Hydronidone

Phase 3Small molecule

BBeijing Continent Pharmaceutical Co, Ltd.

Hydronidone is one of 106 small molecule programs targeting Chronic Hepatitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

105

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic HepatitisNot yet recruiting

Hepatitis BCompleted

Renal InsufficiencyRecruiting

Chronic HepatitisPhase 3

Not yet recruiting

Hepatitis BPhase 3

Completed

Renal InsufficiencyPhase 1

Recruiting

Competition

Competitive Landscape

71 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

Viread

Gilead

Approved

8 2

PEG-Intron

Merck & Co.

Phase 3

43 3

Actos

Takeda

Approved

3 4

Neoral

Novartis

Approved

2 5

Precose

Bayer

Approved

1 6

Opdivo

Bristol-Myers Squibb

Phase 2

2 7

Pegylated Interferon Alfa

Merck & Co.

Phase 3

4 8

NA Therapy

GSK

Phase 3

2 9

AHB-137

AAusper Biopharma Co., Ltd.

Phase 3

3 10

Hydronidone

BBeijing Continent Pharmaceutical Co, Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Renal Insufficiency

NCT07262333

Q4 2028

Phase 3Recruiting

Hepatitis B

NCT05905172

Phase 3Not yet recruiting

Chronic Hepatitis

NCT07412236

Clinical

Trials by Indication[1]

Chronic Hepatitis2 trials

A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

Completed·SShanghai Genomics, Inc.·Phase 2·NCT02499562·168 enrolled

A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT07412236·1,208 enrolled

Hepatitis B2 trials

Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT05115942·248 enrolled

Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis

Recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT05905172·248 enrolled

Chronic Hepatitis B-related Liver Fibrosis2 trials

[¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07471217·6 enrolled

A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 2·NCT07417553·67 enrolled

Liver Fibrosis2 trials

Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07262346·138 enrolled

A Phase I Pharmacokinetic Study of Hydronidone Capsules in Patients With Varying Degrees of Hepatic Impairment and Normal Hepatic Function.

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07394309·30 enrolled

Chronic Hepatitis b2 trials

An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 2·NCT07364448·411 enrolled

A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT07343778·337 enrolled

5 more indications

Interaction1 trial

Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT04124081·12 enrolled

Tics1 trial

Study on Pharmacokinetics of Hydronidone

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT04162821·48 enrolled

Hepatic fibrosis1 trial

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effect of Single-Dose Hydronidone Capsules on QTc Interval in Chinese Healthy Subjects

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07263152·48 enrolled

Renal insufficiency1 trial

Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency

Recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07262333·56 enrolled

Unspecified2 trials

Study on Hydronidone Capsule BE

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·N/A·NCT04125056·40 enrolled

Study on PK of Hydronidone in Patients and Special Population

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT04123769·8 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Hydronidone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hydronidone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Hydronidone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Beijing Continent Pharmaceutical Co, Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBeijing Continent Pharmaceutical Co, Ltd.

Hydronidone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2028

Trials by Indication[1]

Chronic Hepatitis2 trials

Hepatitis B2 trials

Chronic Hepatitis B-related Liver Fibrosis2 trials

Liver Fibrosis2 trials

Chronic Hepatitis b2 trials

Interaction1 trial

Tics1 trial

Hepatic fibrosis1 trial

Renal insufficiency1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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