Drugs / Onradivir
Onradivir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | 安睿威 | influenza | — | “昂拉地韦（ZSP1273）是全球首个获得积极Ⅲ期阳性结果的流感RNA聚合酶PB2抑制剂，目前已获得NDA受理。” raynovent.com ↗ “2023年12月，众生睿创继续抢抓时间，昂拉地韦片安睿威新药上市申请获受理” raynovent.com ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06248567 | Jan → Apr 2024 | impaired renal function disease | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06164431 | Nov → Dec 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06157450 | Oct → Nov 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05954624 | Jul → Nov 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05942365 | Jun → Jul 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05856513 | Jun → Jul 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05873426 | Mar → Apr 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05108051 | Nov 2020 → Mar 2021 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03679143 | Sep 2018 → Mar 2019 | influenza | Guangdong Zhongsheng Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06656026 | Nov 2024 → Jun 2025 | influenza | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04024137 | Dec 2019 → May 2020 | influenza | Guangdong Raynovent Biotech Co., Ltd | Completed | Met primary |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT07229807 | Nov → Dec 2025 overdue | influenza | Guangdong Raynovent Biotech Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07229547 | Nov 2025 → Dec 2026 expected | influenza | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT07229820 | Nov → Dec 2025 overdue | influenza | Guangdong Raynovent Biotech Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04683406 | Dec 2020 → Apr 2023 | influenza | Guangdong Raynovent Biotech Co., Ltd | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-11-21 | Guangdong Raynovent Biotech Co., Ltd | Results 重磅|全球首个流感RNA聚合酶PB2蛋白抑制剂昂拉地韦片Ⅲ期临床研究获得积极结果 raynovent.com ↗
昂拉地韦片治疗成人单纯性甲型流感的Ⅲ期临床研究近日完成顶线数据分析，结果表明，昂拉地韦较安慰剂可显著缩短中位七项流感症状缓解时间和中位发热缓解时间，较安慰剂或奥司他韦可更好更快地降低甲型流感病毒载量，显著缩短病毒转阴时间。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-11-21 | Guangdong Raynovent Biotech Co., Ltd | 重磅|全球首个流感RNA聚合酶PB2蛋白抑制剂昂拉地韦片Ⅲ期临床研究获得积极结果 raynovent.com ↗ |
| 2020-12-07 | Guangdong Raynovent Biotech Co., Ltd | 众生睿创预防和治疗甲型流感及人禽流感的一类创新药物 ZSP1273 片Ⅲ期临床试验启动 raynovent.com ↗ |
| 2019-08-25 | Guangdong Raynovent Biotech Co., Ltd | 众生睿创预防和治疗甲型流感及人禽流感的一类创新药物 ZSP1273 片Ⅱ期临床试验启动 raynovent.com ↗ |
| 2019-06-20 | Guangdong Raynovent Biotech Co., Ltd | 众生睿创一类创新药 ZSP1273 片获得Ⅱ期临床试验伦理批件 raynovent.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Onradivir | “Onradivir is an influenza A virus RNA polymerase basic protein 2 inhibitor that is currently under development for the treatment of influenza A.” PMID 40757817 ↗ Aug 20253“BACKGROUND: Onradivir (ZSP1273) is a potent inhibitor of the PB2 subunit of influenza A virus (IAV) polymerase.” PMID 40489986 ↗ Jun 2025 “Onradivir (ZSP1273) is a novel anti-influenza A virus inhibitor.” PMID 38330975 ↗ Feb 2024 |
| Known as | [14C] ZSP1273 | “Drug: [14C] ZSP1273” NCT05873426 ↗ |
| Known as | ZSP1273 | “BACKGROUND: Onradivir (ZSP1273) is a potent inhibitor of the PB2 subunit of influenza A virus (IAV) polymerase.” PMID 40489986 ↗ Jun 2025 |
| Action | Inhibit | “ZSP1273 is a small-molecule anti-influenza drug targeting the RNA polymerase PB2 subunit of the influenza virus.” PMID 34654349 ↗ Nov 2021 |
| Modality | Small molecule | “ZSP1273 is a small-molecule anti-influenza drug” PMID 34654349 ↗ Nov 2021 |
| Route | Oral | “ZSP1273 tablets administered orally once daily under fasted condition” NCT03679143 ↗ |