Datopotamab deruxtecan
As of the edition of 20 October 2026, Datopotamab deruxtecan is an antibody drug conjugate: marketed, first approved in 2025 (US); acts on TACSTD2 and TOP1; US protection ends in 2037.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Antibody drug conjugate
- Brand name
- Datroway
- First approved
- 17 January 2025 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Daiichi Sankyo; 2 holders in all
- Registered trials
- 49, 1 stopped early
- Disease areas
- Cancer; Lungs and airways; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Digestive system
US protection
US protection ends in 2037.
US protection ends in 2037, 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 product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Datopotamab deruxtecan.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 5 | 0 | 5 | 0 |
| Phase 2 | 24 | 1 | 22 | 1 |
| Phase 3 | 17 | 0 | 17 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Originator, Applicant and Lead sponsor of trials | 2018 to now |