FULL APPROVAL

FDA approves Arcutis's Zoryve cream for plaque psoriasis in children as young as 2

The approval, based on a 4-week pharmacokinetics and safety study, extends Zoryve's label below the age of 6 and marks the drug's seventh FDA nod in four years.

By AppliedXLJune 29, 2026Trial NCT04746911

Executive Summary

The FDA approved an expansion of Arcutis's topical psoriasis treatment to children as young as 2, resolving the regulatory decision on its original target date with a positive outcome.
The approval rested on a small, open-label pharmacokinetics and safety study rather than a placebo-controlled efficacy trial, consistent with how pediatric extensions of an already-approved topical are typically supported.
The drug sits in a crowded field of PDE4 inhibitors and other oral and topical mechanisms in plaque psoriasis, and this approval competes less on mechanism than on being a steroid-free option cleared for use anywhere on the body without a duration limit.
The clearance extends the addressable pediatric population beyond the prior age-6 floor and adds to a run of label expansions for the same molecule since its first approval.

The decision

Arcutis Biotherapeutics, Inc. said the FDA approved its supplemental New Drug Application to expand the indication for Zoryve cream 0.3% for topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. The decision landed on the FDA's June 29, 2026 target action date, with no delay from the timeline the company had guided in January 2026. Zoryve cream 0.3% was previously approved for plaque psoriasis in adults and children down to age 6, so the action lowers the age floor rather than opening a new indication. FDA+1

The evidence behind it

The approval drew on a 4-week Maximal Usage Systemic Exposure study, ARQ-151-216, that evaluated Zoryve cream 0.3% in children ages 2 to 5 with plaque psoriasis, registered as NCT04746911. The open-label, single-arm trial enrolled 10 children across sites in the United States, Canada and the Dominican Republic and measured adverse-event incidence as its primary outcome, assessing pharmacokinetics, safety, tolerability and exploratory efficacy rather than running a placebo-controlled efficacy comparison. Supportive safety data came from an ongoing open-label extension study, ARQ-151-306, covering use out to 24 weeks. Lisa Swanson, a pediatric dermatologist and trial investigator at Ada West Dermatology, said the drug "demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents, and was safe and well tolerated in children as young as age 2". NCT04746911+1

What the label reflects

The FDA-approved label lists the most common adverse events in the pediatric population as diarrhea in 3.1% of patients and headache in 2.4%, consistent with the safety pattern observed in the adult and older-pediatric trials that supported earlier approvals. Arcutis framed the drug as suitable for use anywhere on the body with no restriction on duration, a distinction from topical steroids, which carry warnings against long-term or continuous use on sensitive skin such as the face and skin folds. This is the seventh FDA approval for Zoryve in four years, following the original 2022 approval and subsequent expansions to intertriginous areas, to children ages 6 to 11, and to other inflammatory skin indications. FDA

The competitive field

Plaque psoriasis draws small-molecule and biologic entrants across multiple mechanisms, including JAK1 inhibitors such as AbbVie's upadacitinib, TYK2 inhibitors such as Bristol-Myers Squibb's deucravacitinib, and IL-17 and IL-23 biologics such as UCB's bimekizumab, most of which are systemic therapies rather than topicals. Within the PDE4 class itself, Roflumilast is also in Phase 4 testing for atopic dermatitis through an Integrative Skin Science and Research trial, while Amgen's apremilast, an oral PDE4 inhibitor, is approved for psoriatic arthritis and adult and pediatric plaque psoriasis rather than this pediatric topical population. Zoryve's differentiation in this pediatric extension is less about mechanism than about formulation and use pattern: a topical, once-daily, steroid-free cream cleared for children as young as 2 fills a gap in an age group where topical steroids are the default but are not recommended for long-term or sensitive-area use. FDA

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