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Clobetasol propionate
Clobex, Impeklo, Impoyz, Olux (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. In addition, it is known to target cytochrome P450 3A5.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
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
CLOBEXGaldermaN-021644 RX2004-02-05
1 products, RLD, RS
CLOBEXGaldermaN-021535 RX2003-07-24
1 products, RLD, RS
CLOBEXGaldermaN-021835 RX2005-10-27
1 products, RLD, RS
OLUXMylanN-021142 RX2000-05-26
1 products, RLD, RS
OLUX EMylanN-022013 RX2007-01-12
1 products, RLD, RS
IMPEKLOMylanN-213691 RX2020-05-19
1 products, RLD, RS
IMPOYZPrimus PharmaceuticalsN-209483 RX2017-11-28
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
clobetasol propionateANDA2023-06-02
clobex New Drug Application2023-02-02
impekloNew Drug Application2020-05-15
impoyzNew Drug Application2021-11-05
olux-eNew Drug Application2018-05-17
temovate New Drug Application2012-07-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
dermatitisHP_0011123D003872L30.9
facial dermatoses—D005148—
foot dermatoses—D005533—
hand dermatoses—D006229—
inflammationMP_0001845D007249—
leg dermatoses—D007868—
scalp dermatoses—D012536—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Clobetasol Propionate, Impoyz, Primus Pharms
98553342035-03-11DP
99562312030-08-31DPU-88, U-193, U-742, U-1408, U-1761, U-1858
100648752030-08-31DPU-88, U-193, U-742, U-1408, U-1858
105889142030-08-31DPU-2771
Clobetasol Propionate, Olux E, Mylan
84606412028-11-05DPU-1410
89620002025-08-31DPU-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
4 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EczemaD004485HP_0000964L30.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug resistant epilepsyD000069279—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.01————1
Non-hodgkin lymphomaD008228C85.91————1
Multiple myelomaD009101C90.01————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
Hodgkin diseaseD006689C811————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40————11
Seborrheic dermatitisD012628L21————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCLOBETASOL PROPIONATE
INNclobetasol
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
PDB7LAD
CAS-ID25122-46-7
RxCUI21245
ChEMBL IDCHEMBL1159650
ChEBI ID31414
PubChem CID32798
DrugBankDB01013
UNII IDADN79D536H (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
2908
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Q6N0A4
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
CYP3A5
CYP3A5
Organism
Homo sapiens
Gene name
CYP3A5
Gene synonyms
NCBI Gene ID
1577
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
Q9HB56
Mouse ortholog
—
—
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,568 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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27 adverse events reported
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