Everolimus
As of the edition of 20 October 2026, Everolimus is a small molecule: marketed, first approved in 2004 (ES); acts on FKBP1A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Afinitor
- First approved
- 29 March 2004 (ES)
- Approvals on record
- 36 in 7 regions
- Holder of the most recent approval
- Novartis; 4 holders in all
- Registered trials
- 713, 121 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue; Digestive system; Nervous system
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 Everolimus.
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 |
|---|---|---|
| FKBP1A | Peptidyl-prolyl cis-trans isomerase FKBP1A | P62942 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 32 | 14 | 4 | 4 |
| Phase 1 | 154 | 104 | 18 | 25 |
| Phase 2 | 364 | 204 | 44 | 74 |
| Phase 3 | 90 | 57 | 13 | 11 |
| Phase 4 | 73 | 49 | 6 | 7 |
| All trials | 713 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2005 to now |