Risdiplam
As of the edition of 20 October 2026, Risdiplam is a small molecule: marketed, first approved in 2020 (US); acts on SMN2; US protection ends in 2041.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Evrysdi
- First approved
- 7 August 2020 (US)
- Approvals on record
- 11 in 6 regions
- Holder of the most recent approval
- Roche; 6 holders in all
- Registered trials
- 20, 0 stopped early
- Disease areas
- Nervous system; Inherited and neonatal
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Roche.
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 product10 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 10 listings behind itRequest access. Nothing is shown until you do.
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 Risdiplam.
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 |
|---|---|---|
| SMN2 | Survival motor neuron protein | Q16637 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 6 | 4 | 2 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| Phase 4 | 4 | 0 | 3 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Originator, Applicant and Lead sponsor of trials | 2016 to now |