Maralixibat chlorideProduct ingredient for Maralixibat

Maralixibat (also known as SHP625, LUM001, and lopixibat) is an ileal bile acid transporter inhibitor, like odevixibat.^1,2,3 Maralixibat is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome.³

Previously, patients with cholestatic pruritus associated with Alagille syndrome were treated with antihistamines, rifampin, ursodeoxycholic acid, cholestyramine, naltrexone, and sertraline alone or in combination.² No clinical trials have been performed to assess the efficacy of these treatments for cholestatic pruritus and treatments were given based on a prescriber's clinical experience.² Surgical interventions such as partial external bile diversion and ileal exclusion have also been used as treatments.²

Maralixibat represents the first FDA-approved treatment for cholestatic pruritus in patients with Alagille syndrome. It was granted FDA approval on 29 September 2021.³ In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended maralixibat be granted marketing authorization for the treatment of cholestatic pruritus in patients with Alagille syndrome:⁴ it was granted marketing authorization in Europe on 13 December 2022.⁶ On July 21, 2023, maralixibat was also approved by Health Canada.⁷