Sonidegib
As of the edition of 20 October 2026, Sonidegib is a small molecule: marketed, first approved in 2015 (CH); acts on SMO; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Odomzo
- First approved
- 30 June 2015 (CH)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- SUN Pharmaceutical Industries; 3 holders in all
- Registered trials
- 41, 11 stopped early
- Disease areas
- Cancer; Digestive system; Blood and lymph; Skin and connective tissue; Hormones; Immune system
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by SUN Pharmaceutical Industries.
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 |
|---|---|---|
| SMO | Protein smoothened | Q99835 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 2 | 1 | 1 |
| Phase 1 | 20 | 16 | 1 | 3 |
| Phase 2 | 16 | 7 | 2 | 7 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2009 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2015 to now |