TheraRadar
Data updated: May 26, 2026

ZEGALOGUE (AUTOINJECTOR) (dasiglucagon hydrochloride)

Metabolic Approved 2021-03-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2021-03-22
Patent Cliff
2035

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

ZEALAND PHARMA
Active Ingredient: DASIGLUCAGON HYDROCHLORIDE

ZEGALOGUE (AUTOINJECTOR) Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Mar 2021 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What ZEGALOGUE (AUTOINJECTOR) Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 (AUTOINJECTOR) FDA Label Details

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2 OB patents · 1 families · 48 international docs across 28 countries

ZEGALOGUE (AUTOINJECTOR) Patents & Exclusivity

Latest Patent: Feb 2035
Exclusivity: Mar 2026

Patents (2 active)

US10442847 Expires Feb 3, 2035
US11795204 Expires Jan 6, 2034

Exclusivity

NCE Until Mar 2026
NCE Until Mar 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 4 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA214231 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.