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Drugs acting on the gastrointestinal system and metabolism
Maralixibat chloride
Другие языки:

    Maralixibat chloride

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    Maralixibat chloride
    Maralixibat chloride skeletal.svg
    Clinical data
    Trade names Livmarli
    Other names LUM001
    AHFS/Drugs.com Monograph
    License data
    Routes of
    administration    		 By mouth
    Drug class Ileal bile acid transporter (IBAT) inhibitor
    ATC code
    Legal status
    Legal status
    Identifiers
    • 1-[4-({4-[(4R,5R)-3,3-Dibutyl-7-(dimethylamino)-4-hydroxy-1,1-dioxido-2,3,4,5-tetrahydro-1-benzothiepin-5-yl]phenoxy}methyl)benzyl]-4-aza-1-azoniabicyclo[2.2.2]octane
    CAS Number
    DrugBank
    ChemSpider
    UNII
    KEGG
    ChEMBL
    Chemical and physical data
    Formula C40H56ClN3O4S
    Molar mass 710.42 g·mol−1
    3D model (JSmol)
    • CCCCC1(CCCC)CS(=O)(=O)C2=CC=C(C=C2[C@H]([C@H]1O)C1=CC=C(OCC2=CC=C(C[N+]34CCN(CC3)CC4)C=C2)C=C1)N(C)C
    • InChI=1S/C40H56N3O4S/c1-5-7-19-40(20-8-6-2)30-48(45,46)37-18-15-34(41(3)4)27-36(37)38(39(40)44)33-13-16-35(17-14-33)47-29-32-11-9-31(10-12-32)28-43-24-21-42(22-25-43)23-26-43/h9-18,27,38-39,44H,5-8,19-26,28-30H2,1-4H3/q+1/t38-,39-/m1/s1
    • Key:STPKWKPURVSAJF-LJEWAXOPSA-N

    Maralixibat chloride, sold under the brand name Livmarli, is a medication used to treat cholestatic pruritus in people with Alagille syndrome. Maralixibat chloride is an ileal bile acid transporter (IBAT) inhibitor.

    The most common side effects include diarrhea and abdominal pain (belly ache).

    Maralixibat chloride was approved for medical use in the United States in September 2021, and in the European Union in December 2022.

    Medical uses

    Maralixibat chloride is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome.

    History

    The U.S. Food and Drug Administration (FDA) granted the application for maralixibat chloride orphan drug designations in 2013, and in 2020.

    Society and culture

    Legal status

    On 13 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). The applicant for this medicinal product is Mirum Pharmaceuticals International B.V. Maralixibat chloride was approved for medical use in the European Union in December 2022.

    Names

    Maralixibat chloride is the international nonproprietary name (INN).

    External links

    • "Maralixibat". Drug Information Portal. U.S. National Library of Medicine.
    • "Maralixibat chloride". Drug Information Portal. U.S. National Library of Medicine.
    • Clinical trial number NCT02160782 for "Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS) (ICONIC)" at ClinicalTrials.gov



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