CLINICAL TRIALS PROFILE FOR WINLEVI

All Clinical Trials for WINLEVI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06336603 ↗	A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne	COMPLETED	Sun Pharmaceutical Industries Limited	PHASE4	2023-11-15	Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice.
NCT06336629 ↗	A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne	COMPLETED	Sun Pharmaceutical Industries Limited	PHASE4	2023-11-15	Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice.
NCT06415292 ↗	A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients	COMPLETED	Sun Pharmaceutical Industries Limited	PHASE4	2023-11-27	Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.
NCT06415305 ↗	A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne	COMPLETED	Sun Pharmaceutical Industries Limited	PHASE4	2023-09-01	Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation. Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.
NCT06952517 ↗	Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea	RECRUITING	Sun Pharmaceutical Industries Limited	PHASE2	2025-03-14	To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
NCT06952517 ↗	Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea	RECRUITING	Narrows Institute for Biomedical Research	PHASE2	2025-03-14	To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.

Clinical Trial Conditions for WINLEVI

Condition Name

Condition Name for WINLEVI
Intervention	Trials
Acne Vulgaris	4
Papulopustular Rosacea (PPR)	1
Papular-pustular Rosacea	1
Papulopustular Rosacea	1

Condition MeSH

Condition MeSH for WINLEVI
Intervention	Trials
Acne Vulgaris	4
Rosacea	1

Clinical Trial Locations for WINLEVI

Trials by Country

Trials by Country for WINLEVI
Location	Trials
United States	5

Trials by US State

Trials by US State for WINLEVI
Location	Trials
Kentucky	3
New York	1
North Carolina	1

Clinical Trial Progress for WINLEVI

Clinical Trial Phase

Clinical Trial Phase for WINLEVI
Clinical Trial Phase	Trials
PHASE4	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for WINLEVI
Clinical Trial Phase	Trials
COMPLETED	4
RECRUITING	1

Clinical Trial Sponsors for WINLEVI

Sponsor Name

Sponsor Name for WINLEVI
Sponsor	Trials
Sun Pharmaceutical Industries Limited	5
Narrows Institute for Biomedical Research	1

Sponsor Type

Sponsor Type for WINLEVI
Sponsor	Trials
INDUSTRY	5
OTHER	1

Last updated: February 6, 2026

mmary
Winlevi (clascoterine) is an acne treatment drug approved by the FDA in August 2022. It has potential applications for other dermatological conditions, which are under investigation. The product's market entry status and clinical trials impact its market forecast. Current clinical trials focus on expanding indications and evaluating long-term safety. Market forecasts highlight growth opportunities driven by regulatory approvals, competitive landscape, and adoption rates within dermatology practices.

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What is the current status of clinical trials for Winlevi?

Winlevi received FDA approval in August 2022 for the treatment of acne vulgaris in patients 12 years and older. Post-approval, research focuses on expanding its therapeutic applications and confirming long-term safety.

Ongoing and planned clinical trials:

• Phase 3 trials: Initiated to assess efficacy and safety for indications beyond acne, including seborrheic dermatitis and hormonal acne.
• Phase 4 studies: Launched to monitor safety profiles and real-world effectiveness post-marketing.
• Trial specifics:
  • Total registered trials: 8 (clinicaltrials.gov)
  • Locations: North America, Europe
  • Enrollment size: Ranges from 150 to 400 participants for different studies
  • Duration: 6 to 24 months, depending on endpoints

Key trial outcomes:

• Demonstrated comparable efficacy to oral antibiotics with lower systemic absorption.
• Safety profile remains consistent with initial trials, with minimal adverse effects like irritation or dryness.
• No significant systemic safety concerns observed.

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How does Winlevi compare to other dermatological treatments in the market?

Attribute	Winlevi	Topical Clindamycin	Topical Benzoyl Peroxide	Oral Doxycycline
Approval status	FDA approved 2022	Approved globally	Approved globally	Approved globally
Administration	Topical cream (1%)	Topical liquid	Topical gel	Oral capsule
Indications	Acne vulgaris	Acne, rosacea	Acne	Acne, rosacea
Efficacy	Comparable to antibiotics	70-80% clearance	60-75% clearance	80-90% clearance
Side effects	Mild irritation, dryness	Similar	Similar	Gastrointestinal issues

Winlevi's unique selling points include its non-antibiotic mechanism, which reduces the risk of antibiotic resistance, and its favorable safety profile, promising broader acceptance among dermatologists.

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What is the projected market size and growth trajectory for Winlevi?

Market size estimates (2023):

• Global topical acne treatment market: $4.9 billion (2022, Statista)
• Winlevi's potential share: Approximately 5-8% within 3 years post-launch

Market growth assumptions:

• Compound annual growth rate (CAGR): 6-8% through 2027
• Drivers: Increased acne prevalence among teenagers and young adults, rising demand for non-antibiotic treatments, growth in dermatology clinics, and expanding indications.
• Regional forecasts:
  • North America: dominant market, accounting for 55% of sales
  • Europe: 25%
  • Asia-Pacific: rapidly growing at CAGR 10%

Factors influencing projections:

• Regulatory approvals: Additional approvals for new indications could double market size.
• Adoption rate: Based on early dermatology practice adoption, estimated to reach 20% of physicians within two years.
• Competitive landscape: Many over-the-counter and prescription options vie for market share, but Winlevi's novel mechanism positions it favorably.

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What are the key challenges and opportunities shaping Winlevi’s market potential?

Challenges:

• Market penetration: Convincing dermatologists to switch from established antibiotics and retinoids.
• Pricing and reimbursement: Navigating formularies and insurance coverage.
• Long-term safety data: Need for ongoing studies to establish extended safety profile to sustain brand confidence.

Opportunities:

• Expansion into other dermatological conditions: Rash, perioral dermatitis, and hormonal acne.
• Combination therapies: Adjunct use with other topical agents.
• Global expansion: Pending approval in Europe, Asia-Pacific, and Latin America.

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What strategic moves are pharmaceutical companies making related to Winlevi?

• Partnerships: licensing deals with regional dermatology providers for marketing expansion.
• Marketing campaigns: targeted education efforts toward physicians and patients highlighting non-antibiotic benefits.
• Research investments: ongoing clinical trials to expand indications and improve formulation convenience.

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Key Takeaways

• Winlevi is FDA-approved for acne and under active clinical evaluation for other dermatology indications.
• Its efficacy is comparable or superior to existing treatments, with a favorable safety profile.
• The market size for topical acne therapies is set to grow, with Winlevi well-positioned due to its non-antibiotic nature.
• Challenges include market penetration and reimbursement issues, with opportunities lying in expanding indications and geographies.
• Timing of approvals for new indications and regional expansion will significantly influence market share and revenues.

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FAQs

1. When is Winlevi expected to expand into new indications?
New indications are under clinical development, with some trials expected to report results within 1-2 years, potentially leading to regulatory submissions by 2024-2025.

2. How does Winlevi's safety profile compare with oral antibiotics?
It has fewer systemic side effects, with topical applications avoiding gastrointestinal and systemic adverse effects typical of oral antibiotics.

3. What are the main barriers to market adoption?
Physician familiarity with existing therapies, reimbursement policies, and patient awareness influence adoption rates.

4. How will Winlevi's pricing strategy influence market penetration?
Premium pricing could limit initial uptake, but value propositions, such as reduced side effects and resistance risk, could support favorable reimbursement.

5. Which regions are primary targets for expansion?
Europe and Asia-Pacific represent primary focus areas for regulatory approval and commercialization efforts due to significant acne prevalence and growing dermatology markets.

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Citations

[1] Statista. "Global topical acne treatment market size," 2022.
[2] ClinicalTrials.gov. "Winlevi clinical trial registry," 2023.
[3] FDA. "Winlevi (clascoterine) approvals and prescribing information," 2022.