Reuters, 10/8	Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
	no change in recovery (p=1). Trial CTRI/2021/05/033864 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].
Sep 13 2021	Malone et al., Nature Structural & Molecular Biology, doi:10.1038/s41594-021-00657-8	Molnupiravir: coding for catastrophe
	Review of recent studies on molnupiravir's mechanism of lethal mutagenesis. Authors note that potential off-target effects require further investigation, because molnupiravir may be mutagenic to host DNA during host DNA replication.
Aug 27 2021	Khoo et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkab318	Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study
	33% worse recovery (p=0.63). Dose and safety study of molnupiravir with 18 participants, finding no serious adverse events in short-term followup. There was no significant difference in clinical outcomes. NCT04746183.
Jul 9 2021	Hetero, Press Release	Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
	70% lower hospitalization (p=0.003) and 33% faster recovery (p=0.0001). Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.
Jul 9 2021	Abdelnabi et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab361	Molnupiravir Inhibits Replication of the Emerging SARS-CoV-2 Variants of Concern in a Hamster Infection Model
	Hamster study showing molnupiravir effective against the original, B.1.1.7, and B.1.351 variants.
Jun 18 2021	Fischer et al., medRxiv, doi:10.1101/2021.06.17.21258639	Molnupiravir, an Oral Antiviral Treatment for COVID-19
	77% lower mortality (p=0.31) and 49% improved viral clearance (p=0.12). RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570.
May 7 2021	Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247	β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
	In vitro study showing that NHC (initial metabolite of molnupiravir) has high antiviral activity against SARS-CoV-2, but also shows host mutational activity in an animal cell culture assay. Authors note the concern that mutations in host ..
Apr 15 2021	Merck, News Release	Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19
	News release reporting that the trial of molnupiravir with hospitalized patients (NCT04575584) has been discontinued because data indicates it is unlikely to demonstrate a clinical benefit in hospitalized patients. Results are not availab..