Diazoxide

Overview

Diazoxide is a non-diuretic benzothiadiazine derivative that activates ATP-sensitive potassium channels. It is chemically related to thiazide diuretics but does not inhibit carbonic anhydrase and does not have chloriuretic or natriuretic activity. Diazoxide is commonly used in the treatment of hyperinsulinaemic hypoglycemia due to its ability to inhibit insulin release. Diazoxide also exhibits hypotensive activity and reduces arteriolar smooth muscle and vascular resistance. When administered intravenously, diazoxide can be used to treat hypertensive emergencies; however, this specific form of diazoxide is no longer available in the US. Diazoxide is usually well tolerated, and some of its more common side effects include fluid retention and electrolyte disturbances. In September 2015, the FDA issued a safety alert regarding post-marketing reports of pulmonary hypertension occurring in infants and neonates.

Indication

Oral diazoxide is indicated to manage hypoglycemia due to hyperinsulinism associated with conditions such as inoperable islet cell adenoma or carcinoma, and extrapancreatic malignancy in adults, or leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, and adenomatosis in infants and children. In infants and children oral diazoxide may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. Diazoxide may also be used parentally or intravenously to treat hypertensive emergencies.

Associated Conditions

Hyperinsulinemic Hypoglycemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial	2024/03/13	NCT06308107	Phase 1	Completed	Johns Hopkins University
Glycemic Effect of Diazoxide in NAFLD	2023/02/15	NCT05729282	Phase 1	Recruiting	Columbia University
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome	2023/01/27	NCT05701774	Phase 3	Active, not recruiting	Soleno Therapeutics, Inc.
Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass	2021/04/05	NCT04830982	Phase 1	Withdrawn	Johns Hopkins University
An Open-Label Study of DCCR Tablet in Patients With PWS	2019/09/12	NCT04086810	Phase 3	Withdrawn	Soleno Therapeutics, Inc.
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period	2018/10/22	NCT03714373	Phase 3	Completed	Soleno Therapeutics, Inc.
The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients	2018/09/26	NCT03685773	Phase 2	Withdrawn	Albert Einstein College of Medicine
Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)	2018/07/31	NCT03608163	Phase 4	Active, not recruiting	Albert Einstein College of Medicine
Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide	2018/06/25	NCT03566511	Phase 2	Terminated	Meredith Hawkins
Regulation of Endogenous Glucose Production by Central KATP Channels	2018/05/30	NCT03540758	Phase 2	Recruiting	Meredith Hawkins

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Proglycem	Teva Pharmaceuticals USA, Inc.	0575-6200	ORAL	50 mg in 1 mL	3/29/2023
Diazoxide	Par Pharmaceutical, Inc	0254-1010	ORAL	50 mg in 1 mL	3/8/2023
Diazoxide	e5 Pharma, LLC	13517-100	ORAL	50 mg in 1 mL	5/3/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DBL DIAZOXIDE 300mg/20mL Injection BP	16377	Pfizer Australia Pty Ltd	Medicine	A	10/8/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PROGLYCEM SUSP 50MG/ML	schering-plough canada inc	00503320	Suspension - Oral	50 MG / ML	12/31/1984
HYPERSTAT INJ 15MG/ML	schering-plough canada inc	00269271	Liquid - Intravenous	15 MG / ML	12/31/1973
PROGLYCEM	Merck Canada Inc	00503347	Capsule - Oral	100 MG	12/31/1985

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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