Sotorasib
As of the edition of 20 October 2026, Sotorasib is a small molecule: marketed, first approved in 2021 (US); acts on KRAS; US protection ends in 2040.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Lumakras
- First approved
- 28 May 2021 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Amgen; 2 holders in all
- Registered trials
- 65, 13 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Hormones; Heart and blood vessels; Inherited and neonatal
US protection
US protection ends in 2040.
The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Amgen.
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 product33 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 33 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 Sotorasib.
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 |
|---|---|---|
| KRAS | GTPase KRas | P01116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 0 |
| Phase 1 | 29 | 16 | 8 | 5 |
| Phase 2 | 28 | 3 | 13 | 8 |
| Phase 3 | 4 | 2 | 2 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 65 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Originator, Applicant and Lead sponsor of trials | 2019 to now |