The Food and Drug Administration (FDA) has granted orphan drug designation to lixivaptan (Palladio Biosciences) for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Currently, there are no FDA-approved treatments for ADPKD.

Lixivaptan is a potent, selective vasopressin V2 receptor antagonist which may delay the progression of an autosomal dominant form of polycystic kidney disease. This investigational agent was previously tested in 1,673 patients across 36 clinical studies as part of a prior clinical development program for the treatment of hyponatremia.

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“Lixivaptan has the potential to slow the progression of ADPKD and possibly delay the need for dialysis or a kidney transplant,” said Lorenzo Pellegrini, Ph.D., Founder and Chief Executive Officer of Palladio. “The granting of orphan drug designation is an important milestone in the lixivaptan development program.”

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