Hydronidone

Phase 3Small molecule

BBeijing Continent Pharmaceutical Co, Ltd.

Hydronidone is one of 134 small molecule programs targeting Hepatic fibrosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

133

Competitors

Pipeline

Status by Indication[3][1]

Indication

Hepatic FibrosisActive, not recruiting

Chronic HepatitisActive, not recruiting

FibrosisActive, not recruiting

Hepatitis BActive, not recruiting

Renal InsufficiencyActive, not recruiting

Hepatic FibrosisPhase 3

Active, not recruiting

Chronic HepatitisPhase 2

Active, not recruiting

FibrosisPhase 2

Active, not recruiting

Hepatitis BPhase 3

Active, not recruiting

Renal InsufficiencyPhase 1

Active, not recruiting

Competition

Competitive Landscape

624 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

Hydronidone

BBeijing Continent Pharmaceutical Co, Ltd.

Phase 3

3 2

PEG-Intron

Merck & Co.

Preclinical

43 3

Sovaldi

Gilead

Preclinical

34 4

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

199 5

Incivek

Vertex Pharmaceuticals

Preclinical

10 6

Intron a

Sanofi

Preclinical

7 7

Roferon-a

Roche

Preclinical

3 8

Medrol

Pfizer

Preclinical

1 9

Dasabuvir

AbbVie

Preclinical

7 10

SOF/VEL

Gilead

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Study completion

NCT07471217

Phase 2Not yet recruiting

Chronic Hepatitis

NCT07417553

Phase 2Not yet recruiting

Fibrosis

NCT07364448

Q4 2026

Phase 3Not yet recruiting

Hepatic Fibrosis

NCT07343778

Phase 1Not yet recruiting

Hepatic Impairment

NCT07394309

Q4 2028

Phase 3Recruiting

Hepatitis B

NCT05905172

Clinical

Trials by Indication[1]

Chronic Hepatitis3 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

A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 2·NCT07417553·150 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

ESS1 trial

QTc Assessment in a Single-Dose Study of Hydronidone Capsules

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07263152·48 enrolled

Interaction1 trial

Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects

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

Renal insufficiency1 trial

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency

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

6 more indications

Hepatic fibrosis1 trial

A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT07343778·300 enrolled

Fibrosis1 trial

A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 2·NCT07364448·200 enrolled

Clinical Trial1 trial

The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07262346·138 enrolled

Hepatic Impairment1 trial

Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07394309·30 enrolled

Tics1 trial

Study on Pharmacokinetics of Hydronidone

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

Unspecified3 trials

Study on Hydronidone Capsule BE

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

[¹⁴C] Hydronidone Mass Balance Study

Not yet recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07471217·8 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

Q3 2026

Q4 2026

Q4 2028

Trials by Indication[1]

Chronic Hepatitis3 trials

Hepatitis B2 trials

ESS1 trial

Interaction1 trial

Renal insufficiency1 trial

Hepatic fibrosis1 trial

Fibrosis1 trial

Clinical Trial1 trial

Hepatic Impairment1 trial

Tics1 trial

Unspecified3 trials

References

Drug Info

Quick Facts

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