ZEGALOGUE (dasiglucagon hydrochloride)
Zegalogue is an antihypoglycemic medication used for severe hypoglycemia in adults and children aged 6 and older who have diabetes. It helps patients with dangerously low blood sugar levels by quickly increasing the concentration of glucose in the blood. This treatment is prescribed to manage emergency situations where a patient's blood sugar has dropped to a severe level.
How ZEGALOGUE Works
Dasiglucagon works by binding to and activating glucagon receptors located in the liver. This process triggers the breakdown of stored glycogen, which is then released into the bloodstream as glucose to raise blood sugar levels. Because of this mechanism, the medication requires the patient to have existing hepatic glycogen stores to produce its effect.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2021-03-22
- Patent Cliff
- 2035
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ZEGALOGUE Approval History
What ZEGALOGUE Treats
2 indicationsZEGALOGUE is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoglycemia
- Diabetes
ZEGALOGUE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 ZEGALOGUE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZEGALOGUE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZEGALOGUE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03941236 | ZP4207-17106 | Ph 3 | active not recruiting | Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism |
| NCT06588504 | NN9515-7675 U1111-1300-1855, jRCT2071240050 | Ph 1 | completed | Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents |
| NCT05378672 results posted | ZP4207-21052 | Ph 3 | completed | A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D |
| NCT04172441 results posted | ZP4207-17103 2017-004545-24 | Ph 2, Ph 3 | completed | Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism |
| NCT05454709 STABLE-1 | NL76691.100.22 | Ph 2 | withdrawn | A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System |
| NCT03777176 results posted | ZP4207-17109 | Ph 3 | completed | A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism |
| NCT04824872 | ZP4207-20123 | Ph 2 | withdrawn | Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults |
| NCT03895697 | ZP4207-17084 | Ph 3 | completed | A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM |
| NCT04836273 SHERRY | CKN-DASI120-RYGB 2020-005241-16 | Ph 2 | completed | Treatment of Post-bariatric Hypoglycaemia |
| NCT04764968 | 77119 H-21000002, 2020-005745-16 | Ph 2 | completed | Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes |
| NCT03667053 results posted | ZP4207-17086 | Ph 3 | completed | Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children |
| 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 |
| NCT03688711 results posted | ZP4207-17145 | Ph 3 | completed | Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM |
| 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 |
| NCT03735225 | ZP4207-17144 | Ph 1 | completed | Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration |
| NCT04449692 | H-20013256 2020-000551-12, H-20013256 | Ph 2 | completed | Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes |
| NCT03840278 results posted | 2019P000252 19-002 | Ph 2, Ph 3 | completed | The Bihormonal iLet Bionic Pancreas Feasibility Study |
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.
ZEGALOGUE FDA Label Details
Indications & Usage
FDA Label (PDF)ZEGALOGUE is indicated for the treatment of Hypoglycemia; Diabetes.
ZEGALOGUE Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZEGALOGUE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 4 active patents
Trial Analysis
- • 18 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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