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Ursolvan
Ursolvan is a Small molecule drug developed by Hopital Foch. It is currently in Phase 3 development for Calculus in biliary tract, Cholelithiasis Prevention, Primary biliary cirrhosis.
Ursodiol, also known as ursodeoxycholic acid, is a secondary bile acid used to treat or prevent several diseases of the liver or bile ducts. It has been studied in clinical trials for conditions such as primary biliary cirrhosis, liver cirrhosis, and severe obesity.
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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 | Ursolvan |
|---|---|
| Sponsor | Hopital Foch |
| Target | Aldo-keto reductase family 1 member C2, CDGSH iron-sulfur domain-containing protein 1, Ectonucleotide pyrophosphatase/phosphodiesterase family member 2 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
- Calculus in biliary tract
- Cholelithiasis Prevention
- Primary biliary cirrhosis
Common side effects
Key clinical trials
- Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (PHASE4)
- Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation (PHASE2)
- Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
- The Role of Secondary Bile Acids in Intestinal Inflammation (PHASE2, PHASE3)
- Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine. (PHASE2)
- A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. (PHASE3)
- Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (PHASE3)
- Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy (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:
- Ursolvan CI brief — competitive landscape report
- Ursolvan updates RSS · CI watch RSS
- Hopital Foch portfolio CI
Frequently asked questions about Ursolvan
What is Ursolvan?
What is Ursolvan used for?
Who makes Ursolvan?
What development phase is Ursolvan in?
What does Ursolvan target?
Related
- Target: All drugs targeting Aldo-keto reductase family 1 member C2, CDGSH iron-sulfur domain-containing protein 1, Ectonucleotide pyrophosphatase/phosphodiesterase family member 2
- Manufacturer: Hopital Foch — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Calculus in biliary tract
- Indication: Drugs for Cholelithiasis Prevention
- Indication: Drugs for Primary biliary cirrhosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing