Vykat XR FDA Approval History
Last updated by Judith Stewart, BPharm on March 27, 2025.
FDA Approved: Yes (First approved March 26, 2025)
Brand name: Vykat XR
Generic name: diazoxide choline
Dosage form: Extended-Release Tablets
Previous Name: DCCR
Company: Soleno Therapeutics, Inc.
Treatment for: Prader-Willi Syndrome
Vykat XR (diazoxide choline) is an extended-release formulation of the crystalline salt of diazoxide for use in the treatment of hyperphagia in patients with Prader-Willi syndrome.
- Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by hyperphagia (feelings of intense, persistent hunger), behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), accumulation of excess body fat, developmental delays, and incomplete sexual development.
- Vykat XR is thought to work in the treatment of hyperphagia in PWS patients through activation of the adenosine triphosphate-sensitive potassium channels in the hypothalamus.
- Diazoxide has been approved for decades for use in the emergency reduction of severely elevated blood pressure and the management of hypoglycemia due to hyperinsulinism.
- FDA approval of Vykat XR was based on data from the Phase 3 Study 2-RWP (Study C602-RWP) multi-center, double-blind, placebo-controlled trial. During the 16-week randomized withdrawal study period, individuals randomized to switch to placebo demonstrated a statistically significant worsening of hyperphagia compared with individuals who remained on Vykat XR.
- Vykat XR extended-release tablets are administered orally once daily.
- Warnings and precautions associated with Vykat XR include hyperglycemia and risk of fluid overload.
- Common adverse reactions (incidence ≥10% and at least 2% greater than in placebo) include hypertrichosis, edema, hyperglycemia, and rash.
Development timeline for Vykat XR
Further information
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