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Hydronidone capsules
Hydronidone capsules is a Corticosteroid Small molecule drug developed by Beijing Continent Pharmaceutical Co, Ltd.. It is currently in Phase 3 development for Inflammatory and autoimmune disorders (specific indications in phase 3 development unknown). Also known as: F351.
Hydronidone is a corticosteroid that reduces inflammation and suppresses immune responses by binding to glucocorticoid receptors.
Hydronidone capsules are being studied in clinical trials for the treatment of conditions such as chronic hepatitis B-related liver fibrosis, hepatitis B and liver dysfunction, liver fibrosis, and chronic hepatitis B with hepatic fibrosis. The exact mechanism of action of Hydronidone capsules is not specified in the provided information, but it is being evaluated in a Phase II clinical trial for its safety in treating these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Hydronidone capsules |
|---|---|
| Also known as | F351 |
| Sponsor | Beijing Continent Pharmaceutical Co, Ltd. |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology/Inflammation |
| Phase | Phase 3 |
Mechanism of action
As a synthetic corticosteroid, hydronidone exerts anti-inflammatory effects through glucocorticoid receptor activation, leading to decreased production of inflammatory cytokines and immune cell activation. It is used in capsule formulation for systemic delivery to treat inflammatory and autoimmune conditions.
Approved indications
- Inflammatory and autoimmune disorders (specific indications in phase 3 development unknown)
Common side effects
- Hyperglycemia
- Hypertension
- Osteoporosis
- Immunosuppression/increased infection risk
- Adrenal suppression
Key clinical trials
- A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis (PHASE2)
- A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B. (PHASE3)
- Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls (PHASE1)
- A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis (PHASE2)
- A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis (PHASE3)
- A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency (PHASE1)
- Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide (PHASE1)
- QTc Assessment in a Single-Dose Study of Hydronidone Capsules (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydronidone capsules CI brief — competitive landscape report
- Hydronidone capsules updates RSS · CI watch RSS
- Beijing Continent Pharmaceutical Co, Ltd. portfolio CI
Frequently asked questions about Hydronidone capsules
What is Hydronidone capsules?
How does Hydronidone capsules work?
What is Hydronidone capsules used for?
Who makes Hydronidone capsules?
Is Hydronidone capsules also known as anything else?
What drug class is Hydronidone capsules in?
What development phase is Hydronidone capsules in?
What are the side effects of Hydronidone capsules?
What does Hydronidone capsules target?
Related
- Drug class: All Corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Beijing Continent Pharmaceutical Co, Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology/Inflammation
- Indication: Drugs for Inflammatory and autoimmune disorders (specific indications in phase 3 development unknown)
- Also known as: F351
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing