Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clascoterone
Drug ID BADD_D02543
Description Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity.[A218771] By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways.[A218846] In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older.[L15621] Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.[A218766]
Indications and Usage Clascoterone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.[L15626]
Marketing Status approved; investigational
ATC Code D10AX06
DrugBank ID DB12499
KEGG ID D11451
MeSH ID C496269
PubChem ID 11750009
TTD Drug ID D08TEJ
NDC Product Code 58175-0650; 73309-359; 47335-994; 82891-011
UNII XN7MM8XG2M
Synonyms Clascoterone | CB-03-01 | cortexolone 17alpha-propionate | winlevi
Chemical Information
Molecular Formula C24H34O5
CAS Registry Number 19608-29-8
SMILES CCC(=O)OC1(CCC2C1(CCC3C2CCC4=CC(=O)CCC34C)C)C(=O)CO
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acne23.02.01.0010.001467%Not Available
Amenorrhoea21.01.02.001; 05.05.01.0020.000629%
Condition aggravated08.01.03.0040.000419%Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.000419%Not Available
Drug ineffective08.06.01.0060.001258%Not Available
Erythema23.03.06.0010.000419%Not Available
Fatigue08.01.01.0020.000419%
Hair growth abnormal23.02.06.0060.000419%Not Available
Menstruation irregular21.01.01.005; 05.05.01.0080.000419%
Pruritus23.03.12.0010.000419%
Skin irritation23.03.04.0090.000419%Not Available
Skin striae23.01.05.0020.000838%Not Available
The 1th Page    1    Total 1 Pages