Pimecrolimus
Elidel, Pimecrolimus (pimecrolimus) is a small molecule pharmaceutical. Pimecrolimus was first approved as Elidel on 2001-12-13. It is used to treat atopic dermatitis in the USA. The pharmaceutical is active against peptidyl-prolyl cis-trans isomerase FKBP1A.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Elidel (generic drugs available since 2018-12-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pimecrolimus
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ELIDEL | Bausch Health Companies | N-021302 RX | 2001-12-13 | 1 products, RLD, RS |
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
71 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 3 | 3 | 8 | 25 | 7 | 46 |
| Oral lichen planus | D017676 | — | — | — | 2 | 1 | 1 | — | 4 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | — | — | 1 | — | 1 |
| Vitiligo | D014820 | EFO_0004208 | L80 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary disease | D003327 | — | — | — | — | 2 | — | — | 2 |
| Perioral dermatitis | D019557 | EFO_1001305 | L71.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exanthema | D005076 | HP_0000988 | — | — | 1 | — | — | — | 1 |
| Prurigo | D011536 | — | L28.2 | — | 1 | — | — | — | 1 |
| Seborrheic dermatitis | D012628 | HP_0001051 | L21 | — | 1 | — | — | — | 1 |
| Lichen sclerosus et atrophicus | D018459 | — | L90.0 | — | 1 | — | — | — | 1 |
| Netherton syndrome | D056770 | — | — | 1 | 1 | — | — | — | 1 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Discoid lupus erythematosus | D008179 | — | L93.0 | — | — | — | — | 2 | 2 |
| Cutaneous lupus erythematosus | D008178 | EFO_0003834 | L93.1 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pimecrolimus |
| INN | pimecrolimus |
| Description | Pimecrolimus is an immunosuppressant drug of the calcineurin inhibitor class used in the treatment of atopic dermatitis (eczema). It is available as a topical cream, once marketed by Novartis (however, Galderma has been promoting the compound in Canada since early 2007) under the trade name Elidel.
|
| Classification | Small molecule |
| Drug class | immunosuppressives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H]1/C=C(\C)C[C@H](C)C[C@H](OC)[C@H]2O[C@@](O)(C(=O)C(=O)N3CCCC[C@H]3C(=O)O[C@H](/C(C)=C/[C@@H]3CC[C@H](Cl)[C@H](OC)C3)[C@H](C)[C@@H](O)CC1=O)[C@H](C)C[C@@H]2OC |
Identifiers
| PDB | — |
| CAS-ID | 137071-32-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200686 |
| ChEBI ID | — |
| PubChem CID | 16051947 |
| DrugBank | DB00337 |
| UNII ID | 7KYV510875 (ChemIDplus, GSRS) |
Target
Agency Approved
FKBP1A
FKBP1A
Organism
Homo sapiens
Gene name
FKBP1A
Gene synonyms
FKBP1, FKBP12
NCBI Gene ID
Protein name
peptidyl-prolyl cis-trans isomerase FKBP1A
Protein synonyms
12 kDa FK506-binding protein, 12 kDa FKBP, Calstabin-1, FK506 binding protein 1A, 12kDa, FK506 binding protein12, FK506-binding protein 1, FK506-binding protein 12, FK506-binding protein 1A, FK506-binding protein, T-cell, 12-kD, FKBP-12, FKBP-1A, FKBP12-Exip3, Immunophilin FKBP12, PPIase FKBP1A, protein kinase C inhibitor 2, Rotamase
Uniprot ID
Mouse ortholog
Fkbp1a (14225)
peptidyl-prolyl cis-trans isomerase FKBP1A (Q545E9)
Alternate
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Variants
No data
Financial
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Estimated US medical usage
Pimecrolimus
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,465 adverse events reported
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