8 completed, 2 recruiting, 2 terminated. 6 Phase 1, 4 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 5, Terminated 1 |
| Phase 2 | 4 | Completed 2, Recruiting 1, Terminated 1 |
| Phase 3 | 3 | Recruiting 2, Completed 1 |
Follow ziresovir: new trials by email Literature Review of ziresovir trials Research Report on ziresovir
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 Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection. Ziresovir (AK0529), Placebo - Respiratory Syncytial Virus Infections | Phase 2 / Phase 3 | Recruiting | Shanghai Ark Biopharmaceutical Co., Ltd. | 290 | 2026-03-03 | 2026-06-22 |
| Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects Ziresovir 125 mg, Ziresovir 500 mg, Placebo - Healthy Volunteers | Phase 1 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 34 | 2024-09-25 | 2026-06-22 |
| A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants AK0529, Placebo - Respiratory Synctial Virus Infections | Phase 3 | Recruiting | Shanghai Ark Biopharmaceutical Co., Ltd. | 180 | 2024-02-29 | 2025-01-15 |
| A Study of AK0529 in Adults Patients Hospitalized With RSV Infection AK0529, Placebo - Respiratory Syncytial Virus Infections | Phase 2 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 25 | 2023-07-20 | 2025-04-24 |
| A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects Ziresovir, Placebo - Healthy Subjects | Phase 1 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 24 | 2021-03-24 | 2022-02-15 |
| A Study of AK0529 in Chinese Infants Hospitalized With RSV AK0529, Matching placebo of AK0529 - Respiratory Syncytial Virus Infections | Phase 3 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 311 | 2020-09-22 | 2024-02-13 |
| Anti-RSV Study in Chinese Patients (ASCENT) AK0529, Placebo - Respiratory Syncytial Virus Infections | Phase 2 | Terminated | Shanghai Ark Biopharmaceutical Co., Ltd. | 1 | 2019-03-28 | 2026-06-22 |
| A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529 AK0529 - Healthy | Phase 1 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 7 | 2018-01-05 | 2018-09-11 |
| A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers AK0529, Placebo - Healthy | Phase 1 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 51 | 2017-10-23 | 2021-06-09 |
| Viral Inhibition in Children for Treatment of RSV AK0529, Placebo - RESPIRATORY SYNCYTIAL VIRUS INFECTIONS | Phase 2 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 72 | 2016-05-27 | 2024-02-20 |
| A Study of AK0529 in Infants Hospitalized With RSV AK0529 - Respiratory Syncytial Virus Infections | Phase 1 | Terminated | Shanghai Ark Biopharmaceutical Co., Ltd. | 1 | 2015-08-28 | 2018-07-02 |
| Safety, Tolerability and PK Study of AK0529 in Healthy Human AK0529, Placebo - Respiratory Syncytial Virus Infections | Phase 1 | Completed | Shanghai Ark Biopharmaceutical Co., Ltd. | 74 | 2014-10-01 | 2015-10-20 |
Respiratory Syncytial Virus Infections (7) · Heart Diseases (1)
Shanghai Ark Biopharmaceutical Co., Ltd. (12)
China (6) · Australia (3) · United States (2) · Hong Kong (1) · Israel (1) · Lebanon (1) · Malaysia (1) · Poland (1) · Taiwan (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Jimmy Gu (2) · David Han, M.D., M.P.H (1) · Paul Griffin, MD (1) · Stephen Toovey, MD PhD (1) · Yu Chen, MD (1)