Pimecrolimus
As of the edition of 20 October 2026, Pimecrolimus is a small molecule: marketed, first approved in 2001 (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 2003
- Kind
- Small molecule
- Brand name
- Elidel
- First approved
- 13 December 2001 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Bausch Health; 2 holders in all
- Registered trials
- 41, 5 stopped early
- Disease areas
- Skin and connective tissue; Inherited and neonatal; Immune system; Mouth and teeth; Eye; Lungs and airways
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Pimecrolimus.
See the 2 companies 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 | 5 | 2 | 2 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 6 | 4 | 0 | 2 |
| Phase 3 | 13 | 11 | 1 | 0 |
| Phase 4 | 16 | 14 | 0 | 2 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator and Lead sponsor of trials | 2001 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2005 to now |