Proglycem

(Diazoxide)

ApprovedSmall molecule

Teva

Proglycem is one of 103 small molecule programs targeting Hypoglycemia. It is currently in Approved.

Indications

Total Trials

Active Trials

102

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HypoglycemiaTerminated

Polycystic Ovary SyndromeActive, not recruiting

Type 1 DiabetesCompleted

HypoglycemiaApproved

Terminated

Polycystic Ovary SyndromePreclinical

Active, not recruiting

Type 1 DiabetesApproved

Completed

Competition

Competitive Landscape

77 competitors in Type 1 Diabetes

#DrugCompanyPhaseTrials

Mounjaro

Eli Lilly

Approved

6 2

Alka-Seltzer

AAbbott

Approved

1 3

Ozempic

Novo Nordisk

Phase 3

7 4

Proglycem

Teva

Approved

1 5

Stelara

Johnson & Johnson

Phase 3

1 6

Inpefa

LLexicon Pharmaceuticals

Phase 3

5 7

Tricor

JJagotec

Phase 3

2 8

Atorvastatin Calcium

Merck & Co.

Phase 3

1 9

Diamox

Teva

Phase 2

2 10

AFREZZA

MMannkind Corporation

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Study completion

NCT03540758

Clinical

Trials by Indication[1]

Obese2 trials

Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

Completed·RRijnstate Hospital·Phase 2·NCT00151684·25 enrolled

DZX Mediated Insulin Suppression in Obese Men

Completed·RRijnstate Hospital·Phase 2·NCT00631033·51 enrolled

Major Depression1 trial

Does Enhanced Glutamate Transporter Function Produce Antidepressant Effects in People With Major Depression?

Terminated·NNational Institute of Mental Health (NIMH)·Phase 1/2·NCT02049385·10 enrolled

Injury1 trial

Ischemic Injury and Ischemic Preconditioning in Diabetes

Completed·RRadboud University Medical Center··NCT00184821·20 enrolled

Neuroendocrine Tumor1 trial

Pasireotide Treatment for Neuroendocrine Tumor

Withdrawn·UUniversity of Maryland, Baltimore·Phase 4·NCT02779257

Obesity1 trial

Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT00306683·40 enrolled

10 more indications

Metabolism1 trial

Central Mechanisms That Regulate Glucose Metabolism in Humans

Terminated·MMeredith Hawkins·Phase 4·NCT01028846·10 enrolled

Polycystic Ovary Syndrome1 trial

Insulin and Polycystic Ovary Syndrome

Completed·VVirginia Commonwealth University·N/A·NCT00683774·21 enrolled

Acute1 trial

Use of Diazoxide in Acute Hypoglycaemia

Completed·UUniversity of Dundee·Phase 4·NCT01488136·12 enrolled

Hypoglycemia1 trial

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

Terminated·—·Phase 4·NCT03608163·4 enrolled

Type 1 Diabetes1 trial

Efficacy of Diazoxide in Type 1 Diabetes

Completed·—·Phase 4·NCT00131755·40 enrolled

Age1 trial

Diazoxide In the Management Of Hypoglycemic Neonates

Unknown status·UUniversity of Saskatchewan·Phase 2/3·NCT00994149·100 enrolled

Liver Transplant1 trial

The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients

Withdrawn·—·Phase 2·NCT03685773

Function1 trial

Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide

Terminated·MMeredith Hawkins·Phase 2·NCT03566511·37 enrolled

Hypothalamic Obesity1 trial

Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy

Completed·TThe Hospital for Sick Children·Phase 2·NCT00892073·9 enrolled

Unspecified1 trial

Regulation of Endogenous Glucose Production by Central KATP Channels

Recruiting·MMeredith Hawkins·Phase 2·NCT03540758·100 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

PROGLYCEM

NDA NDA017425

Jan 1, 1982

HYPERSTAT

NDA NDA016996

Jan 1, 1982

PROGLYCEM

NDA NDA017453

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Diazoxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Diazoxide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Diazoxide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA017425). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Teva

Proglycem

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Obese2 trials

Major Depression1 trial

Injury1 trial

Neuroendocrine Tumor1 trial

Obesity1 trial

Metabolism1 trial

Polycystic Ovary Syndrome1 trial

Acute1 trial

Hypoglycemia1 trial

Type 1 Diabetes1 trial

Age1 trial

Liver Transplant1 trial

Function1 trial

Hypothalamic Obesity1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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