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1. Cb-03-01
2. Clascoterone
3. Winlevi
1. Clascoterone
2. 19608-29-8
3. Cb-03-01
4. 17 Alpha-propionate
5. 17alpha-propionate
6. Winlevi
7. Cortexolone 17 Alpha-propionate
8. Clascoterone [usan]
9. Xn7mm8xg2m
10. Pregn-4-ene-3,20-dione, 21-hydroxy-17-(1-oxopropoxy)-
11. Cortexolone 17.alpha.-propionate
12. Cortodoxone 17.alpha.-propionate
13. Clascoterone (usan)
14. Pregn-4-ene-3,20-dione, 17,21-dihydroxy-, 17-propionate
15. (8r,9s,10r,13s,14s,17r)-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl Propionate
16. [(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
17. Breezula
18. Unii-xn7mm8xg2m
19. Cortodoxone 17alpha-propionate
20. 17
21. A-propionate
22. Clascoterone [mi]
23. Clascoterone [inn]
24. Cortexolone 17a-propionate
25. Clascoterone [who-dd]
26. Schembl1231152
27. Chembl3590187
28. Gtpl11215
29. Dtxsid10471883
30. Clascoterone [orange Book]
31. Bcp02565
32. Ex-a1953
33. Zinc6716459
34. 11-deoxycortisol 17alpha-propionate
35. S6896
36. Akos030526694
37. At22231
38. Bcp9000062
39. Cb-0301
40. Cs-1151
41. Db12499
42. 17alpha-(propionyloxy)deoxycorticosterone
43. Ac-31957
44. Hy-13331
45. Clascoterone; 19608-29-8; Cb-03-1
46. D11451
47. A854304
48. Q27293917
49. 21-hydroxy-3,20-dioxopregn-4-en-17-yl Propanoate
50. Cortexolone 17alpha-propionate;(8r,9s,10r,13s,14s,17r)-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl Propionate;cortexolone 17 Alpha-propionate
Molecular Weight | 402.5 g/mol |
---|---|
Molecular Formula | C24H34O5 |
XLogP3 | 3.9 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 5 |
Exact Mass | 402.24062418 g/mol |
Monoisotopic Mass | 402.24062418 g/mol |
Topological Polar Surface Area | 80.7 Ų |
Heavy Atom Count | 29 |
Formal Charge | 0 |
Complexity | 769 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Clascoterone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Clascoterone exerts anti-androgenic effects by working as an antagonist at androgen receptors (ARs) expressed throughout the skin, including sebaceous glands, sebocytes, and dermal papilla cells. Clascoterone blocks the effects of testosterone and dihydrotestosterone (DHT), which are androgens that bind to the ARs and contribute to the development of androgen-dependent conditions such as acne and alopecia. _In vitro_, the antiandrogenic effects of clascoterone in human primary sebocytes occurred in a dose-dependent manner. Clascoterone mediates selective topical activity by mainly targeting androgen receptors at the site of application. It has limited systemic effects. In clinical trials, HPA axis suppression was observed as a 30-minute post-stimulation serum cortisol level of 18 mcg/dL in 5% of adult subjects and 9% of adolescent subjects with acne vulgaris following two weeks of topical treatment of clascoterone. HPA axis function returned to normal following the discontinuation of drug treatment.
D - Dermatologicals
D10 - Anti-acne preparations
D10A - Anti-acne preparations for topical use
D10AX - Other anti-acne preparations for topical use
D10AX06 - Clascoterone
Absorption
Upon topical application, clascoteronet permeates the skin to the dermal levels with minimal systemic absorption. In clinical trials, adult subjects with moderate to severe facial acne vulgaris received twice-daily topical application of six grams of clascoterone. The steady-state concentrations of the drug were reached within five days. Following two weeks, the mean SD Cmax was 4.5 2.9 ng/mL and the mean SD area under the plasma concentration-time over the dosing interval (AUC) was 37.1 22.3 h*ng/mL. The mean SD average plasma concentration (Cavg) was 3.1 1.9 ng/mL.
Route of Elimination
Excretion of clascoterone has not been fully characterized in humans. Upon topical application, clascoterone is quickly hydrolyzed in the epidermis.
Volume of Distribution
There is no information available on the volume of distribution.
Clearance
There is limited information on clearance of clascoterone.
According to _in vitro_ and clinical studies, the main possible primary metabolite of clascoterone is cortexolone, which is an inactive metabolite. The plasma concentrations of cortexolone were generally below or near the lower limit of quantitation (0.5 ng/mL). Although clascoterone penetrates the skin, the systemic activity of the drug is limited due to rapid hydrolysis of clascoterone into the inactive metabolite by skin and plasma esterases, namely carboxylesterase.
There is limited information on the half life of clascoterone.
Acne is a multifactorial skin condition characterized by excess sebum production, epithelial hyperkeratinization, proliferation of the skin commensal bacteria, and inflammation. Circulating and locally synthesized natural ligands, testosterone and dihydrotestosterone (DHT), serve as causative factors in both males and females. Upon binding of DHT, the DHT-androgen receptor complex dimerizes and translocates to the nucleus where it promotes the transcription of genes involved in acne pathogenesis, including proliferation and differentiation of sebocytes, excess sebum production, and inflammatory cytokine production. Clascoterone is a potent antagonist at ARs and competes for androgens in binding to the receptor, thereby inhibiting downstream signalling of ARs that promote acne. Androgenetic alopecia is also an androgen-dependent and highly genetic condition. Dihydrotestosterone (DHT) binds to ARs expressed on dermal papilla cells (DPC) in the scalp to induce AR-mediated transcription of genes that contribute to androgenic alopecia. By blocking the interaction between DHT and aARs, clascoterone inhibits AR-regulated transcription and DHT-induced IL-6 synthesis.
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PharmaCompass offers a list of Clascoterone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Clascoterone manufacturer or Clascoterone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clascoterone manufacturer or Clascoterone supplier.
PharmaCompass also assists you with knowing the Clascoterone API Price utilized in the formulation of products. Clascoterone API Price is not always fixed or binding as the Clascoterone Price is obtained through a variety of data sources. The Clascoterone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Clascoterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clascoterone, including repackagers and relabelers. The FDA regulates Clascoterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clascoterone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Clascoterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clascoterone supplier is an individual or a company that provides Clascoterone active pharmaceutical ingredient (API) or Clascoterone finished formulations upon request. The Clascoterone suppliers may include Clascoterone API manufacturers, exporters, distributors and traders.
click here to find a list of Clascoterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clascoterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Clascoterone active pharmaceutical ingredient (API) in detail. Different forms of Clascoterone DMFs exist exist since differing nations have different regulations, such as Clascoterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clascoterone DMF submitted to regulatory agencies in the US is known as a USDMF. Clascoterone USDMF includes data on Clascoterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clascoterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clascoterone suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Clascoterone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clascoterone API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Clascoterone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Clascoterone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clascoterone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clascoterone suppliers with NDC on PharmaCompass.
Clascoterone Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Clascoterone GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Clascoterone GMP manufacturer or Clascoterone GMP API supplier for your needs.
A Clascoterone CoA (Certificate of Analysis) is a formal document that attests to Clascoterone's compliance with Clascoterone specifications and serves as a tool for batch-level quality control.
Clascoterone CoA mostly includes findings from lab analyses of a specific batch. For each Clascoterone CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Clascoterone may be tested according to a variety of international standards, such as European Pharmacopoeia (Clascoterone EP), Clascoterone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clascoterone USP).