Nilutamide
As of the edition of 20 October 2026, Nilutamide is a small molecule: marketed, first approved in 1986 (FR); acts on AR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Nilandron
- First approved
- 2 July 1986 (FR)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Advanz Pharma; 3 holders in all
- Registered trials
- 8, 1 stopped early
- Disease areas
- Cancer; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Nilutamide.
See the 2 companies 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 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 3 | 2 | 1 | 0 |
| Phase 3 | 4 | 1 | 3 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Earlier holder | 1996 to now |
| Cheplapharm Arzneimittel | Applicant | 1997 to now |
| Advanz Pharma | Acquired holder | 2025 to now |