Organon Canada Announces the Approval and Availability of NDUVRA® (Tapinarof Cream), 1%, a New Steroid-Free Topical Treatment for Moderate to Severe Atopic Dermatitis in Adult and Pediatric Patients 2 Years of Age and Older

KIRKLAND, QC, Sept. 28, 2026 /CNW/ -- Organon Canada, a global healthcare company, today announces the approval and availability of NDUVRA^® (tapinarof cream), 1%, for the topical treatment of moderate to severe atopic dermatitis in adult and pediatric patients 2 years of age and older.

"Winter is coming, and with it, the dry, cold, and windy climate that frequently results in flares for patients with atopic dermatitis, an inflammatory skin condition that can have a significant impact on sleep, mental health, and quality of life. The approval and now availability of tapinarof cream are welcome additions to the range of treatment options currently available," said Dr. Vimal H. Prajapati, Clinical Associate Professor at the University of Calgary, Dermatologist (Co-founder and Co-director) of the Skin Health & Wellness Centre, Dermatology Research Institute, Dermphi Centre, and Dermphi Shop, and Councillor for the International Eczema Council.

NDUVRA^® (tapinarof cream) is a topical aryl hydrocarbon receptor agonist formulated with tapinarof.^i,ii,iii,iv Its approval for atopic dermatitis builds on a distinctly Canadian research story as tapinarof was discovered in Canada, and its clinical development has included participant enrolment at study sites across the country.

"Patients I see with atopic dermatitis are often looking for relief from symptoms and a non steroid treatment option that can be started promptly. Tapinarof cream provides family physicians with an additional topical treatment option that can be prescribed without requiring specialist referral, helping eligible patients access care sooner," said Dr. Simraaj Powar, Family Physician. 

Atopic Dermatitis, also known as eczema, is one of the most common chronic inflammatory skin diseases globally, affecting up to 20% of children and 3% of adults, with a higher prevalence among women^v,vi,vii In Canada, AD affects approximately 15% of children and 4% of adults.^viii Women with these skin conditions carry a disproportionate psychosocial burden, often reporting greater levels of depression, anxiety, fatigue, loneliness and stigma.^ix,x

"Atopic dermatitis is a chronic condition that can have a profound impact on patients and their families, from children living with the condition from an early age to women who may experience disease flares during the menstrual cycle, pregnancy, and menopause^xi," said Dominic Bégin, President and Managing Director, Organon Canada. "The availability of tapinarof cream for adults and children reflects our commitment to expanding our dermatology portfolio and providing more treatment options for people living with this disease. For us, what matters most is helping support patients in managing their condition."

This marks the second approved indication for tapinarof cream in Canada, following its initial approval in 2025 for the treatment of plaque psoriasis in adults.

For more information about NDUVRA^® (tapinarof cream), including important safety information, visit https://www.organon.com/canada-en/wp-content/uploads/sites/5/2025/04/NDUVRA_PM_E.pdf 

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, Biosimilars and General Medicines, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. 

For more information, visit https://www.organon.com/canada-en/ and connect with us on LinkedIn.

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ⁱ Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024;91(3):457-465.

ⁱⁱ VTAMA (tapinarof) cream, 1%. Prescribing Information. Organon; 2025.

ⁱⁱⁱ Paller AS, Hebert AA, Gonzalez ME, et al. Maximal usage trial of tapinarof cream 1% once daily in pediatric patients down to 2 years of age with extensive atopic dermatitis. Am J Clin Dermatol. 2025;26:449-456.

^iv Jett JE, McLaughlin M, Lee MS, et al. Tapinarof cream 1% for extensive plaque psoriasis: a maximal use trial on safety, tolerability, and pharmacokinetics. Am J Clin Dermatol. 2022;23(1):83-91.

^v Arnīte A, Bondare-Ansberga V, Reinberga L, Hartmane I, Mikažāns I. Depression, Anxiety and Quality of Life in Patients with Atopic Dermatitis and Psoriasis. Medicina. 2026;62(1):164. doi:10.3390/medicina62010164

^vi Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23(8 Suppl):S115-S123.

^vii Ng AE, Boersma P. Diagnosed Allergic Conditions in Adults: United States, 2021. NCHS Data Brief. 2023;(460):1-8.

^viii Lynde C, et al. Canadian Consensus Guidelines for the Management of Atopic Dermatitis with Topical Therapies. Dermatol Ther (Heidelb). 2025

^ix Guillet C, Seeli C, Nina M, Maul LV, Maul J-T. The impact of gender and sex in psoriasis: What to be aware of when treating women with psoriasis. Int J Womens Dermatol. 2022;8(2):e010. doi:10.1097/JW9.0000000000000010

^x Gottlieb AB, Ryan C, Murase JE. Clinical considerations for the management of psoriasis in women. Int J Womens Dermatol. 2019;5(3):141-150. doi:10.1016/j.ijwd.2019.04.021

^xi Eczema Society of Canada. Unraveling the link between hormones and eczema flares, Online.

Unraveling the link between hormones and eczema flares | Eczema Society of Canada

SOURCE Organon Canada Inc.

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