Data updated: Nov 8, 2026
ISEMBYLD (apitegromab-mstn) · SCHOLAR ROCK INC
Approved 2026-09-11
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-09-11
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Latest ISEMBYLD News
All ISEMBYLD news →- Oct 8, 2026 Regulatory · Scholar RockScholar Rock Resubmits Apitegromab Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA) ↗
- Sep 11, 2026 Regulatory · Scholar RockScholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA) ↗
- Sep 2, 2026 Regulatory · Scholar RockScholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE Trial ↗
- Aug 21, 2026 Regulatory · Scholar RockScholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan ↗
ISEMBYLD Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What ISEMBYLD Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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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.
ISEMBYLD FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.