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tauroursodeoxycholic
tauroursodeoxycholic is a Small molecule drug developed by Beijing Trendful Kangjian Medical Information Consulting Limited Company. It is currently in Phase 3 development. Also known as: TUDCA, Taurolite.
Tauroursodeoxycholic acid is a small molecule with an unknown mechanism of action, according to ChEMBL. It is being studied in clinical trials for various conditions, including hypertension, ulcerative colitis, and hepatocellular carcinoma, among others, as per ClinicalTrials.gov.
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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 | tauroursodeoxycholic |
|---|---|
| Also known as | TUDCA, Taurolite |
| Sponsor | Beijing Trendful Kangjian Medical Information Consulting Limited Company |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
- TUDCA as a Therapy for Ulcerative Colitis (UC) (PHASE1)
- Effect of Oral Supplement on Influenza Vaccine Long-term Response
- A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma (PHASE2)
- Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab (PHASE2)
- Open Label Extension Study of AMX0035 in Patients With ALS (PHASE2)
- Tauroursodeoxycholic Acid Combined With PD-1/PD-L1 Immunotherapy in Advanced Hepatocellular Carcinoma: A Prospective Study (PHASE2)
- Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes (PHASE2)
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:
- tauroursodeoxycholic CI brief — competitive landscape report
- tauroursodeoxycholic updates RSS · CI watch RSS
- Beijing Trendful Kangjian Medical Information Consulting Limited Company portfolio CI
Frequently asked questions about tauroursodeoxycholic
What is tauroursodeoxycholic?
Who makes tauroursodeoxycholic?
Is tauroursodeoxycholic also known as anything else?
What development phase is tauroursodeoxycholic in?
Related
- Manufacturer: Beijing Trendful Kangjian Medical Information Consulting Limited Company — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: TUDCA, Taurolite
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing