Tisotumab vedotin
As of the edition of 20 October 2026, Tisotumab vedotin is an antibody drug conjugate: marketed, first approved in 2021 (US); acts on F3, TUBB and TUBB1 and 7 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
- Antibody drug conjugate
- Brand name
- Tivdak
- First approved
- 20 September 2021 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Merus; 3 holders in all
- Registered trials
- 12, 1 stopped early
- Disease areas
- Cancer; Pregnancy and women's health; Urinary and reproductive; Hormones; Digestive system; Lungs and airways
US protection
US protection ends in 2033.
US protection ends in 2033, 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 Pfizer. 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
11 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product11 company-target rows are on route B because of Tisotumab vedotin.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| TUBB4A | Tubulin beta-4A chain | P04350 |
| TUBB | Tubulin beta chain | P07437 |
| F3 | Tissue factor | P13726 |
| TUBB4B | Tubulin beta-4B chain | P68371 |
| TUBB3 | Tubulin beta-3 chain | Q13509 |
| TUBB2A | Tubulin beta-2A chain | Q13885 |
| TUBB8 | Tubulin beta-8 chain | Q3ZCM7 |
| TUBB6 | Tubulin beta-6 chain | Q9BUF5 |
| TUBB2B | Tubulin beta-2B chain | Q9BVA1 |
| TUBB1 | Tubulin beta-1 chain | Q9H4B7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 9 | 6 | 2 | 1 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 12 |