Organon's VTAMA® (tapinarof) cream, 1%, Granted Strong Recommendation in the 2026 American Academy of Dermatology Guidelines for Pediatric Atopic Dermatitis
- The American Academy of Dermatology (AAD) provided a strong, evidence-based recommendation for the use of VTAMA cream, the only steroid-free topical treatment the AAD found to be supported by a high certainty of evidence that is indicated across all severities in children aged 2 years and older with atopic dermatitis (AD)
- This recommendation reflects the proven efficacy, safety, and tolerability of VTAMA cream as a first-in-class, steroid-free, topical aryl hydrocarbon receptor (AhR) agonist for children and adolescents with AD
- AD, the most common form of eczema, impacts nearly 10 million children in the US
Organon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that VTAMA cream was granted a strong, evidence-based recommendation by the American Academy of Dermatology (AAD) in their 2026 guidelines for the management and treatment of atopic dermatitis (AD) in pediatric patients, published on April 7, 2026. The guidelines name VTAMA cream as the only steroid-free topical treatment the AAD found to be supported by a high certainty of evidence, that is indicated across all severities in children aged 2 years and older with AD. In the pivotal studies for VTAMA in AD, 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.
The 2026 AAD pediatric atopic dermatitis guidelines are the first pediatric-specific AD guidelines issued by the AAD, and underscore important considerations for pediatric versus adult dermatological care. The pediatric guidelines provide evidence-based recommendations for topical therapies (prescription and non-prescription), phototherapy, and systemic therapies, ensuring the dermatology community has access to the best available data when developing prevention and treatments plans for pediatric patients.
"Following the strong recommendation VTAMA cream received in the 2025 AAD guidelines for adults with AD, we are thrilled to see VTAMA recognized in the newly released 2026 pediatric AD guidelines, especially as the only treatment with a high certainty of evidence and a strong recommendation for pediatric patients that is indicated across all disease severities," said Rafael Chaves Cardona, Head of US Medical Affairs at Organon. "While patients with AD may share similarities across life stages, children and adolescents may have distinct treatment considerations compared with adults, such as safety and dosing, highlighting the need for clear, pediatric-specific guidance. These updated guidelines not only support clinicians and patients, but also help to provide caregivers with clear, evidence-based direction to help inform treatment discussions with their care team and confidently support those in their care. This AAD recommendation once again reinforces VTAMA cream as a steroid-free topical prescription option with just one strength, one formulation, and once-daily dosing that has no label restrictions on use based on disease severity, affected body surface area, or duration of use."
The strong recommendation by the AAD for VTAMA cream was supported by robust evidence from the Phase 3 pivotal trials, ADORING 1 and ADORING 2.
The US Food and Drug Administration (FDA) first approved VTAMA cream on May 24, 2022, for the topical treatment of plaque psoriasis in adults. In December 2024, the FDA approved VTAMA cream for the treatment of AD in adults and pediatric patients aged 2 years and older.
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 US 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 US.2,4 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.3 Itching is an especially bothersome symptom for those with AD, and tends to worsen at night.2
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 and potential future commercial applications for VTAMA. Forward-looking statements may be identified by words such as "will," "plan," "mission," "may," 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.
© 2026 Organon group of companies. All rights reserved. US-VTA-113097 04/26
References
- Davis DMR, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in pediatric patients. J Am Acad Dermatol. Published online April 7, 2026. doi:10.1016/j.jaad.2026.02.113
- Eczema stats. National Eczema Association. Accessed June 5, 2025. https://nationaleczema.org/research/eczema-facts/
- 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
- 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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