Temsirolimus
As of the edition of 20 October 2026, Temsirolimus is a small molecule: marketed, first approved in 2007 (US); acts on FKBP1A; no US protection is listed.
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
- Torisel
- First approved
- 30 May 2007 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Registered trials
- 193, 39 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Blood and lymph; Immune system; Skin and connective tissue
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FKBP1A | Peptidyl-prolyl cis-trans isomerase FKBP1A | P62942 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 5 | 1 | 3 |
| Phase 1 | 74 | 55 | 5 | 14 |
| Phase 2 | 102 | 75 | 2 | 21 |
| Phase 3 | 8 | 6 | 1 | 1 |
| All trials | 193 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2002 to now |