Enfortumab vedotin
As of the edition of 20 October 2026, Enfortumab vedotin is an antibody drug conjugate: marketed, first approved in 2019 (US); acts on NECTIN4, TUBB and TUBB1 and 7 more; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Antibody drug conjugate
- Brand name
- Padcev
- First approved
- 18 December 2019 (US)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- Astellas; 3 holders in all
- Registered trials
- 79, 5 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue; Digestive system; Hormones
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 Astellas. 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
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Enfortumab vedotin.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| TUBB4A | Tubulin beta-4A chain | P04350 |
| TUBB | Tubulin beta chain | P07437 |
| TUBB4B | Tubulin beta-4B chain | P68371 |
| TUBB3 | Tubulin beta-3 chain | Q13509 |
| TUBB2A | Tubulin beta-2A chain | Q13885 |
| TUBB8 | Tubulin beta-8 chain | Q3ZCM7 |
| NECTIN4 | Nectin-4 | Q96NY8 |
| 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 not stated | 4 | 0 | 3 | 0 |
| Phase 1 | 12 | 4 | 7 | 1 |
| Phase 2 | 52 | 2 | 46 | 4 |
| Phase 3 | 9 | 2 | 7 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 79 |