Clascoterone

drug
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Also known as BreezulaClascoteronaCortexolone 17.alpha.-propionateCortodoxone 17.alpha.-propionateWinlevicortexolone-17alpha-propionate

Summary

Clascoterone (CHEMBL3590187) is an approved small molecule (ATC D10AX06) targeting AR; indicated across 2 conditions including acne and androgenetic alopecia.

At a glance

  • Status: Approved (max clinical phase 4)
  • Modality: Small molecule
  • ATC class: D10AX06
  • Targets: 1 (AR)
  • Indications: 2 conditions
  • Clinical trials: 6
  • Chemistry: 402.5 Da · C24H34O5

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL3590187
NameClascoterone
TypeSmall molecule
Max phase4
FDA approvedyes
PubChem CID11750009
ATCD10AX06
Molecular formulaC24H34O5
Molecular weight402.5
InChIKeyGPNHMOZDMYNCPO-PDUMRIMRSA-N

SMILES: CCC(=O)O[C@@]1(CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C)C(=O)CO

IUPAC name: [(8R,9S,10R,13S,14S,17R)-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] propanoate

Also known as: Breezula, Clascoterona, Clascoterone, Cortexolone 17.alpha.-propionate, Cortodoxone 17.alpha.-propionate, Winlevi, CLASCOTERONE, cortexolone-17alpha-propionate

Patent coverage: 127 distinct patent families (421 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

GeneTargetActionpAffinityCancer dependencyUniProt
ARAndrogen receptorAntagonist7.4P10275

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Androgen receptor.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
AR7.4Ki40nMCHEMBL_ACT_15638801
AR7.3IC5050nMCHEMBL_ACT_15638181

Target pathways

Aggregated over 1 target gene(s): AR.

Top Reactome pathways

23 total, by targets touching each:

PathwayTargetsGenes
Signal Transduction1AR
Signaling by Rho GTPases1AR
RHO GTPase Effectors1AR
Generic Transcription Pathway1AR
Cellular responses to stress1AR
SUMOylation1AR
SUMO E3 ligases SUMOylate target proteins1AR
HSP90 chaperone cycle for steroid hormone receptors (SHR) in the presence of ligand1AR
Nuclear Receptor transcription pathway1AR
Metabolism of proteins1AR
SUMOylation of intracellular receptors1AR
RHO GTPases activate PKNs1AR
Activated PKN1 stimulates transcription of AR (androgen receptor) regulated genes KLK2 and KLK31AR
Deubiquitination1AR
Ub-specific processing proteases1AR
Post-translational protein modification1AR
RNA Polymerase II Transcription1AR
Gene expression (Transcription)1AR
Transcriptional regulation by RUNX21AR
RUNX2 regulates osteoblast differentiation1AR
RUNX2 regulates bone development1AR
Cellular responses to stimuli1AR
Signaling by Rho GTPases, Miro GTPases and RHOBTB31AR

Dominant GO biological processes

GO termTargets
negative regulation of transcription by RNA polymerase II1
MAPK cascade1
in utero embryonic development1
regulation of systemic arterial blood pressure1
epithelial cell morphogenesis1
transcription by RNA polymerase II1
signal transduction1
cell-cell signaling1
spermatogenesis1
single fertilization1
positive regulation of cell population proliferation1
negative regulation of cell population proliferation1
male gonad development1
positive regulation of gene expression1
male somatic sex determination1

Indications & clinical

Indications

2 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

IndicationTrial phaseMONDOEFO
acne4MONDO:0011438EFO:0003894
androgenetic alopecia3MONDO:0005339EFO:0004191

Clinical trials

Total trials: 6.

Phase distribution

PhaseTrials
PHASE33
PHASE22
PHASE1/PHASE21

Top trials by phase / activity

NCTPhaseStatusTitle
NCT05910450PHASE3ACTIVE_NOT_RECRUITINGA Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
NCT06403501PHASE3RECRUITINGEfficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
NCT05914805PHASE3COMPLETEDA Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
NCT05891795PHASE1/PHASE2ACTIVE_NOT_RECRUITINGClascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
NCT01631474PHASE2COMPLETEDA Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
NCT02279823PHASE2COMPLETEDA Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

129 molecules share ≥1 primary target. Top 60 by shared-target count:

MoleculeSourceStatusShared targets
MEGESTROLChEMBL + PubChemPhase 4 (approved)AR
ABIRATERONEChEMBLPhase 4 (approved)AR
APALUTAMIDEChEMBLPhase 4 (approved)AR
ARIPIPRAZOLEChEMBLPhase 4 (approved)AR
BECLOMETHASONE DIPROPIONATEChEMBLPhase 4 (approved)AR
BETAMETHASONEChEMBLPhase 4 (approved)AR
BICALUTAMIDEChEMBLPhase 4 (approved)AR
BITHIONOLChEMBLPhase 4 (approved)AR
BROMHEXINEChEMBLPhase 4 (approved)AR
BUDESONIDEChEMBLPhase 4 (approved)AR
CHLORMADINONEChEMBLPhase 4 (approved)AR
CLARITHROMYCINChEMBLPhase 4 (approved)AR
CLOCORTOLONE PIVALATEChEMBLPhase 4 (approved)AR
CLOMIPHENEChEMBLPhase 4 (approved)AR
CORTISONEChEMBLPhase 4 (approved)AR
CYCLOFENILChEMBLPhase 4 (approved)AR
DAROLUTAMIDEChEMBLPhase 4 (approved)AR
DESOGESTRELChEMBLPhase 4 (approved)AR
DESOXIMETASONEChEMBLPhase 4 (approved)AR
DEXAMETHASONEChEMBLPhase 4 (approved)AR
DIETHYLSTILBESTROLChEMBLPhase 4 (approved)AR
DIFLORASONE DIACETATEChEMBLPhase 4 (approved)AR
DORZOLAMIDEChEMBLPhase 4 (approved)AR
DROSPIRENONEChEMBLPhase 4 (approved)AR
DYDROGESTERONEChEMBLPhase 4 (approved)AR
ENZALUTAMIDEChEMBLPhase 4 (approved)AR
EPLERENONEChEMBLPhase 4 (approved)AR
ESTRADIOLChEMBLPhase 4 (approved)AR
ESTRADIOL CYPIONATEChEMBLPhase 4 (approved)AR
ESTRADIOL VALERATEChEMBLPhase 4 (approved)AR
ESTRIOLChEMBLPhase 4 (approved)AR
ESTRONEChEMBLPhase 4 (approved)AR
ETHINYL ESTRADIOLChEMBLPhase 4 (approved)AR
ETHYNODIOL DIACETATEChEMBLPhase 4 (approved)AR
ETONOGESTRELChEMBLPhase 4 (approved)AR
FLUMETHASONE PIVALATEChEMBLPhase 4 (approved)AR
FLUOCINOLONE ACETONIDEChEMBLPhase 4 (approved)AR
FLUOCINONIDEChEMBLPhase 4 (approved)AR
FLUOXYMESTERONEChEMBLPhase 4 (approved)AR
FLURANDRENOLIDEChEMBLPhase 4 (approved)AR
FLUTAMIDEChEMBLPhase 4 (approved)AR
FLUTICASONE FUROATEChEMBLPhase 4 (approved)AR
FLUTICASONE PROPIONATEChEMBLPhase 4 (approved)AR
HALCINONIDEChEMBLPhase 4 (approved)AR
HALOBETASOL PROPIONATEChEMBLPhase 4 (approved)AR
HEXACHLOROPHENEChEMBLPhase 4 (approved)AR
HEXESTROLChEMBLPhase 4 (approved)AR
HYDROCORTISONEChEMBLPhase 4 (approved)AR
INDOMETHACINChEMBLPhase 4 (approved)AR
LEVONORGESTRELChEMBLPhase 4 (approved)AR
MEDROXYPROGESTERONEChEMBLPhase 4 (approved)AR
METHYLPREDNISOLONEChEMBLPhase 4 (approved)AR
MIFEPRISTONEChEMBLPhase 4 (approved)AR
MOMETASONE FUROATEChEMBLPhase 4 (approved)AR
NILUTAMIDEChEMBLPhase 4 (approved)AR
NOMEGESTROLChEMBLPhase 4 (approved)AR
NORETHINDRONEChEMBLPhase 4 (approved)AR
NORETHYNODRELChEMBLPhase 4 (approved)AR
OXANDROLONEChEMBLPhase 4 (approved)AR
OXICONAZOLEChEMBLPhase 4 (approved)AR