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Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India

Hetero, Press Release, Jul 2021
https://c19early.org/hetero.html
Hospitalization 70% improvement lower risk ← → higher risk Recovery time 33% Molnupiravir  Hetero et al.  EARLY TREATMENT RCT Is early treatment with molnupiravir beneficial for COVID-19? RCT 741 patients in India Lower hospitalization (p=0.0027) and faster recovery (p=0.0001) c19early.org Hetero, Press Release, July 2021 0 0.5 1 1.5 2+ RR
Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.
Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-15. Multiple analyses have identified variants potentially created by molnupiravir16-20.
risk of hospitalization, 69.6% lower, RR 0.30, p = 0.003, treatment 7 of 371 (1.9%), control 23 of 370 (6.2%), NNT 23.
recovery time, 33.3% lower, relative time 0.67, p < 0.001, treatment 371, control 370.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Hetero et al., 9 Jul 2021, Randomized Controlled Trial, India, peer-reviewed, 1 author.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2025 India United Kingdom Russia USA Sudan Angola Colombia Kenya Mozambique Pakistan Argentina Vietnam Peru Philippines Spain Brazil Italy France Japan China Uzbekistan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Bosnia-Herzegovina Ukraine Côte d'Ivoire Bulgaria Greece Slovakia Singapore Iceland New Zealand Czechia Mongolia Israel Trinidad and Tobago Hong Kong North Macedonia Belarus Qatar Panama Serbia CAR Chad Syria India favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org November 2025 India United Kingdom Russia USA Sudan Angola Colombia Kenya Mozambique Pakistan Argentina Vietnam Peru Philippines Spain Brazil Italy France Japan China Uzbekistan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Ukraine Côte d'Ivoire Eritrea Bulgaria Greece Slovakia Singapore New Zealand Czechia Mongolia Israel Trinidad and Tobago North Macedonia Belarus Qatar Panama Benin Serbia CAR Syria India favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
~ Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, Faster Time to Clinical Improvement and early negative SARS CoV-2 RT PCR with Molnupiravir Treatment in Mild COVID 19 Patients Compared to Standard of Care alone~ ~ Hetero has approached the Drug Controller General of India (DCGI) to seek Emergency Use Authorization for Molnupiravir in India ~ India, Hyderabad, 9 th July 2021: Hetero, a globally renowned vertically integrated pharmaceutical organization, today announced the interim clinical results from Phase III Clinical trials of Molnupiravir in mild Covid-19 patients conducted across multiple COVID-19 dedicated hospital sites across India. In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs). Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog, being developed globally by MSD, that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19 with demonstrated activity against SARS-CoV-2 in human airway epithelial cell cultures and potential to completely eliminate SARS CoV-2 from the body within 5 days. Hetero had commenced a phase-III, comparative, randomized, multicenter clinical trial on mild Covid-19 patients (N=1218). These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care (test arm) versus standard of care alone (control
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