TheraRadar
Data updated: Jun 28, 2026

ZEGALOGUE (AUTOINJECTOR) (dasiglucagon hydrochloride) · ZEALAND PHARMA

Metabolic Approved 2021-03-22

ZEGALOGUE (AUTOINJECTOR) is FDA-approved to treat 2 conditions (same as ZEGALOGUE).

2
Indications
--
Phase 3 Trials
1
Priority Reviews
5
Years on Market

Details

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

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: DASIGLUCAGON HYDROCHLORIDE

ZEGALOGUE (AUTOINJECTOR) Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2021 to 2026 · 1 indication expansions
Jun 2026 SUPPL Priority
Efficacy
Mar 2021 ORIGINAL
New Drug · Type 1 - New Molecular Entity

What ZEGALOGUE (AUTOINJECTOR) Treats

2 indications

ZEGALOGUE (AUTOINJECTOR) is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ZEGALOGUE (same active ingredient).

Source: FDA Label

ZEALAND PHARMA's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
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

Indications & Usage

FDA Label (PDF)

ZEGALOGUE (AUTOINJECTOR) is FDA-approved to treat 2 conditions — same approved indications as ZEGALOGUE.

View full patent landscape →
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

Pro Intelligence Preview

Deep insights for ZEGALOGUE (AUTOINJECTOR)

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
Unlock Full Intelligence

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.