VYKAT XR is approved for adults and children 4 years of age and older with Prader-Willi syndrome experiencing hyperphagia. This treatment, approved by the US Food and Drug Administration in March 2025, is the first and only FDA-approved treatment for hyperphagia in PWS.
VYKAT XR is a prescription oral medication for individuals living with Prader-Willi syndrome (PWS) ages 4 and older with hyperphagia. VYKAT XR is an extended-release tablet that must be swallowed whole at the same time every day, with or without food. Crushing, splitting, or chewing the extended-release tablet may compromise the characteristics of the safety and efficacy of the medication.
Dosage is determined based on the patient’s body weight and titrated (increased) on a biweekly basis under a clinician’s supervision until the target dose has been met. Clinicians will use a titration schedule based on VYKAT XR prescribing information.
Prior to receiving treatment, patients must go through laboratory testing to establish a baseline. The bloodwork will test for fasting plasma glucose and HbA1c to ensure the patient is safe to begin treatment and establish safe levels to continue during treatment.
Data from the Phase 3 clinical trial showed statistically significant improvement in hyperphagia, as well as these other benefits:
Note: Clinical trial participants have shared that it can take time for these benefits to be observed and have suggested that you shouldn’t expect immediate results
Some side effects noted from the Phase 3 clinical trial included:
The VYKAT XR Medication Guide recommends checking blood sugar levels before you start VYKAT XR, at least 1 time every week for the first 2 weeks of treatment, then at least 1 time every 4 weeks and as needed during treatment.
Before starting any medication, it’s essential to talk with your doctor about all relevant factors. Proper nutritional management remains a mainstay during VYKAT XR treatment.
For more information about VYKAT XR to treat hyperphagia for those living with PWS, download this VYKAT XR fact sheet from Soleno.
Additional resources from Soleno include:
The Foundation for Prader-Willi Research (federal tax id 31-1763110) is a nonprofit corporation with federal tax exempt status as a public charity under section 501(c)(3).
The mission of FPWR is to eliminate the challenges of Prader-Willi syndrome through the advancement of research and therapeutic development.
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