Clinical data | |
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Trade names | Livmarli |
Other names | LUM001 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a621056 |
License data | |
Routes of administration | By mouth |
Drug class | Ileal bile acid transporter (IBAT) inhibitor |
ATC code | |
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Chemical and physical data | |
Formula | C40H56ClN3O4S |
Molar mass | 710.42 g·mol−1 |
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Maralixibat chloride, sold under the brand name Livmarli, is a medication used to treat cholestatic pruritus in people with Alagille syndrome.[5][6] Maralixibat chloride is an ileal bile acid transporter (IBAT) inhibitor.[5]
The most common side effects include diarrhea and abdominal pain (belly ache).[6]
Maralixibat chloride was approved for medical use in the United States in September 2021,[5][7][8][9] and in the European Union in December 2022.[6]
Maralixibat chloride is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome.[5][6]
The U.S. Food and Drug Administration (FDA) granted the application for maralixibat chloride orphan drug designations in 2013,[10][11] and in 2020.[12][13]
In October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Livmarli, intended for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).[14] The applicant for this medicinal product is Mirum Pharmaceuticals International B.V.[14] Maralixibat chloride was approved for medical use in the European Union in December 2022.[6][15]
Maralixibat chloride is the international nonproprietary name (INN).[16]