Drugs / Diazoxide
Diazoxide
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 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 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| Phase 1 | NCT04830982 | Sep 2023 → Aug 2025 | myocardial stunning | Johns Hopkins University | Withdrawn | No outcome recorded |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 | NCT05729282 | Aug 2023 → Sep 2025 | NAFLD1, hyperinsulinism, prediabetes syndrome | Columbia University | Completed | 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2 | NCT03685773 | Apr 2019 → Apr 2023 | hyperglycemia, type 2 diabetes mellitus | Albert Einstein College of Medicine | Withdrawn | No outcome recorded |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 Stop: Business |
| 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 · 1 missed | ||||||
| Phase 3 | NCT00306683 | Apr 2006 → Apr 2009 | craniopharyngioma, pituitary gland disorder | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 4 | NCT02779257 Background | Apr → Jun 2016 | digestive system neuroendocrine neoplasm | University of Maryland, Baltimore | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
Press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diazoxide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03608163 ↗ |
| 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 20161“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 ↗ |