Soleno Therapeutics launches VYKAT XR for patients with Prader-Willi syndrome

Soleno Therapeutics has launched VYKAT XR (diazoxide choline) extended-release tablets, the company’s treatment for hyperphagia in patients four years of age and older with Prader-Willi syndrome (PWS), which was approved by the FDA in March 2025. Prescriptions of VYKAT XR have now been delivered to the first individuals living with PWS who have been prescribed the medication.

PWS is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births.

The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterised by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behaviour problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behaviour) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.

“We are extremely pleased to begin delivering VYKAT XR, the only FDA-approved treatment for hyperphagia, to individuals living with PWS. Hyperphagia, the hallmark condition of PWS, is the leading cause of mortality in the PWS population and creates a significant burden for caregivers,” said Dr Anish Bhatnagar, Chief Executive Officer of Soleno Therapeutics. “Since FDA approval, we have seen strong interest in VYKAT XR. Our team is fully prepared to meet demand and is well-positioned to execute a successful commercial launch of this first-to-market treatment. These first shipments mark an important step in our efforts to deliver this new treatment to the PWS community and are an exciting milestone reflecting our dedication to ensuring timely access to treatment.”