Intercept Pharmaceuticals has terminated its Phase 3 long-term safety extension of obeticholic acid (OCA; Ocaliva) in primary biliary cholangitis (PBC), the registry record now shows — a closure that follows the FDA’s withdrawal of approval for Ocaliva.
The trial, NCT06488911, was an open-label extension evaluating the safety and tolerability of a fixed-dose combination tablet of obeticholic acid 5 mg plus bezafibrate 400 mg SR in PBC patients rolling over from two earlier studies (747-213 and 747-214). Its status is now listed as TERMINATED, with an enrollment of 62 participants and a completion date of October 21, 2025. The study ran at sites in the United States and across more than a dozen other countries, including Argentina, Australia, the United Kingdom, and several EU member states.
In the registry’s “why stopped” field, Intercept says it “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.” That clinical-hold statement is Intercept’s own characterization in the ClinicalTrials.gov record; the FDA’s Federal Register withdrawal notice does not mention any clinical hold, addressing only the withdrawal of the marketing applications.
If you take Ocaliva for PBC: do not stop the medication on your own. Talk to your healthcare provider about safely transitioning to an alternative therapy. This is general information, not medical advice.
What patients on Ocaliva should know
This is a regulatory and trial-status story, not a directive to stop treatment. PBC patients currently taking Ocaliva should not discontinue the medication on their own and should consult their healthcare provider about transitioning to an alternative therapy. The withdrawal was deliberately structured with a transition period — the drug came off the US commercial market on November 14, 2025, after a window for patients to consult their providers about other options — precisely to avoid abrupt, unsupervised discontinuation. Intercept’s own withdrawal guidance states that “Patients should talk to their healthcare professionals” and that “Other therapies are FDA approved for the treatment of PBC.”
Losing Ocaliva does not mean PBC goes untreated. First-line therapy remains ursodiol (ursodeoxycholic acid, UDCA), which is FDA-approved for PBC; additional FDA-approved second-line options exist for patients with an inadequate response to or intolerance of UDCA, including elafibranor (Iqirvo), which received FDA accelerated approval in June 2024. The right next step for an affected reader is a conversation with their clinician, not self-discontinuation.
Why approval was pulled
The closure follows the FDA’s November 24, 2025 Federal Register notice withdrawing approval of NDA 207999 for Ocaliva tablets, 5 mg and 10 mg, along with three generic ANDAs (214862, 214980, and 215017). Two distinct dates sit in the public record and should not be collapsed into a single event: the commercial market withdrawal — when the product came off US shelves after the patient transition window — took effect on or about November 14, 2025, while the approval withdrawal of the marketing applications became effective November 24, 2025 under the Federal Register notice. Ocaliva had reached the US market in 2016 under accelerated approval, which the FDA notes was “subject to the requirement that Intercept conduct a postmarketing trial to verify and describe the clinical benefit of OCALIVA.” Per the FDA, that trial fell short: on August 27, 2025, the agency notified Intercept “that the postmarketing trial did not verify clinical benefit and that OCALIVA-treated PBC patients in the postmarketing trial who had early-stage disease at baseline had an excess of liver transplants and deaths.”
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.” — ClinicalTrials.gov NCT06488911, sponsor-authored field
Intercept submitted a letter on September 10, 2025 asking the agency to withdraw the NDA under § 314.150(d) and to waive the expedited withdrawal procedures; approval was withdrawn as of November 24, 2025, under docket FDA-2025-N-5935. The notice was signed by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
The terminated extension was a safety study, not an efficacy trial: its primary outcomes were counts of treatment-emergent adverse events, with all-cause mortality among the secondary measures. No comparative efficacy endpoint was at stake here. The decisive evidence sat in the confirmatory postmarketing trial the FDA cites — the basis for an accelerated approval that has now been unwound.