Odevixibat is under clinical development by Albireo Pharma and currently in the Phase II, Phase III and Pre-Registration 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 Odevixibat’s likelihood of approval (LoA) and phase transition for Pruritus took place on 07 Sep 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Odevixibat overview

Odevixibat Sesquihydrate (Bylvay) is acts by targeting ileal bile acid transporter (IBAT) which is developed based on specialized delivery technology in which the bile acids are neutralized in the large bowel. It is formulated as capsules, pellets, hard capsules for oral route of administration. Bylvay is indicated for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC).

A-4250 is under development for the treatment of pediatric cholestatic liver diseases such as primary sclerosing cholangitis, progressive familial intrahepatic cholestasis (PFIC), cholestatic pruritus, biliary atresia and alagille syndrome. It is administered as a once a daily capsule through oral route. The drug candidate acts by targeting ileal bile acid transporter (IBAT). The drug candidate is developed based on specialized delivery technology in which the bile acids are neutralized in the large bowel.

The drug candidate was under development for the treatment of pediatric cancer, primary biliary cholangitis (PBC), primary sclerosing cholangitis, nonalcoholic steatohepatitis (NASH) primary biliary cirrhosis, nonalcoholic fatty liver disease (NAFLD) and dyslipidemia.

Albireo Pharma overview

Albireo Pharma (Albireo), formerly Biodel, It focuses on the development and commercialization of novel bile acid modulators for treatment of orphan pediatric liver diseases, gastrointestinal (GI) disorders and other diseases. Its pipeline products include odevixibat (A4250) intended for treatment of progressive familial intrahepatic cholestasis (PFIC), biliary atresia, alagille syndrome and other cholestaticc; A3384 for bile acid malabsorption; and elobixibat for nonalcoholic steatohepatitis (NASH). Elobixibat is approved in Japan for the treatment of chronic constipation. The company is investigating bile acid modulator for nonalcoholic steatohepatitis (NASH) and other preclinical trials for the treatment of adult liver diseases. It operates in the US, the UK, and Sweden. Albireo is headquartered in Boston, Massachusetts, the US.

Quick View Odevixibat LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Odevixibat
Administration Pathway
  • Oral
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Genetic Disorders
  • 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.