Abiraterone
As of the edition of 20 October 2026, Abiraterone is a small molecule: marketed, first approved in 2011 (US); acts on AR, CYP17A1 and SRD5A1 and 2 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Zytiga
- First approved
- 28 April 2011 (US)
- Approvals on record
- 16 in 7 regions
- Holder of the most recent approval
- Johnson & Johnson; 7 holders in all
- Registered trials
- 107, 20 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Digestive system; Skin and connective tissue; Hormones
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Abiraterone.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 8 | 2 | 1 |
| Phase 1 | 25 | 9 | 5 | 10 |
| Phase 2 | 52 | 19 | 18 | 9 |
| Phase 3 | 17 | 2 | 14 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 107 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2009 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2022 to now |