Live from ClinicalTrials.gov + Open Targets, fetched 2026-11-12 02:03 UTC. Every row links to its source record.
Postmortem · what the sponsor and named sources said, kept apart from what merely happened at the same time
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
NCT04594694 · Intercept Pharmaceuticals · PHASE2 · terminated · last registry update 2026-07-16 · Decision brief
No research has been run for this trial yet, so only the registry's own reason and the timeline are shown.
What was said, and by whom
Stated is the sponsor's own words; Reported is a named third party. The category is our label from a fixed list; the quote is the evidence.
| Kind | Quote | Our category | Source |
|---|---|---|---|
| Stated | “Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.” | – | Registry record, Intercept Pharmaceuticals |
Also happening at the time. Not shown to be a cause.
Registry events on other trials of drugs against NR1H4 within 12 months either side of this trial's last update, live from ClinicalTrials.gov. Nothing here was stated as a reason.
- 2026-10-28Results posted on the registry: King's College London, Metformin + Ursodeoxycholic Acid (NCT04407650)
- 2026-10-28Also stopped (terminated): King's College London, Metformin + Ursodeoxycholic Acid (NCT04407650)
- 2026-10-09Also stopped (withdrawn): University of Alabama at Birmingham, placebo capsule (NCT07457632)
- 2026-10-01Phase 3 first posted: Tanta University, Standard medical treatment + Ursodeoxycholic Acid (NCT07852780)
- 2026-08-12Also stopped (withdrawn): HighTide Therapeutics (Hong Kong) Limited, HTD1801 + Ursodeoxycholic Acid (NCT03678480)
- 2026-08-06Also stopped (terminated): Chang Gung Memorial Hospital, Ursodeoxycholic Acid (URSO) + Simvastatin (NCT07102979)
- 2026-06-08Results posted on the registry: Intercept Pharmaceuticals, FDC tablet (OCA 5 mg + BZF 400 mg SR) (NCT06488911)
- 2026-06-08Also stopped (terminated): Intercept Pharmaceuticals, FDC tablet (OCA 5 mg + BZF 400 mg SR) (NCT06488911)
- 2026-03-11Also stopped (terminated): Stanford University, ursodiol (ursodeoxycholic acid, UDCA) (NCT03724175)
- 2026-02-20Phase 3 first posted: Zydus Therapeutics Inc., Saroglitazar Magnesium 1 mg + Placebo (NCT07424677)
- 2025-12-22Phase 3 first posted: Xijing Hospital of Digestive Diseases, Fenofibrate + UDCA (Ursodeoxycholic acid) (NCT07296458)
- 2025-12-15Phase 3 first posted: Cascade Pharmaceuticals, Inc, 2mg CS0159 + Placebo (NCT07282353)
- 2025-11-26Results posted on the registry: Gilead Sciences, Semaglutide (SEMA) + Cilofexor (CILO)/Firsocostat (FIR) (NCT04971785)
What is not public
- Internal portfolio and board discussions
- Unpublished trial data and interim analyses
- Terms of any partner or licence decision