Drugs / Ensitrelvir
Ensitrelvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | Japan (PMDA) | — | COVID-19 | 2022-02-25 | “Shionogi submitted a supplemental New Drug Application in Japan for an expanded indication of ensitrelvir for the post‑exposure prophylaxis of COVID‑19.” shionogi.com ↗ “on February 25, 2022, Shionogi has filed for manufacturing and sales approval to the Pharmaceuticals and Medical Devices Agency (PMDA)” shionogi.com ↗ “has filed for manufacture and sales approval, requesting review under the conditional approval system in Japan.” shionogi.com ↗ “including those located in Japan, where it filed for manufacture and sales approval on February 25, 2022” shionogi.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | XOCOVA | — | 2026-05-29 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06775730 | Dec 2024 → Apr 2025 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT05409911 | Sep 2022 → Apr 2023 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT05363215 | Aug 2022 → Apr 2023 | impaired renal function disease | Shionogi | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06161688 | Apr → Dec 2024 overdue | long COVID-19 | Timothy Henrich | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05041907 | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | Mixed |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05897541 | Jun 2023 → Aug 2024 | Orthocoronavirinae infectious disease | Shionogi | Completed | Met primary |
| Phase 3 | NCT05605093 | Dec 2022 → Oct 2025 | COVID-19 | University of Minnesota | Terminated | No outcome recorded |
| Phase 3 | NCT05305547 | Aug 2022 → Jan 2024 | COVID-19 | Shionogi | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2026-09-28 | Shionogi | Regulatory Shionogi Announces European Commission Approval of Zokovea® (ensitrelvir) for Post-Exposure Prophylaxis of COVID-19 shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that the European Commission (EC) has granted marketing authorization for Zokovea® (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents aged 12 years and older. |
| 2026-06-19 | Shionogi | Regulatory Shionogi Announces Supplemental Approval in Japan for Pediatric Dosage and Administration of XOCOVA® to Treat COVID-19 shionogi.com ↗ |
| 2026-06-01 | Shionogi | Regulatory Shionogi Announces FDA Approval of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure shionogi.com ↗ |
| 2026-05-14 | Shionogi | Results New England Journal of Medicine Publishes Shionogi Study Demonstrating Ensitrelvir Prevents COVID-19 Following Exposure shionogi.com ↗
A five-day course of ensitrelvir significantly reduced the risk of symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared to placebo. |
| 2026-03-23 | Shionogi | Regulatory Shionogi Announces Approval in Japan of a Supplemental Indication for XOCOVA® (Ensitrelvir Fumaric Acid) for the Post-Exposure Prophylaxis of COVID-19. shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that it has received approval in Japan for an expanded indication of XOCOVA® (generic name: ensitrelvir fumaric acid; hereafter ‘XOCOVA’), an anti SARS-CoV-2 drug, for post-exposure prophylaxis of COVID-19. |
| 2025-11-05 | Shionogi | Results New Clinical Data on the Efficacy of Antiviral Treatments for Post-COVID-19 Condition shionogi.com ↗
For ensitrelvir alone, the risk was also significantly reduced by about 14% compared to non-antiviral treatment (adjusted risk ratio: 0.86 [95% CI: 0.79–0.95]; P = 0.002). |
| 2025-09-03 | Shionogi | Regulatory FDA Accepts Shionogi’s Ensitrelvir NDA for Review as the First Oral Therapy for the Prevention of COVID-19 Following Exposure shionogi.com ↗ |
| 2025-06-30 | Shionogi | Regulatory Shionogi Submits Supplemental New Drug Application for Ensitrelvir in Japan for the Treatment of COVID-19 in Pediatric Patients Aged 6 Years and Older shionogi.com ↗ |
| 2025-04-01 | Shionogi | Regulatory Shionogi Initiates New Drug Application Submission for Ensitrelvir for Post-Exposure Prophylaxis with the U.S. Food and Drug Administration shionogi.com ↗
The rolling submission of ensitrelvir for Post-Exposure Prophylaxis is being made based on the positive results from the Global Phase 3 Study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post-Exposure Prophylaxis (SCORPIO-PEP). |
| 2025-03-27 | Shionogi | Regulatory Shionogi Submits Supplemental New Drug Application for Ensitrelvir in Japan for the Post-Exposure Prophylaxis of COVID-19. shionogi.com ↗ |
| 2025-03-13 | Shionogi | Results Late-Breaking at CROI 2025: SCORPIO-PEP Phase 3 Trial: Ensitrelvir is the First and Only COVID-19 Oral Antiviral to Demonstrate Prevention of COVID-19 as Post Exposure Prophylaxis shionogi.com ↗
Ensitrelvir demonstrated a statistically significant reduction (67%) in the risk of COVID-19, meeting its primary endpoint, in uninfected individuals treated after exposure, compared to placebo at day 10. |
| 2025-01-22 | Shionogi | Regulatory Acceptance of a New Drug Application for the COVID-19 Treatment, Ensitrelvir Fumaric Acid, in Taiwan and Conclusion of Government Stockpiling Contract shionogi.com ↗
OSAKA, Japan, January 22, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that the Taiwan Food and Drug Administration has accepted our new drug application (NDA) for ensitrelvir fumaric acid (hereafter “ensitrelvir”) for the treatment of COVID-19. |
| 2024-12-19 | Shionogi | Regulatory Regarding Filing for Ensitrelvir Fumaric Acid, a Therapeutic Drug for COVID-19 in South Korea shionogi.com ↗
Consequently, the current application has been withdrawn voluntarily by Ildong, and a new application with additional data will be submitted. |
| 2024-10-29 | Shionogi | Results Shionogi Announces Global Phase 3 Trial Demonstrates Post-Exposure Prophylactic Use of Ensitrelvir Prevents Symptomatic COVID-19 shionogi.com ↗
Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. |
| 2024-06-28 | Shionogi | Results Shionogi Presented New Clinical Data on the COVID-19 Treatment Ensitrelvir shionogi.com ↗
As a result, the incidence of hospitalization from all causes was statistically lower by approximately 37% in the ensitrelvir group than those receiving no antiviral treatment |
| 2024-05-13 | Shionogi | Results Shionogi Provides Updates from SCORPIO-HR, a Global Phase 3 Study of Ensitrelvir for Non-Hospitalized Participants with COVID-19 shionogi.com ↗
Although ensitrelvir demonstrated a numerical reduction in the time to symptom resolution compared to placebo among participants treated within 3 days of symptom onset, the difference was not statistically significant. |
| 2024-03-05 | Shionogi | Regulatory Shionogi Announces Xocova® (Ensitrelvir Fumaric Acid) Obtained Standard Approval in Japan for the Treatment of SARS-CoV-2 Infection shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that it has obtained standard approval from the Ministry of Health, Labour and Welfare (MHLW) for Xocova® (Generic name: ensitrelvir fumaric acid), a novel anti-SARS-CoV-2 drug for the indication of SARS-CoV-2 infection in Japan. |
| 2024-02-13 | Shionogi | Results Shionogi Announces New Phase 3 Data Showing Early Resolution of Many Common COVID-19 Symptoms in JAMA Network Open shionogi.com ↗
The median time to symptom resolution was approximately one day shorter in the 125 mg ensitrelvir group versus placebo (approximately 7 days versus 8 days, respectively). |
| 2023-12-27 | Shionogi | Regulatory Filing for a Manufacturing License for Ensitrelvir Fumaric Acid, a Therapeutic Drug for COVID-19 to Build a Domestic Drug Product Production and Supply System in South Korea shionogi.com ↗
has filed for a manufacturing license for ensitrelvir with the MFDS (Ministry of Food and Drug Safety) in South Korea. |
| 2023-12-19 | Shionogi | Regulatory 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) shionogi.com ↗
Ensitrelvir has been approved in Singapore on November 15, 2023, based on the Special Access Route (SAR) application. |
| 2023-10-12 | Shionogi | Results Shionogi Presents New Ensitrelvir COVID-19 Data Supporting Effectiveness in Real-World and Clinical Settings at IDWeek 2023 shionogi.com ↗
After ensitrelvir administration, the median time to resolution of fever was about 1.5 days and median time to resolution of all symptoms was about 6.5 days, independent of age or presence of risk factors for severe disease. |
| 2023-09-19 | Shionogi | Results Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023 shionogi.com ↗
which shows that ensitrelvir may reduce the risk of a number of persistent and new late-onset symptoms associated with long COVID over one year. |
| 2023-04-11 | Shionogi | Regulatory Shionogi filed for Emergency Use Authorization of Ensitrelvir Fumaric Acid in Taiwan, for the Treatment of COVID-19 shionogi.com ↗ |
| 2023-04-05 | Shionogi | Results ECCMID 2023: Shionogi to Present Data Showing COVID-19 Symptom Recurrence is Not Associated with Ensitrelvir Treatment Additional Data to be Presented Showing Significantly Faster Time to Negative Viral Titer (Culture) Compared to Placebo shionogi.com ↗
The first late-breaking poster presentation included a post-hoc analysis of the Phase 3 part showing that viral rebound and symptom recurrence were infrequently seen up to 21 days after treatment with ensitrelvir. |
| 2023-04-04 | Shionogi | Regulatory Shionogi Receives U.S. FDA Fast Track Designation for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19 shionogi.com ↗ |
| 2023-02-22 | Shionogi | Results Shionogi Presents Pivotal Ensitrelvir Fumaric Acid Phase 3 Data and Exploratory Long COVID Data at CROI shionogi.com ↗
The Study was also the first to show a statistically significant reduction (p<0.0001) in the time to negative infectious viral titer versus placebo, a key secondary endpoint. |
| 2023-01-04 | Shionogi | Regulatory New Drug Application of Ensitrelvir Fumaric Acid, a Therapeutic Drug for COVID-19 Accepted for Review in South Korea shionogi.com ↗ |
| 2023-01-04 | IlDong Pharmaceutical Co Ltd | Regulatory 일동제약, 코로나치료제 ‘엔시트렐비르(S-217622)’ 식약처 허가 신청 ildong.com ↗
일동제약(대표 윤웅섭)이 홍콩 핑안시오노기와의 계약을 통해 국내 판권을 확보한 코로나19치료제 엔시트렐비르푸마르산(후보물질명 S-217622, 이하 엔시트렐비르)과 관련해 식품의약품안전처에 품목 허가를 신청했다. |
| 2022-11-22 | Shionogi | Regulatory Xocova® (Ensitrelvir Fumaric Acid) Tablets 125mg Approved in Japan for the Treatment of SARS-CoV-2 Infection, under the Emergency Regulatory Approval System shionogi.com ↗
This approval was granted under the emergency regulatory approval system provided for in Article 14-2-2 of the Pharmaceuticals and Medical Devices Act. |
| 2022-09-28 | Shionogi | Results 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 shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that ensitrelvir fumaric acid (S-217622: hereafter "ensitrelvir"), an investigational, 3CL protease inhibitor, administered once daily for five days, being evaluated as an antiviral treatment for COVID-19, achieved the primary endpoint in the Phase 3 part of a Phase 2/3 study conducted in Asia. |
| 2022-08-10 | Shionogi | Results Ensitrelvir Fumaric Acid (S-217622), a Therapeutic Drug for COVID-19, Shows High In Vitro Antiviral Activity Against Omicron Subvariants BA.2.75 shionogi.com ↗ |
| 2022-07-04 | Shionogi | Regulatory Notice Regarding the Initiation of the Submission of Preparation Materials for a New Drug Application for S-217622, a Therapeutic Drug for COVID-19, in China shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that, a joint venture between Shionogi and Ping An Life Insurance Company of China, Ltd. ※1 (Headquarters: Guangdong Province, China), Ping An-Shionogi Co., Ltd. (Head Office: Shanghai, China; Chairman and CEO: Tatsumori Yoshida, hereafter" Ping An-Shionogi ") has initiated the submission of preparation materials for an application for new drug approval application for S-217622, an orally administered antiviral drug for COVID-19, to the Center for Drug Evaluation, NMPA (hereafter "CDE"). |
| 2022-04-24 | Shionogi | Results New Data for Shionogi’s COVID-19 Once-Daily Oral Antiviral S-217622 Show Rapid Virus Clearance shionogi.com ↗
S-217622 demonstrated rapid clearance of the infectious SARS-CoV-2 virus. |
| 2022-03-16 | Shionogi | Regulatory ACTG and Shionogi Announce Progress on Global Phase 3 Trial of Novel COVID-19 Oral Antiviral Agent S-217622 shionogi.com ↗
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for S-217622, enabling SCORPIO-HR to proceed. |
| 2022-02-25 | Shionogi | Regulatory Shionogi Files for Approval of S-217622, a Therapeutic Drug for COVID-19, in Japan shionogi.com ↗ |
| 2022-02-07 | Shionogi | Results Shionogi Presents Phase 2/3 Clinical Trial Results (Phase 2a Part) for the COVID-19 Therapeutic Drug S-217622 shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announces that Shionogi has completed its analysis of the Phase 2a part of a Phase 2/3 clinical trial of S-217622, an orally administered antiviral drug for COVID-19, and presented the results today. |
| 2022-01-31 | Shionogi | Results Shionogi Presents Clinical Trial Results of the COVID-19 Therapeutic Drug S-217622 shionogi.com ↗
A rapid virus reduction effect was confirmed in the S-217622 group compared to placebo. |
| 2021-12-20 | Shionogi | Results Shionogi Announces Commitment to Address the Omicron Variant of SARS-CoV-2 shionogi.com ↗
According to the companies’ preliminary data, Shionogi confirmed that S-217622, an oral antiviral drug that selectively inhibits 3CL protease, exhibits high antiviral activity against the Omicron variant similar to other existing variants. |
| 2021-10-21 | Shionogi | Results Shionogi Presents COVID-19 Therapeutic Agent Results at the ISIRV-WHO Virtual Conference shionogi.com ↗
Single oral administration of S-217622 to Japanese healthy subjects was safe and well tolerated. |
All press releases naming this drug 54 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ensitrelvir | “Ensitrelvir, a severe acute respiratory syndrome coronavirus-2 main protease inhibitor, has demonstrated clinical and virologic efficacy in previous studies.” PMID 39960062 ↗ Jul 2025 |
| Known as | ENSITRELVIR FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5183847 ↗ |
| Known as | S-217622 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05605093 ↗ |
| Known as | S-217622B | ChEMBL registry synonym — accepted as the source's own label CHEMBL5183847 ↗ |
| Action | Inhibit | “Ensitrelvir, a severe acute respiratory syndrome coronavirus-2 main protease inhibitor” PMID 39960062 ↗ Jul 2025 |
| Modality | Small molecule | “In the meta-analysis of all unblinded small molecule drugs evaluated in the platform trial, nirmatrelvir and ensitrelvir had the largest antiviral effects” PMID 41082886 ↗ Oct 2025 |
| Route | Oral | “including oral ensitrelvir and oral ritonavir-boosted nirmatrelvir at standard doses” PMID 41082886 ↗ Oct 2025 |