Intercept Pharmaceuticals is dedicated to developing innovative treatments for rare and serious liver diseases, with a particular focus on primary biliary cholangitis (PBC). The company has pioneered the use of Farnesoid X Receptor (FXR) biology as a central element of its therapeutic research, leading to the development of the first and only FDA-approved FXR agonist for the second-line treatment of PBC. Intercept's research portfolio is built on novel scientific targets that have the potential for therapeutic application across various liver conditions, including severe alcohol-associated hepatitis. This commitment to advancing liver health is reflected in their ongoing clinical trials and the exploration of fixed-dose combination therapies aimed at improving patient outcomes.

In addition to its research and development efforts, Intercept Pharmaceuticals emphasizes the importance of compassionate use programs, allowing patients with life-threatening conditions to access investigational medicines outside of clinical trials when traditional treatment options have been exhausted. The company has established criteria for evaluating such requests, ensuring that the potential benefits of the investigational therapies outweigh the risks. This approach underscores Intercept's dedication to patient care and its mission to provide meaningful solutions for individuals affected by liver diseases.

United States

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).

Digestive System Diseases

Liver Diseases

Intercept Pharmaceuticals

COVID-19

Infectious disease

Liver disease

Primary biliary cholangitis

Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf">Source</a> - FDA Label (section 12.1)

OCALIVA® (obeticholic acid)

Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids. (<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf">page 10</a>)&nbsp;
 
Bezafibrate, a pan-peroxisome proliferator-activated receptor (PPAR) agonist that has been studied in PBC, is not approved in the U.S. for any indication. I

Ocaliva + Bezafibrate

Alcoholic hepatitis

INT-787

Non-alcoholic steatohepatitis

Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids. (<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf">page 10</a>)&nbsp;

Ocaliva

Primary sclerosing cholangitis

Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf">Source</a> - FDA Label (section 12.1)

Intercept Pharmaceuticals

Company Details