Trastuzumab deruxtecan
As of the edition of 20 October 2026, Trastuzumab deruxtecan is an antibody drug conjugate: marketed, first approved in 2019 (US); acts on ERBB2 and TOP1; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Antibody drug conjugate
- Brand name
- Enhertu
- First approved
- 20 December 2019 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- AstraZeneca; 3 holders in all
- Registered trials
- 162, 7 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Lungs and airways; Urinary and reproductive; Pregnancy and women's health
US protection
US protection ends in 2031.
US protection ends in 2031, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Daiichi Sankyo. The date is computed, not published.
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 product2 listings count towards this date. The exact date and each listing are in the product.
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 Trastuzumab deruxtecan.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 3 | 12 | 1 |
| Phase 1 | 26 | 5 | 21 | 0 |
| Phase 2 | 90 | 11 | 72 | 5 |
| Phase 3 | 25 | 1 | 23 | 1 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 162 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Originator, Applicant and Lead sponsor of trials | 2015 to now |
| AstraZeneca | Applicant and Lead sponsor of trials | 2017 to now |