Data updated: May 26, 2026
Zolgensma (onasemnogene abeparvovec-xioi)
Approved 2019-05-23
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-05-23
- Patent Cliff
- 2031
- Revenue
- $307M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- Injection
Zolgensma Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
May 2019 ORIGINAL
Update · CBER biologic (Purple Book)
What Zolgensma Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2019)
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03381729 STRONG results posted | AVXS-101-CL-102 2020-003678-28, COAV101A12102 | Ph 1 | terminated | Study of Intrathecal Administration of Onasemnogene Abeparvovec-xioi for Spinal Muscular Atrophy |
| NCT03306277 STR1VE results posted | AVXS-101-CL-303 2020-000095-38, COAV101A12302 | Ph 3 | completed | Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1 |
| NCT03837184 results posted | AVXS-101-CL-306 194664, 201900208 | Ph 3 | completed | Single-Dose Gene Replacement Therapy Using for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies |
| NCT03505099 SPR1NT results posted | AVXS-101-CL-304 2017-004087-35, JapicCTI-184203 | Ph 3 | completed | Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2 |
| NCT03461289 STRIVE-EU results posted | AVXS-101-CL-302 2017-000266-29, COAV101A12301 | Ph 3 | completed | Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1 |
| NCT04042025 | AVXS-101-LT-002 2019-002611-26, 205305 | Ph 3 | active not recruiting | Long-term Follow-up Study of Patients Receiving Onasemnogene Abeparvovec-xioi |
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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.
Zolgensma FDA Label Details
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Revenue Insights
- • Q4-2025: $307M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.