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

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).

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

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.

Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as ...

Soleno Therapeutics today announced that the US FDA has approved VYKAT XR (diazoxide choline) extended-release tablets, for ...

PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to ...

The US Food and Drug Administration (FDA) has approved Soleno Therapeutics’ Vykat XR (diazoxide choline) extended-release ...

Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for Prader-Willi syndrome (PWS), a rare genetic ...

The FDA’s approval of VYKAT XR for the treatment of hyperphagia in patients with PWS came with a clean label and reasonable monitoring requirements. This outcome represents a best-case scenario ...

Vykat XR is specifically indicated to address hyperphagia, or the abnormally strong sensation of hunger, which often leads to ...

US FDA approves Soleno Therapeutics’ Vykat XR to treat hyperphagia in Prader-Willi syndrome: Redwood City, California Saturday, March 29, 2025, 18:00 Hrs [IST] Soleno Therapeuti ...