15 completed, 7 recruiting, 6 unknown, 1 not yet recruiting. 13 Phase 1, 8 Phase 2, 8 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 9, Recruiting 2, Unknown 2 |
| Phase 2 | 8 | Completed 3, Recruiting 3, Unknown 2 |
| Phase 3 | 8 | Recruiting 3, Completed 2, Unknown 2, Not yet recruiting 1 |
| Not applicable | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| [¹⁴C] Hydronidone Mass Balance Study [¹⁴C]Hydronidone - Chronic Hepatitis B-related Liver Fibrosis | Phase 1 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 6 | 2026-04-17 | 2026-09-21 |
| A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis Hydronidone capsules - Chronic Hepatitis B-related Liver Fibrosis | Phase 2 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 67 | 2026-04-15 | 2026-08-13 |
| Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg）, Pirfenidone Capsules（0mg） - Radiation-induced Lung Injury, Immune-related Pneumonia | Phase 2 / Phase 3 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 298 | 2026-03-26 | 2026-04-22 |
| Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls Hydronidone capsules - Liver Fibrosis | Phase 1 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 30 | 2026-03-25 | 2026-08-13 |
| A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis Hydronidone Capsules - Chronic Hepatitis B With Hepatic Fibrosis | Phase 3 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 337 | 2026-03-16 | 2026-08-13 |
| Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide Entecavir, Tenofovir Disoproxil Fumarate（TDF）, Tenofovir alafenamide（TAF） - Chronic Hepatitis B Liver Fibrosis, DDI (Drug-Drug Interaction) | Phase 1 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 64 | 2026-03-15 | 2026-08-13 |
| A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis Hydronidone capsules - Chronic Hepatitis B With Hepatic Fibrosis | Phase 2 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 411 | 2026-03-12 | 2026-08-13 |
| A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B. Hydronidone (270mg), Hydronidone (Placebo Group) - Liver Fibrosis, Liver Fibrosis in Chronic Hepatitis B | Phase 3 | Not yet recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 1208 | 2026-01-30 | 2026-02-17 |
| QTc Assessment in a Single-Dose Study of Hydronidone Capsules Hydronidone, Placebo - Hepatic Fibrosis | Phase 1 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 48 | 2025-12-30 | 2026-08-13 |
| A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency Hydronidone capsules - Renal Insufficiency Chronic | Phase 1 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 56 | 2025-12-25 | 2026-08-13 |
| The Phase Ⅰd Clinical Trial of Hydronidone Capsules Hydronidone capsules, Placebo capsules - Liver Fibrosis | Phase 1 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 138 | 2025-12-24 | 2026-09-21 |
| Preliminary Human Trials of F230 Tablets F230 tablets - Pulmonary Hypertension | Phase 1 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 136 | 2025-05-15 | 2026-03-11 |
| Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis Hydronidone capsules, The placebo capsules - Liver Fibrosis | Phase 3 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 248 | 2023-08-12 | 2025-06-04 |
| F573 for Injection for the Treatment of Liver Injury/Failure F573 for injection, Sterilizing water for injection - Acute Liver Failure, Acute-On-Chronic Liver Failure | Phase 2 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 97 | 2023-03-24 | 2025-11-19 |
| PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients Pirfenidone/Placebo - Acute Lung Injury, Prevention | Phase 2 | Recruiting | Fujian Medical University Union Hospital | 214 | 2023-03-16 | 2025-08-08 |
| Pirfenidone Treat Myocardial Fibrosis After Acute Myocardial Infarction Pirfenidone Oral Capsule, Placebo Oral Capsule - Myocardial Fibrosis | Phase 2 | Unknown | Shanghai Zhongshan Hospital | 100 | 2022-08-05 | 2022-11-10 |
| Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis Pirfenidone Capsules, placebo capsules - Pneumoconiosis | Phase 3 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 272 | 2022-06-07 | 2025-11-24 |
| Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial. Hydronidone capsules, The placebo capsules - Liver Fibrosis | Phase 3 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 248 | 2021-12-30 | 2024-12-20 |
| Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP Pirfenidone, methylprednisolone, Methylprednisolone - Pneumonitis, Malignant Tumor | Phase 1 | Unknown | Zhou Chengzhi | 48 | 2021-10-10 | 2022-03-15 |
| F573 Ia Clinical Trial F573, Placebo - Tolerance, Pharmacokinetic | Phase 1 | Completed | Beijing Continent Pharmaceutical Co, Ltd. | 100 | 2021-02-08 | 2022-11-08 |
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Liver Cirrhosis (6) · Acute Lung Injury (1) · Acute-On-Chronic Liver Failure (1) · Breast Neoplasms (1) · Hepatitis B (1) · Hypertension, Pulmonary (1) · Liver Diseases (1) · Liver Failure, Acute (1) · Neoplasms (1) · Pneumoconiosis (1) · Pneumonia (1) · Radiation Pneumonitis (1) · Renal Insufficiency (1) · Renal Insufficiency, Chronic (1)
hydronidone (12) · pirfenidone (10) · 5-methyl-1-(4-hydroxylphenyl)-2-(1H)-pyridone (2) · Edible Grain (1) · Injections (1) · Methylprednisolone (1) · benzyloxycarbonyl-valyl-aspartic acid fluoromethyl ketone (1) · entecavir (1)
China (28)
Chengzhi Zhou, MA (1) · Huaping Dai, Dr (1) · Jun Cheng, Dr (1) · Jun Cheng, Dr. (1) · Junbo Ge, Doctor (1) · Lungen Lu, Dr (1) · Lungen Lu, Dr. (1) · Ming Chen (1) · Shaojun Shaojun, Doctor (1) · Yong Yang, Doctor (1)