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PharmaceuticalApproved

Clascoterone (Winlevi)

klas-KOH-ter-own

Research profile · How we handle evidence

Category

Pharmaceutical

Compound type

Phase / Status

Approved

FDA approved for acne

Standard Dose

Twice daily topical

As directed

Half-life

Local only

Plasma elimination

Route(s)

TO

Topical

Research Stage

Market Approved

Regulatory approval granted; post-market monitoring ongoing.

Overview

Clascoterone (Winlevi) is a prescription cream that targets androgen receptors in the skin. It's used to help manage hormonal acne and is designed to be applied locally as directed by a clinician. Results usually take consistency over several weeks, so it's normal to see changes gradually rather than immediately. If you have sensitive skin or past reactions to topical acne treatments, start with your dermatologist's guidance.

Plain-language summary

Clascoterone (Winlevi) is a prescription cream that targets androgen receptors in the skin. It's used to help manage hormonal acne and is designed to be applied locally as directed by a clinician. Results usually take consistency over several weeks, so it's normal to see changes gradually rather than immediately. If you have sensitive skin or past reactions to topical acne treatments, start with your dermatologist's guidance.

Administration Routes

  • Topical

Also known as

WinleviCB-03-01Cortexolone 17-propionateCortexolone 17alpha-propionateClasco

Mechanisms

1

Topical androgen receptor antagonist

Detailed mechanism

Clascoterone competitively binds to androgen receptors in skin cells, preventing DHT and testosterone from activating androgen-dependent gene transcription in sebocytes and dermal papilla cells. By blocking local androgen signaling, it reduces sebum production and follicular hyperkeratinization without significant systemic hormonal absorption. This peripheral mechanism distinguishes it from systemic anti-androgens, making it suitable for topical acne management in both male and female patients.

Safety

Side effects

  • Mild skin irritation
  • Dryness
  • Redness or itching

Reported benefits

  • Treats acne
  • Targets androgen signaling in skin
  • Prescription topical option

Safety profile

Consult medical professional before use

Clinical trials

See research status

Structure

View 3D structure

Verified structure

Clascoterone (Winlevi)

Exact 2D structure can be rendered from a PubChem-backed canonical SMILES string.

Verified via PubChemMatched by casNumber
Source: PubChemLookup: 19608-29-8InChIKey GPNHMOZDMYNCPO-PDUMRIMRSA-N
Chemical Formula
C24H34O5
Molecular Weight
402.5 g/mol
CAS Number
19608-29-8
InChIKey
GPNHMOZDMYNCPO-PDUMRIMRSA-N

Stack Context

No stack data available.

References

  1. 1

    Efficacy and Safety of Clascoterone Cream 1% for the Treatment of Facial Acne Vulgaris: Two Phase 3 Randomized Clinical Trials

    2020

    View source
  2. 2

    Cortexolone 17alpha-propionate (CB-03-01), a new acne treatment that combines two mechanisms of action: androgen receptor antagonism and inhibition of sebum production

    2019

    View source
  3. 3

    Clascoterone: First Approval for Acne Vulgaris

    2020

    View source
  4. 4

    Phase 2 clinical trial of clascoterone (CB-03-01) cream 1% for acne vulgaris

    2018

    View source

This profile summarizes research literature for education only. It is not medical advice, and it does not diagnose, treat, or recommend a dose. Consult a qualified professional before changing a protocol.

Research-driven insights.Evidence-based decisions.