NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYKAT XR is an extended-release oral tablet containing diazoxide choline, approved by the FDA on March 26, 2025. The drug is indicated for rare disease management and represents a novel formulation of diazoxide designed for improved patient convenience and compliance. Mechanism of action and specific indications are under commercial development by Soleno Therapeutics.
Growth9.1 years to LOE
Early-stage growth product with minimal competitive pressure offers opportunity to build market presence and establish commercial infrastructure from launch.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Why This Matters for Your Career
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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.