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Specifications of Clascoterone丨CAS 19608-29-8
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Appearance: |
White to off-white crystalline or crystalline powder |
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Assay: |
98.0% ~ 102.0% |
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Solubility: |
Very soluble in dichloromethane, freely soluble in methanol, insoluble in water |
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Identification: |
HPLC: The retention time of the main peak of the solution should be consistent with the retention time of the main peak of the reference solution |
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Water: |
0.5% max |
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Residue on ignition: |
0.2% max |
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Residual solvents: |
Dichloromethane: 600 ppm max Acetonitrile: 410 ppm max MTBE: 5000 ppm max |
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Heavy metal: |
10 ppm max |
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Related substances: |
Single impurity: 0.5% max Total impurity: 1.5% max |
Applications of Clascoterone丨CAS 19608-29-8
1. Dermatology: Treatment of Acne Vulgaris
Clascoterone丨CAS 19608-29-8 is currently approved by the U.S. FDA under the brand name Winlevi® for the topical treatment of acne vulgaris in patients 12 years and older.
● Mechanism of Action:
Acts as a topical androgen receptor antagonist, inhibiting the effects of dihydrotestosterone (DHT) in the skin. This:
oReduces sebum production
oDecreases inflammation
oPrevents androgen-driven acne formation
● Clinical Benefits:
oNon-systemic: Designed for minimal systemic absorption
oAvoids common side effects of oral antiandrogens (e.g., hormonal imbalance, systemic toxicity)
oSuitable for both males and females, unlike some hormonal treatments
2. Potential in Androgenic Alopecia (Hair Loss)
Although not yet FDA-approved for this use, Clascoterone is under clinical investigation for treating androgenetic alopecia (pattern hair loss) in both men and women.
● Rationale:
By blocking DHT locally in the scalp, it may prevent hair follicle miniaturization, a key factor in androgenic hair loss.
3. Possible Future Applications
Clascoterone's local antiandrogenic properties may lend itself to future therapies for:
● Hirsutism (excess facial/body hair in women)
● Seborrheic dermatitis
● Other androgen-sensitive dermatoses
These applications are still under preclinical or clinical evaluation.
Benefits of Clascoterone丨CAS 19608-29-8
√ Targeted Topical Activity
Acts only at the site of application, reducing the risk of systemic hormonal side effects.
√ Non-antibiotic Option for Acne
Addresses the hormonal root cause of acne without contributing to antibiotic resistance.
√ Rapid Onset
Clinical studies show improvement in acne symptoms as early as 2–4 weeks, with peak effects at 8–12 weeks.
√ Minimal Side Effects
Well tolerated with minor side effects like local irritation or erythema, making it suitable for long-term use.
√ No Hormonal Suppression
Unlike oral antiandrogens, Clascoterone does not affect systemic hormone levels, making it safe for broader demographics, including adolescent males.
Conclusion
Clascoterone丨CAS 19608-29-8 is a breakthrough in topical dermatologic therapies, especially for acne treatment. With its non-systemic antiandrogenic mechanism and excellent safety profile, it fills a crucial gap between cosmetic treatments and oral hormonal therapies. As ongoing trials explore its role in hair loss and other androgen-mediated skin conditions, Clascoterone represents a promising, next-generation topical therapeutic with wide-reaching potential in the skincare and dermatology market.
