Organon Debuts New Analysis of VTAMA® (tapinarof) cream, 1%, Phase 3 Pooled Data Demonstrating Early and Consistent Skin Clearance and Itch Improvement in Atopic Dermatitis Patients Down to 2 Years of Age
- VTAMA demonstrated early and consistent response rates in disease severity and itch improvements, measured by the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) and Peak Pruritus-Numeric Rating Scale (PP-NRS) with results seen as early as week 1, and continued through week 8
- Statistically significant ≥75% improvement in Eczema Area and Severity Index (EASI75) response was achieved as early as week 1 and continued through week 8
- Improvements in Eczema Area and Severity Index (EASI) scores were achieved by the majority of patients (96.9%) from baseline at week 8
The findings demonstrated early and consistent improvement in disease severity, as measured by vIGA-AD and
“In treating atopic dermatitis, our goal as healthcare providers is to find therapies that deliver fast and clinically meaningful skin clearance and itch reduction, and a favorable safety profile,” said Dr.
In the ADORING 1 and ADORING 2 pivotal trials, adults and children ≥2 years (N=813) with moderate to severe AD were randomized to VTAMA cream or vehicle once daily for 8 weeks.
Notable findings from the post-hoc pooled analysis of ADORING 1 and ADORING 2 comparing VTAMA cream versus vehicle include1:
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Significant improvements in vIGA-AD, EASI75, and PP-NRS response rates as early as week 1
- Significant vIGA-AD response was observed, defined as clear (vIGA-AD=0) or almost clear (vIGA-AD=1) skin with a ≥2-grade improvement from baseline, as early as week 1 (5.8% vs. 1.6%, P=0.0315) and continued through week 8 (45.9% vs. 15.9%, P<0.0001).
- Significant EASI75 response was achieved as early as week 1 (9.0% vs. 3.3%, P=0.0164) and continued through week 8 (57.4% vs 22.1%, P<0.0001).
- Significant itch improvement, defined as a ≥4-point reduction in PP-NRS score for patients with a baseline score of ≥4, was achieved as early as week 1 (18.8% vs. 11.3%, P=0.0128) and continued through week 8 (59.3% vs. 33.5%, P<0.0001).
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The vast majority (96.9%) of patients achieved any
EASI improvement from baseline at week 8 with VTAMA cream.
Consistent with the prescribing information, VTAMA was well tolerated, with the most frequently reported (≥3% in any group) treatment-emergent adverse events being folliculitis, headache, upper respiratory tract infection, and nasopharyngitis.
“Atopic dermatitis presents a significant clinical challenge for patients, where the dual burden of persistent itch and visible skin inflammation can be hard to manage,” said
In
About the Phase 3
ADORING was the Phase 3 AD clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.
INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:
- the topical treatment of plaque psoriasis in adults
- the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older
SELECTED SAFETY INFORMATION
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
Before prescribing VTAMA cream, please read the Prescribing Information .
For more information about VTAMA (tapinarof) cream, 1%, visit www.vtamahcp.com.
About Atopic Dermatitis (AD)
AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting an estimated 26 million people in the
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about atopic dermatitis treatment goals, the potential future commercial applications for VTAMA, and Organon’s intent to present results from a post-hoc sub-analysis of pooled data at the AAD Annual Meeting. Forward-looking statements may be identified by words such as “will,” “goal,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the
vIGA-AD is a trademark of Eli Lilly and Co.
© 2026 Organon group of companies. All rights reserved. US-VTA-113182 03/26
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1 Silverberg JI, Eichenfield LF, |
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2 Atopic dermatitis. |
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3 Eczema stats. |
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4 Global Report on Atopic Dermatitis 2022. |
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