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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

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: 12 Oct 2023

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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

    • 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.
    • 25 Jul 2023 According to a Mirum Pharmaceuticals media release, data from this study were published in the Hepatology.
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