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Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome

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Trial Profile

Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2024

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At a glance

  • Drugs Maralixibat (Primary)
  • Indications Alagille syndrome; Cholestasis; Pruritus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ICONIC
  • Sponsors Lumena Pharmaceuticals; Mirum Pharmaceuticals; Shire; Takeda

Most Recent Events

  • 02 Apr 2024 According to a Mirum Pharmaceuticals media release, the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee has recommended public reimbursement for LIVMARLI for the treatment of cholestatic pruritus in patients with ALGS, with certain conditions. The CADTH recommendation is based on data from this study including six years of data across the LIVMARLI clinical program resulting in a robust body of evidence in patients with cholestatic pruritus in ALGS.
  • 08 Oct 2023 According to a CANbridge Pharmaceuticals media release, CAN108 (Maralixibat Chloride Oral Solution /LIVMARLI) has been approved by the Taiwan Food and Drug Administration (TFDA), based on data from pivotal ICONIC study and RISE infant safety study, in addition to years of data collected from the program in patients with ALGS.
  • 28 Sep 2023 According to a CANbridge Pharmaceuticals media release, company announced the marketing approval of CAN108 (Maralixibat Chloride Oral Solution/LIVMARLI) by the Pharmacy & Poisons Board of Hong Kong. The approval of LIVMARLI is based on data from Mirum Pharmaceuticals pivotal ICONIC study and RISE infant safety study, in addition to years of data collected from the program in patients with ALGS.

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