Taletrectinib
As of the edition of 20 October 2026, Taletrectinib is a small molecule: marketed, first approved in 2025 (US); acts on NTRK1, NTRK2 and NTRK3 and 1 more; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Ibtrozi
- First approved
- 11 June 2025 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Nippon Kayaku; 2 holders in all
- Registered trials
- 14, 1 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Hormones; Skin and connective tissue
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Nuvation Bio.
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 product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
8 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product8 company-target rows are on route B because of Taletrectinib.
See the 8 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 | 3 | 0 | 2 | 0 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 4 | 0 | 2 | 1 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Nuvation Bio | Originator and Lead sponsor of trials | 2025 to now |
| Nippon Kayaku | Applicant | 2025 to now |