Golodirsen
As of the edition of 20 October 2026, Golodirsen is an oligonucleotide: marketed, first approved in 2019 (US); acts on DMD; US protection ends in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Oligonucleotide
- Brand name
- Vyondys 53
- First approved
- 12 December 2019 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Avi Biopharma
- Registered trials
- 6, 2 stopped early
- Disease areas
- Bones, joints and muscles; Inherited and neonatal; Nervous system
US protection
US protection ends in 2026.
The last listed US exclusivity ends in 2026. The application that gives this date is held by Avi Biopharma.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| DMD | Dystrophin | P11532 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 2 | 1 | 0 | 1 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Avi Biopharma | Originator and Lead sponsor of trials | 2015 to now |