Intercept Pharmaceuticals
Intercept Pharmaceuticals works on 2 rare diseases tracked on Trial Friend, including Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, with 1 recruiting clinical trial and 1 FDA-approved rare disease drug.
Intercept Pharmaceuticals, acquired by Alfasigma in November 2023, developed therapies for rare liver diseases. The company's key product Ocaliva (obeticholic acid) was voluntarily withdrawn from the US market in September 2025 following FDA safety concerns regarding serious liver injury risk, with all US clinical trials involving obeticholic acid placed on clinical hold.
Focus areas at Intercept Pharmaceuticals
As a rare disease specialist, Intercept Pharmaceuticals has active clinical trial programs and drug development efforts across 2 rare diseases, including Primary Biliary Cholangitis, Primary Sclerosing Cholangitis. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.
The clinical trials section below shows all active and recruiting studies sponsored by Intercept Pharmaceuticals, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.
Intercept Pharmaceuticals is headquartered in Morristown, United States, founded in 2002, a subsidiary of Alfasigma. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.
Intercept Pharmaceuticals Drug Pipeline
Intercept Pharmaceuticals has 1 active clinical trial across 1 development stage, with 1 currently recruiting participants. 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 includes all of Intercept Pharmaceuticals's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.
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.
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.