Viokat (diazoxide choline)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- diazoxide choline
- Status
- Application withdrawn
- Therapeutic area
- Prader-Willi Syndrome
- CHMP opinion
- Thu 23 Apr 2026
- Designations
- Orphan
- Application
- EMEA/H/C/006576
- ATC
- N07X
- Official record
- www.ema.europa.eu
Indication
Treatment of adult and paediatric patients with Prader-Willi syndrome (PWS).
Regulatory milestones
Mon 29 Jun 2026🇪🇺 Expected EC decisionestimate
Viokat (diazoxide choline): expected EC decision
Estimated as CHMP opinion (2026-04-23) + 67 days, the standard Commission decision period. Not an official date. · source
Thu 23 Apr 2026🇪🇺 CHMP positive opinion
Viokat (diazoxide choline): CHMP positive opinion
Orphan · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.