Anastrozole
As of the edition of 20 October 2026, Anastrozole is a small molecule: marketed, first approved in 1995 (US); acts on CYP19A1; no US protection is listed.
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
- Arimidex
- First approved
- 27 December 1995 (US)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 4 holders in all
- Registered trials
- 268, 36 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Urinary and reproductive; Hormones; Pregnancy and women's health; Nutrition and metabolism
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 Anastrozole.
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 |
|---|---|---|
| CYP19A1 | Aromatase | P11511 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 41 | 21 | 8 | 2 |
| Phase 1 | 33 | 18 | 8 | 5 |
| Phase 2 | 126 | 63 | 28 | 22 |
| Phase 3 | 53 | 23 | 20 | 5 |
| Phase 4 | 15 | 11 | 1 | 2 |
| All trials | 268 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator and Lead sponsor of trials | 1995 to now |
| ANI Pharmaceuticals | Acquired holder | 2018 to now |