Tofersen
As of the edition of 20 October 2026, Tofersen is an oligonucleotide: marketed, first approved in 2023 (US); acts on SOD1; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Oligonucleotide
- Brand name
- Qalsody
- First approved
- 25 April 2023 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Biogen Japan Ltd.; 3 holders in all
- Registered trials
- 8, 0 stopped early
- Disease areas
- Nervous system; Nutrition and metabolism
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Biogen.
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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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Tofersen.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SOD1 | Superoxide dismutase [Cu-Zn] | P00441 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biogen | Originator, Applicant and Lead sponsor of trials | 2023 to now |