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 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 won approval for a drug that treats excessive hunger associated with a rare disease, and the biotech stock rocketed.

Soleno expects VYKAT XR to be available in the U.S. beginning in April 2025. “The approval of VYKAT XR is a significant milestone for Soleno and, most importantly, for the PWS community who have ...

The FDA has approved Soleno Therapeutics’ Vykat XR (diazoxide choline) extended-release tablets to treat hyperphagia in individuals aged four years and older with Prader-Willi syndrome (PWS). The ...

Diazoxide (as choline) 25mg, 75mg, 150mg; ext-rel tabs. <4yrs: not established. Swallow whole. Take with or without food once daily. ≥4yrs: (20–<30kg): Initially 25mg (Weeks 1 and 2), increase ...

Prescriptions of VYKAT XR have now been delivered to the first individuals living with PWS who have been prescribed the medication. “We are extremely pleased to begin delivering VYKAT XR ...

INDICATION VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). Contraindications Use of VYKAT XR is ...