NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
VYKAT XR (diazoxide choline) by Soleno Therapeutics. Approved for hypertriglyceridemia. First approved in 2025.
Drug data last refreshed 20h ago
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (4)
An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities
Started Jan 2023
30 enrolled
SH2B1 Deficiency ObesityObesity Associated With PCSK1 Mutation (rs6232 Variant)SIM1 Deficiency Obesity
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Started May 2018
127 enrolled
Prader-Willi Syndrome
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
Started Oct 2010
44 enrolled
HypertriglyceridemiaDyslipidemia
Diazoxide Choline in Hypertriglyceridemia
Started Jun 2008
80 enrolled
Hypertriglyceridemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.