FDA Approves VYKAT XR, First Therapy for Hyperphagia in Prader-Willi Syndrome

The once-daily oral treatment will be available in the U.S. starting April 2025, offering new hope for patients and families affected by the rare genetic disorder.

VYKAT XR, developed by Soleno Therapeutics, is the first FDA-approved therapy to treat hyperphagia in individuals with Prader-Willi syndrome (PWS).
The approval is based on a Phase 3 trial that demonstrated significant efficacy in managing hyperphagia-related behaviors compared to placebo.
The drug, suitable for adults and children aged 4 and older, has a well-established safety profile, with common side effects including hypertrichosis, edema, hyperglycemia, and rash.
Advocacy groups and medical professionals have celebrated the approval as a transformative milestone for the PWS community.
Soleno Therapeutics has launched the Soleno One program to support patient access, and the company’s stock surged over 40% following the announcement.