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Diazoxide choline

Phase 2FDA approved

Hypertriglyceridemia | Small molecule | Metabolic |Medpace Holdings, Inc. Common Stock|Last Updated: Nov 8, 2010

Development status

FDA approval on record Mar 26, 2025 as Vykat Xr
Approval holderSoleno Therap
ApplicationNDA216665
Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2008

Label indication VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). ( 1 ) FDA label

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Diazoxide choline · 1 trial · 1 indication

Phase 2 1
NCT00696475Diazoxide Choline in HypertriglyceridemiaHypertriglyceridemia
COMPLETED80 Analytics
PHASE2COMPLETED
Diazoxide Choline in Hypertriglyceridemia
Hypertriglyceridemia
NCT0069647580
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Study Endpoints

Primary Endpoints

To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
8 weeks

Secondary Endpoints

To assess the effect on other lipid parameters (LDL, HDL, VLDL, and non-HDL cholesterol), insulin, glucose and weight of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
8 weeks
To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDiazoxide equivalent dose
2EXPERIMENTALDiazoxide equivalent dose
3EXPERIMENTALDiazoxide equivalent dose
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Diazoxide cholineDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * triglycerides ≥ 250 mg/dL and \< 600 mg/dL * BMI between 18.5 and 45 * Signed informed consent form Exclusion Criteria: * Fasting glucose ≥ 126 mg/dL * Glycosylated hemoglobin (HbA1c) \> 6.5% * LDL cholesterol \> 190 mg/dL * Known history of type I and II DM * Known history ...

Countries:United States
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