5 completed, 1 active not recruiting, 1 recruiting, 1 terminated. 3 Phase 1, 3 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 2 | 2 | Active not recruiting 1, Recruiting 1 |
Follow ensitrelvir: new trials by email Literature Review of ensitrelvir trials Research Report on ensitrelvir
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants Ensitrelvir - Healthy Adult Female Participants | Phase 1 | Completed | Shionogi | 24 | 2024-12-30 | 2025-05-04 |
| Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID Ensitrelvir, Placebo - Long COVID, Post Acute Sequelae of COVID-19 | Phase 2 | Active not recruiting | Timothy Henrich | 40 | 2024-04-09 | 2026-04-02 |
| Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection S-217622, Placebo - SARS-CoV-2 Infection | Phase 3 | Completed | Shionogi | 3701 | 2023-06-09 | 2026-10-07 |
| Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir) Shionogi Protease Inhibitor (S-217622), placebo - COVID-19 | Phase 3 | Terminated | University of Minnesota | 602 | 2022-12-23 | 2026-09-24 |
| A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants S-217622 - Hepatic Impairment | Phase 1 | Completed | Shionogi | 25 | 2022-09-13 | 2023-05-26 |
| A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants S-217622 - Renal Impairment | Phase 1 | Completed | Shionogi | 32 | 2022-08-10 | 2023-04-24 |
| A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 S-217622, Placebo - SARS-CoV-2 Infection | Phase 3 | Completed | Shionogi | 2093 | 2022-08-03 | 2026-08-20 |
| Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Nirmatrelvir/ritonavir (e.g. PAXLOVID™), Nitazoxanide, Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™) - COVID-19 | Phase 2 | Recruiting | University of Oxford | 3800 | 2021-09-30 | 2026-02-19 |
COVID-19 (4) · Post-Acute COVID-19 Syndrome (1) · Renal Insufficiency (1)
Shionogi (5) · Timothy Henrich (1) · University of Minnesota (1) · University of Oxford (1)
United States (7) · Argentina (3) · Brazil (3) · Japan (3) · South Africa (3) · Thailand (3) · Mexico (2) · Pakistan (2) · Peru (2) · Poland (2) · Uganda (2) · Australia (1) · Colombia (1) · Denmark (1) · Georgia (1)
Cavan Reilly, PhD (1) · Jason Baker, MD (1) · Michael Peluso, MD (1) · Timothy Henrich, MD (1)
PMID 36803992, PMID 37470445, PMID 37778363, PMID 38225598, PMID 38677300, PMID 39896880, PMID 39960062, PMID 41082886, PMID 41321979, PMID 41672106, PMID 41915378, PMID 42127390
2023 (1)