GLUCAGEN (glucagon hydrochloride) · Novo Nordisk
GLUCAGEN is FDA-approved to treat 1 condition (same as GLUCAGON).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1998-06-22
- Routes
- INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- POWDER
GLUCAGEN Approval History
What GLUCAGEN Treats
1 indicationsGLUCAGEN is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoglycemia
Same approved indications as GLUCAGON (same active ingredient).
Novo Nordisk's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05454709 STABLE-1 | NL76691.100.22 | Ph 2 | withdrawn | A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System |
| NCT03378635 results posted | ZP4207-16137 | Ph 3 | completed | A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects |
| NCT03216226 results posted | ZP4207-16136 | Ph 3 | completed | A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus |
| NCT02660008 | ZP4207-15126 | Ph 2 | completed | Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon |
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.
GLUCAGEN FDA Label Details
Indications & Usage
FDA Label (PDF)GLUCAGEN is FDA-approved to treat 1 condition — same approved indications as GLUCAGON.
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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