Intercept Pharmaceuticals
Intercept Pharmaceuticals works on 2 rare diseases tracked on Trial Friend, including Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, with 1 active clinical trial and 1 FDA-approved rare disease drug.
Intercept Pharmaceuticals, a Morristown, New Jersey company focused on rare liver diseases, has been a wholly owned subsidiary of Alfasigma since November 2023. Its first drug, Ocaliva (obeticholic acid), is no longer available in the US. Intercept withdrew it from the US market on September 11, 2025 at the FDA's request, after the FDA raised concerns about serious liver injury, and the FDA placed a clinical hold on all Intercept trials of obeticholic acid run under a US IND. The FDA withdrew Ocaliva's approval effective November 24, 2025. Intercept now markets Lynavoy (linerixibat) in the US, a twice-daily tablet the FDA approved on March 17, 2026 for itch caused by primary biliary cholangitis in adults. GSK developed it and licensed worldwide rights to Alfasigma in a deal that closed on April 27, 2026.
Intercept Pharmaceuticals Drug Pipeline
Intercept Pharmaceuticals has 1 active clinical trial across 1 development stage. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.
Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.
Intercept Pharmaceuticals Clinical Trials (1)
Active and recruiting clinical trials sponsored by Intercept Pharmaceuticals, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.
Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.
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Intercept Pharmaceuticals FDA-Approved Drugs (1)
Medications developed or marketed by Intercept Pharmaceuticals that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.
| Drug Name | Brand Name | Rare Diseases | Approval Date |
|---|---|---|---|
| LINERIXIBAT Ileal Bile Acid Transporter Inhibitor [EPC] | Lynavoy oral | Mar 17, 2026 |
Intercept Pharmaceuticals Trial Locations
Intercept Pharmaceuticals clinical trials are running at 18 sites in 10 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.
Rare Disease Focus Areas (2)
Diseases targeted by Intercept Pharmaceuticals's clinical trial and drug development programs
Primary Biliary Cholangitis (PBC) is a chronic autoimmune liver disease in which the immune system mistakenly attacks the small bile ducts in the liver, leading to bile duct destruction and progressiv...
Primary Sclerosing Cholangitis (PSC) is a rare chronic liver disease characterized by inflammation and progressive scarring of the bile ducts, both inside and outside the liver. This leads to bile duc...
Patient Resources
Organizations and resources related to Intercept Pharmaceuticals's rare disease focus areas
Frequently Asked Questions About Intercept Pharmaceuticals
Common questions about Intercept Pharmaceuticals's rare disease programs, clinical trials, and treatments.