Obeticholic acid is under clinical development by Intercept Pharmaceuticals and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Obeticholic acid’s likelihood of approval (LoA) and phase transition for Primary Sclerosing Cholangitis took place on 25 Feb 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Obeticholic acid Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Obeticholic acid overview

Obeticholic acid (Ocaliva) is a bile acid analouge. It is formulated as tablets and film coated tablets for oral route of administration. Ocaliva is indicated in the treatment of primary biliary cholangitis, also known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

Obeticholic acid is under development for the treatment of primary sclerosing cholangitis and liver cirrhosis, biliary atresia, alcoholic hepatitis. It is derived from the primary human bile acid chenodeoxycholic acid (CDCA). The drug candidate was under development for the treatment of type 2 diabetes, portal hypertension and bile acid diarrhea. It was also under development for nonalcoholic steatohepatitis (NASH) and for primary biliary cirrhosis (PBC) in China .

Intercept Pharmaceuticals overview

Intercept Pharmaceuticals (Intercept) is a biopharmaceutical company that researches, develops, and commercializes treatments for non-viral, progressive liver diseases. It develops products using proprietary bile acid chemistry. The company’s lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor. The company is advancing OCA for the treatment of various other liver diseases. The company harnesses its proprietary bile acid chemistry to develop innovative drugs. It is also advancing INT-787, an FXR agonist with anti-inflammatory and anti-fibrotic effects that can be used in a broad range of diseases. The company has operations in the US, Europe and Canada. Intercept is headquartered in New York, the US.

Quick View Obeticholic acid LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Obeticholic acid
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Gastrointestinal
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.