Drugs / Ensitrelvir
Ensitrelvir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XOCOVA | — | 2026-05-29 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| 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 | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05897541 | Jun 2023 → Aug 2024 | COVID-19 | Shionogi | Completed | No outcome recorded |
| 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 |
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 |