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
JERSEY CITY, N.J.–(BUSINESS WIRE)–
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present results from a post-hoc sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating the efficacy and safety of VTAMA cream versus vehicle in an oral session at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, on Saturday, March 28, 2026. VTAMA cream is the only aryl hydrocarbon receptor (AhR) agonist indicated for the treatment of both plaque psoriasis in adults and treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years and older.
The findings demonstrated early and consistent improvement in disease severity, as measured by vIGA-AD and EASI, and itch, as measured by PP-NRS, for patients down to age 2 with moderate to severe AD.
“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. Linda Stein Gold, Director of Clinical Research and Division Head of Dermatology, Henry Ford Health System, and an author of the analysis being presented at AAD. “The new findings from this analysis demonstrate significant improvements across key clinical endpoints, including reductions in disease severity and itch, as early as week one. Seeing these positive outcomes in many patients across the study, especially since 80% of the trial participants were children, highlights the potential of VTAMA cream to address common symptoms, such as itch, early in the treatment course and provides healthcare providers with an evidence-based option to help manage the disease.”
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:
-
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).
- 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 Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “These new findings evaluating the pooled efficacy over time for VTAMA cream demonstrate significant skin clearance and early and consistent itch relief in patients as young as two years old. Organon is proud of our commitment to dermatology and to continuing to bring new data to those treating and living with atopic dermatitis.”
In December 2024, the US Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of atopic dermatitis in adults and pediatric patients two years of age and older. VTAMA cream was also approved by the FDA in May 2022 for the topical treatment of plaque psoriasis in adults.
About the Phase 3 Program for VTAMA cream in Atopic Dermatitis
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 U.S. alone and up to 10% of adults worldwide.2,3 AD occurs most frequently in children, affecting up to 20% worldwide, including nearly 10 million children in the U.S.3,4 The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck.2 Itching is an especially bothersome symptom for those with AD, and tends to worsen at night.3
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 Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok, and Facebook.
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 SEC, including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
vIGA-AD is a trademark of Eli Lilly and Co.
© 2026 Organon group of companies. All rights reserved. US-VTA-113182 03/26
| 1 Silverberg JI, Eichenfield LF, Stein Gold L, Arjona Ferreira JC, Bissonnette R. Efficacy and safety of tapinarof cream 1% once daily monotherapy in adults and children with atopic dermatitis: pooled results from ADORING 1 and 2. Presented at: American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado. | |
| 2 Atopic dermatitis. National Institute of Arthritis and Musculoskeletal and Skin Diseases. November 2022. Accessed August 19, 2025. https://www.niams.nih.gov/health-topics/atopic-dermatitis. | |
| 3 Eczema stats. National Eczema Association. Accessed June 5, 2025. https://nationaleczema.org/eczema-facts/. | |
| 4 Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies; 2022. Accessed February 25, 2025. https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf. | |
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