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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Commercial
Therapeutic Areas
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Trade Name
FDA
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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 |
|---|---|---|---|---|
| WINLEVI | Sun Pharmaceutical Industries | N-213433 RX | 2020-08-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| winlevi | New Drug Application | 2023-01-27 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CLASCOTERONE, WINLEVI, SUN PHARM | |||
| 2025-08-26 | NCE | ||
HCPCS
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Clinical
Clinical Trials
23 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 vulgaris | D000152 | EFO_0003894 | L70 | 2 | 4 | 4 | 6 | 1 | 16 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | 1 | 2 | — | — | 3 |
| Alopecia | D000505 | HP_0002293 | L64 | — | 1 | 2 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Paranasal sinus diseases | D010254 | — | — | — | 1 | — | — | — | 1 |
| Pilonidal sinus | D010864 | HP_0010769 | L05 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
| Retrospective studies | D012189 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clascoterone |
| INN | clascoterone |
| 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 class | antiandrogens |
| Image (chem structure or protein) |  |
| 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-ID | 19608-29-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3590187 |
| ChEBI ID | — |
| PubChem CID | 11750009 |
| DrugBank | DB12499 |
| UNII ID | XN7MM8XG2M (ChemIDplus, GSRS) |
Target
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Safety
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Adverse Events
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685 adverse events reported
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