Sirolimus
As of the edition of 20 October 2026, Sirolimus is a small molecule: marketed, first approved in 1999 (US); acts on FKBP1A; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Rapamune
- First approved
- 15 September 1999 (US)
- Approvals on record
- 20 in 5 regions
- Holder of the most recent approval
- Nobelpharma; 6 holders in all
- Registered trials
- 576, 89 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Inherited and neonatal; Urinary and reproductive; Heart and blood vessels
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Nobelpharma holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original 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 Sirolimus.
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 | 36 | 18 | 8 | 3 |
| Phase 1 | 130 | 77 | 23 | 25 |
| Phase 2 | 278 | 132 | 81 | 48 |
| Phase 3 | 68 | 34 | 17 | 10 |
| Phase 4 | 64 | 39 | 5 | 3 |
| All trials | 576 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 1998 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2014 to now |
| Whitehawk Therapeutics | Later holder and Lead sponsor of trials | 2015 to now |
| Plusultra pharma | Later holder | 2023 to now |