Obeticholic Acid
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Obeticholic Acid: From Liver Disease Therapy to Rheumatoid Arthritis
One-Sentence Summary
Obeticholic acid is a potent FXR (farnesoid X receptor) agonist marketed in India as an oral tablet. The data compiled for this report do not include its approved indication text. The TxGNN model predicts it may be effective for rheumatoid arthritis, but there are no registered clinical trials and only one directly relevant preclinical study (rat arthritis model) supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available in the data compiled for this report (all license records have empty indication text) |
| Predicted New Indication | Rheumatoid arthritis |
| TxGNN Prediction Score | 0.9967 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not formally available in the compiled data. Based on known information, obeticholic acid is a potent FXR agonist. FXR activation has anti-inflammatory effects, such as suppression of NF-κB signalling and pro-inflammatory cytokines, which provides a plausible link to autoimmune arthritis.
A 2026 preclinical study (PMID 42758264) reported that obeticholic acid attenuated Complete Freund’s Adjuvant-induced arthritis in rats through FXR-mediated modulation of the TGF-β/TAK1/MKK3/p38 MAPK pathway, inflammation and oxidative stress. A second study (PMID 33704005) showed that FXR activation protected against liver injury caused by Tripterygium wilfordii preparations, which are used to treat RA. This suggests a possible hepatoprotective role alongside RA therapy rather than direct disease modification.
No human data exist in RA, so this remains a research question rather than a validated repurposing candidate.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 42758264 | 2026 | Preclinical animal study | Inflammopharmacology | Obeticholic acid attenuated CFA-induced arthritis in rats via FXR-mediated modulation of TGF-β/TAK1/MKK3/p38 MAPK signalling, inflammation and oxidative stress |
| 33704005 | 2021 | Preclinical study | Xenobiotica | FXR activation prevented liver injury induced by Tripterygium wilfordii preparations (used in RA) in mice |
| 32299307 | 2020 | Review | United European Gastroenterol J | Diagnosis and treatment of primary biliary cholangitis, an autoimmune liver disease (background context) |
| 35903109 | 2022 | Review | Front Immunol | Animal models of autoimmune hepatitis and treatment of autoimmune liver diseases (background context) |
India Market Information
Showing 5 of 20 valid single-ingredient registrations (all oral tablets, strips of 10). Approved indication text is not available for these records.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 169175 | Obent 10mg Tablet | Strip of 10 tablets | TNT Lifesciences |
| 104598 | Hebexr 10 Tablet | Strip of 10 tablets | La Renon Healthcare Pvt Ltd |
| 161679 | Obetohep 10mg Tablet | Strip of 10 tablets | Alkem Laboratories Ltd |
| 162630 | Obstela 10 Tablet | Strip of 10 tablets | Sun Pharmaceutical Industries Ltd |
| 162745 | Obitocip 10 Tablet | Strip of 10 tablets | Cipla Ltd |
Safety Considerations
Package insert warnings and contraindications could not be retrieved. Please refer to the package insert for safety information.
Drug Interactions: 50 interactions were identified in the interaction database. Examples of the main ones:
- Major: Grazoprevir
- Moderate: Lidocaine, caffeine, theophylline, aminophylline, clozapine, duloxetine, clomipramine, flutamide, anisindione, dicoumarol (anticoagulant-related), and bile acid sequestrants (cholestyramine, colesevelam, colestipol)
- Minor: Esomeprazole
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score is supported only by a single rat arthritis study and indirect mechanistic reasoning. There are no human studies or registered trials, and package insert safety information is missing, so the candidate remains at the research-question stage.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulatory source (currently a blocking gap for safety screening)
- Approved indication and detailed mechanism of action data
- Replication of the preclinical findings in additional arthritis models
- Early-phase human studies, with attention to hepatic safety and interactions with commonly used RA therapies
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.