Data updated: May 26, 2026
Casgevy (exagamglogene autotemcel)
Approved 2023-12-07
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-12-07
- Patent Cliff
- 2031
- Routes
- Intravenous
- Dosage Forms
- Suspension
Casgevy Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Dec 2023 ORIGINAL
Update · CBER biologic (Purple Book)
What Casgevy Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2023)
🔬
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.
Casgevy FDA Label Details
Read on TheraRadar
Casgevy Doesn’t Fix the Sickle Cell Mutation
It goes around it. That’s why it works.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.