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PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT Study

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Trial Profile

PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT Study

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 May 2023

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At a glance

  • Drugs Lixivaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions
  • Acronyms The ALERT Study
  • Sponsors Centessa Pharmaceuticals; Palladio Biosciences

Most Recent Events

  • 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.
  • 24 Feb 2022 Status changed from not yet recruiting to recruiting.

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