Enzalutamide
As of the edition of 20 October 2026, Enzalutamide is a small molecule: marketed, first approved in 2012 (US); acts on AR; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Xtandi
- First approved
- 31 August 2012 (US)
- Approvals on record
- 12 in 7 regions
- Holder of the most recent approval
- Laboratorio Stada S.L.; 4 holders in all
- Registered trials
- 307, 47 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Skin and connective tissue; Digestive system; Pregnancy and women's health; Lungs and airways
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Astellas.
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 product6 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Enzalutamide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AR | Androgen receptor | P10275 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 28 | 20 | 5 | 2 |
| Phase 1 | 67 | 38 | 16 | 13 |
| Phase 2 | 159 | 69 | 55 | 27 |
| Phase 3 | 44 | 10 | 26 | 4 |
| Phase 4 | 9 | 7 | 1 | 1 |
| All trials | 307 |