Odevixibat is a Small Molecule owned by Albireo Pharma, and is involved in 16 clinical trials, of which 10 were completed, 5 are ongoing, and 1 is planned.

Bylvay (A-4250) acts by inhibiting ileal bile acid transporter (IBAT). Ileum absorbs glyco-and taurine-conjugated forms of the bile salts. The apical sodium-dependent bile salt transporter (ASBT, IBAT) is the first step in absorption at the brush-border membrane. A4250 works by decreasing the re-absorption of bile acids and reduces the toxic levels of bile acids during the progression of the disease. It exhibits therapeutic intervention by checking the transport of bile acids.

The revenue for Odevixibat is expected to reach a total of $7.9bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Odevixibat NPV Report.

Odevixibat was originated by AstraZeneca and is currently owned by Albireo Pharma.

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.

The company reported revenues of (US Dollars) US$40.6 million for the fiscal year ended December 2021 (FY2021), compared to a revenue of US$8.3 million in FY2020. The operating loss of the company was US$123.5 million in FY2021, compared to an operating loss of US$96.3 million in FY2020. The net loss of the company was US$34 million in FY2021, compared to a net loss of US$107.6 million in FY2020. The company reported revenues of US$9.8 million for the third quarter ended September 2022, an increase of 19.8% over the previous quarter.

Quick View – Odevixibat

Report Segments
  • Innovator (NME)
Drug Name
  • Odevixibat
Administration Pathway
  • Oral
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Genetic Disorders
  • Metabolic Disorders
Key Companies
Highest Development Stage
  • Marketed

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.