clascoterone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiandrogens | 5410 | 19608-29-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Clascoterone is an androgen receptor inhibitor. The mechanism of action of Winlevi cream for the topical treatment of acne vulgaris is unknown.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 26, 2020 | FDA | CASSIOPEA SPA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Product physical consistency issue | 257.94 | 197.85 | 27 | 51 | 672 | 63488272 |
| Product use complaint | 214.33 | 197.85 | 26 | 52 | 2448 | 63486496 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D10AX06 | DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Other anti-acne preparations for topical use |
| FDA MoA | N0000000243 | Androgen Receptor Antagonists |
| FDA EPC | N0000175560 | Androgen Receptor Inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acne vulgaris | indication | 88616000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1% | WINLEVI | SUN PHARM | N213433 | Aug. 26, 2020 | RX | CREAM | TOPICAL | 8143240 | Jan. 12, 2024 | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE |
| 1% | WINLEVI | SUN PHARM | N213433 | Aug. 26, 2020 | RX | CREAM | TOPICAL | 8865690 | July 24, 2024 | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE |
| 1% | WINLEVI | SUN PHARM | N213433 | Aug. 26, 2020 | RX | CREAM | TOPICAL | 9486458 | July 24, 2028 | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE |
| 1% | WINLEVI | SUN PHARM | N213433 | Aug. 26, 2020 | RX | CREAM | TOPICAL | 10159682 | Aug. 14, 2028 | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE |
| 1% | WINLEVI | SUN PHARM | N213433 | Aug. 26, 2020 | RX | CREAM | TOPICAL | 11207332 | Nov. 20, 2028 | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1% | WINLEVI | SUN PHARM | N213433 | Aug. 26, 2020 | RX | CREAM | TOPICAL | Aug. 26, 2025 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Androgen receptor | Nuclear hormone receptor | ANTAGONIST | IC50 | 7.30 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| D11451 | KEGG_DRUG |
| XN7MM8XG2M | UNII |
| C4730996 | UMLSCUI |
| CHEMBL3590187 | ChEMBL_ID |
| 11750009 | PUBCHEM_CID |
| DB12499 | DRUGBANK_ID |
| 11215 | IUPHAR_LIGAND_ID |
| 018485 | NDDF |
| 898156008 | SNOMEDCT_US |
| 898164002 | SNOMEDCT_US |
| 4039914 | VANDF |
| 2474340 | RXNORM |
| 350958 | MMSL |
| 39936 | MMSL |
| C496269 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10891 | INN_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Winlevi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47335-994 | CREAM | 1 g | TOPICAL | NDA | 25 sections |
| Winlevi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47335-994 | CREAM | 1 g | TOPICAL | NDA | 25 sections |