Larotrectinib
As of the edition of 20 October 2026, Larotrectinib is a small molecule: marketed, first approved in 2018 (US); acts on NTRK1, NTRK2 and NTRK3; US protection ends in 2036.
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
- Vitrakvi
- First approved
- 26 November 2018 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- Bayer; 3 holders in all
- Registered trials
- 21, 0 stopped early
- Disease areas
- Cancer; Lungs and airways; Blood and lymph; Hormones; Immune system; Nervous 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 Bayer.
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 product12 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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Larotrectinib.
See the 3 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 | 5 | 2 | 2 | 0 |
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 12 | 1 | 11 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 21 |