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更新于：2026-09-12
Onradivir
昂拉地韦
更新于：2026-09-12
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国澳门 (2025-05-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C22H22F2N6O2 |
InChIKeyJCHDJLSIYWBAHI-ZWHBIUKWSA-N |
CAS号2200336-20-3 |
关联
25
项与 昂拉地韦 相关的临床试验ChiCTR2600126666
Real-World Study of Onradivir Tablets in Patients with Influenza A Virus Infection
NCT07229807
A Phase 3 Study of ZSP1273 in Otherwise Healthy Children 2-11 Years Old With Influenza A
NCT07229547
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Onradivir Tablets in Participants Aged 12 to 17 Years With Uncomplicated Influenza A.
100 项与 昂拉地韦 相关的临床结果
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100 项与 昂拉地韦 相关的转化医学
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100 项与 昂拉地韦 相关的专利（医药）
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8
项与 昂拉地韦 相关的文献（医药）2026-06-01DRUG METABOLISM AND DISPOSITION
Population pharmacokinetic analysis of onradivir to support dosing recommendations in elderly adults with influenza
Article
作者: Huang, Chao-Chao ; Huang, Yi-Huan ; Xu, Yan ; Zheng, Xiao-Jie ; Su, Yu-Wen ; Lv, Jiong-Xian ; Li, Hai-Jun ; Zhang, Qing ; Wang, Yuan-Hui ; Su, Chang ; Ma, Jun-Heng ; Sun, Zhong-Yi
Onradivir (ZSP1273) is a novel oral inhibitor of the influenza A virus polymerase PB2 subunit, developed for the treatment of influenza. Given that elderly patients represent a key target population and may experience age-related changes in pharmacokinetics (PK), this study aimed to characterize the PK of onradivir in young and elderly adults, identify covariate effects, and evaluate the need for dose adjustment in older patients. Data were obtained from a phase I, open-label, parallel-group study in 32 healthy subjects (16 young, 16 elderly) receiving a single 600 mg oral dose of onradivir. Plasma concentrations were analyzed using nonlinear mixed-effects modeling. A two-compartment model with sequential zero- and first-order absorption and first-order elimination best described the data. Covariate effects were assessed using stepwise forward inclusion and backward elimination. Model adequacy was evaluated via goodness-of-fit plots, prediction-corrected visual predictive checks, and bootstrap analysis. Body weight, aspartate aminotransferase, and age group were significant covariates affecting onradivir PK. Body weight followed allometric scaling (exponents 0.75 for clearance and Q; 1.0 for Vc and Vp), aspartate aminotransferase negatively affected clearance, and age group influenced Vc. Simulations showed that compared with young adults, elderly subjects had ∼49% higher Cmax,ss and ∼18% higher AUCss, whereas all other exposure changes were within 25%. No exposure-safety relationship was observed, and onradivir was well tolerated in both groups. Onradivir exhibited linear, predictable PK and a favorable safety profile across age groups. Although elderly subjects had slightly higher exposure than younger adults, the difference was within the observed variability and was not associated with clinically meaningful safety findings. These results suggest that dose adjustment based on age alone is not necessary, and a fixed 600 mg oral dose is appropriate for adults, including older individuals similar to those of the geriatric participants in this study. SIGNIFICANT STATEMENT: Influenza causes disproportionate morbidity in older adults, yet few antiviral therapies have robust pharmacokinetic data in this population. Using a dedicated population pharmacokinetic study of onradivir in young and elderly adults, we show that age, body weight, and liver enzymes have only modest effects on exposure, supporting the use of a 600-mg dose without adjustment based on age in populations similar to those studied.
2025-12-01DRUGS
Onradivir: First Approval
Review
作者: Lee, Arnold
Onradivir (®, Anruiwei) is a small molecule RNA polymerase inhibitor that potently binds to the PB2 cap-binding domain of RNA polymerase to inhibit the replication of the influenza A virus. It was developed by Guangdong Raynovent Biotech and received its first approval in May 2025 in China based on results from the NCT04683406 phase III trial. This article summarizes the milestones in the development of onradivir leading to this first approval for the treatment of uncomplicated influenza A in adults, excluding those at high risk for influenza-related complications.
2025-07-01Lancet Respiratory Medicine
Efficacy and safety of onradivir in adults with acute uncomplicated influenza A infection in China: a multicentre, double-blind, randomised, placebo-controlled and oseltamivir-controlled, phase 3 trial
Article
作者: Liang, Shiwei ; Huang, Jufang ; Zhong, Nanshan ; Ding, Banghan ; Fang, Zhonghao ; Lin, Zejun ; Zeng, Huiqing ; Li, Zhengtu ; Yang, Zifeng ; Zhang, Xiuwei ; Luo, Jincan ; Lin, Zhengshi ; Song, Yudi ; Zhan, Yangqing ; Chen, Xiaolin ; Li, Haijun ; Chen, Xiaoxin
BACKGROUND:
Onradivir (ZSP1273) is a potent inhibitor of the PB2 subunit of influenza A virus (IAV) polymerase. Our previous, phase 2 clinical trial showed that a 600 mg regimen of onradivir initiated within 48 h of symptom onset can expedite the recovery of adult patients from acute, uncomplicated influenza. Here, we aimed to evaluate the safety and therapeutic efficacy of onradivir in a larger group with acute, uncomplicated influenza.
METHODS:
This randomised, double-blind, multicentre, placebo-controlled and oseltamivir-controlled, phase 3 trial was conducted at 68 clinical sites in China. Eligible participants were adults (aged 18-64 years) with an influenza-like illness who screened positive by rapid IAV antigen testing at the first clinical visit, and had a fever (axillary temperature ≥38·0°C) with at least one moderate systemic and one moderate respiratory symptom within 48 h of symptom onset. Patients were randomly assigned into three treatment groups, stratified by influenza symptom scores (≤11 or ≥12), in a 2:1:1 ratio by an interactive web response system, with each treatment lasting 5 days: 600 mg oral onradivir tablets once daily, 75 mg oral oseltamivir phosphate capsules twice daily, or oral placebo. The primary outcome was the efficacy of onradivir versus placebo in the time to alleviation of symptoms (TTAS), from treatment initiation to the remission of influenza symptoms, in the intention-to-treat infection (ITTI) population (ie, all participants who were randomly assigned and tested positive for IAV). The safety endpoints were the frequency and severity of adverse events in all participants who received treatment at least once. This trial is registered with ClinicalTrials.gov (NCT04683406) and is completed. This clinical trial was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China (EC-2020-080[YW]-02).
FINDINGS:
Between May 12, 2022, and May 16, 2023, 943 patients were screened, of whom 750 met the inclusion criteria and were randomly assigned to a group. 48 had negative IAV tests, resulting in an ITTI population of 702 participants (413 [59%] men and 289 [41%] women; mean age 28·1 years [SD 9·7]): 349 in the onradivir group, 177 in the oseltamivir group, and 176 in the placebo group. The baseline viral load (mean 5·15 log10 copies per mL [SD 1·02]) and the total score of seven influenza symptoms at enrolment were similarly distributed among the groups. The median TTAS in the onradivir group was significantly shorter than that of placebo (38·83 h [95% CI 35·32-41·18] vs 63·35 h [55·48-68·48], difference -24·52 h, p<0·0001, HR 1·53 [95% CI 1·27-1·85]) and similar to that of the oseltamivir group (42·17 h [38·27-52·83], p=0·092, HR 1·12 [0·93-1·35]. Adverse events occurred in 250 (67%) of 373 in the onradivir group, 104 (55%) of 189 in the placebo group, and 89 (47%) of 188 in the oseltamivir group. Although the incidence of diarrhoea was higher in the onradivir group (184 [49%]) than in the placebo (44 [23%]) or oseltamivir (28 [15%]) groups, most incidences were grade 1 or 2, lasted a median of 2 days (IQR 1-3), and resolved without medication.
INTERPRETATION:
Onradivir has similar curative efficacy to oseltamivir for acute, uncomplicated influenza infections in adult patients, with an acceptable safety profile. At a time when reduced susceptibility to antiviral drugs is a growing concern, this study indicates that onradivir could be an alternative antiviral option or a candidate for use in combination with other antiviral agents for uncomplicated IAV infection.
FUNDING:
National Multidisciplinary Innovation Team Project of Traditional Chinese Medicine; National Natural Science Foundation of China; Guangdong Science and Technology Foundation; Major Project of Guangzhou National Laboratory; Guangdong Raynovent Biotechnology.
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 甲型流感病毒感染 | 中国澳门 | 2025-05-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肝损伤 | 临床1期 | 中国 | 2023-06-15 | |
| 禽流感 | 临床1期 | 中国 | 2018-09-20 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 750 | Onradivir 600 mg | 蓋淵鏇願醖遞遞糧鹽積(積積積簾顧願襯壓憲廠) = 糧糧淵壓壓鑰築窪蓋壓 壓鑰鏇繭廠鏇醖廠鏇鑰 (窪憲範淵顧積醖鹹廠繭, 35.32 ~ 41.18) 更多 | 积极 | 2025-07-01 | ||
Oseltamivir 75 mg | 蓋淵鏇願醖遞遞糧鹽積(積積積簾顧願襯壓憲廠) = 網鑰網鹹鏇鹹淵構繭鏇 壓鑰鏇繭廠鏇醖廠鏇鑰 (窪憲範淵顧積醖鹹廠繭, 38.27 ~ 52.83) 更多 | ||||||
临床3期 | 702 | 鏇繭廠醖築選廠襯獵窪(築鹹鑰簾廠窪鑰獵膚齋) = 顧網淵鬱構鹽壓窪膚鏇 願繭簾網齋憲餘構艱膚 (繭鹽製淵範艱壓選範衊 ) | 积极 | 2023-07-03 | |||
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