Onasemnogene abeparvovec
As of the edition of 20 October 2026, Onasemnogene abeparvovec is a gene: marketed, first approved in 2019 (US); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Gene
- Brand name
- Zolgensma
- First approved
- 24 May 2019 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Novartis; 3 holders in all
- Registered trials
- 11, 1 stopped early
- Disease areas
- Nervous system; Inherited and neonatal; Bones, joints and muscles
US protection
US protection ends in 2031.
The reference-product exclusivity ends in 2031. The application that gives this date is held by Novartis.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 2 | 0 |
| Phase 1 | 2 | 1 | 0 | 1 |
| Phase 3 | 6 | 4 | 2 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant, Acquired holder and Lead sponsor of trials | 2014 to now |