Viltolarsen
As of the edition of 20 October 2026, Viltolarsen is an oligonucleotide: marketed, first approved in 2020 (JP); acts on DMD; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Oligonucleotide
- Brand name
- Viltepso
- First approved
- 25 March 2020 (JP)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Nippon Shinyaku
- Registered trials
- 8, 0 stopped early
- Disease areas
- Bones, joints and muscles; Inherited and neonatal; Nervous system
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Nippon Shinyaku.
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.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DMD | Dystrophin | P11532 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 2 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Nippon Shinyaku | Applicant | 2020 to now |