Diazoxide

also known as DZX · diazoxide choline · Eudemine (Diazoxide) · Proglycem

Developed for: obesity disorder · hyperinsulinism · hypoglycemia · myocardial stunning · type 1 diabetes mellitus · acquired hypothalamic obesity · depressive disorder · hypertriglyceridemia
+5 more
· metabolic dysfunction-associated steatotic liver disease · obesity due to prohormone convertase I deficiency · obesity due to SIM1 deficiency · polycystic ovary syndrome · severe early-onset obesity-insulin resistance syndrome due to SH2B1 deficiency
Investigated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Albert Einstein College of Medicine · American Diabetes Association · Columbia University · Essentialis, Inc. · Johns Hopkins University
+18 more
· Rijnstate Hospital · Assistance Publique - Hôpitaux de Paris · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Grill, Valdemar, M.D. · Heidelberg University · Magic That Matters · Medpace, Inc. · Meredith Hawkins · National Institute of Mental Health (NIMH) · National Institutes of Health (NIH) · Rutgers University · Soleno Therapeutics, Inc. · The Hospital for Sick Children · University of California, Berkeley · University of Pisa · University of Saskatchewan · Vanderbilt University Medical Center · Virginia Commonwealth University

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (2)	US (FDA)	HYPERSTAT	—	1981-04-20 – 1984-08-21	fda.gov ↗
Approved	US (FDA)	HYPERSTAT	—	1973-01-22	fda.gov ↗

Trials 19 · a red edge is where a trial was stopped

today

US approved 1973

NCT07403604 · Ph 1 NCT06606327 · Ph 1 NCT06308107 · Ph 1 NCT04830982 · Ph 1 NCT05532020 · Ph 2 NCT03685773 · Ph 2 NCT03608163 · Ph 4 NCT03540758 · Ph 2 NCT03566511 · Ph 2 NCT02893618 · Ph 2 NCT02049385 · Ph 1/2 NCT00994149 · Ph 2/3 NCT00631033 · Ph 2 NCT00696475 · Ph 2 NCT00892073 · Ph 2 NCT00306683 · Ph 3 NCT00683774 · not/applicable NCT00131755 · Ph 4 NCT00151684 · Ph 2

197219731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028202920302031

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 14 trials
Phase 1	NCT07403604	Jul 2026 → Sep 2029 expected	hyperinsulinism, metabolic dysfunction-associated steatotic liver disease, obesity disorder, prediabetes syndrome	Columbia University	Recruiting	No outcome recorded
Phase 1	NCT06606327	Oct 2024 → Nov 2027 expected	hyperinsulinism, obesity disorder	Columbia University	Recruiting	No outcome recorded
Phase 1	NCT06308107	Jul 2024 → May 2025	myocardial stunning	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT04830982	Sep 2023 → Aug 2025	myocardial stunning	Johns Hopkins University	Withdrawn	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT02049385	Jan 2014 → Jul 2016	depressive disorder	National Institute of Mental Health (NIMH)	Terminated	No outcome recorded
Phase 29 trials
Phase 2	NCT05532020	Jan 2023 → Jan 2024	obesity due to SIM1 deficiency, obesity due to prohormone convertase I deficiency, severe early-onset obesity-insulin resistance syndrome due to SH2B1 deficiency	Soleno Therapeutics, Inc.	Unknown	No outcome recorded
Phase 2	NCT03685773	Apr 2019 → Apr 2023	hyperglycemia, type 2 diabetes mellitus	Albert Einstein College of Medicine	Withdrawn	No outcome recorded
Phase 2	NCT03540758	Aug 2018 → Apr 2027 expected	diabetes mellitus	Albert Einstein College of Medicine	Recruiting	No outcome recorded
Phase 2	NCT03566511	Jun 2018 → Aug 2020	hyperglycemia, type 2 diabetes mellitus	Meredith Hawkins	Terminated	No outcome recorded
Phase 2	NCT02893618	Jul → Oct 2017	Prader-Willi syndrome	Essentialis, Inc.	Unknown	No outcome recorded
Phase 2	NCT00631033	Jul 2008 → Dec 2011	obesity disorder	Rijnstate Hospital	Completed	No outcome recorded
Phase 2	NCT00696475	Jun 2008 → Jan 2009	hypertriglyceridemia	Essentialis, Inc.	Completed	No outcome recorded
Phase 2	NCT00892073	May 2006 → Jan 2008	acquired hypothalamic obesity	The Hospital for Sick Children	Completed	No outcome recorded
Phase 2	NCT00151684	Nov 2004 → ?	hyperinsulinism, obesity disorder	Rijnstate Hospital	Completed	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT00994149	Oct 2009 → Oct 2011	diabetes mellitus, hypoglycemia	University of Saskatchewan	Unknown	No outcome recorded
Phase 31 trial
Phase 3	NCT00306683	Apr 2006 → Apr 2009	craniopharyngioma, pituitary gland disorder	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 42 trials
Phase 4	NCT03608163	Jan → Aug 2019	hypoglycemia, type 1 diabetes mellitus	Albert Einstein College of Medicine	Terminated	No outcome recorded
Phase 4	NCT00131755	Feb 2005 → Aug 2008	type 1 diabetes mellitus	Grill, Valdemar, M.D.	Completed	No outcome recorded
Phase not applicable1 trial
—	NCT00683774	Nov 2005 → Dec 2008	polycystic ovary syndrome	Virginia Commonwealth University	Completed	No outcome recorded

Also used as a comparator or background therapy in 3 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 4	NCT02779257 Background	Apr → Jun 2016	digestive system neuroendocrine neoplasm	University of Maryland, Baltimore	Withdrawn	No outcome recorded
Phase 4	NCT01488136 Comparator	Jan 2012 → Mar 2013	type 1 diabetes mellitus	University of Dundee	Completed	No outcome recorded
Phase 4	NCT01028846 Comparator	Nov 2006 → Dec 2007	hyperglycemia, type 2 diabetes mellitus	Meredith Hawkins	Terminated	No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

Field	Value	Cited text
Known as	Diazoxide	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03608163 ↗ 21 NCT07403604 ↗ NCT00631033 ↗ NCT00696475 ↗ NCT05532020 ↗ NCT00306683 ↗ NCT00683774 ↗ NCT06606327 ↗ NCT00131755 ↗ NCT03540758 ↗ NCT02779257 ↗ NCT03685773 ↗ NCT02049385 ↗ NCT01028846 ↗ NCT06308107 ↗ NCT01488136 ↗ NCT02893618 ↗ NCT04830982 ↗ NCT00892073 ↗ NCT03566511 ↗ NCT00994149 ↗ NCT00151684 ↗
Known as	diazoxide choline	“DCCR (diazoxide choline) extended-release tablets” NCT05532020 ↗
Known as	DZX	“The objective was to evaluate the safety and efficacy of diazoxide (DZX) for decreasing obesity with hyperinsulinemia in patients treated for hypothalamic-pituitary lesions...” PMID 27603903 ↗ Sep 2016 1 “diazoxide (DZX)-mediated insulin suppression” PMID 30202851 ↗ Nov 2018
Known as	Eudemine (Diazoxide)	“Eudemine (Diazoxide)” NCT01488136 ↗
Known as	Proglycem	“Brand Name: Proglycem” NCT00994149 ↗
Action	Inhibit	“diazoxide, a well known inhibitor of glucose stimulated insulin secretion” NCT00151684 ↗
Route	Oral	“100mg orally three times per day for 10 days” NCT00683774 ↗