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A 2-Year, Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase

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Trial Profile

A 2-Year, Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2023

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At a glance

  • Drugs Lixivaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ACTION
  • Sponsors Palladio Biosciences

    • Most Recent Events

    • 13 Oct 2022 According to Eudra record, the trial has been prematurely ended in Spain, Hungary, Slovakia, Poland, and Bulgaria.
    • 02 Jun 2022 According to a Centessa Pharmaceuticals media release, the company has decided to discontinue development of lixivaptan for ADPKD including both the ACTION and the open-label ALERT Study based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD, and the incremental development challenges and associated costs, following a recent observation of ALT and AST elevations in one subject in the ALERT Study.
    • 02 Jun 2022 Status changed from recruiting to discontinued, according to a Centessa Pharmaceuticals media release.
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