Diazoxide choline
Orphan DrugFDA Approved (2025)
Description
An extended-release oral formulation of diazoxide choline for hyperphagia in Prader-Willi syndrome. First FDA-approved therapy for PWS hyperphagia (March 2025).
Indications & Therapeutic Use
Prader-Willi syndrome (hyperphagia)
Linked Diseases:
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| Standard Marketing Authorization | — | — | Approved |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Diazoxide choline
| Generic Name | diazoxide choline |
| Brands | 1 brand available |
| Active Ingredient | diazoxide choline |
| Drug Class | Prader-Willi syndrome (hyperphagia) |
| Manufacturer | Soleno Therapeutics |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Not Required |
| Reg. Status | FDA Approved (2025) |
| Countries | 1 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes