Clascoterone

updated

Clascoterone is an FDA-approved topical androgen receptor inhibitor for acne vulgaris in patients 12 and older (WINLEVI cream 1%, 2020). Two phase 3 trials in 1,440 patients back it, with a modest effect: treatment success 18.4% and 20.3% versus 9.0% and 6.5% on vehicle. Sebum reduction appears in one uncontrolled 40-patient study, scalp androgen findings come from cell culture, and the hair-loss trials have no posted results. No reported trial result tests it in anabolic steroid users or a defined high-androgen group.

Topical androgen receptor inhibitor

  • FDA approved WINLEVI (clascoterone) cream 1% under NDA 213433 on 26 August 2020; the European Commission authorized it on 17 October 2025.
  • Two phase 3 trials in 1,440 patients with moderate or severe facial acne found treatment success of 18.4% versus 9.0% and 20.3% versus 6.5% on vehicle at 12 weeks.
  • The label states that the mechanism of action in acne is unknown, and warns about local irritation and HPA axis suppression.
  • A single-arm study of 40 patients reported a 27% fall in casual sebum over 12 weeks, with no vehicle arm.
  • SCALP1 (703 men) and SCALP2 (762 men), phase 3 trials of a 5% solution in androgenetic alopecia, show completion dates and no posted results.
  • A PubMed search on 9 October 2026 returned 17 records on clascoterone with androgen-related terms; none tested it in anabolic steroid users or a defined high-androgen group.

What is clascoterone approved to do?

FDA approved WINLEVI (clascoterone) cream 1% on 26 August 2020 for acne vulgaris in patients 12 and older, and the European Commission authorized it on 17 October 2025. Neither approval covers hair loss.

The WINLEVI label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older. The label version used here took effect on 2 January 2025. FDA approved WINLEVI under NDA 213433 on 26 August 2020, with Sun Pharma listed as sponsor. It was the only clascoterone application in the FDA record, and no hair-loss product appears.

The European Commission authorized WINLEVI throughout the EU on 17 October 2025, after a CHMP opinion adopted on 25 August 2025. The EU indication is acne vulgaris in adults and facial acne vulgaris in adolescents aged 12 to under 18, and the medicine is under additional monitoring. The EU authorization does not include hair loss.

Clascoterone is cortexolone 17alpha-propionate (CB-03-01; C24H34O5, 402.5 g/mol, CAS 19608-29-8). The approved product is a 1% cream, while the hair-loss trials used a 5% solution, so cream data do not transfer to scalp solutions or to unregulated vendor products.

WINLEVI label, version effective 2 January 2025: indication, warnings, PK, trial results

FDA prescribing information

DailyMed, U.S. National Library of Medicine. WINLEVI (clascoterone) cream 1%, topical, prescribing information, label version effective 2 January 2025. Set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older, and states that its mechanism of action in acne is unknown. Warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression: after 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects. With a mean of about 6 grams applied twice daily in adults, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The most common adverse reactions (7 to 12%) were erythema, pruritus, and scaling or dryness. In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% (Trial 1) and 20.9% versus 6.6% (Trial 2). The label names cortexolone as a possible primary metabolite.

Participants / model
Patients 12 and older with acne vulgaris; PK and HPA-axis study subjects
Treatment
WINLEVI cream 1%, topical
Follow-up
Label version effective 2 January 2025; efficacy at week 12
Study design
FDA prescribing information
Funding
not stated in the source

The label states the mechanism of action in acne is unknown. The page gives no label dose or application amount.

Read the original source
Drugs@FDA: WINLEVI approved 26 August 2020

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 213433 (WINLEVI, clascoterone). Dates read from the openFDA Drugs@FDA records.

FDA approved WINLEVI under NDA 213433 on 26 August 2020, with Sun Pharma listed as sponsor. It was the only clascoterone application returned; no hair-loss product appears.

Participants / model
Not a clinical population
Treatment
Drug application
Follow-up
Approval on 26 August 2020
Study design
FDA application record
Funding
not stated in the source

The record gives the approval date and sponsor. The indication comes from the product label.

Read the original source
EMA: authorized in the EU on 17 October 2025 for acne vulgaris

Regulatory record

European Medicines Agency. WINLEVI, European public assessment report page, clascoterone cream.

The European Commission authorized WINLEVI throughout the EU on 17 October 2025 after a CHMP opinion adopted on 25 August 2025. The EU indication is acne vulgaris in adults and facial acne vulgaris in adolescents aged 12 to under 18, and the medicine is under additional monitoring. The EU authorization does not include hair loss.

Participants / model
Adults and adolescents 12 to under 18 with acne vulgaris
Treatment
WINLEVI cream, topical
Follow-up
Authorization on 17 October 2025
Study design
EMA regulatory record
Funding
not stated in the source

The EU indication is narrower for adolescents than the US label: facial acne only.

Read the original source
PubChem CID 11750009: C24H34O5, 402.5 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 11750009, clascoterone (cortexolone 17alpha-propionate, CB-03-01).

Clascoterone is cortexolone 17alpha-propionate (CB-03-01): PubChem CID 11750009, C24H34O5, 402.5 g/mol, CAS 19608-29-8; PubChem synonyms include Winlevi and Breezula. The approved product is a 1% cream, while the hair-loss trials used a 5% solution, so cream data do not transfer to scalp solutions or to unregulated vendor products. The label names cortexolone as a possible primary metabolite.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

What did the acne trials find?

Two phase 3 trials in 1,440 patients found treatment success of 18.4% and 20.3% on clascoterone versus 9.0% and 6.5% on vehicle after 12 weeks. The effect is modest and the trials did not select for androgen levels or steroid use.

Two identical phase 3 trials randomized 1,440 patients aged 9 and older with moderate or severe facial acne to clascoterone 1% or vehicle cream twice daily for 12 weeks. Treatment success was 18.4% versus 9.0% in CB-03-01/25 and 20.3% versus 6.5% in CB-03-01/26. Inflammatory lesions fell by 19.3 versus 15.5 and 20.0 versus 12.6, and noninflammatory lesions by 19.4 versus 13.0 and 19.4 versus 10.8. The trials were registered as NCT02608450 and NCT02608476, and the authors include sponsor employees and paid advisors.

In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% on vehicle (Trial 1) and 20.9% versus 6.6% (Trial 2).

Enrollment was defined by acne severity and lesion counts, not by androgen levels or steroid use. In an open-label extension, 600 patients aged 12 and older used clascoterone 1% on the face, and optionally the trunk, for up to 9 more months. Among per-protocol completers, facial IGA 0 or 1 reached 48.9% (156 of 319) and truncal IGA 0 or 1 reached 52.4% (65 of 124) at study end. There was no control group.

Two phase 3 trials: 1,440 patients, treatment success 18.4 and 20.3% versus 9.0 and 6.5%

Randomized controlled trial

Hebert A et al. JAMA Dermatol. 2020;156(6):621-630. PMID 32320027.

Treatment success was 18.4% versus 9.0% in CB-03-01/25 and 20.3% versus 6.5% in CB-03-01/26. Inflammatory lesions fell by 19.3 versus 15.5 and 20.0 versus 12.6, and noninflammatory lesions by 19.4 versus 13.0 and 19.4 versus 10.8. Adverse events were mostly mild, mainly trace or mild erythema.

Participants / model
1,440 patients aged 9 and older with moderate or severe facial acne
Treatment
Clascoterone cream 1% or vehicle cream to the face, twice daily
Follow-up
12 weeks
Study design
Two identical randomized vehicle-controlled phase 3 trials
Funding
Authors include sponsor employees and paid advisors

Enrollment was defined by acne severity and lesion counts, not by androgen levels or steroid use. Endpoints were IGA treatment success, lesion counts and adverse events.

Read the original source
WINLEVI label, version effective 2 January 2025: indication, warnings, PK, trial results

FDA prescribing information

DailyMed, U.S. National Library of Medicine. WINLEVI (clascoterone) cream 1%, topical, prescribing information, label version effective 2 January 2025. Set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older, and states that its mechanism of action in acne is unknown. Warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression: after 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects. With a mean of about 6 grams applied twice daily in adults, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The most common adverse reactions (7 to 12%) were erythema, pruritus, and scaling or dryness. In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% (Trial 1) and 20.9% versus 6.6% (Trial 2). The label names cortexolone as a possible primary metabolite.

Participants / model
Patients 12 and older with acne vulgaris; PK and HPA-axis study subjects
Treatment
WINLEVI cream 1%, topical
Follow-up
Label version effective 2 January 2025; efficacy at week 12
Study design
FDA prescribing information
Funding
not stated in the source

The label states the mechanism of action in acne is unknown. The page gives no label dose or application amount.

Read the original source
Extension: 600 patients, up to 9 more months, no control group

Clinical trial

Eichenfield LF et al. J Drugs Dermatol. 2023;22(8):810-816. PMID 37556524.

Treatment-emergent adverse events occurred in 108 of 598 treated patients (18.1%); the most common local reactions were facial erythema and scaling or dryness. Among per-protocol completers, facial IGA 0 or 1 reached 48.9% (156 of 319) and truncal IGA 0 or 1 reached 52.4% (65 of 124) at study end.

Participants / model
600 patients 12 and older from the phase 3 trials; 343 completed
Treatment
Clascoterone cream 1% to the face, and optionally the trunk, twice daily
Follow-up
Up to 9 more months
Study design
Open-label extension study
Funding
not stated in the source

There was no control group. Endpoints were adverse events, local skin reactions and IGA.

Read the original source

Does clascoterone lower sebum in people?

One uncontrolled study of 40 patients measured a 27% fall in casual sebum over 12 weeks. With no vehicle arm, the size of any drug effect on sebum is not established.

In a single-arm, sponsor-funded study, 40 patients 12 and older with mild-to-moderate acne (mean age 20.9) used clascoterone 1% twice daily for 12 weeks. Casual sebum measurements fell 27% from baseline, inflammatory lesions 54% and noninflammatory lesions 34% (all p < 0.001), with no tolerability issues in the 12-week interim analysis. The trial is registered as NCT06415279.

There was no vehicle arm, so the size of any drug effect on sebum is not established. In laboratory work, clascoterone reduced androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes, which is cell evidence and not a measured sebum change in people.

Single-arm study: 40 patients, casual sebum down 27%

Clinical trial

Draelos ZD et al. Dermatol Ther (Heidelb). 2025;15(9):2657-2666. PMID 40682762.

Casual sebum measurements fell 27% from baseline, inflammatory lesions 54% and noninflammatory lesions 34% (all p < 0.001), with no tolerability issues in the 12-week interim analysis.

Participants / model
40 patients 12 and older with mild-to-moderate acne, mean age 20.9
Treatment
Clascoterone cream 1%, topical, twice daily
Follow-up
12 weeks (interim analysis)
Study design
Open-label single-arm study, interim analysis
Funding
Sponsor-funded

There was no vehicle arm, so the size of any drug effect on sebum is not established.

Read the original source
Cell study: androgen receptor binding, sebocyte lipid and cytokines

Cell study

Rosette C et al. J Drugs Dermatol. 2019;18(5):412-418. PMID 31141847.

Clascoterone bound the androgen receptor with high affinity, inhibited androgen-regulated transcription in a reporter cell line, and reduced androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes in a dose-dependent manner, with stronger cytokine inhibition than spironolactone.

Participants / model
Human primary sebocytes and a reporter cell line
Treatment
In-vitro clascoterone exposure
Follow-up
not stated in the source
Study design
Original laboratory study
Funding
not stated in the source

This is cell evidence, not a measured sebum change in people.

Read the original source

Do the claims about sebum, scalp androgens and DHT-driven acne hold up?

Partly. Acne efficacy is shown in general acne trials, sebum reduction in one uncontrolled study, and scalp androgen activity only in cell culture. No reported trial result tests clascoterone in anabolic steroid users or a defined high-androgen group.

Sellers say topical clascoterone reduces sebum and scalp androgen activity, has off-label and trial interest for androgenetic alopecia, and is good for DHT-driven facial acne.

A PubMed search on 9 October 2026 for clascoterone (also cortexolone 17alpha-propionate and CB-03-01) with anabolic, testosterone, hyperandrogenism, dihydrotestosterone, transgender or polycystic terms returned 17 records. They were narrative reviews and commentaries, a guideline, a first-approval summary, laboratory, preclinical and skin-permeation studies, a microneedle formulation study, and a skin-moisturization study. None tested clascoterone in people using anabolic steroids or in a defined high-androgen group. The DHT-driven acne claim rests on mechanism and on general acne trials, not on a trial in that population.

One registered trial, NCT05891795 from Stanford University, tests clascoterone 1% cream versus vehicle for steroid-related facial acne in transgender male or gender-diverse patients on stable masculinizing hormone therapy, with change in papules and pustules at week 12 as the primary outcome. Estimated enrollment is 18. The record shows active, not recruiting, primary completion in January 2026, and no posted results. It is the only registered test of clascoterone in an androgen-driven acne population located.

The scalp androgen claim rests on one cell-culture study. In cultured human scalp dermal papilla cells stimulated with DHT, clascoterone inhibited IL-6 synthesis more than enzalutamide, and it inhibited androgen-regulated transcription in a reporter line with efficacy similar to finasteride. That is not a measurement in a human scalp.

PubMed search, 9 October 2026: 17 records, none in steroid users or a defined high-androgen group

PubMed search record

PubMed search run on 9 October 2026: (clascoterone OR cortexolone 17alpha-propionate OR CB-03-01) AND (anabolic OR testosterone OR hyperandrogenism OR dihydrotestosterone OR transgender OR polycystic). 17 records returned.

The search returned 17 records: narrative reviews and commentaries, a guideline, a first-approval summary, laboratory, preclinical and skin-permeation studies, a microneedle formulation study, and a skin-moisturization study. None tested clascoterone in people using anabolic steroids or in a defined high-androgen group. The claim that clascoterone is good for DHT-driven facial acne rests on mechanism and on general acne trials, not on a trial in that population.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 9 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Read the original source
Stanford phase 1/2: steroid-related acne on masculinizing hormones, no posted results

Trial registry record

ClinicalTrials.gov record NCT05891795. Sponsor Stanford University.

The registry lists a phase 1/2 trial of clascoterone 1% cream versus vehicle for steroid-related facial acne in transgender male or gender-diverse patients on stable masculinizing hormone therapy, with change in papules and pustules at week 12 as the primary outcome. Estimated enrollment is 18; the record shows active, not recruiting, primary completion in January 2026, and no posted results.

Participants / model
Transgender male or gender-diverse patients on testosterone with facial acne
Treatment
Clascoterone cream 1% versus vehicle, topical
Follow-up
12 weeks
Study design
Registered phase 1/2 trial; no posted results
Funding
Sponsor Stanford University

It is the only registered test of clascoterone in an androgen-driven acne population located. Registered lesion-count endpoint; no posted results.

Read the original source
Cell study: DHT-stimulated scalp cells, IL-6 and transcription

Cell study

Rosette C et al. J Drugs Dermatol. 2019;18(2):197-201. PMID 30811143.

In cultured human scalp dermal papilla cells stimulated with DHT, clascoterone inhibited IL-6 synthesis more than enzalutamide, and it inhibited androgen-regulated transcription in a reporter line with efficacy similar to finasteride.

Participants / model
Primary human scalp dermal papilla cells and a reporter cell line
Treatment
In-vitro clascoterone exposure
Follow-up
not stated in the source
Study design
Original laboratory study
Funding
not stated in the source

This is the only scalp-cell androgen study located. It is cell culture, not a measurement in a human scalp.

Read the original source
Single-arm study: 40 patients, casual sebum down 27%

Clinical trial

Draelos ZD et al. Dermatol Ther (Heidelb). 2025;15(9):2657-2666. PMID 40682762.

Casual sebum measurements fell 27% from baseline, inflammatory lesions 54% and noninflammatory lesions 34% (all p < 0.001), with no tolerability issues in the 12-week interim analysis.

Participants / model
40 patients 12 and older with mild-to-moderate acne, mean age 20.9
Treatment
Clascoterone cream 1%, topical, twice daily
Follow-up
12 weeks (interim analysis)
Study design
Open-label single-arm study, interim analysis
Funding
Sponsor-funded

There was no vehicle arm, so the size of any drug effect on sebum is not established.

Read the original source

What is the status of clascoterone for hair loss?

Three registered trials of a 5% scalp solution in men with androgenetic alopecia are complete, with no posted results and no peer-reviewed report located. Neither FDA nor the EU has approved clascoterone for hair loss.

A phase 2 trial, NCT02279823, compared clascoterone solution 5% with minoxidil solution 5% and vehicle, applied twice daily for 26 weeks in 95 men with mild to moderate androgenetic alopecia, with change in target area hair count at month 6 as a primary outcome. The registry lists completion in May 2016 and sponsor Intrepid Therapeutics. No results are posted and no peer-reviewed report was located.

SCALP1 (NCT05910450) was a phase 3, randomized, double-blind, vehicle-controlled trial of clascoterone 5% solution in men 18 and older with Norwood-Hamilton IIIv to V androgenetic alopecia: 6 months double-blind, then 6 months single-blind. Co-primary endpoints were change in non-vellus target area hair count at month 6 and a patient-reported hair coverage item. Actual enrollment was 703, and the record shows completion on 26 January 2026.

SCALP2 (NCT05914805) registered the same design in 762 men, with completion on 16 July 2025. Both phase 3 records are from sponsor Cassiopea SpA and show no posted results as of 9 October 2026.

The approved product is a 1% cream for acne. Cream data do not transfer to the 5% scalp solution, and the FDA record shows no hair-loss product.

Phase 2 hair-loss trial: 95 men, completed 2016, no posted results

Trial registry record

ClinicalTrials.gov record NCT02279823. Sponsor Intrepid Therapeutics.

The registry lists a completed phase 2 trial of CB-03-01 (clascoterone) solution 5% versus minoxidil solution 5% versus vehicle, applied twice daily for 26 weeks in 95 men with androgenetic alopecia, with change in target area hair count at month 6 as a primary outcome. Completion is listed as May 2016. No results are posted and no peer-reviewed report was located.

Participants / model
95 men with mild to moderate androgenetic alopecia
Treatment
Clascoterone solution 5%, topical scalp, versus minoxidil solution 5% or vehicle, twice daily
Follow-up
26 weeks
Study design
Registered phase 2 randomized trial; no posted results
Funding
Sponsor Intrepid Therapeutics

Registered hair-count and self-assessment endpoints; no posted results.

Read the original source
SCALP1 phase 3: 703 men, completed January 2026, no posted results

Trial registry record

ClinicalTrials.gov record NCT05910450 (SCALP1). Sponsor Cassiopea SpA.

The registry lists a phase 3, randomized, double-blind, vehicle-controlled trial of clascoterone 5% solution in men 18 and older with Norwood-Hamilton IIIv to V androgenetic alopecia: 6 months double-blind, then 6 months single-blind. Co-primary endpoints were change in non-vellus target area hair count at month 6 and a patient-reported hair coverage item. Actual enrollment was 703, and the record shows completion on 26 January 2026. No results are posted.

Participants / model
703 men with androgenetic alopecia
Treatment
Clascoterone 5% topical solution
Follow-up
6 months double-blind, then 6 months single-blind
Study design
Registered phase 3 randomized double-blind vehicle-controlled trial; no posted results
Funding
Sponsor Cassiopea SpA

Registered hair-count and patient-reported endpoints; no posted results.

Read the original source
SCALP2 phase 3: 762 men, completed July 2025, no posted results

Trial registry record

ClinicalTrials.gov record NCT05914805 (SCALP2). Sponsor Cassiopea SpA.

The registry lists the same design as SCALP1 in 762 men, with completion on 16 July 2025. No results are posted.

Participants / model
762 men with androgenetic alopecia
Treatment
Clascoterone 5% topical solution
Follow-up
6 months double-blind, then 6 months single-blind
Study design
Registered phase 3 randomized double-blind vehicle-controlled trial; no posted results
Funding
Sponsor Cassiopea SpA

Registered hair-count and patient-reported endpoints; no posted results.

Read the original source
Drugs@FDA: WINLEVI approved 26 August 2020

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 213433 (WINLEVI, clascoterone). Dates read from the openFDA Drugs@FDA records.

FDA approved WINLEVI under NDA 213433 on 26 August 2020, with Sun Pharma listed as sponsor. It was the only clascoterone application returned; no hair-loss product appears.

Participants / model
Not a clinical population
Treatment
Drug application
Follow-up
Approval on 26 August 2020
Study design
FDA application record
Funding
not stated in the source

The record gives the approval date and sponsor. The indication comes from the product label.

Read the original source
EMA: authorized in the EU on 17 October 2025 for acne vulgaris

Regulatory record

European Medicines Agency. WINLEVI, European public assessment report page, clascoterone cream.

The European Commission authorized WINLEVI throughout the EU on 17 October 2025 after a CHMP opinion adopted on 25 August 2025. The EU indication is acne vulgaris in adults and facial acne vulgaris in adolescents aged 12 to under 18, and the medicine is under additional monitoring. The EU authorization does not include hair loss.

Participants / model
Adults and adolescents 12 to under 18 with acne vulgaris
Treatment
WINLEVI cream, topical
Follow-up
Authorization on 17 October 2025
Study design
EMA regulatory record
Funding
not stated in the source

The EU indication is narrower for adolescents than the US label: facial acne only.

Read the original source

How does clascoterone work, and what does the body do with it?

The label describes clascoterone as an androgen receptor inhibitor but states that its mechanism of action in acne is unknown. In cells it bound the androgen receptor with high affinity.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne and states that its mechanism of action in acne is unknown.

In laboratory studies, clascoterone bound the androgen receptor with high affinity, inhibited androgen-regulated transcription in a reporter cell line, and reduced androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes in a dose-dependent manner, with stronger cytokine inhibition than spironolactone. These are cell findings, not measured changes in people.

In the label's pharmacokinetic study in adults, with a mean of about 6 grams applied twice daily, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The label names cortexolone as a possible primary metabolite. A half-life and a time to peak are not established in the sources reviewed.

WINLEVI label, version effective 2 January 2025: indication, warnings, PK, trial results

FDA prescribing information

DailyMed, U.S. National Library of Medicine. WINLEVI (clascoterone) cream 1%, topical, prescribing information, label version effective 2 January 2025. Set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older, and states that its mechanism of action in acne is unknown. Warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression: after 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects. With a mean of about 6 grams applied twice daily in adults, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The most common adverse reactions (7 to 12%) were erythema, pruritus, and scaling or dryness. In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% (Trial 1) and 20.9% versus 6.6% (Trial 2). The label names cortexolone as a possible primary metabolite.

Participants / model
Patients 12 and older with acne vulgaris; PK and HPA-axis study subjects
Treatment
WINLEVI cream 1%, topical
Follow-up
Label version effective 2 January 2025; efficacy at week 12
Study design
FDA prescribing information
Funding
not stated in the source

The label states the mechanism of action in acne is unknown. The page gives no label dose or application amount.

Read the original source
Cell study: androgen receptor binding, sebocyte lipid and cytokines

Cell study

Rosette C et al. J Drugs Dermatol. 2019;18(5):412-418. PMID 31141847.

Clascoterone bound the androgen receptor with high affinity, inhibited androgen-regulated transcription in a reporter cell line, and reduced androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes in a dose-dependent manner, with stronger cytokine inhibition than spironolactone.

Participants / model
Human primary sebocytes and a reporter cell line
Treatment
In-vitro clascoterone exposure
Follow-up
not stated in the source
Study design
Original laboratory study
Funding
not stated in the source

This is cell evidence, not a measured sebum change in people.

Read the original source
Cell study: DHT-stimulated scalp cells, IL-6 and transcription

Cell study

Rosette C et al. J Drugs Dermatol. 2019;18(2):197-201. PMID 30811143.

In cultured human scalp dermal papilla cells stimulated with DHT, clascoterone inhibited IL-6 synthesis more than enzalutamide, and it inhibited androgen-regulated transcription in a reporter line with efficacy similar to finasteride.

Participants / model
Primary human scalp dermal papilla cells and a reporter cell line
Treatment
In-vitro clascoterone exposure
Follow-up
not stated in the source
Study design
Original laboratory study
Funding
not stated in the source

This is the only scalp-cell androgen study located. It is cell culture, not a measurement in a human scalp.

Read the original source
PubChem CID 11750009: C24H34O5, 402.5 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 11750009, clascoterone (cortexolone 17alpha-propionate, CB-03-01).

Clascoterone is cortexolone 17alpha-propionate (CB-03-01): PubChem CID 11750009, C24H34O5, 402.5 g/mol, CAS 19608-29-8; PubChem synonyms include Winlevi and Breezula. The approved product is a 1% cream, while the hair-loss trials used a 5% solution, so cream data do not transfer to scalp solutions or to unregulated vendor products. The label names cortexolone as a possible primary metabolite.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

What risks do the label and trials report?

The label warns about local irritation and suppression of the hypothalamic-pituitary-adrenal axis. After 2 weeks of twice-daily use, 1 of 20 adults and 2 of 22 adolescents had laboratory suppression, and all recovered by 4 weeks after stopping.

The label's warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression. After 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects.

The most common adverse reactions in the label (7 to 12%) were erythema, pruritus, and scaling or dryness. In the phase 3 trials, adverse events were mostly mild, mainly trace or mild erythema. In the open-label extension, treatment-emergent adverse events occurred in 108 of 598 treated patients (18.1%), most commonly facial erythema and scaling or dryness.

The sources reviewed give no safety data for the 5% scalp solution beyond the registered hair-loss trials, which have no posted results.

WINLEVI label, version effective 2 January 2025: indication, warnings, PK, trial results

FDA prescribing information

DailyMed, U.S. National Library of Medicine. WINLEVI (clascoterone) cream 1%, topical, prescribing information, label version effective 2 January 2025. Set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older, and states that its mechanism of action in acne is unknown. Warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression: after 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects. With a mean of about 6 grams applied twice daily in adults, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The most common adverse reactions (7 to 12%) were erythema, pruritus, and scaling or dryness. In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% (Trial 1) and 20.9% versus 6.6% (Trial 2). The label names cortexolone as a possible primary metabolite.

Participants / model
Patients 12 and older with acne vulgaris; PK and HPA-axis study subjects
Treatment
WINLEVI cream 1%, topical
Follow-up
Label version effective 2 January 2025; efficacy at week 12
Study design
FDA prescribing information
Funding
not stated in the source

The label states the mechanism of action in acne is unknown. The page gives no label dose or application amount.

Read the original source
Two phase 3 trials: 1,440 patients, treatment success 18.4 and 20.3% versus 9.0 and 6.5%

Randomized controlled trial

Hebert A et al. JAMA Dermatol. 2020;156(6):621-630. PMID 32320027.

Treatment success was 18.4% versus 9.0% in CB-03-01/25 and 20.3% versus 6.5% in CB-03-01/26. Inflammatory lesions fell by 19.3 versus 15.5 and 20.0 versus 12.6, and noninflammatory lesions by 19.4 versus 13.0 and 19.4 versus 10.8. Adverse events were mostly mild, mainly trace or mild erythema.

Participants / model
1,440 patients aged 9 and older with moderate or severe facial acne
Treatment
Clascoterone cream 1% or vehicle cream to the face, twice daily
Follow-up
12 weeks
Study design
Two identical randomized vehicle-controlled phase 3 trials
Funding
Authors include sponsor employees and paid advisors

Enrollment was defined by acne severity and lesion counts, not by androgen levels or steroid use. Endpoints were IGA treatment success, lesion counts and adverse events.

Read the original source
Extension: 600 patients, up to 9 more months, no control group

Clinical trial

Eichenfield LF et al. J Drugs Dermatol. 2023;22(8):810-816. PMID 37556524.

Treatment-emergent adverse events occurred in 108 of 598 treated patients (18.1%); the most common local reactions were facial erythema and scaling or dryness. Among per-protocol completers, facial IGA 0 or 1 reached 48.9% (156 of 319) and truncal IGA 0 or 1 reached 52.4% (65 of 124) at study end.

Participants / model
600 patients 12 and older from the phase 3 trials; 343 completed
Treatment
Clascoterone cream 1% to the face, and optionally the trunk, twice daily
Follow-up
Up to 9 more months
Study design
Open-label extension study
Funding
not stated in the source

There was no control group. Endpoints were adverse events, local skin reactions and IGA.

Read the original source

Why does clascoterone sit in A tier?

Two phase 3 trials in 1,440 patients, a 2020 FDA approval and a 2025 EU authorization support the A for acne. The effect is modest and the hair-loss and DHT-driven acne uses have no reported trial results.

The A applies to the 1% cream for acne vulgaris. Treatment success was about 18 to 21% versus 7 to 9% on vehicle, and the US marketing history is about six years.

The supplier's uses are separate questions. Sebum reduction appears only in cells and in one uncontrolled 40-patient study, scalp androgen activity appears only in cell culture, and the hair-loss trials have no posted or peer-reviewed results. No reported trial result tests clascoterone in DHT-driven or steroid-associated acne.

WINLEVI label, version effective 2 January 2025: indication, warnings, PK, trial results

FDA prescribing information

DailyMed, U.S. National Library of Medicine. WINLEVI (clascoterone) cream 1%, topical, prescribing information, label version effective 2 January 2025. Set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older, and states that its mechanism of action in acne is unknown. Warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression: after 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects. With a mean of about 6 grams applied twice daily in adults, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The most common adverse reactions (7 to 12%) were erythema, pruritus, and scaling or dryness. In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% (Trial 1) and 20.9% versus 6.6% (Trial 2). The label names cortexolone as a possible primary metabolite.

Participants / model
Patients 12 and older with acne vulgaris; PK and HPA-axis study subjects
Treatment
WINLEVI cream 1%, topical
Follow-up
Label version effective 2 January 2025; efficacy at week 12
Study design
FDA prescribing information
Funding
not stated in the source

The label states the mechanism of action in acne is unknown. The page gives no label dose or application amount.

Read the original source
Two phase 3 trials: 1,440 patients, treatment success 18.4 and 20.3% versus 9.0 and 6.5%

Randomized controlled trial

Hebert A et al. JAMA Dermatol. 2020;156(6):621-630. PMID 32320027.

Treatment success was 18.4% versus 9.0% in CB-03-01/25 and 20.3% versus 6.5% in CB-03-01/26. Inflammatory lesions fell by 19.3 versus 15.5 and 20.0 versus 12.6, and noninflammatory lesions by 19.4 versus 13.0 and 19.4 versus 10.8. Adverse events were mostly mild, mainly trace or mild erythema.

Participants / model
1,440 patients aged 9 and older with moderate or severe facial acne
Treatment
Clascoterone cream 1% or vehicle cream to the face, twice daily
Follow-up
12 weeks
Study design
Two identical randomized vehicle-controlled phase 3 trials
Funding
Authors include sponsor employees and paid advisors

Enrollment was defined by acne severity and lesion counts, not by androgen levels or steroid use. Endpoints were IGA treatment success, lesion counts and adverse events.

Read the original source
EMA: authorized in the EU on 17 October 2025 for acne vulgaris

Regulatory record

European Medicines Agency. WINLEVI, European public assessment report page, clascoterone cream.

The European Commission authorized WINLEVI throughout the EU on 17 October 2025 after a CHMP opinion adopted on 25 August 2025. The EU indication is acne vulgaris in adults and facial acne vulgaris in adolescents aged 12 to under 18, and the medicine is under additional monitoring. The EU authorization does not include hair loss.

Participants / model
Adults and adolescents 12 to under 18 with acne vulgaris
Treatment
WINLEVI cream, topical
Follow-up
Authorization on 17 October 2025
Study design
EMA regulatory record
Funding
not stated in the source

The EU indication is narrower for adolescents than the US label: facial acne only.

Read the original source
SCALP1 phase 3: 703 men, completed January 2026, no posted results

Trial registry record

ClinicalTrials.gov record NCT05910450 (SCALP1). Sponsor Cassiopea SpA.

The registry lists a phase 3, randomized, double-blind, vehicle-controlled trial of clascoterone 5% solution in men 18 and older with Norwood-Hamilton IIIv to V androgenetic alopecia: 6 months double-blind, then 6 months single-blind. Co-primary endpoints were change in non-vellus target area hair count at month 6 and a patient-reported hair coverage item. Actual enrollment was 703, and the record shows completion on 26 January 2026. No results are posted.

Participants / model
703 men with androgenetic alopecia
Treatment
Clascoterone 5% topical solution
Follow-up
6 months double-blind, then 6 months single-blind
Study design
Registered phase 3 randomized double-blind vehicle-controlled trial; no posted results
Funding
Sponsor Cassiopea SpA

Registered hair-count and patient-reported endpoints; no posted results.

Read the original source
SCALP2 phase 3: 762 men, completed July 2025, no posted results

Trial registry record

ClinicalTrials.gov record NCT05914805 (SCALP2). Sponsor Cassiopea SpA.

The registry lists the same design as SCALP1 in 762 men, with completion on 16 July 2025. No results are posted.

Participants / model
762 men with androgenetic alopecia
Treatment
Clascoterone 5% topical solution
Follow-up
6 months double-blind, then 6 months single-blind
Study design
Registered phase 3 randomized double-blind vehicle-controlled trial; no posted results
Funding
Sponsor Cassiopea SpA

Registered hair-count and patient-reported endpoints; no posted results.

Read the original source
PubMed search, 9 October 2026: 17 records, none in steroid users or a defined high-androgen group

PubMed search record

PubMed search run on 9 October 2026: (clascoterone OR cortexolone 17alpha-propionate OR CB-03-01) AND (anabolic OR testosterone OR hyperandrogenism OR dihydrotestosterone OR transgender OR polycystic). 17 records returned.

The search returned 17 records: narrative reviews and commentaries, a guideline, a first-approval summary, laboratory, preclinical and skin-permeation studies, a microneedle formulation study, and a skin-moisturization study. None tested clascoterone in people using anabolic steroids or in a defined high-androgen group. The claim that clascoterone is good for DHT-driven facial acne rests on mechanism and on general acne trials, not on a trial in that population.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 9 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Read the original source

Studies and sources

WINLEVI label, version effective 2 January 2025: indication, warnings, PK, trial results

FDA prescribing information

DailyMed, U.S. National Library of Medicine. WINLEVI (clascoterone) cream 1%, topical, prescribing information, label version effective 2 January 2025. Set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09.

The label describes clascoterone as an androgen receptor inhibitor for topical treatment of acne vulgaris in patients 12 years and older, and states that its mechanism of action in acne is unknown. Warnings cover local irritation and hypothalamic-pituitary-adrenal (HPA) axis suppression: after 2 weeks of twice-daily use, 1 of 20 adults (5%) and 2 of 22 adolescents (9%) had laboratory HPA suppression, and all recovered by 4 weeks after stopping. Potassium shifted from normal to elevated in 5% of clascoterone-treated and 4% of vehicle-treated subjects. With a mean of about 6 grams applied twice daily in adults, mean Cmax at day 14 was 4.5 ng/mL (SD 2.9). The most common adverse reactions (7 to 12%) were erythema, pruritus, and scaling or dryness. In the label's analysis of patients 12 and older, IGA success at week 12 was 18.8% versus 8.7% (Trial 1) and 20.9% versus 6.6% (Trial 2). The label names cortexolone as a possible primary metabolite.

Participants / model
Patients 12 and older with acne vulgaris; PK and HPA-axis study subjects
Treatment
WINLEVI cream 1%, topical
Follow-up
Label version effective 2 January 2025; efficacy at week 12
Study design
FDA prescribing information
Funding
not stated in the source

The label states the mechanism of action in acne is unknown. The page gives no label dose or application amount.

Read the original source
Drugs@FDA: WINLEVI approved 26 August 2020

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 213433 (WINLEVI, clascoterone). Dates read from the openFDA Drugs@FDA records.

FDA approved WINLEVI under NDA 213433 on 26 August 2020, with Sun Pharma listed as sponsor. It was the only clascoterone application returned; no hair-loss product appears.

Participants / model
Not a clinical population
Treatment
Drug application
Follow-up
Approval on 26 August 2020
Study design
FDA application record
Funding
not stated in the source

The record gives the approval date and sponsor. The indication comes from the product label.

Read the original source
EMA: authorized in the EU on 17 October 2025 for acne vulgaris

Regulatory record

European Medicines Agency. WINLEVI, European public assessment report page, clascoterone cream.

The European Commission authorized WINLEVI throughout the EU on 17 October 2025 after a CHMP opinion adopted on 25 August 2025. The EU indication is acne vulgaris in adults and facial acne vulgaris in adolescents aged 12 to under 18, and the medicine is under additional monitoring. The EU authorization does not include hair loss.

Participants / model
Adults and adolescents 12 to under 18 with acne vulgaris
Treatment
WINLEVI cream, topical
Follow-up
Authorization on 17 October 2025
Study design
EMA regulatory record
Funding
not stated in the source

The EU indication is narrower for adolescents than the US label: facial acne only.

Read the original source
Two phase 3 trials: 1,440 patients, treatment success 18.4 and 20.3% versus 9.0 and 6.5%

Randomized controlled trial

Hebert A et al. JAMA Dermatol. 2020;156(6):621-630. PMID 32320027.

Treatment success was 18.4% versus 9.0% in CB-03-01/25 and 20.3% versus 6.5% in CB-03-01/26. Inflammatory lesions fell by 19.3 versus 15.5 and 20.0 versus 12.6, and noninflammatory lesions by 19.4 versus 13.0 and 19.4 versus 10.8. Adverse events were mostly mild, mainly trace or mild erythema.

Participants / model
1,440 patients aged 9 and older with moderate or severe facial acne
Treatment
Clascoterone cream 1% or vehicle cream to the face, twice daily
Follow-up
12 weeks
Study design
Two identical randomized vehicle-controlled phase 3 trials
Funding
Authors include sponsor employees and paid advisors

Enrollment was defined by acne severity and lesion counts, not by androgen levels or steroid use. Endpoints were IGA treatment success, lesion counts and adverse events.

Read the original source
Extension: 600 patients, up to 9 more months, no control group

Clinical trial

Eichenfield LF et al. J Drugs Dermatol. 2023;22(8):810-816. PMID 37556524.

Treatment-emergent adverse events occurred in 108 of 598 treated patients (18.1%); the most common local reactions were facial erythema and scaling or dryness. Among per-protocol completers, facial IGA 0 or 1 reached 48.9% (156 of 319) and truncal IGA 0 or 1 reached 52.4% (65 of 124) at study end.

Participants / model
600 patients 12 and older from the phase 3 trials; 343 completed
Treatment
Clascoterone cream 1% to the face, and optionally the trunk, twice daily
Follow-up
Up to 9 more months
Study design
Open-label extension study
Funding
not stated in the source

There was no control group. Endpoints were adverse events, local skin reactions and IGA.

Read the original source
Single-arm study: 40 patients, casual sebum down 27%

Clinical trial

Draelos ZD et al. Dermatol Ther (Heidelb). 2025;15(9):2657-2666. PMID 40682762.

Casual sebum measurements fell 27% from baseline, inflammatory lesions 54% and noninflammatory lesions 34% (all p < 0.001), with no tolerability issues in the 12-week interim analysis.

Participants / model
40 patients 12 and older with mild-to-moderate acne, mean age 20.9
Treatment
Clascoterone cream 1%, topical, twice daily
Follow-up
12 weeks (interim analysis)
Study design
Open-label single-arm study, interim analysis
Funding
Sponsor-funded

There was no vehicle arm, so the size of any drug effect on sebum is not established.

Read the original source
Cell study: androgen receptor binding, sebocyte lipid and cytokines

Cell study

Rosette C et al. J Drugs Dermatol. 2019;18(5):412-418. PMID 31141847.

Clascoterone bound the androgen receptor with high affinity, inhibited androgen-regulated transcription in a reporter cell line, and reduced androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes in a dose-dependent manner, with stronger cytokine inhibition than spironolactone.

Participants / model
Human primary sebocytes and a reporter cell line
Treatment
In-vitro clascoterone exposure
Follow-up
not stated in the source
Study design
Original laboratory study
Funding
not stated in the source

This is cell evidence, not a measured sebum change in people.

Read the original source
Cell study: DHT-stimulated scalp cells, IL-6 and transcription

Cell study

Rosette C et al. J Drugs Dermatol. 2019;18(2):197-201. PMID 30811143.

In cultured human scalp dermal papilla cells stimulated with DHT, clascoterone inhibited IL-6 synthesis more than enzalutamide, and it inhibited androgen-regulated transcription in a reporter line with efficacy similar to finasteride.

Participants / model
Primary human scalp dermal papilla cells and a reporter cell line
Treatment
In-vitro clascoterone exposure
Follow-up
not stated in the source
Study design
Original laboratory study
Funding
not stated in the source

This is the only scalp-cell androgen study located. It is cell culture, not a measurement in a human scalp.

Read the original source
Phase 2 hair-loss trial: 95 men, completed 2016, no posted results

Trial registry record

ClinicalTrials.gov record NCT02279823. Sponsor Intrepid Therapeutics.

The registry lists a completed phase 2 trial of CB-03-01 (clascoterone) solution 5% versus minoxidil solution 5% versus vehicle, applied twice daily for 26 weeks in 95 men with androgenetic alopecia, with change in target area hair count at month 6 as a primary outcome. Completion is listed as May 2016. No results are posted and no peer-reviewed report was located.

Participants / model
95 men with mild to moderate androgenetic alopecia
Treatment
Clascoterone solution 5%, topical scalp, versus minoxidil solution 5% or vehicle, twice daily
Follow-up
26 weeks
Study design
Registered phase 2 randomized trial; no posted results
Funding
Sponsor Intrepid Therapeutics

Registered hair-count and self-assessment endpoints; no posted results.

Read the original source
SCALP1 phase 3: 703 men, completed January 2026, no posted results

Trial registry record

ClinicalTrials.gov record NCT05910450 (SCALP1). Sponsor Cassiopea SpA.

The registry lists a phase 3, randomized, double-blind, vehicle-controlled trial of clascoterone 5% solution in men 18 and older with Norwood-Hamilton IIIv to V androgenetic alopecia: 6 months double-blind, then 6 months single-blind. Co-primary endpoints were change in non-vellus target area hair count at month 6 and a patient-reported hair coverage item. Actual enrollment was 703, and the record shows completion on 26 January 2026. No results are posted.

Participants / model
703 men with androgenetic alopecia
Treatment
Clascoterone 5% topical solution
Follow-up
6 months double-blind, then 6 months single-blind
Study design
Registered phase 3 randomized double-blind vehicle-controlled trial; no posted results
Funding
Sponsor Cassiopea SpA

Registered hair-count and patient-reported endpoints; no posted results.

Read the original source
SCALP2 phase 3: 762 men, completed July 2025, no posted results

Trial registry record

ClinicalTrials.gov record NCT05914805 (SCALP2). Sponsor Cassiopea SpA.

The registry lists the same design as SCALP1 in 762 men, with completion on 16 July 2025. No results are posted.

Participants / model
762 men with androgenetic alopecia
Treatment
Clascoterone 5% topical solution
Follow-up
6 months double-blind, then 6 months single-blind
Study design
Registered phase 3 randomized double-blind vehicle-controlled trial; no posted results
Funding
Sponsor Cassiopea SpA

Registered hair-count and patient-reported endpoints; no posted results.

Read the original source
Stanford phase 1/2: steroid-related acne on masculinizing hormones, no posted results

Trial registry record

ClinicalTrials.gov record NCT05891795. Sponsor Stanford University.

The registry lists a phase 1/2 trial of clascoterone 1% cream versus vehicle for steroid-related facial acne in transgender male or gender-diverse patients on stable masculinizing hormone therapy, with change in papules and pustules at week 12 as the primary outcome. Estimated enrollment is 18; the record shows active, not recruiting, primary completion in January 2026, and no posted results.

Participants / model
Transgender male or gender-diverse patients on testosterone with facial acne
Treatment
Clascoterone cream 1% versus vehicle, topical
Follow-up
12 weeks
Study design
Registered phase 1/2 trial; no posted results
Funding
Sponsor Stanford University

It is the only registered test of clascoterone in an androgen-driven acne population located. Registered lesion-count endpoint; no posted results.

Read the original source
PubChem CID 11750009: C24H34O5, 402.5 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 11750009, clascoterone (cortexolone 17alpha-propionate, CB-03-01).

Clascoterone is cortexolone 17alpha-propionate (CB-03-01): PubChem CID 11750009, C24H34O5, 402.5 g/mol, CAS 19608-29-8; PubChem synonyms include Winlevi and Breezula. The approved product is a 1% cream, while the hair-loss trials used a 5% solution, so cream data do not transfer to scalp solutions or to unregulated vendor products. The label names cortexolone as a possible primary metabolite.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

Why is Clascoterone in A tier?

A fits an approved acne medicine with two phase 3 trials in 1,440 patients and a 2025 EU authorization, balanced against a modest effect (treatment success about 18 to 21% versus 7 to 9% on vehicle), about six years of US marketing, and no posted or peer-reviewed phase 3 results for the hair-loss use. The grade covers the acne cream, not the sebum, scalp or DHT-driven acne claims.