Last reviewed: 1 Jan 2023
Last updated: 30 Sep 2022
30 Sep 2022

FDA approves tapinarof for adults with plaque psoriasis

Tapinarof, a small-molecule topical aryl hydrocarbon receptor (AhR) agonist, is the first topical novel chemical entity (corticosteroid-free) treatment to be approved by the US Food and Drug Administration in 25 years for adults with any severity of plaque psoriasis.

Two identical phase 3 randomised controlled trials demonstrated tapinarof significantly reduced the severity of plaque psoriasis, compared with vehicle, in patients with mild to severe plaque psoriasis at 12 weeks.[118] Patients who completed the 12 week trial were eligible to be included in a 40 week phase 3 open label trial with a 4 week follow up.[119] The trial reported that 41% of patients achieved complete disease clearance (physician global assessment [PGA] score 0), and that 58% of patients who entered the trial with PGA ≥2 achieved PGA of 0 or 1. The mean duration of remission for patients who achieved PGA 0 was 130 days. The most frequent adverse effects were folliculitis, contact dermatitis, and upper respiratory tract infection.[119]

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Original source of update



History and exam

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Risk factors

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Andrea Chiricozzi, MD

Assistant Professor

University of Pisa

Consultant Dermatologist

University Hospital of Pisa




AC has served as an advisory board member and consultant and has received fees and speaker's honoraria or has participated in clinical trials for AbbVie, Almirall, Biogen, Fresenius Kabi, Leo Pharma, Lilly, Janssen, Novartis, Sanofi Genzyme, and UCB Pharma; AC is also an author of a reference cited in this topic.


Dr Andrea Chiricozzi would like to gratefully acknowledge Dr April W. Armstrong and Dr Tsu-Yi Chuang, previous contributors to this topic.


TC declares that he has no competing interests. AWA is an investigator and consultant for Abbott, Amgen, and Janssen; AWA is also an author of references cited in this topic.

Peer reviewers

David Burden, MD, FRCP

Western Infirmary, Glasgow

Consultant Dermatologist Dermatology




DB has been reimbursed as a consultant, researcher, and lecturer for Abbott, Leo, Pfizer, Merck, Janssen-Cilag, and Novartis.

Paradi Mirmirani, MD


Department of Dermatology

Kaiser Permanente Vallejo Medical Center




PM declares that she has no competing interests.

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