MedPath

Tapinarof

Generic Name
Tapinarof
Brand Names
Vtama
Drug Type
Small Molecule
Chemical Formula
C17H18O2
CAS Number
79338-84-4
Unique Ingredient Identifier
84HW7D0V04
Background

Tapinarof is a novel, first-in-class, small-molecule AhR agonist that is indicated for the treatment of adult psoriasis. It is available as a topical cream to be applied to the affected area once daily. Tapiranof was first discovered as a metabolite (3,5-dihydroxy-4-isopropylstilbene) produced in Photorhabdus luminescens, a gram-negative bacillus that lives symbiotically with the Heterorhabditis nematodes. In 1959, it was noticed that Heterorhabditis with a high amount of 3,5-dihydroxy-4-isopropylstilbene did not putrefy once dead, thus suggesting its potential anti-inflammatory activity.

Tapinarof received initial approval from the FDA in 2022.

Indication

Tapinarof is indicated for the topical treatment of plaque psoriasis in adults.

Associated Conditions
Psoriasis Vulgaris (Plaque Psoriasis)

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Conduit Pharmaceuticals Files Novel Cocrystal Patent for VTAMA, Extending Therapeutic Potential Beyond 2027

• Conduit Pharmaceuticals has filed groundbreaking patents for a dual active cocrystal formulation of tapinarof (VTAMA®), potentially addressing both inflammatory conditions and associated symptoms like pain and itch. • The strategic patent filing comes as VTAMA approaches its 2027 exclusivity expiration, positioning Conduit for high-value licensing partnerships in the $233.6 billion anti-inflammatory therapeutics market. • The novel cocrystal approach aims to improve patient tolerability, extend patent protection, and expand therapeutic applications beyond psoriasis and atopic dermatitis into other inflammatory and autoimmune conditions.

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FDA Approves Organon's Vtama (Tapinarof) Cream for Atopic Dermatitis in Adults and Children

• The FDA has approved Vtama (tapinarof) cream 1% for treating atopic dermatitis in adults and children aged 2 years and older. • Vtama demonstrated statistically significant improvements in skin clearance and itch reduction compared to the vehicle in clinical trials. • The treatment offers a steroid-free option with no label warnings, contraindications, or restrictions on treatment duration or body surface area affected. • Long-term studies showed sustained efficacy and a favorable safety profile, with many patients experiencing extended treatment-free intervals.

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FDA Extends Review of Organon's Vtama for Atopic Dermatitis to March

• The FDA has extended the review period for Organon's Vtama cream for treating atopic dermatitis, setting a new target action date for March 12. • The extension was prompted by the FDA's request for final datasets and the clinical-study report from a long-term extension study. • Organon anticipates Vtama will contribute approximately $125 million in revenue next year due to the delay, impacting 2025 earnings. • The FDA has not raised concerns about the safety or efficacy of Vtama, which is already approved for plaque psoriasis treatment.

Vtama Cream Shows Positive Long-Term Results in Atopic Dermatitis Trial

• Dermavant's Vtama (tapinarof) cream demonstrated efficacy and safety in treating atopic dermatitis (AD) in patients as young as two years old. • In a long-term extension study, 51.9% of patients achieved complete disease clearance at least once during the 48-week study period. • Patients who achieved complete disease clearance experienced an average treatment-free interval of nearly 80 days after discontinuing Vtama. • The FDA is expected to make a decision on Dermavant’s application for Vtama in AD in the fourth quarter of this year.

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Organon Expands Dermatology Portfolio with $1.2 Billion Acquisition of Dermavant

• Organon is set to acquire Dermavant for up to $1.2 billion, gaining Vtama (tapinarof) cream, a commercialized plaque psoriasis drug. • Vtama, a non-steroidal topical cream, is under FDA review for atopic dermatitis, with a decision expected in Q4, potentially triggering a $75 million milestone payment. • Organon aims to leverage its global reach to maximize Vtama's commercial potential, combining Dermavant's U.S. presence with Organon's market access and regulatory expertise. • Roivant's sale of Dermavant aligns with its strategy to focus on specialty drug candidates with blockbuster potential, following previous sales and new subsidiary launches.

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• Experts at the Skin of Color Update 2024 emphasized the importance of diversity in clinical trials to address health disparities and improve data for all patient populations. • Recent FDA approvals of topical therapies like roflumilast and tapinarof for atopic dermatitis and other conditions were highlighted for their efficacy and safety. • Advances in biologic therapies, including bimekizumab, secukinumab, and nemolizumab, offer new treatment options for conditions like psoriasis, hidradenitis suppurativa and prurigo nodularis. • The FDA's Diversity Action Plan (DAP) aims to increase the enrollment of underrepresented groups in clinical trials, ensuring treatments are effective across diverse populations.
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