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Tauroursodeoxycholic Acid Capsules
Tauroursodeoxycholic Acid Capsules is a Bile acid derivative Small molecule drug developed by Beijing Friendship Hospital. It is currently in Phase 3 development for Amyotrophic lateral sclerosis (ALS). Also known as: Taurolite.
Tauroursodeoxycholic acid is a bile acid derivative that modulates the unfolded protein response (UPR) and reduces endoplasmic reticulum stress.
Tauroursodeoxycholic acid capsules are a small molecule intervention with an unknown mechanism of action. They have been studied in clinical trials for various conditions, including influenza vaccine response, diabetic macular edema, type 2 diabetes mellitus, vasodilation, and arterial stiffness.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 Acid Capsules |
|---|---|
| Also known as | Taurolite |
| Sponsor | Beijing Friendship Hospital |
| Drug class | Bile acid derivative |
| Target | IRE1α, PERK |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
It does this by inhibiting the activation of the inositol-requiring enzyme 1 alpha (IRE1α) and the protein kinase RNA-like ER kinase (PERK), which are key components of the UPR. This leads to a reduction in the production of pro-inflammatory cytokines and an improvement in cellular function.
Approved indications
- Amyotrophic lateral sclerosis (ALS)
Common side effects
- Nausea
- Vomiting
- Diarrhea
Key clinical trials
- TUDCA as a Therapy for Ulcerative Colitis (UC) (PHASE1)
- Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine. (PHASE2)
- Effect of Oral Supplement on Influenza Vaccine Long-term Response
- Targeting ER Stress in Vascular Dysfunction (EARLY_PHASE1)
- Effect of Oral Supplements for Influenza Vaccine Response (NA)
- Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS (PHASE3)
- A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis (PHASE1, PHASE2)
- Open Label Extension of TUDCA-ALS Study (PHASE3)
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 Acid Capsules CI brief — competitive landscape report
- Tauroursodeoxycholic Acid Capsules updates RSS · CI watch RSS
- Beijing Friendship Hospital portfolio CI
Frequently asked questions about Tauroursodeoxycholic Acid Capsules
What is Tauroursodeoxycholic Acid Capsules?
How does Tauroursodeoxycholic Acid Capsules work?
What is Tauroursodeoxycholic Acid Capsules used for?
Who makes Tauroursodeoxycholic Acid Capsules?
Is Tauroursodeoxycholic Acid Capsules also known as anything else?
What drug class is Tauroursodeoxycholic Acid Capsules in?
What development phase is Tauroursodeoxycholic Acid Capsules in?
What are the side effects of Tauroursodeoxycholic Acid Capsules?
What does Tauroursodeoxycholic Acid Capsules target?
Related
- Drug class: All Bile acid derivative drugs
- Target: All drugs targeting IRE1α, PERK
- Manufacturer: Beijing Friendship Hospital — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Amyotrophic lateral sclerosis (ALS)
- Also known as: Taurolite
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing