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Fuzhenghuayu
Fuzhenghuayu is a Small molecule drug developed by Xijing Hospital of Digestive Diseases. It is currently in Phase 3 development.
Fuzhenghuayu is a treatment being studied for liver cirrhosis and primary biliary cirrhosis. It is being compared to other interventions, including the Huangqi Decoction Granule and ursodeoxycholic acid (UDCA), in clinical trials.
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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).
| 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 | Fuzhenghuayu |
|---|---|
| Sponsor | Xijing Hospital of Digestive Diseases |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid (PHASE3)
- Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (PHASE3)
- TCM Etiological Study on the Theory of XuSunShengJi in Liver Cirrhosis (NA)
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:
- Fuzhenghuayu CI brief — competitive landscape report
- Fuzhenghuayu updates RSS · CI watch RSS
- Xijing Hospital of Digestive Diseases portfolio CI
Frequently asked questions about Fuzhenghuayu
What is Fuzhenghuayu?
Who makes Fuzhenghuayu?
What development phase is Fuzhenghuayu in?
Related
- Manufacturer: Xijing Hospital of Digestive Diseases — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing