Drug Update · Dermatology

FDA Approves Roflumilast (ZORYVE) Cream for Plaque Psoriasis: IGA Success 41.5% (DERMIS-1)

September 01, 2026

FDA approval date

06/29/2026

Approved indication

Topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.

DERMIS-1 primary result

IGA success 41.5% vs 5.8% at Week 8 (ZORYVE cream, 0.3% vs vehicle) [DERMIS-1]

DERMIS-2 primary result

IGA success 36.7% vs 7.1% at Week 8 (ZORYVE cream, 0.3% vs vehicle) [DERMIS-2]

Recommended dosing (plaque psoriasis)

Apply ZORYVE cream, 0.3%, once daily to affected areas.

Clinical Perspective

Dermatologists and pediatric clinicians treating plaque psoriasis can now prescribe ZORYVE cream, 0.3%, once daily for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older per the revised FDA labeling ^[1]^[2]. The DERMIS-1 and DERMIS-2 randomized trials reported IGA treatment success rates of 41.5% vs 5.8% and 36.7% vs 7.1% (ZORYVE vs vehicle) at Week 8, supporting efficacy of once-daily 0.3% cream in the studied populations ^[3]. How roflumilast cream will be positioned relative to other topical or systemic options in children 2 to 5 years of age requires further clinical experience and comparative data?

Dr. Rohan Gupta, MBBS, MD (Dermatology, Venereology & Leprosy) · Dermatology

The FDA approved ZORYVE (roflumilast) cream, 0.3%, for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older, effective 06/29/2026 ^[2]^[1]. The expanded indication follows submission and review of pediatric postmarketing data and is supported by randomized, vehicle-controlled DERMIS-1 and DERMIS-2 trials that demonstrated higher Investigator Global Assessment (IGA) treatment success with ZORYVE cream, 0.3% versus vehicle at Week 8 ^[3].

Clinical Context

ZORYVE is a topical formulation of roflumilast, a phosphodiesterase-4 (PDE4) inhibitor marketed by Arcutis Biotherapeutics ^[2]^[1]. The approved product line includes cream formulations at 0.3%, 0.15%, and 0.05% strengths for topical use, with distinct labeled indications across those strengths ^[1]. The June 29, 2026 approval expands the 0.3% cream indication to include pediatric patients down to 2 years of age for plaque psoriasis, including intertriginous areas ^[2]^[1]. The regulatory action closed the sponsor’s PMR for long-term safety and permitted labeling to reflect use in patients 2 years and older ^[2].

Key Findings

DERMIS-1 showed ZORYVE cream, 0.3%, achieved IGA treatment success of 41.5% versus 5.8% with vehicle at Week 8 in adult and pediatric subjects with plaque psoriasis (Subjects randomized: ZORYVE N=286; Vehicle N=153) ^[3].
DERMIS-2 showed ZORYVE cream, 0.3%, achieved IGA treatment success of 36.7% versus 7.1% with vehicle at Week 8 in adult and pediatric subjects with plaque psoriasis (Subjects randomized: ZORYVE N=290; Vehicle N=152) ^[3].
The pooled development program for ZORYVE cream included two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2) enrolling a total of 881 adult and pediatric subjects 6 years of age and older, and the label now supports use in patients 2 years and older based on supplemental data and postmarketing study fulfillment ^[3]^[2].

Safety & Tolerability

The most common adverse reactions reported in subjects with plaque psoriasis treated with ZORYVE cream, 0.3%, (reported in ≥1% of subjects) were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection ^[1].

Study Design

The DERMIS clinical program for ZORYVE cream included two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2) that enrolled a total of 881 adult and pediatric subjects 6 years of age and older with mild to severe plaque psoriasis; subjects were randomized 2:1 to ZORYVE cream, 0.3%, or vehicle once daily for 8 weeks ^[3]. Clinicians should consult current prescribing information for full dosing guidance. The supplemental approval documented in the FDA sNDA approval letter expanded the 0.3% cream indication to adult and pediatric patients 2 years of age and older and acknowledged fulfillment of the required postmarketing study addressing long-term safety ^[2]^[1].

FAQ

Q1 What is ZORYVE (roflumilast) cream, 0.3%, approved for?

ZORYVE cream, 0.3%, is approved for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older. This approval follows supplemental FDA review and labeling updates that expand the indicated pediatric age range to include children 2 years and older. The approval and labeling are documented in FDA correspondence and the revised prescribing information.

Q2 How does roflumilast (ZORYVE) work?

Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor. Inhibition of PDE4 and its active metabolite’s activity leads to accumulation of intracellular cyclic AMP; the specific mechanism(s) by which roflumilast exerts its therapeutic action in plaque psoriasis are not well defined in the prescribing information. The drug and its N-oxide metabolite are described in the clinical pharmacology sections of the label.

Q3 What is the recommended dose of ZORYVE cream, 0.3% for plaque psoriasis?

For plaque psoriasis, the approved regimen for ZORYVE cream, 0.3%, is to apply the cream once daily to affected areas and rub in completely. The full prescribing information includes administration instructions and cautions regarding topical use only and avoidance of ophthalmic, oral, or intravaginal use. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects of ZORYVE cream, 0.3% in plaque psoriasis?

The most common adverse reactions reported in subjects with plaque psoriasis treated with ZORYVE cream, 0.3%, were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. The label describes adverse reaction frequencies observed in the controlled trials and long-term extension data, and clinicians are directed to the full prescribing information for detailed safety and monitoring information.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Roflumilast (ZORYVE) Cream for Plaque Psoriasis: IGA Success 41.5% (DERMIS-1)

Direct Clinical Takeaway & Evidence Summary

FDA Approves Roflumilast (ZORYVE) Cream for Plaque Psoriasis: IGA Success 41.5% (DERMIS-1)

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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