Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

The FDA has approved the first therapy to address hyperphagia for children and adults aged 4 years and older with ...

The FDA has approved Vykat XR (diazoxide choline) for the treatment of hyperphagia in adults and pediatric patients 4 years ...

Federal regulators are clearing a first-of-its-kind treatment for symptoms of a rare neurodevelopmental disorder that is ...

The United States Food and Drug Administration (US FDA) has approved VYKAT™ XR, a significant milestone as the first approved treatment for hyperphagia in Prader-Willi syndrome (PWS).

Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as Vykat XR – to treat extreme hunger in patients with Prader-Willi ...

Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi ...

Diazoxide choline is the first drug indicated for hyperphagia in the rare genetic disorder. Prior to approval, people with ...

Credit: Solano Therapeutics. Vykat XR contains an extended-release formulation of diazoxide choline, the crystalline salt of diazoxide. Vykat XR is expected to be available in April 2025.

Stacy Ward, CEO of the Prader-Willi Syndrome Association | USA, and Susan Hedstrom, Executive Director of the Foundation for Prader-Willi Research, also acknowledged the approval as a pivotal ...