Drugs / simnotrelvir
simnotrelvir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | XIANNUOXIN | COVID-19 | 2023-01-16 | “has been accepted by the National Medical Products Administration (NMPA)” simcere.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05826249 | Apr → Sep 2023 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05731804 | Mar → Dec 2023 | impaired renal function disease | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05665647 | Dec 2022 → Jan 2023 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05475834 | Jul → Aug 2022 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05339646 | Apr → Oct 2022 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05369676 | May → Aug 2022 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05373446 | May → Oct 2022 | COVID-19 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05506176 | Aug 2022 → Jan 2023 | COVID-19 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 2/3 | NCT05373433 | May 2022 → May 2023 | COVID-19 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-07-23 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Fully Approved! XIANNUOXIN® Becomes the First Oral Anti-COVID-19 Drug Obtaining Regular Approval in China simcere.com ↗
XIANNUOXIN ® has become the first oral anti-COVID-19 drug obtaining regular approval in China. |
| 2023-07-14 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Study of XIANNUOXIN® Aiming to Validate the Efficacy and Safety of SIM0417 plus Ritonavir Published in The Lancet simcere.com ↗ |
| 2023-01-29 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory XIANNUOXIN® - The First Chinese 3CL Anti-COVID-19 Drug - Receives Approval from the NMPA simcere.com ↗
XIANNUOXIN is approved for adults suffering from "mild to moderate COVID-19." |
| 2023-01-16 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Innovative, Potential Best-in-Class, Anti-COVID-19 Drug, XIANNUOXIN® has Received an Accepted New Drug Application from the NMPA simcere.com ↗
has been accepted by the National Medical Products Administration (NMPA) and will be reviewed in special drug approval procedures. |
| 2022-05-20 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere’s Covid-19 Prevention Pill Is First in China to Get Green Light to Start Clinical Trials simcere.com ↗
Chinese drug developer Jiangsu Simcere Pharmaceutical has been given the go-ahead from China’s regulators to start clinical trials of its orally-taken Covid-19 prevention medicine in the country’s first such approval. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-23 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Fully Approved! XIANNUOXIN® Becomes the First Oral Anti-COVID-19 Drug Obtaining Regular Approval in China simcere.com ↗ |
| 2023-07-14 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Study of XIANNUOXIN® Aiming to Validate the Efficacy and Safety of SIM0417 plus Ritonavir Published in The Lancet simcere.com ↗ |
| 2023-01-29 | Jiangsu Simcere Pharmaceutical Co., Ltd. | XIANNUOXIN® - The First Chinese 3CL Anti-COVID-19 Drug - Receives Approval from the NMPA simcere.com ↗ |
| 2023-01-16 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Innovative, Potential Best-in-Class, Anti-COVID-19 Drug, XIANNUOXIN® has Received an Accepted New Drug Application from the NMPA simcere.com ↗ |
| 2022-05-20 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere’s Covid-19 Prevention Pill Is First in China to Get Green Light to Start Clinical Trials simcere.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | simnotrelvir | “OBJECTIVES: Simnotrelvir is a small-molecule highly specific 3C-like protease inhibitor for anti-SARS-CoV-2 and was approved as a combination drug with ritonavir...” PMID 39299559 ↗ Sep 2024 |
| Known as | SIM0417 | “SIM0417 (SSD8432) is an orally administered coronavirus main proteinase (3CLpro) inhibitor with potential anti-SARS-CoV-2 activity.” PMID 37484496 ↗ Jul 2023 |
| Known as | Simnotrelvir component of xiannuoxin | ChEMBL registry synonym — accepted as the source's own label CHEMBL5570561 ↗ |
| Known as | SSD8432 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05373446 ↗ |
| Known as | SY-110 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5570561 ↗ |
| Action | Inhibit | “coronavirus main proteinase (3CLpro) inhibitor” PMID 37484496 ↗ Jul 2023 |
| Modality | Small molecule | “Simnotrelvir is a small-molecule highly specific 3C-like protease inhibitor” PMID 39299559 ↗ Sep 2024 |
| Route | Oral | “SIM0417 (SSD8432) is an orally administered coronavirus main proteinase (3CLpro) inhibitor with potential anti-SARS-CoV-2 activity.” PMID 37484496 ↗ Jul 2023 |