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Drug ReportsClascoterone
Clascoterone
Winlevi (clascoterone) is a small molecule pharmaceutical. Clascoterone was first approved as Winlevi on 2020-08-26. The pharmaceutical is active against androgen receptor.
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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
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Financial
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Safety
Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Winlevi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clascoterone
Tradename
Company
Number
Date
Products
WINLEVISun Pharmaceutical IndustriesN-213433 RX2020-08-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
winleviNew Drug Application2025-01-02
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
CLASCOTERONE, WINLEVI, SUN PHARM
2025-08-26NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Clascoterone, Winlevi, Sun Pharm
87854272030-07-25DP
94336282029-02-28DP
112073322028-11-20DPU-3280
101596822028-08-14U-2942
94864582028-07-24U-2942
81432402025-01-12U-2942
88656902024-07-24U-2942
92112952024-07-24DP
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AX: Other anti-acne preparations for topical use in atc
— D10AX06: Clascoterone
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acne vulgarisD000152EFO_0003894L70———6—6
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RosaceaD012393—L71—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameClascoterone
INNclascoterone
Description
Clascoterone, sold under the brand name Winlevi, is an antiandrogen medication which is used topically in the treatment of acne. It is also under development in a higher concentration for the treatment of androgen-dependent scalp hair loss, under the brand name Breezula. The medication is used as a cream by application to the skin, for instance the face and scalp.
Classification
Small molecule
Drug classantiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCC(=O)O[C@]1(C(=O)CO)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C
Identifiers
PDB—
CAS-ID19608-29-8
RxCUI—
ChEMBL IDCHEMBL3590187
ChEBI ID—
PubChem CID11750009
DrugBankDB12499
UNII IDXN7MM8XG2M (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
367
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Q9UD95
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 424 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,103 adverse events reported
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