Maralixibat chloride is under clinical development by Mirum Pharmaceuticals and currently in the Phase II and Phase III 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 Maralixibat chloride’s likelihood of approval (LoA) and phase transition for Progressive Familial Intrahepatic Cholestasis took place on 26 Oct 2022, 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 Maralixibat chloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Maralixibat chloride overview

Maralixibat chloride (Livmarli) is an anti-pruritus agent. It is formulted as solution for oral route of administration. Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

Maralixibat chloride (SHP-625, LUM-001) is under development for the treatment of alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC) type 2 in children’s, biliary atresia. It is administered orally as a solution. The drug candidate specifically targets the apical sodium-dependent bile acid transporter (ASBT).

 It was also under development for the treatment of primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC).

Mirum Pharmaceuticals overview

Mirum Pharmaceuticals is biopharmaceutical company that develops a pipeline of novel therapies for debilitating liver diseases. The company’s pipeline products include Maralixabat, minimally absorbed, orally administered investigational drug and Volixibat, a minimally absorbed agent designed to selectively inhibit ASBT. It develops products to treat rare cholestatic liver diseases that include progressive familial intrahepatic cholestasis (PFIC), alagille syndrome (ALGS), biliary atresia (BA), primary sclerosing cholangitis (PSC) and intrahepatic cholestasis of pregnancy (ICP). Mirum Pharmaceuticals is headquartered in Foster City, California, the US.

Quick View Maralixibat chloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Maralixibat chloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Genetic Disorders
Key Developers
  • Sponsor Company: Mirum Pharmaceuticals
  • Originator: Pfizer
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.