DCCR FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 28, 2024.
FDA Approved: No
Brand name: DCCR
Generic name: diazoxide choline
Dosage form: Extended-Release Tablets
Company: Soleno Therapeutics, Inc.
Treatment for: Prader-Willi Syndrome
DCCR (diazoxide choline) is an extended-release formulation of the crystalline salt of diazoxide in development for the treatment of patients with Prader-Willi syndrome who have hyperphagia.
- 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.
- DCCR 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. Diazoxide has never been approved for use in PWS.
- The U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for DCCR for the treatment of PWS in individuals four years and older who have hyperphagia, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.
Development timeline for DCCR
| Date | Article |
|---|---|
| Aug 27, 2024 | Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome |
Further information
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