A Phase 3 Study of Ensitrelvir in Japanese Participants Aged 6-11 Years with SARS-CoV-2 Infection
et al., Journal of the Pediatric Infectious Diseases Society, doi:10.1093/jpids/piag071, jRCT2031230140, Aug 2026
50th treatment shown to reduce risk in
July 2023, now with p = 0.024 from 10 studies, recognized in 2 countries.
No treatment is 100% effective. Protocols
combine treatments.
6,700+ studies for
220+ treatments. c19early.org
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RCT 117 pediatric outpatients (6-11 years) with mild-to-moderate COVID-19 in Japan showing improved viral clearance, but no significant difference in time to symptom resolution with ensitrelvir vs. placebo.
Standard of Care (SOC) for COVID-19 in the study country,
Japan, is very poor with very low average efficacy for approved treatments1.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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recovery time, 3.9% lower, relative time 0.96, p = 0.84, treatment 140.5 [109.4-168] n=77, control 146.2 [92.0-188.9] n=37, median time to resolution of key symptoms, Kaplan-Meier.
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viral load, 28.4% lower, relative load 0.72, p < 0.001, treatment mean 3.34 (±1.23) n=74, control mean 2.39 (±1.26) n=36, adjusted per study, "SARS-CoV-2 viral RNA reduction from baseline, log10 copies/mL, day 4.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Nakano et al., 19 Aug 2026, Double Blind Randomized Controlled Trial, placebo-controlled, Japan, peer-reviewed, median age 10.0, 7 authors, trial jRCT2031230140.
Contact: takeki.uehara@shionogi.co.jp.
Abstract:
A Phas e 3 Study of Ensitrelvir in Jap anes e Par ticip ants Age d 6-11 Ye ars wit h SARS-C oV-2 Infe c tion
Takashi Nakano 1 ; Hiroyuki Moriuchi 2 ; Isao Miyairi 3 ; Takumi Imamura 4 ; Maria Matsumoto 4 ; Yuko Tsuge 4 ; Takeki Uehara 4 , *
* Corresponding author: Takeki Uehara, PhD, Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Global Headquarters, GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan (takeki.uehara@shionogi.co.jp).
B ackg round: Children aged < 12 ye ars wit h coronavir us dis e as e 2019 (C OVID-19) have limited tre atment options; c ur rent ly approved oral antivirals are restr ic ted by age or b o dy weig ht. We e valuated t he s afety and plasma concentration-time profiles and explorator y efficac y of ensitrelvir, a once-daily oral 3C-like prote as e inhibitor, in children wit h mild-to-mo derate C OVID-19 in Japan.
Method s: This phas e 3, double-blind, placeb o-controlled study randomized (2:1) par ticipants aged 6 to < 12 ye ars pres enting ≤ 72 h after C OVID-19 ons et to receive ensitrelvir (b o dy weig ht-based dosing) or placeb o once daily for 5 days. Pr imar y endp oints were s afety and phar macokinetics. S econdar y endp oints included change in viral r ibonucleic acid (RNA) and time to res olution (T TR) of ke y C OVID-19 symptoms (stuff y or r unny nos e and coug h) plus fe ver.
Results: Of 117 randomized par ticipants (median age 10 ye ars), 78 received ensitrelvir and 39 received placeb o. Ensitrelvir was well tolerated wit h no ne w s afety concer ns. Plasma concentration-time profiles were similar across b o dy weig ht categor ies (20 to < 30, 30 to < 40, and ≥ 40 kg). Ensitrelvir reduced viral RNA vs placeb o on D ay 4, by approximately 1.0 log 10 copies/mL (95% CI, -1.45 to -0.47). Median T TR of ke y C OVID-19 symptoms was 140.5 h wit h ensitrelvir and 146.2 h wit h placeb o (median difference -5.7 h [95% CI, -73.6 to 43.4 h]).
Conclu sion s: In children aged 6 to < 12 ye ars wit h mild-to-mo derate C OVID-19 tre ated wit h ensitrelvir, we obs er ved a favorable s afety profile, adult-matched plasma concentration-time profile, and a gre ater reduc tion in viral RNA vs placeb o. Ensitrelvir repres ents a p otential tre atment option for unders er ved p ediatr ic patients wit h mild-to-mo derate C OVID-19.
Clinical Tr ial Reg i stration: Japan Registr y of Clinical Tr ials, jRCT2031230140 ( https://jrc t.mhlw.go.jp/enlatestdet ail /jRCT2031230140).
Ke y words: ensitrelvir ; p ediatr ic C OVID-19; SARS-C oV-2 3CL prote as e inhibitor ; phar macokinetics; Japan.
L ay summar y
Oral antiviral tre atment options for C OVID-19 are limited, esp ecially for t hos e aged < 12 ye ars. Oral ensitrelvir administered once daily for 5 days was well tolerated and demonstrated antiviral ac tivity in Japanes e children aged 6 to < 12 ye ars wit h mild-to-mo derate C OVID-19.
DOI record:
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"abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>Children aged &lt;12 years with coronavirus disease 2019 (COVID-19) have limited treatment options; currently approved oral antivirals are restricted by age or bodyweight. We evaluated the safety and plasma concentration-time profiles and exploratory efficacy of ensitrelvir, a once-daily oral 3C-like protease inhibitor, in children with mild-to-moderate COVID-19 in Japan.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>This phase 3, double-blind, placebo-controlled study randomized (2:1) participants aged 6 to &lt;12 years presenting ≤72 h after COVID-19 onset to receive ensitrelvir (bodyweight-based dosing) or placebo once daily for 5 days. Primary endpoints were safety and pharmacokinetics. Secondary endpoints included change in viral ribonucleic acid (RNA) and time to resolution (TTR) of key COVID-19 symptoms (stuffy or runny nose and cough) plus fever.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>Of 117 randomized participants (median age 10 years), 78 received ensitrelvir and 39 received placebo. Ensitrelvir was well tolerated with no new safety concerns. Plasma concentration-time profiles were similar across bodyweight categories (20 to &lt;30, 30 to &lt;40, and ≥40 kg). Ensitrelvir reduced viral RNA vs placebo on Day 4, by approximately 1.0 log10 copies/mL (95% CI, −1.45 to −0.47). Median TTR of key COVID-19 symptoms was 140.5 h with ensitrelvir and 146.2 h with placebo (median difference −5.7 h [95% CI, −73.6 to 43.4 h]).</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>In children aged 6 to &lt;12 years with mild-to-moderate COVID-19 treated with ensitrelvir, we observed a favorable safety profile, adult-matched plasma concentration-time profile, and a greater reduction in viral RNA vs placebo. Ensitrelvir represents a potential treatment option for underserved pediatric patients with mild-to-moderate COVID-19.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Clinical Trial Registration</jats:title>\n <jats:p>Japan Registry of Clinical Trials, jRCT2031230140 (https://jrct.mhlw.go.jp/en-latest-detail/jRCT2031230140).</jats:p>\n </jats:sec>",
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