Data updated: May 26, 2026
Hemgenix (etranacogene dezaparvovec-drlb)
Approved 2022-11-21
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-11-21
- Patent Cliff
- 2034
- Routes
- Intravenous
- Dosage Forms
- Injection
Hemgenix Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2022 to 2022
Nov 2022 ORIGINAL
Update · CBER biologic (Purple Book)
What Hemgenix Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 2022)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
Hemgenix FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.