Tucatinib
As of the edition of 20 October 2026, Tucatinib is a small molecule: marketed, first approved in 2020 (US); acts on ERBB2; US protection ends in 2034.
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
- Tukysa
- First approved
- 17 April 2020 (US)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Registered trials
- 66, 9 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Nervous system; Lungs and airways; Pregnancy and women's health
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Pfizer.
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 product8 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 8 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ERBB2 | Receptor tyrosine-protein kinase erbB-2 | P04626 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 2 | 0 | 0 |
| Phase 1 | 16 | 10 | 5 | 1 |
| Phase 2 | 40 | 5 | 25 | 8 |
| Phase 3 | 5 | 1 | 4 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 66 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2017 to now |