Soleno Therapeutics has announced the commercial launch of VYKAT™ XR (diazoxide choline) extended-release tablets in the United States.
PWS is a rare neurodevelopmental genetic disorder resulting from issues with gene expression on chromosome 15. According to the Prader-Willi Syndrome Association USA, it affects approximately one in every 15,000 live births.
The condition is primarily characterised by hyperphagia—an intense and ongoing sense of hunger that leads to compulsive food-seeking behaviours.
This can result in serious health risks, including stomach rupture, choking, accidental injuries, and long-term complications such as obesity, diabetes, and cardiovascular disease.
The treatment is now available for managing hyperphagia in individuals aged four and above diagnosed with Prader-Willi syndrome (PWS).
VYKAT XR received approval from the U.S. Food and Drug Administration (FDA) on 26 March 2025.
Deliveries of VYKAT XR have commenced, reaching the first patients prescribed the medicine. It is currently the only FDA-approved treatment specifically for hyperphagia associated with PWS.
Hyperphagia, the core symptom of PWS, is a chronic condition marked by an abnormal and persistent hunger that significantly impacts both patients and caregivers. It is also recognised as a leading cause of health complications and increased mortality in individuals with PWS.
To support access to treatment, Soleno has launched a patient support initiative called Soleno ONE™. This programme aims to assist patients, caregivers, and healthcare professionals in navigating the prescription and distribution process.