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# Centessa Scraps Lixivaptan in Kidney Disease
- URL: https://www.fdaweb.com/centessa-scraps-lixivaptan-in-kidney-disease/
- Published: 2022-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:47:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151955

Centessa Pharmaceuticals has decided to discontinue developing lixivaptan for autosomal dominant polycystic kidney disease (ADPKD). The company says its “strategic decision” to stop the Phase 3 ACTION study and the open-label ALERT study was 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 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations in one subject in the ALERT study.”

ALERT was designed to provide an early assessment of lixivaptan’s safety profile in ADPKD patients who previously experienced liver chemistry abnormalities while treated with tolvaptan, the only FDA-approved therapy for ADPKD, the company says. “In assessing the recent data from a subject in the ALERT Study, we believe that lixivaptan is unlikely to achieve the differentiated safety and tolerability profile Centessa required for further development of the program,” it says.