Author: Kinoshita, Masahiro ; Murayama, Hiroyuki ; Monma, Eiji ; Yoden, Takahiro ; Morikawa, Nobuyuki ; Nakagawa, Hidemitsu ; Takahashi, Yusaku ; Higa, Hikari ; Shintani, Ayumi ; Nishiguchi, Sho ; Kudo, Naoko ; Maeda, Yohei ; Kakii, Bumpachi ; Asami, Sadaharu ; Hibino, Makoto ; Higashiue, Shinichi

OBJECTIVES:

To evaluate the associations of early-phase oral antivirals with recovery in outpatients with COVID-19, regardless of baseline risk for severe disease, during the SARS-CoV-2 Omicron JN.1-/KP.3-dominant epidemic era.

METHODS:

This nationwide, multi-institutional (51 acute-care hospitals in Japan), prospective, registry-based cohort study enrolled outpatients aged ≥12 years with laboratory-confirmed COVID-19 within 5 days of symptom onset (February 1-October 31, 2024). Participants were compared between those with and without oral antiviral use at enrollment (ensitrelvir, nirmatrelvir, or molnupiravir) for medical re-consultation, failure to return to usual health, and work productivity and activity impairment through Day 28. Analyses were conducted among participants with complete baseline covariates and valid Day 28 outcome assessments and were adjusted for pre-specified baseline covariates.

RESULTS:

Baseline characteristics were generally comparable between groups (efficacy analysis population: antiviral n = 2271; no antiviral n = 5768). Overall re-consultation rates tended to be lower in the antiviral group (adjusted risk ratio [aRR] 0.93; 95% CI, 0.83-1.04). Antiviral use was associated with lower rates of failure to return to usual health (aRR 0.76; 95% CI, 0.70-0.82) and with improvements in presenteeism, overall work impairment, and activity impairment.

CONCLUSION:

Early-phase oral antiviral use was associated with more favorable patient-reported and functional recovery outcomes, with a trend toward reduced healthcare utilization. These findings may have broader societal implications beyond traditional virological and disease progression endpoints.

01 Aug 2026·JOURNAL OF INFECTION AND CHEMOTHERAPY

Matching-adjusted comparison of the effectiveness and safety of Ensitrelvir versus Remdesivir for high-risk, hospitalized patients with non-severe COVID-19 in Japan

Article

Author: Izumisawa, Tomohiro ; Fukihara, Jun ; Kondoh, Yasuhiro ; Mizutani, Fumika ; Hagimoto, Satoshi ; Kaneko, Tomoyoshi ; Sakurai, Koki ; Yamaguchi, Toshiyuki ; Kimura, Tomoki ; Soejima, Kazuaki ; Sasano, Hajime ; Minato, Yusuke ; Mutoh, Yoshikazu ; Tsukada, Hiroki ; Ichihara, Toshihiko ; Yamano, Yasuhiko ; Yokoyama, Toshiki ; Takei, Reoto ; Umemura, Takumi ; Doi, Yohei ; Kataoka, Kensuke

BACKGROUND:

Ensitrelvir (ESV) is approved in Japan for the treatment of mild to moderate COVID-19 in standard-risk patients; however, real-world evidence regarding outcomes among hospitalized high-risk patients remains limited. We evaluated whether oral ESV could serve as a feasible alternative to intravenous remdesivir (RDV).

METHODS:

We conducted a retrospective multicenter cohort study of hospitalized patients with mild to moderate COVID-19 and at least one risk factor for disease progression treated with ESV or RDV between June 2023 and March 2024 at two hospitals in Japan. Patients unable to receive oral therapy were excluded. Propensity score matching adjusted for baseline differences. The primary outcome was a composite of disease progression or all-cause mortality within 28 days.

RESULTS:

Among 207 patients, 44 received ESV and 163 received RDV. In the overall cohort, the composite outcome occurred in 4 vs. 10 patients (P = 0.49). After matching, 40 patients were included in each group; all patients in the matched cohort had mild disease without oxygen requirement. In the matched cohort, the composite outcome occurred in 4 patients in each group (P > 0.99). Individual components showed no significant differences (mortality: 4 vs. 3; progression: 2 vs. 2).

CONCLUSIONS:

In this multicenter cohort of hospitalized high-risk patients with mild to moderate COVID-19 able to receive oral therapy, no significant differences were observed between ESV and RDV in the matched cohort of patients with mild disease. ESV may represent a feasible oral alternative in selected high-risk patients able to receive oral therapy.

08 Jul 2026·mBio

Identification and characterization of a SARS-CoV-2 M ^pro G23 deletion ensitrelvir-resistant mutant

Article

Author: Khalil, Ahmed Magdy ; Cupic, Anastasija ; Castro, Esteban ; Arya, Shailee ; Rahisuddin, R. ; Ma, Yao ; Gupta, Yogesh K. ; Martinez-Sobrido, Luis ; Bayoumi, Mahmoud ; García-Sastre, Adolfo ; Ye, Chengjin ; Jackson, Nathaniel ; Mahmoud, Sara H. ; Plemper, Richard K.

ABSTRACT:

Ensitrelvir is an antiviral drug that specifically targets the conserved main protease (M pro ) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, mutations in M pro could confer resistance to antivirals, including ensitrelvir. Thus, identifying SARS-CoV-2 drug-resistant mutants and elucidating their mechanisms of resistance are critical for guiding the selection of effective antiviral therapies. Here, we utilized a recombinant luminescent attenuated SARS-CoV-2 lacking the open reading frames (ORF) 3a and 7b proteins (Δ3a7b-Nluc WT) to safely identify ensitrelvir drug-resistant mutants (DRM-E) without the need of using virulent forms of SARS-CoV-2. We isolated a DRM-E containing a M pro G23 deletion (G23del) with high resistance (~1,000-fold) to ensitrelvir, but not to the M pro inhibitor nirmatrelvir or to the RNA-dependent RNA polymerase (RdRp) inhibitor remdesivir. The contribution of G23del in ensitrelvir resistance was confirmed by generating a Δ3a7b-Nluc containing G23del in M pro (Δ3a7b-Nluc G23del). Δ3a7b-Nluc G23del exhibited resistance to ensitrelvir in both cultured cells and in K18 hACE2 transgenic mice. Binding affinity revealed that the G23del mutation altered ensitrelvir, but not nirmatrelvir, binding to M pro . Notably, while Δ3a7b-Nluc G23del was affected in viral fitness, serial passage of Δ3a7b-Nluc G23del in the absence of ensitrelvir resulted in the emergence of substitution L50F in M pro that restored viral fitness loss caused by G23del without altering resistance to ensitrelvir. Our results demonstrate that G23del in M pro can confer resistance to ensitrelvir. Positively, G23del in M pro does not render SARS-CoV-2 resistant to nirmatrelvir or remdesivir, suggesting the feasibility of treating SARS-CoV-2 infections containing G23del M pro with other approved antivirals.

IMPORTANCE:

The clinical use of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antiviral drugs is increasingly challenged by the emergence of drug-resistant mutants. Thus, there is a pressing need to identify and characterize antiviral escape SARS-CoV-2 variants, particularly for Food and Drug Administration-approved antivirals. Our study addresses this by employing a luminescent attenuated SARS-CoV-2 platform (Δ3a7b-Nluc wild type [WT]) to safely identify and characterize resistance mutations without the concern of using virulent forms of SARS-CoV-2. Using this safe approach, we identified a G23 deletion (G23del) in SARS-CoV-2 M pro , which mediates resistance to ensitrelvir in vitro and in vivo . Importantly, while G23del was able to confer ~1,000-fold increased resistance to ensitrelvir, a Δ3a7b-Nluc containing G23del remained sensitive to other M pro (nirmatrelvir) and RdRp (remdesivir) inhibitors. Altogether, this study demonstrates the feasibility of using Δ3a7b-Nluc WT to safely identify and characterize drug-resistant viruses without the biosafety concern of using virulent WT SARS-CoV-2 and advance the design of next-generation antiviral drugs.

News (Medical) associated with Ensitrelvir Fumaric Acid

19 Jun 2026

·www.shionogi.com

Shionogi Announces Supplemental Approval in Japan for Pediatric Dosage and Administration of XOCOVA® to Treat COVID-19

OSAKA, Japan, June 19, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter "Shionogi") announced that it has received supplemental approval in Japan today for the pediatric dosage and administration of XOCOVA® (generic name: ensitrelvir fumaric acid; hereinafter “XOCOVA”), an anti-SARS-CoV-2 drug, for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. In addition, new, smaller 25 mg tablets have also been approved. The approval is based on the results of a Phase 3 clinical trial conducted in pediatric patients aged 6 to under 12 years with SARS‑CoV‑2 infection weighing at least 20 kg in Japan.¹ The trial evaluated the safety and pharmacokinetics of once-daily oral administration of XOCOVA for 5 days at weight-based doses, in a total of 117 participants. As a result, no new safety concerns were identified. Furthermore, the pediatric plasma concentration profiles of XOCOVA observed in the trial were confirmed to be comparable to those predicted for adults receiving therapeutic doses, based on a population pharmacokinetic (PPK) analysis. These findings support the appropriateness of the dosing regimen for children aged 6 to under 12 years. COVID-19 remains a public health threat.2 With this approval, and in addition to its indication for adults and pediatric patients aged 12 years and older, XOCOVA becomes a new treatment option for pediatric patients aged 6 years and older weighing at least 20 kg, and is expected to contribute to the treatment of a broader pediatric population as an oral anti-SARS-CoV-2 drug that can be used regardless of risk factors for progression to severe disease. Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as one of its key focuses, and is working toward the realization of total care for infectious diseases. Shionogi will continue to advance research and development in infectious diseases so that we can rapidly deliver the necessary therapeutics, prophylactics, and vaccines in response to the emergence of new variants and future epidemiological trends. The impact of this matter on the consolidated financial results for the fiscal year ending March 2027 is expected to be minimal. About ensitrelvir Ensitrelvir is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 3 trial conducted in Asia, during the Omicron-dominant phase of the epidemic.3,4,5 In this trial, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (the primary endpoint) and antiviral efficacy (a key secondary endpoint) in patients with mild-to-moderate SARS-CoV-2 infection. Ensitrelvir received emergency regulatory approval in Japan in November 20226 and full approval in March 2024 for the treatment of COVID-19.7 In March 2026, based on the positive results from the global Phase 3 post‑exposure prophylaxis trial (SCORPIO‑PEP), Shionogi obtained approval in Japan for the indication of COVID‑19 post‑exposure prophylaxis.8 In the U.S., Shionogi Inc., our U.S. subsidiary, received approval from the U.S. Food and Drug Administration (FDA) on May 29, 2026 for the indication of post-exposure prophylaxis of COVID‑19.9 In Europe, ensitrelvir has been under review by the European Medicines Agency for the indication of post-exposure prophylaxis and treatment of COVID-19. It became available in Singapore via a Special Access Route application in November 2023,10 and is currently under regulatory review for the indication of postexposure prophylaxis of COVID-19 in Taiwan. In addition, we have entered into a licensing agreement with the Medicines Patent Pool to enable broad access to the drug in low‑ and middle‑income countries (LMICs), and we continue to advance efforts to expand global access.11,12 Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html Reference List: 1. Japan Registry of Clinical Trials（jRCT 2031230140） 2. Six years after COVID-19’s global alarm: Is the world better prepared for the next pandemic?. World Health Organization. Available at: https://www-who-int.libproxy1.nus.edu.sg/news/item/02-02-2026-six-years-after-covid-19-s-global-alarm-is-the-world-better-prepared-for-the-next-pandemic 3. Yotsuyanagi H., et al. Efficacy and Safety of 5-Day Oral Ensitrelvir for Patients with Mild to Moderate COVID-19. JAMA Network Open. 2024 4. Press Release: September 28, 2022 Shionogi Announces Achievement of the Primary Endpoint for Ensitrelvir Fumaric Acid (S-217622) in the Phase 3 part of the Phase 2/3 Clinical Trial in Asia 5. Press Release: February 22, 2023 Shionogi Presents Pivotal Ensitrelvir Fumaric Acid Phase 3 Data and Exploratory Long COVID Data at CROI 6. Press Release: November 22, 2022 Xocova® (Ensitrelvir Fumaric Acid) Tablets 125mg Approved in Japan for the Treatment of SARS-CoV-2 Infection, under the Emergency Regulatory Approval System 7. Press Release: March 5, 2024 Shionogi Announces Xocova® (Ensitrelvir Fumaric Acid) Obtained Standard Approval in Japan for the Treatment of SARS-CoV-2 Infection 8. Press Release: March 23, 2026 Shionogi Announces Approval in Japan of a Supplemental Indication for XOCOVA® (Ensitrelvir Fumaric Acid) for the Post-Exposure Prophylaxis of COVID-19. 9. Press Release: June 1, 2026 Shionogi Announces FDA Approval of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure 10. Press Release: December 19, 2023 Execution of Sub-license Agreement from Ping An-Shionogi Hong Kong to Juniper Therapeutics and SAR approval in Singapore regarding ensitrelvir fumaric acid, a treatment drug for the novel coronavirus infection (COVID-19) 11. Press Release: October 4, 2022 Shionogi and the Medicines Patent Pool (MPP) sign licence agreement for COVID-19 oral antiviral treatment candidate to increase access in low- and middle-income countries 12. Press Release: June 26, 2023 Seven manufacturers sign sublicence agreements with the Medicines Patent Pool to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir to increase access in low- and middle-income countries.

Phase 3Clinical ResultDrug ApprovalLicense out/inFinancial Statement

05 Jun 2026

·www.fiercepharma.com

Fierce Pharma Asia—China's biotech rise; ASCO highlights; Lilly pipeline deals

China's biotech ascent calls for more regulation in Washington and several prominent ASCO presentations made our news this week. The drumbeat of news regarding Asian pharma—and particularly China—continues to grow louder. At the American Society of Clinical Oncology (ASCO) meeting, Akeso took center stage with an ivonescimab presentation, and Fierce’s Angus Liu took a chance to dive into the bigger picture and symbolism behind the event. Elsewhere, calls in Washington to crack down on China biotech transactions are getting louder. Plus more. 1. As Akeso takes center stage at ASCO, China biotech industry cements its coming of age With its ASCO plenary session this past weekend, Akeso made history for the China biopharma industry. Afterward, in a series of interviews, market watchers explained to Fierce how the country’s biopharma rise is now undeniable—and how it’s not likely to slow any time soon. 2. As China biotech crackdown calls reverberate in Washington, the pushback gets louder, too In Washington, D.C., two lawmakers have called for an expansion of the COINS Act to include biopharma transactions. The act, which recently went into law as part of the U.S. defense spending bill, creates new notification requirements for American companies investing in certain Chinese sectors. While it doesn’t include biotechnology yet, some lawmakers aim to change that. And within the industry, skeptics are speaking up. 3. Takeda touts ‘tremendous potential’ of Innovent’s PD-1/IL-2 bispecific after seeing survival data On the drug development front, ASCO provided an opportunity for partners Takeda and Innovent to share a glimpse of the potential benefits of their bispecific candidate, IBI363, in patients with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC). Speaking with Fierce, Teresa Bitetti, president of Takeda's global oncology business unit, said the drug candidate holds “enormous promise.” Separately, Innovent on Thursday reported a phase 3 win for another Takeda-partnered drug, IBI343, in patients in China and Japan with locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. 4. Legend scientific founder returns to ASCO with new ambition for high-yield, non-gene-editing CAR-T platform Even more intrigue swept ASCO with the revelation that Legend’s scientific founder, Frank Fan, M.D., Ph.D., was returning with a new company, Wondercel Therapeutics. The idea behind Wondercel and its approach is to create an off-the-shelf universal CAR-T platform to outmaneuver two prominent bottlenecks in the cell therapy industry: production scalability and the pitfalls associated with gene editing. Fan made his ASCO return after Legend Biotech stole the show at the conference 9 years ago with data on the drug that eventually became Carvykti. 5. Lilly pens $1.2B deal for Hanmi’s GLP-2 drug being aimed at short bowel syndrome Lately, no week can be complete without an Eli Lilly business development deal, and this week was no exception. On Monday, the Indianapolis drug giant linked up with Korea’s Hanmi Pharm in a $1.2 billion deal centered on a GLP-2 drug prospect. Hours later, the company unveiled a partnership with China’s Haisco centered on a handful of drug prospects. No details on targets were shared with the latter deal announcement. 6. Bristol Myers’ $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice After Bristol Myers Squibb forked over $800 million on a first-in-class bispecific antibody-drug conjugate (ADC), there are indications the bet is paying off. In a China-only study, the drug, an EGFRxHER3 ADC called izalontamab brengitecan (iza-bren), significantly reduced the risk of death by 40% compared with the physician’s choice of chemotherapy in patients with previously treated triple-negative breast cancer. The results could serve to create a budding rivalry between the candidate and existing TROP2 ADCs. Other News of Note: 7. UPDATED: After Takeda’s defeat, Dizal picks up baton to take on J&J in EGFR lung cancer subtype 8. Agios signs $165M deal for blood disorder drug from Korea’s Oscotec that flunked phase 2 study 9. Eisai whips up Alzheimer’s dietary guidance to expand nutrition program beyond cancer 10. Shionogi's COVID antiviral Xocova passes muster with FDA as post-exposure preventative

ASCOImmunotherapyPhase 3

04 Jun 2026

·firstwordpharma.com

Biopharma bites: Setbacks for Fulcrum, Praxis, while Shionogi, Moderna make infectious disease strides

Fulcrum ends development of sole clinical candidate, pociredirPraxis' vormatrigine falls short in pivotal seizure studyShionogi gets FDA nod for oral COVID-19 preventativeCEPI promises Moderna up to $50M for Ebola vaccine development Agios nabs Oscotec's SYK inhibitor Fulcrum ends development of sole clinical candidate, pociredirFulcrum Therapeutics' shares crashed close to 50% during after-hours trading on Monday after disclosing it has discontinued its sickle cell disease asset — and only clinical programme — pociredir. The company is planning to launch a comprehensive review to identify any "strategic alternatives" such as a merger, acquisition or business combination.The decision to bin pociredir, an oral small molecule EED inhibitor, was driven by feedback from the FDA. According to Fulcrum, the US regulator had "heightened" concerns about the candidate's risk-benefit profile due to a high rate of secondary haematologic malignancies observed with a mechanistically similar drug, Tazverik (tazemetostat), which Ipsen withdrew from markets in March. Though the two drugs are directed against different targets — pociredir targets EED and Tazverik targets EZH2 — they are both within the PRC2 complex. carries equivalent malignancy risk regardless of the specific subunit engaged.Feedback from the FDA "left no viable regulatory path forward for further clinical development of pociredir," Fulcrum said. The company is now significantly reducing its operating expenses to preserve capital; as of March 31, it had $333.3 million in cash on-hand. Praxis' vormatrigine falls short in pivotal seizure study Praxis Precision Medicines' focal onset seizure (FOS) hopeful vormatrigine has failed the Phase II/III POWER1 study, the company said Monday. The sodium channel inhibitor and functional state modulator did not lead to a statistically significant reduction from baseline in monthly seizure frequency as compared with placebo. Still, the company — whose shares slipped about 10% during after-hours trade Monday — isn't giving up on vormatrigine yet. CEO Marcio Souza said Praxis was "encouraged by the signal we saw on the higher dose arm, the low discontinuation rate and solid safety profile," adding that the drugmaker is taking "some time to review these results to ensure we have the best path forward for developing vormatrigine and the ongoing POWER2 study." The Phase III POWER2 trial is the second registrational study evaluating vormatrigine in adults with FOS; it's expected complete in the second half, with topline results due in 2027.Shionogi gets FDA nod for oral COVID-19 preventativeThe FDA on Monday approved Shionogi's oral antiviral Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID‑19 in adults and children aged 12 and up to prevent infection after coming into contact with someone who has the disease. The approval, which came ahead of Xocova's June 16 PDUFA date, covers a five-day treatment regimen for the SARS-CoV-2 main protease inhibitor. Three tablets are taken on the first day, following exposure, and one tablet is taken on days two through five. Xocova's green light is based on the results of the Phase III SCORPIO-PEP trial, which involved 2387 participants. The PEP treatment significantly reduced the risk of symptomatic COVID-19 by 67% in uninfected individuals following exposure to an infected individual after 10 days, compared with placebo. According to Shionogi, SCORPIO-PEP is the first and only Phase III study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure.CEPI promises Moderna up to $50M for Ebola vaccine development The Coalition for Epidemic Preparedness Innovations (CEPI) is "urgently" backing the development of three Ebola vaccine candidates to combat the viral disease outbreak in the Democratic Republic of the Congo, committing about $60 million in total to the venture. Moderna said Monday that CEPI has pledged up to $50 million to support preclinical development and Phase I testing of its mRNA vaccine candidate. The funds will also go towards manufacturing so the asset can quickly move into large-scale Phase II/III trials if the early safety and immunogenicity data come back positive. The International AIDS Vaccine Initiative will also receive financial support from CEPI to work on a Bundibugyo vaccine candidate, as will the University of Oxford. Agios nabs Oscotec's SYK inhibitor Agios Pharmaceuticals licensed exclusive, global rights to cevidoplenib, a next-generation, oral spleen tyrosine kinase (SYK) inhibitor, from South Korea-based drugmaker Oscotec. It plans to launch a Phase III trial evaluating the drug in patients with immune thrombocytopenia (ITP) in the first half of 2028."Cevidoplenib is a next-generation SYK inhibitor uniquely designed to potentially offer improved tolerability and durability compared to first-generation SYK inhibitors," Agios CEO Brian Goff said in a company release Monday. "Backed by clinically meaningful Phase II data, we believe cevidoplenib has the opportunity to become a best-in-class treatment option for ITP."Under the deal, Oscotec will receive $25 million upfront and is eligible for up to $140 million in development and regulatory milestones across up to three indications in the US and Europe, as well as commercial milestone payments and royalties ranging from high single-digit to mid-teen. The firm also has an option to license exclusive development and commercialisation rights to cevidoplenib in South Korea after the Phase III trial reads out.

VaccinePhase 3Phase 2Clinical ResultLicense out/in

100 Deals associated with Ensitrelvir Fumaric Acid

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	Japan	Shionogi & Co., Ltd.	22 Nov 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 2	United States	Shionogi, Inc.	09 Apr 2024
Post Acute COVID 19 Syndrome	Phase 2	United States	Shionogi, Inc.	09 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05897541 (SCORPIO-PEP, Pubmed \| N Engl J Med)	Phase 3	COVID-19	2,031	Ensitrelvir	goqvwbmyfy(pkgwbezsua) = tpicswvtfj brmrfpwcro (lhdyhcyugq ) View more	Positive	14 May 2026
				Placebo	goqvwbmyfy(pkgwbezsua) = bfhzspqkzn brmrfpwcro (lhdyhcyugq ) View more
NCT06161688 (PREVAIL-LC, CTgov)	Phase 2	Post Acute COVID 19 Syndrome \| Inflammation	40	Ensitrelvir (Ensitrelvir (S-217622))	flwpvochas(sedxvaesqr) = bpqtaecebi mpacqbdpxl (ksbcxaoeti, coalllrcnw - appaojixpi) View more	-	02 Apr 2026
				Placebo (Placebo)	flwpvochas(sedxvaesqr) = rigkaphvhv mpacqbdpxl (ksbcxaoeti, wdvgawmiab - flkgzasame) View more
NCT05041907 (PLATCOV, Pubmed \| Lancet Infect Dis)	Phase 2	COVID-19	604	Ensitrelvir	vlzljuhcqw(fbynyyxvxc) = Viral clearance following ensitrelvir was 82% faster (95% credible interval 61-104) than no study drug and 16% slower (5-25) than ritonavir-boosted nirmatrelvir. fgusgdmtrv (emjierbtip )	Positive	01 Feb 2026
				Ritonavir-boosted Nirmatrelvir
NCT05041907 (PLATCOV, Pubmed \| Lancet Infect Dis)	Phase 2	COVID-19	604	Ensitrelvir	dtobyevkex(ggbplxgthc) = Viral clearance following ensitrelvir was 82% faster (95% credible interval 61-104) than no study drug and 16% slower (5-25) than ritonavir-boosted nirmatrelvir. wyimxiyhfi (wlqufbqolm )	Positive	01 Oct 2025
				Ritonavir-boosted Nirmatrelvir
NEWS Manual	Not Applicable	COVID-19	-	Ensitrelvir	jxtvhhuedj(bfzntpuldi) = cugdefwtuq ltenaxhtop (wsekmxfaze ) View more	Positive	20 Mar 2025
				Placebo	jxtvhhuedj(bfzntpuldi) = rhpwbzzbgi ltenaxhtop (wsekmxfaze ) View more
NCT05897541 (SCORPIO-PEP, Company_Website) Manual	Phase 3	COVID-19	-	Ensitrelvir	unoxqfzxqe(qwxuoqlcfq) = rdhbhtqhcu yynhvwnnug (njjidjzbjg ) Met View more	Positive	17 Mar 2025
				Placebo	unoxqfzxqe(qwxuoqlcfq) = xgnkhhgwdo yynhvwnnug (njjidjzbjg ) Met View more
NCT05305547 (SCORPIO-HR, Pubmed \| Clin Infect Dis)	Phase 3	COVID-19	1,888	Ensitrelvir	codgdqbklu(degraajafa) = uvmrcrtdps jkmhmwbink (aocljohfqd ) View more	Negative	17 Feb 2025
				Placebo	codgdqbklu(degraajafa) = mljtupkhpc jkmhmwbink (aocljohfqd ) View more
NCT05305547 (SCORPIO-HR, Pubmed \| NEWS)	-	COVID-19	2,093	Ensitrelvir	xhcfiyswur(iyyzlvukoj) = plyyiqzrie qwxyoqkxqr (xfszdowakc )	Negative	13 May 2024
				安慰剂	xhcfiyswur(iyyzlvukoj) = sfffhhielh qwxyoqkxqr (xfszdowakc )

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