Since the FDA approved recombinant human growth hormone (rhGH) for Prader-Willi syndrome in 2000, numerous companies have faced challenges in developing more advanced treatments for hyperphagia, the uncontrollable hunger associated with PWS.
However, in March 2025, Soleno Therapeutics marked a major milestone with the approval of VYKAT XR (diazoxide choline), making it the first FDA-approved Prader-Willi syndrome drug for hyperphagia. VYKAT XR is indicated for patients aged 4 years and older with PWS, a disorder characterized by low muscle tone, short stature, and cognitive and developmental difficulties.
Before that, multiple companies have encountered obstacle...
