Darolutamide
As of the edition of 20 October 2026, Darolutamide is a small molecule: marketed, first approved in 2019 (US); acts on AR; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Nubeqa
- First approved
- 30 July 2019 (US)
- Approvals on record
- 8 in 6 regions
- Holder of the most recent approval
- Bayer; 3 holders in all
- Registered trials
- 114, 7 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Skin and connective tissue; Pregnancy and women's health; Digestive system; Inherited and neonatal
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Bayer.
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 product12 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 Darolutamide.
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 | 19 | 5 | 14 | 0 |
| Phase 1 | 25 | 12 | 11 | 2 |
| Phase 2 | 45 | 10 | 28 | 3 |
| Phase 3 | 21 | 3 | 16 | 2 |
| Phase 4 | 4 | 0 | 4 | 0 |
| All trials | 114 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Originator, Applicant and Lead sponsor of trials | 2014 to now |