PROGLYCEM (diazoxide)
PROGLYCEM is indicated for the treatment of Hypoglycemia; Hyperinsulinism; Islet Cell Adenoma; Islet Cell Carcinoma; Extrapancreatic Malignancy; Leucine Sensitivity; Islet Cell Hyperplasia; Nesidioblastosis; Adenomatosis.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1976-05-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SUSPENSION
PROGLYCEM Approval History
What PROGLYCEM Treats
9 indicationsPROGLYCEM is approved for 9 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoglycemia
- Hyperinsulinism
- Islet Cell Adenoma
- Islet Cell Carcinoma
- Extrapancreatic Malignancy
- Leucine Sensitivity
- Islet Cell Hyperplasia
- Nesidioblastosis
PROGLYCEM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PROGLYCEM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PROGLYCEM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PROGLYCEM
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03540758 | 2018-9039 R01DK069861 | Ph 2 | recruiting | Regulation of Endogenous Glucose Production by Central KATP Channels |
| NCT03608163 results posted | 2018-9208 R01DK079974 | Ph 4 | terminated | Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF) |
| NCT03566511 results posted | 2018-9040 R01DK069861 | Ph 2 | terminated | Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide |
| NCT03685773 | 2018-9506 | Ph 2 | withdrawn | The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients |
| NCT02779257 | HP-00069513EU | Ph 4 | withdrawn | Pasireotide Treatment for Neuroendocrine Tumor |
| NCT01488136 | 2010DM03 2011-005011-93 | Ph 4 | completed | Use of Diazoxide in Acute Hypoglycaemia |
| NCT02049385 results posted | 140041 14-M-0041 | Ph 1, Ph 2 | terminated | Does Enhanced Glutamate Transporter Function Produce Antidepressant Effects in People With Major Depression? |
| NCT00631033 | LTC-511-230108 | Ph 2 | completed | DZX Mediated Insulin Suppression in Obese Men |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROGLYCEM FDA Label Details
Indications & Usage
FDA Label (PDF)PROGLYCEM is indicated for the treatment of Hypoglycemia; Hyperinsulinism; Islet Cell Adenoma; Islet Cell Carcinoma; Extrapancreatic Malignancy; Leucine Sensitivity; Islet Cell Hyperplasia; Nesidioblastosis; Adenomatosis.
Track PROGLYCEM with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment