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Ocaliva
Ocaliva is a Small molecule drug developed by Universitaire Ziekenhuizen KU Leuven. It is currently in Phase 2 development for Primary cholangitis. Also known as: obeticholic acid.
Obeticholic acid, sold under the brand name Ocaliva, is a small molecule medication used to treat primary biliary cholangitis. It is a semi-synthetic bile acid analogue with the chemical structure 6α-ethyl-chenodeoxycholic acid.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Ocaliva |
|---|---|
| Also known as | obeticholic acid |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Target | G-protein coupled bile acid receptor 1, Bile acid receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
- Primary cholangitis
Common side effects
Key clinical trials
- A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response t (Phase 3)
- The Effect of Obeticholic Acid on Gut Microbiota, Gastric Motility, Accommodation, Gastrointestinal Peptide in Healthy Volunteers (NA)
- Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients (Phase 2)
- Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis (N/A)
- A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Bi (Phase 2)
- Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT- A Randomized Clinical Control Trial Study (NA)
- Obeticholic Acid Treatment in Patients With Bile Acid Diarrhoea: an Open-label, Pilot Study of Mechanisms, Safety and Symptom Response. (Phase 2)
- An Open Label Trial to Assess the Effects of Food on the Pharmacokinetic Parameters of Obeticholic Acid (OCA) (Phase 1)
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:
- Ocaliva CI brief — competitive landscape report
- Ocaliva updates RSS · CI watch RSS
- Universitaire Ziekenhuizen KU Leuven portfolio CI
Frequently asked questions about Ocaliva
What is Ocaliva?
What is Ocaliva used for?
Who makes Ocaliva?
Is Ocaliva also known as anything else?
What development phase is Ocaliva in?
What does Ocaliva target?
Related
- Target: All drugs targeting G-protein coupled bile acid receptor 1, Bile acid receptor
- Manufacturer: Universitaire Ziekenhuizen KU Leuven — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Primary cholangitis
- Also known as: obeticholic acid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing