Data updated: Nov 8, 2026
ELEVIDYS (delandistrogene moxeparvovec-rokl) · Sarepta Therapeutics
Approved 2023-06-22
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-06-22
- Patent Cliff
- 2035
- Routes
- Intravenous
- Dosage Forms
- Suspension
Latest ELEVIDYS News
All ELEVIDYS news →- Sarepta Therapeutics Announces Third Quarter 2026 Financial Results and Recent Corporate Developments ↗
- Sarepta Therapeutics Presents New Data at 2026 World Muscle Society Annual Congress Demonstrating Safety and Clinically Meaningful Functional Benefit of ELEVIDYS (delandistrogene moxeparvovec) in Older Ambulatory Patients with Duchenne ↗
- Sarepta Therapeutics Announces Presentations at 2026 World Muscle Society Annual Congress ↗
- Sarepta Therapeutics to Present New Data from its Neuromuscular Portfolio at 27th Annual Neuromuscular Study Group Scientific Meeting ↗
ELEVIDYS Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Jun 2023 ORIGINAL
Update · CBER biologic (Purple Book)
What ELEVIDYS Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2023)
Sarepta Therapeutics's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07542314 ENHANCE | SRP-9001-402 | Ph 4 | recruiting | Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting |
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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.
ELEVIDYS FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.