CLINICAL TRIALS PROFILE FOR TAPINAROF

All Clinical Trials for Tapinarof

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03956355 ↗	Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)	Completed	IQVIA Biotech	Phase 3	2019-05-21	This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
NCT03956355 ↗	Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)	Completed	Dermavant Sciences GmbH	Phase 3	2019-05-21	This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
NCT03983980 ↗	Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)	Completed	IQVIA Biotech	Phase 3	2019-06-06	This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
NCT03983980 ↗	Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)	Completed	Dermavant Sciences GmbH	Phase 3	2019-06-06	This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
NCT04042103 ↗	Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis	Completed	Dermavant Sciences GmbH	Phase 2	2019-07-23	This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.
NCT04053387 ↗	Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)	Completed	IQVIA Biotech	Phase 3	2019-08-13	This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.
NCT04053387 ↗	Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)	Completed	Dermavant Sciences GmbH	Phase 3	2019-08-13	This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Clinical Trial Conditions for Tapinarof

Condition Name

Condition Name for Tapinarof
Intervention	Trials
Plaque Psoriasis	5
Atopic Dermatitis	4
Psoriasis	3
ICD10 Code L40.9 for Psoriasis	1

Condition MeSH

Condition MeSH for Tapinarof
Intervention	Trials
Psoriasis	9
Dermatitis, Atopic	4
Dermatitis	4
Eczema	4

Clinical Trial Locations for Tapinarof

Trials by Country

Trials by Country for Tapinarof
Location	Trials
United States	154
Canada	13

Trials by US State

Trials by US State for Tapinarof
Location	Trials
Florida	10
California	9
Texas	9
Indiana	7
Arkansas	7

Clinical Trial Progress for Tapinarof

Clinical Trial Phase

Clinical Trial Phase for Tapinarof
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tapinarof
Clinical Trial Phase	Trials
Recruiting	6
Completed	5
Not yet recruiting	2

Clinical Trial Sponsors for Tapinarof

Sponsor Name

Sponsor Name for Tapinarof
Sponsor	Trials
Dermavant Sciences GmbH	6
Dermavant Sciences, Inc.	6
IQVIA Biotech	3

Sponsor Type

Sponsor Type for Tapinarof
Sponsor	Trials
Industry	15
Other	2

Tapinarof: A Promising Treatment for Atopic Dermatitis

Introduction to Tapinarof

Tapinarof, a nonsteroidal, topical aryl hydrocarbon receptor (AhR) modulator, has been making significant strides in the treatment of atopic dermatitis (AD), a common and debilitating inflammatory skin disease. Here, we will delve into the clinical trials, market analysis, and projections for this promising drug.

Mechanism of Action

Tapinarof works by binding to the AhR, which leads to the modulation of type 17 helper T cytokines and the activation of the nuclear factor erythroid 2‐related factor 2 (NRF‐2) pathway. This results in the production of antioxidative enzymes that suppress oxidative stress and inflammatory pathways, thereby promoting skin barrier normalization[1][3][4].

Clinical Trials Update

Phase III Trials

The Phase III clinical trials for tapinarof have shown highly significant efficacy and favorable safety and tolerability in patients with AD. In two 8-week Phase III trials, tapinarof cream 1% demonstrated superior outcomes compared to the vehicle control. The primary efficacy endpoint, which included achieving a Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 with a ≥2-grade improvement from baseline at Week 8, was met with statistical significance in both trials (45.4% vs 13.9% and 46.4% vs 18.0%, respectively)[3].

Additionally, a 52-week open-label trial in Japanese patients showed that the efficacy responses improved over time and were maintained over the treatment period. The Investigator's Global Assessment (IGA) treatment success rate and Eczema Area and Severity Index 75 (EASI75) response rates were significantly higher in the tapinarof group compared to the vehicle group[4].

Safety and Tolerability

The clinical trials have also highlighted the favorable safety profile of tapinarof. Common adverse events, such as folliculitis, headache, and nasopharyngitis, were mostly mild or moderate, with lower discontinuations due to adverse events in the tapinarof groups compared to the vehicle groups[3][4].

FDA Review and Approval Process

The FDA has extended the review period for the supplemental New Drug Application (sNDA) of VTAMA (tapinarof) cream 1% by three months, with the new target action date set for March 12, 2025. This extension is due to the FDA's request for final datasets and a clinical study report from the long-term extension study, which is considered a major amendment to the sNDA[2][5].

Despite this delay, Organon, the company behind VTAMA, remains confident in the robust efficacy and safety data submitted to the FDA. The company is committed to working with the FDA to ensure all necessary information is provided for the review process[2].

Market Analysis and Projections

Market Opportunity

Atopic dermatitis affects over 26 million people in the United States alone, making it a significant market opportunity for effective treatments. The pipeline landscape for AD includes various therapeutic approaches, such as biologics, oral small molecules, anti-puritics, and topical small molecules. Tapinarof's unique mechanism of action targeting the AhR positions it favorably in this competitive landscape[1].

Sales Projections

GlobalData estimates that, subject to approval, tapinarof's sales could reach $766 million globally by 2030 for the treatment of AD. This projection underscores the commercial potential of tapinarof, especially given its broad age range positioning, targeting both adult and pediatric populations as young as 2 years old[1].

Competitive Landscape

The market for AD treatments is highly competitive, with several innovator assets in Phase III and pre-registration stages. However, tapinarof's established safety profile in psoriasis and its promising clinical trial results in AD make it a strong contender. Other notable pipeline assets include Jiangsu Hengrui Medicine’s ivarmacitinib sulfate, Arcutis’s roflumilast, and several others, but tapinarof’s AhR-modulating mechanism offers a distinct advantage[1].

Financial Implications

Organon projects $125 million in VTAMA revenue for 2025, despite the FDA review extension. This revenue projection is supported by the company's confidence in the drug's efficacy and safety data. The extension, while causing a delay, does not indicate any safety, efficacy, or approvability concerns, and thus does not significantly impact the financial outlook for VTAMA[2].

Key Takeaways

• Clinical Efficacy: Tapinarof has demonstrated significant efficacy and favorable safety in clinical trials for atopic dermatitis.
• Mechanism of Action: Tapinarof works by modulating the AhR, reducing pro-inflammatory cytokines and oxidative stress.
• FDA Review: The FDA has extended the review period for VTAMA to March 12, 2025, but this does not indicate any safety or efficacy concerns.
• Market Potential: Tapinarof has a strong market potential, with projected sales of $766 million by 2030.
• Competitive Landscape: Tapinarof competes in a crowded market but stands out due to its unique mechanism of action and broad age range positioning.

FAQs

What is the mechanism of action of tapinarof?

Tapinarof works by binding to the aryl hydrocarbon receptor (AhR), which leads to the modulation of type 17 helper T cytokines and the activation of the NRF-2 pathway, reducing oxidative stress and inflammatory pathways[1][3][4].

What are the key findings from the Phase III clinical trials of tapinarof?

The Phase III trials showed that tapinarof cream 1% achieved significant efficacy endpoints, including IGA scores and EASI75 responses, with a favorable safety and tolerability profile[3][4].

Why has the FDA extended the review period for VTAMA?

The FDA extended the review period to request final datasets and a clinical study report from the long-term extension study, which is considered a major amendment to the sNDA[2][5].

What are the projected sales for VTAMA by 2030?

GlobalData estimates that tapinarof's sales could reach $766 million globally by 2030, subject to approval[1].

What is the competitive landscape for atopic dermatitis treatments?

The market includes various therapeutic approaches such as biologics, oral small molecules, anti-puritics, and topical small molecules. Tapinarof stands out due to its unique AhR-modulating mechanism and broad age range positioning[1].

Sources

1. Clinical Trials Arena: "Tapinarof may mark Dermavant's first atopic dermatitis approval"[1]
2. Stock Titan: "FDA Extends Organon's VTAMA Review by 3 Months"[2]
3. PubMed: "Tapinarof cream 1% once daily: Significant efficacy in the treatment of atopic dermatitis"[3]
4. PubMed: "Tapinarof cream for the treatment of atopic dermatitis: Efficacy and safety in Japanese patients"[4]
5. Investing.com: "FDA extends Organon's VTAMA cream review to March 2025"[5]