Treats hyperphagia. NDA 216665, held by Soleno. Diazoxide Choline.
As of Nov 13, 2026, NDA 216665 (Vykat Xr), held by Soleno, was first approved by FDA on Mar 26, 2025, with 0 approved supplements and 0 published complete response letters.
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).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2025 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vykat Xr25MG · tablet, extended release;oral | Diazoxide Choline | RxReference drug |
| Vykat Xr75MG · tablet, extended release;oral | Diazoxide Choline | RxReference drug |
| Vykat Xr150MG · tablet, extended release;oral | Diazoxide Choline | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
