Rare disease drugmaker · part of Alfasigma · based in Morristown, United States · founded 2002 · interceptpharma.com
Intercept Pharmaceuticals works on Primary Biliary Cholangitis and Primary Sclerosing Cholangitis, 2 of the rare diseases we track. It has 1 active clinical trial, though none is looking for new volunteers right now. It also has 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 Pharmaceuticals pipeline
Each row lists the diseases Intercept Pharmaceuticals is studying at that stage, from the ones closest to approval down to the earliest work.
Studies with no phase listed, such as registries and natural history studies.
NAFLD
Intercept Pharmaceuticals clinical trials
These are Intercept Pharmaceuticals trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
1 trial underway, not taking new volunteers
Underway, not taking new volunteersHasn't posted an update in over a yearNCT05479721
LITMUS Imaging Study
For NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver and Steatosis of Liver
The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.
Are any of these trials recruiting near Nashville?
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Trial Alerts, when a new trial opens or a trial changes
Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
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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.
Where Intercept Pharmaceuticals trials take place
The trials above run at 18 study sites in 10 countries. Tap a country to see its states, cities and hospitals.
United Kingdom
4▼
Spain
3▼
France
2▼
Germany
2▼
Italy
2▼
United States
1▼
Finland
1▼
Greece
1▼
Sweden
1▼
Switzerland
1▼
Rare diseases Intercept Pharmaceuticals works on
Each disease page lists every open trial, not only Intercept Pharmaceuticals's, plus approved treatments.
Primary Biliary Cholangitis (PBC) is a chronicautoimmune liver disease in which the immune system mistakenly attacks the small bile ducts in the liver, leading to bile duct destruction and...
How common: About 14.6 per 100,000 people worldwide in a 2021 pooled analysis of 47 population studies, highest in North America (21.8 per 100,000) and lowest in the Asia-Pacific region (9.8 per 100,000)
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.
How common: About 13.5 per 100,000 people in a 2024 pooled analysis of 12 population studies from North America, Europe, Asia and Oceania, with about 0.9 new cases per 100,000 people a year (Cooper et al., Inflamm Bowel Dis 2024); higher in Scandinavian countries; associated with IBD in 50-80% of PSC patients
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Intercept Pharmaceuticals's own site is interceptpharma.com, and our help paying for treatment page lists drugmaker programs and charity funds.
1 shared disease, including Primary Biliary Cholangitis
Questions about Intercept Pharmaceuticals
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 has active programs across 2 rare diseases: Primary Biliary Cholangitis, Primary Sclerosing Cholangitis. Each disease page on Trial Friend shows the latest recruiting trials, FDA-approved treatments, and patient resources.
Yes. Intercept Pharmaceuticals is a rare disease specialist headquartered in Morristown, United States, founded in 2002. The company focuses primarily on developing treatments for rare and orphan diseases, with programs targeting Primary Biliary Cholangitis, Primary Sclerosing Cholangitis. It operates as part of Alfasigma.
The clinical trials section on this page shows active and recruiting rare disease trials sponsored by Intercept Pharmaceuticals, pulled live from ClinicalTrials.gov. Each trial card includes the study phase, recruitment status, conditions being studied, number of trial sites, and a direct link to the full study record. You can also explore individual disease pages to see trials from all sponsors for a specific condition.
To explore enrollment, find a recruiting trial in the clinical trials list on this page and click "View full study" to see the full ClinicalTrials.gov record, which includes eligibility criteria, study locations, and contact information for each trial site. Your doctor can also help determine if a specific trial is appropriate for your condition. Not all trials are open at every location, so check the site list for one near you.
Intercept Pharmaceuticals has 1 FDA-approved drug with a rare disease use that we track, as of November 2026.
Source: the FDA's openFDA label database, matched to the rare diseases on Trial Friend; the list updates automatically and can include older products.
Yes, for 1 of its FDA-approved rare disease medicine that we track, each checked on Intercept Pharmaceuticals' own website.
Lynavoy: Interconnect Support Services (Intercept Pharmaceuticals), 1-844-622-4278. Offers copay help with private insurance and insurance help. Checked November 9, 2026.
Medicare and Medicaid: drugmaker copay cards are limited to private insurance, so people with government coverage usually look to a free medicine program or a charity fund, both on the help paying page.
Eligibility is decided by each program, so call the number listed before a prescription is filled.
Intercept Pharmaceuticals was founded in 2002 and is headquartered in Morristown, United States. The company has been active for 24 years. It is a subsidiary of Alfasigma. As a rare disease specialist, the company dedicates its resources to developing therapies for patients with rare and orphan conditions.