Numerous clinical trials spanning early to late phases evaluate diazoxide across metabolic and endocrine conditions, including congenital hyperinsulinism, hypertriglyceridemia, diabetes mellitus, Prader-Willi syndrome, ischemia-reperfusion injury, and obesity. Sponsored by biopharmaceutical companies and academic institutions, these studies encompass completed, recruiting, active, and withdrawn protocols. Across diverse patient populations, these trials assess pharmacokinetic profiles, pathway mechanisms, and therapeutic efficacy.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07403604 | RECRUITING | Hyperinsulinemia; Insulin Resistance; Non-Alcoholic Fatty Liver Disease; Prediabetic State; Obesity |
Columbia University |
2026-07-01 | PHASE1 |
| NCT05701774 | ACTIVE_NOT_RECRUITING | Prader-Willi Syndrome |
Soleno Therapeutics, Inc. |
2023-01-31 | PHASE3 |
| NCT03540758 | RECRUITING | Diabetes Mellitus; Glucose Metabolism Disorders |
Albert Einstein College of Medicine |
2018-08-01 | PHASE2 |
| NCT06606327 | TERMINATED | Insulin Resistance; Hyperinsulinemia; Obesity |
Columbia University |
2024-10-23 | PHASE1 |
| NCT05729282 | COMPLETED | Hyperinsulinemia; Insulin Resistance; Non-Alcoholic Fatty Liver Disease; Prediabetic State |
Columbia University |
2023-08-01 | PHASE1 |
| NCT04830982 | WITHDRAWN | Myocardial Stunning |
Johns Hopkins University |
2023-09-01 | PHASE1 |
| NCT06308107 | COMPLETED | Myocardial Stunning |
Johns Hopkins University |
2024-07-08 | PHASE1 |
| NCT05532020 | UNKNOWN | SH2B1 Deficiency Obesity; Obesity Associated With PCSK1 Mutation (rs6232 Variant); SIM1 Deficiency Obesity |
Soleno Therapeutics, Inc. |
2023-01 | PHASE2 |
| NCT03714373 | COMPLETED | Prader-Willi Syndrome |
Soleno Therapeutics, Inc. |
2018-10-01 | PHASE3 |
| NCT03685773 | WITHDRAWN | Diabetes Mellitus, Type 2; Glucose, High Blood; Glucose Metabolism Disorders |
Albert Einstein College of Medicine |
2019-04-21 | PHASE2 |
| NCT03566511 | TERMINATED | Diabetes Mellitus, Type 2; Glucose, High Blood; Glucose Metabolism Disorders (Including Diabetes Mellitus) |
Meredith Hawkins |
2018-06-12 | PHASE2 |
| NCT03440814 | COMPLETED | Prader-Willi Syndrome |
Soleno Therapeutics, Inc. |
2018-05-09 | PHASE3 |
| NCT04086810 | WITHDRAWN | Prader-Willi Syndrome |
Soleno Therapeutics, Inc. |
2019-10 | PHASE3 |
| NCT03608163 | TERMINATED | Diabetes Mellitus, Type 1; Hypoglycemia; Hypoglycemia Unawareness |
Albert Einstein College of Medicine |
2019-01-08 | PHASE4 |
| NCT03941236 | Active not recruiting | Congenital Hyperinsulinism |
Zealand Pharma |
2019-05-01 | Phase 3 |
| NCT02893618 | UNKNOWN | Prader-Willi Syndrome |
Essentialis, Inc. |
2017-07 | PHASE2 |
| NCT02049385 | TERMINATED | Depression |
National Institute of Mental Health (NIMH) |
2014-01-03 | PHASE1; PHASE2 |
| NCT02779257 | WITHDRAWN | Gastro-enteropancreatic Neuroendocrine Tumor |
University of Maryland, Baltimore |
2016-04 | PHASE4 |
| NCT02034071 | COMPLETED | Prader-Willi Syndrome |
Essentialis, Inc. |
2014-04 | PHASE1; PHASE2 |
| NCT01488136 | COMPLETED | Type 1 Diabetes |
University of Dundee |
2012-01 | PHASE4 |
| NCT00631033 | COMPLETED | Obesity |
Rijnstate Hospital |
2008-07 | PHASE2 |
| NCT00973271 | WITHDRAWN | Hypertriglyceridemia |
Essentialis, Inc. |
2011-03 | PHASE3 |
| NCT00994149 | UNKNOWN | Infant, Newborn, Diseases; Pregnancy in Diabetics; Infant, Diabetic Mother; Hypoglycemia; Infant, Large for Gestational Age |
University of Saskatchewan |
2009-10 | PHASE2; PHASE3 |
| NCT01211847 | COMPLETED | Hypertriglyceridemia; Dyslipidemia |
Essentialis, Inc. |
2010-10 | PHASE2 |
| NCT00901823 | Withdrawn | Hypertriglyceridemia |
Essentialis Inc. |
2011-03 | Phase 1 |
| NCT00901823 | WITHDRAWN | Hypertriglyceridemia |
Essentialis, Inc. |
2011-03 | PHASE1 |
| NCT01211860 | COMPLETED | Hypertriglyceridmia |
Essentialis, Inc. |
2010-10 | PHASE1 |
| NCT00306683 | COMPLETED | Hypothalamic-pituitary Lesions; Craniopharyngiomas |
Assistance Publique - Hôpitaux de Paris |
2006-04 | PHASE3 |
| NCT00696475 | COMPLETED | Hypertriglyceridemia |
Essentialis, Inc. |
2008-06 | PHASE2 |
| NCT00683774 | COMPLETED | PCOS |
Virginia Commonwealth University |
2005-11 | |
| NCT00131755 | COMPLETED | Diabetes Mellitus, Type 1 |
Grill, Valdemar, M.D. |
2005-02 | PHASE4 |
| NCT00696475 | Completed | Hypertriglyceridemia |
Essentialis Inc.|Medpace Inc. |
2008-06 | Phase 2 |
| NCT00688857 | COMPLETED | Hypertriglyceridemia |
Essentialis, Inc. |
2008-05 | PHASE1 |
| NCT00688857 | Completed | Hypertriglyceridemia |
Essentialis Inc.|Cetero Research San Antonio |
2008-05 | Phase 1 |
| NCT00892073 | COMPLETED | Hypothalamic Obesity |
The Hospital for Sick Children |
2006-05 | PHASE2 |
| NCT01028846 | TERMINATED | Type 2 Diabetes; Glucose Metabolism Disorders; Glucose, High Blood |
Meredith Hawkins |
2006-11-02 | PHASE4 |
| NCT00151684 | COMPLETED | Obesity; Hyperinsulinism |
Rijnstate Hospital |
2004-11 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-06)
Check the
Diazoxide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.