Clobetasol propionate
Clobetasol, Clobex, Impoyz (clobetasol propionate) is a small molecule pharmaceutical. Clobetasol propionate was first approved as Temovate on 1985-12-27. It is used to treat dermatitis, facial dermatoses, foot dermatoses, hand dermatoses, and inflammation amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Clobex, Impeklo, Impoyz, Olux (generic drugs available since 1994-02-16, discontinued: Embeline, Temovate)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clobetasol propionate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CLOBEX | Galderma | N-021644 RX | 2004-02-05 | 1 products, RLD, RS |
| CLOBEX | Galderma | N-021535 RX | 2003-07-24 | 1 products, RLD, RS |
| CLOBEX | Galderma | N-021835 RX | 2005-10-27 | 1 products, RLD, RS |
| OLUX | Mylan | N-021142 RX | 2000-05-26 | 1 products, RLD, RS |
| OLUX E | Mylan | N-022013 RX | 2007-01-12 | 1 products, RLD, RS |
| IMPEKLO | Mylan | N-213691 RX | 2020-05-19 | 1 products, RLD, RS |
| IMPOYZ | Primus Pharmaceuticals | N-209483 RX | 2017-11-28 | 1 products, RLD, RS |
Show 5 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| calcipotriene 0.005% / clobetasol propionate 0.05% | unapproved drug other | 2019-05-20 |
| ciclopirox 1% / clobetasol propionate 0.05% | unapproved drug other | 2019-04-24 |
| ciclopirox olamine 0.77% / clobetasol propionate 0.05% / salicylic acid 3%. | unapproved drug other | 2019-05-16 |
| clobetasol propionate | ANDA | 2024-01-31 |
| clobetasol propionate (emmolient) | ANDA | 2023-07-26 |
| clobetasol propionate (emollient) | ANDA | 2021-07-01 |
| clobetasol propionate 0.05% / coal tar 8% / salicylic acid 6% | unapproved drug other | 2019-05-14 |
| clobetasol propionate 0.05% / levocetirizine dihydrochloride 2% | unapproved drug other | 2019-05-16 |
| clobetasol propionate 0.05% / niacinamide 4% | unapproved drug other | 2019-05-02 |
| clobetasol propionate cream usp, 0.05% | ANDA | 2023-08-01 |
Show 8 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| dermatitis | HP_0011123 | D003872 | L30.9 |
| facial dermatoses | — | D005148 | — |
| foot dermatoses | — | D005533 | — |
| hand dermatoses | — | D006229 | — |
| inflammation | MP_0001845 | D007249 | — |
| leg dermatoses | — | D007868 | — |
| scalp dermatoses | — | D012536 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Clobetasol Propionate, Impoyz, Primus Pharms | |||
| 9855334 | 2035-03-11 | DP | |
| 9956231 | 2030-08-31 | DP | U-88, U-193, U-742, U-1408, U-1761, U-1858 |
| 10064875 | 2030-08-31 | DP | U-88, U-193, U-742, U-1408, U-1858 |
| 10588914 | 2030-08-31 | DP | U-2771 |
| Clobetasol Propionate, Olux E, Mylan | |||
| 8460641 | 2028-11-05 | DP | U-1410 |
| 8962000 | 2025-08-31 | DP | U-1410 |
ATC Codes
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AD: Corticosteroids, very potent (group iv)
— D07AD01: Clobetasol
— D07C: Corticosteroids, combinations with antibiotics
— D07CD: Corticosteroids, very potent, combinations with antibiotics
— D07CD01: Clobetasol and antibiotics
HCPCS
No data
Clinical
Clinical Trials
126 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 9 | 9 | 8 | 15 | 4 | 44 |
| Vulvar lichen sclerosus | D007724 | — | N90.4 | — | 4 | 3 | 1 | 4 | 11 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 2 | 1 | 2 | — | 5 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | — | 1 | 1 | — | 3 |
| Contact dermatitis | D003877 | — | L25 | 1 | — | — | 1 | — | 2 |
| Occupational dermatitis | D009783 | — | — | — | — | — | 1 | — | 1 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | 1 | — | 1 |
| Hypertrophic cicatrix | D017439 | — | L91.0 | — | — | — | 1 | — | 1 |
| Photosensitivity disorders | D010787 | HP_0000992 | L57.1 | — | — | — | 1 | — | 1 |
| Alopecia | D000505 | HP_0002293 | L64 | — | — | — | 1 | — | 1 |
Show 1 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral lichen planus | D017676 | — | — | — | 6 | 2 | — | 3 | 10 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | 1 | — | — | 2 |
| Lichen sclerosus et atrophicus | D018459 | — | L90.0 | — | 1 | 1 | — | — | 2 |
| Cataract | D002386 | HP_0000518 | H26.9 | — | — | 2 | — | — | 2 |
| Oral manifestations | D009912 | — | — | — | — | 1 | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 1 | — | — | 1 |
| Seborrheic dermatitis | D012628 | HP_0001051 | L21 | — | — | 1 | — | — | 1 |
| Acne keloid | D000153 | — | L73.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 3 | 1 | — | — | 1 | 4 |
| Phlebitis | D010689 | EFO_1001395 | I80 | 1 | 1 | — | — | — | 1 |
| Stevens-johnson syndrome | D013262 | EFO_0004276 | L51.1 | 1 | 1 | — | — | — | 1 |
| Herpes labialis | D006560 | EFO_1001347 | B00.1 | — | 1 | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | 3 | 7 |
| Vasoconstriction | D014661 | — | — | 1 | — | — | — | — | 1 |
| Skin and connective tissue diseases | D017437 | — | — | 1 | — | — | — | — | 1 |
| Oral ulcer | D019226 | HP_0000155 | — | 1 | — | — | — | — | 1 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Drug hypersensitivity syndrome | D063926 | EFO_1002004 | D72.12 | — | — | — | — | 1 | 1 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | — | — | — | 1 | 1 |
| Low-level light therapy | D028022 | — | — | — | — | — | — | 1 | 1 |
| Lyme disease | D008193 | — | A69.2 | — | — | — | — | 1 | 1 |
| Precancerous conditions | D011230 | — | — | — | — | — | — | 1 | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | — | 1 | 1 |
| Lentigo | D007911 | — | L81.4 | — | — | — | — | 1 | 1 |
| Hyperpigmentation | D017495 | HP_0000953 | — | — | — | — | — | 1 | 1 |
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clobetasol propionate |
| INN | clobetasol |
| Description | Clobetasol propionate is the 17-O-propionate ester of clobetasol. A potent corticosteroid, it is used to treat various skin disorders, including exzema and psoriasis. It has a role as an anti-inflammatory drug. It is an 11beta-hydroxy steroid, a 20-oxo steroid, a glucocorticoid, a fluorinated steroid, a 3-oxo-Delta(1),Delta(4)-steroid and a chlorinated steroid. It is functionally related to a clobetasol and a propionic acid. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)O[C@]1(C(=O)CCl)[C@@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 25122-46-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1159650 |
| ChEBI ID | 31414 |
| PubChem CID | 32798 |
| DrugBank | DB01013 |
| UNII ID | 779619577M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP3A5
CYP3A5
Organism
Homo sapiens
Gene name
CYP3A5
Gene synonyms
NCBI Gene ID
Protein name
cytochrome P450 3A5
Protein synonyms
aryl hydrocarbon hydroxylase, CYPIIIA5, cytochrome P450 HLp2, cytochrome P450, family 3, subfamily A, polypeptide 5, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 5, Cytochrome P450-PCN3, flavoprotein-linked monooxygenase, microsomal monooxygenase, xenobiotic monooxygenase
Uniprot ID
Mouse ortholog
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Variants
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Financial
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Estimated US medical usage
Clobetasol propionate
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Clobetasol
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,218 adverse events reported
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