Selpercatinib
As of the edition of 20 October 2026, Selpercatinib is a small molecule: marketed, first approved in 2020 (US); acts on RET; US protection ends in 2038.
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
- Retevmo
- First approved
- 8 May 2020 (US)
- Approvals on record
- 15 in 4 regions
- Holder of the most recent approval
- Eli Lilly; 2 holders in all
- Registered trials
- 38, 1 stopped early
- Disease areas
- Cancer; Lungs and airways; Hormones; Skin and connective tissue; Digestive system; Urinary and reproductive
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Eli Lilly.
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 product138 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 138 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 Selpercatinib.
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 |
|---|---|---|
| RET | Proto-oncogene tyrosine-protein kinase receptor Ret | P07949 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 0 |
| Phase 1 | 16 | 15 | 1 | 0 |
| Phase 2 | 13 | 0 | 11 | 1 |
| Phase 3 | 3 | 0 | 3 | 0 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 38 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Originator, Applicant and Lead sponsor of trials | 2018 to now |