Fulvestrant
As of the edition of 20 October 2026, Fulvestrant is a small molecule: marketed, first approved in 2002 (US); acts on ESR1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Faslodex
- First approved
- 25 April 2002 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Avyxa; 4 holders in all
- Registered trials
- 423, 72 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Urinary and reproductive; Hormones; Pregnancy and women's health; Lungs and airways
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
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 Fulvestrant.
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 |
|---|---|---|
| ESR1 | Estrogen receptor | P03372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 10 | 2 | 1 |
| Phase 1 | 85 | 35 | 31 | 17 |
| Phase 2 | 242 | 77 | 86 | 45 |
| Phase 3 | 65 | 21 | 29 | 7 |
| Phase 4 | 9 | 3 | 2 | 2 |
| All trials | 423 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator, Applicant and Lead sponsor of trials | 1997 to now |
| Fresenius Kabi | Later holder and Lead sponsor of trials | 2016 to now |
| Teva | Later holder | 2019 to now |
| Avyxa | Acquired holder | 2024 to now |