Selumetinib
As of the edition of 20 October 2026, Selumetinib is a small molecule: marketed, first approved in 2020 (US); acts on MAP2K1 and MAP2K2; US protection ends in 2032.
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
- Koselugo
- First approved
- 10 April 2020 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 2 holders in all
- Registered trials
- 124, 17 stopped early
- Disease areas
- Cancer; Nervous system; Inherited and neonatal; Digestive system; Lungs and airways; Skin and connective tissue
US protection
US protection ends in 2032.
The last listed US exclusivity ends in 2032. The application that gives this date is held by AstraZeneca.
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 product32 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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Selumetinib.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 44 | 31 | 9 | 4 |
| Phase 2 | 71 | 34 | 22 | 12 |
| Phase 3 | 7 | 1 | 5 | 1 |
| All trials | 124 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator, Applicant and Lead sponsor of trials | 2019 to now |