Exemestane
As of the edition of 20 October 2026, Exemestane is a small molecule: marketed, first approved in 1999 (CH); acts on CYP19A1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Aromasin
- First approved
- 14 October 1999 (CH)
- Approvals on record
- 6 in 6 regions
- Holder of the most recent approval
- Pfizer
- Registered trials
- 212, 31 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Hormones; Inherited and neonatal
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
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 Exemestane.
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 | 28 | 16 | 2 | 3 |
| Phase 1 | 24 | 15 | 5 | 3 |
| Phase 2 | 102 | 54 | 16 | 20 |
| Phase 3 | 50 | 22 | 17 | 3 |
| Phase 4 | 8 | 6 | 0 | 2 |
| All trials | 212 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1998 to now |