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, Pimecrolimus
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
Brand Name | Status | Last Update |
|---|---|---|
| elidel | New Drug Application | 2020-09-30 |
| pimecrolimus | NDA authorized generic | 2024-03-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatitis | D003872 | — | L30.9 | 3 | 4 | 11 | 25 | 8 | 51 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 3 | 3 | 9 | 25 | 8 | 48 |
| Eczema | D004485 | — | L30.9 | 3 | 3 | 8 | 25 | 8 | 47 |
| Oral lichen planus | D017676 | — | — | — | 3 | 1 | 1 | — | 5 |
| Lichen planus | D008010 | — | L43 | — | 3 | 1 | 1 | — | 5 |
| Vitiligo | D014820 | EFO_0004208 | L80 | — | 1 | — | 1 | — | 2 |
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 |
| Dandruff | D063807 | — | L21.0 | — | 1 | 1 | — | — | 1 |
| Pityriasis | D010915 | — | — | — | 1 | 1 | — | — | 1 |
| Pityriasis rosea | D017515 | — | L42 | — | 1 | 1 | — | — | 1 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exanthema | D005076 | — | — | — | 1 | — | — | — | 1 |
| Prurigo | D011536 | — | L28.2 | — | 1 | — | — | — | 1 |
| Seborrheic dermatitis | D012628 | — | L21 | — | 1 | — | — | — | 1 |
| Vulvar lichen sclerosus | D007724 | — | N90.4 | — | 1 | — | — | — | 1 |
| Lichen sclerosus et atrophicus | D018459 | — | L90.0 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
| Netherton syndrome | D056770 | — | — | 1 | 1 | — | — | — | 1 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 1 | — | — | — | 1 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 1 | — | — | — | 1 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | 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 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | — | — | 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
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,500 documents
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Safety
Black-box Warning
Black-box warning for: Elidel, Pimecrolimus
Adverse Events
Top Adverse Reactions
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3,317 adverse events reported
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