Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months
Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months
Arcutis (Nasdaq: ARQT) submitted an sNDA to the FDA to expand ZORYVE cream 0.05% (roflumilast) for treatment of mild-to-moderate atopic dermatitis in infants aged ≥3 months to 24 months.The filing is supported by a Phase 1 PK trial (n=19) and the Phase 2 INTEGUMENT-INFANT study (n=101) reporting tolerability and multiple efficacy endpoints, including 34.4% vIGA-AD success at Week 4 and 58.3% EASI-75 at Week 4.
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Positive
sNDA seeks age expansion to infants ≥3 months, widening addressable pediatric population
INTEGUMENT-INFANT enrolled 101 infants showing 58.3% EASI-75 at Week 4
34.4% vIGA-AD success (≥2-grade improvement to 0/1) among completers at Week 4
This announcement highlights Arcutis’ sNDA to extend ZORYVE 0.05% to infants as young as 3 months, b...
Analysis
This announcement highlights Arcutis’ sNDA to extend ZORYVE 0.05% to infants as young as 3 months, backed by Phase 1 and INTEGUMENT-INFANT Phase 2 data showing meaningful rates of vIGA-AD success, EASI-75 responses, and itch improvement. It builds on earlier milestones such as topline infant results and prior pediatric sNDAs. Investors following the story may focus on regulatory timelines, future pediatric label decisions, and how expanding use in younger patients could interact with the company’s broader ZORYVE franchise strategy.
Key Figures
Affected infants (US):1 million childrenPhase 1 enrollment:19 infantsINTEGUMENT-INFANT enrollment:101 infants+5 more
8 metrics
Affected infants (US)1 million childrenChildren under 2 with atopic dermatitis in the United States
Phase 1 enrollment19 infantsPhase 1 PK, safety and efficacy trial over four weeks
INTEGUMENT-INFANT enrollment101 infantsPhase 2 open-label trial, once-daily ZORYVE 0.05% for four weeks
vIGA-AD success34.4%Week 4 vIGA-AD success among 96 infants completing treatment
vIGA-AD Clear/Almost Clear49%Infants with vIGA-AD Clear or Almost Clear at Week 4
vIGA-scalp success67.5% (27/40)Infants with scalp involvement achieving vIGA-scalp success at Week 4
EASI-75 Week 458.3%Infants achieving at least 75% EASI improvement at Week 4
WSI-NRS success72.7%Infants with ≥4-point itch improvement at Week 4 (n=77)
Submitted sNDA for ZORYVE 0.3% to extend plaque psoriasis label to ages 2–5.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Clinical and regulatory milestones for ZORYVE often draw positive stock reactions, but enrollment and data-presentation updates have sometimes seen price declines despite constructive news.
Recent Company History
Over the past months, Arcutis has steadily advanced ZORYVE across pediatric indications. A Feb 2, 2026 update reported positive INTEGUMENT-INFANT topline data and plans for an sNDA. Earlier, the company completed INTEGUMENT-INFANT enrollment and submitted/advanced sNDAs for plaque psoriasis in children ages 2–5, with a PDUFA date of Jun 29, 2026. Today’s infant atopic dermatitis sNDA and detailed efficacy figures build directly on that sequence of pediatric clinical milestones.
Key Terms
supplemental new drug application, snda, validated investigator global assessment for atopic dermatitis, eczema area and severity index, +3 more
7 terms
supplemental new drug applicationregulatory
"announced the submission of a supplemental New Drug Application (sNDA) to the U.S."
A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.
sndaregulatory
"announced the submission of a supplemental New Drug Application (sNDA) to the U.S."
A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.
validated investigator global assessment for atopic dermatitismedical
"34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success"
A validated Investigator Global Assessment for atopic dermatitis is a clinician-rated scale that gives a single, standardized score for how severe a patient’s eczema is at a given time. It matters to investors because it is a common, accepted trial endpoint used to show whether a treatment works; clear improvements on this scale can drive regulatory approvals, label claims and market uptake, much like a referee’s overall score confirming a team’s performance.
eczema area and severity indexmedical
"at least a 75% reduction from baseline in Eczema Area and Severity Index (EASI-75) at Week 4"
A standardized clinical score that measures how much skin is affected by eczema and how severe the lesions are, combining area and intensity into one number much like a report card for a skin condition. Investors care because changes in this score are often used as a primary measure of a treatment’s effectiveness in clinical trials, influencing regulatory approval chances, market potential, and the perceived value of companies developing eczema therapies.
easi-75medical
"at least a 75% reduction from baseline in Eczema Area and Severity Index (EASI-75) at Week 4"
EASI-75 is a clinical result meaning a patient has achieved at least a 75% improvement on the Eczema Area and Severity Index, a standardized score that combines how much skin is affected and how severe the symptoms are. Investors watch EASI-75 because it serves as a clear, widely accepted benchmark of a drug’s effectiveness in eczema trials—like a pass/fail meter—so higher EASI-75 rates improve a therapy’s approval odds and commercial prospects.
dynamic pruritus scalemedical
"25% improvement from baseline in pruritus based on the Dynamic Pruritus Scale (DPS-25)"
A dynamic pruritus scale is a measurement tool that tracks how an individual’s itch intensity rises and falls over time, often using repeated patient ratings or sensors to capture moment-to-moment changes rather than a single snapshot. Investors care because it can serve as a clinical trial endpoint or regulatory evidence that a treatment meaningfully reduces uncomfortable fluctuations; think of it like a weather app for symptoms that shows whether a therapy clears up storms or only dulls a breeze.
pharmacokineticmedical
"supported by positive results from a Phase 1 open-label pharmacokinetic (PK) trial"
Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.
Submission supported by data from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis
Once-daily ZORYVE cream was well tolerated with a safety profile consistent with that in older children and adults
Atopic dermatitis impacts 1 million children under the age of 2 in the United States
Only one other FDA-approved topical non-steroidal anti-inflammatory agent available for this vulnerable population
WESTLAKE VILLAGE, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication for ZORYVE® (roflumilast) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months.
“Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited. Parents and caregivers are often faced with difficult decisions around managing these symptoms, including concerns about the long-term use of topical steroids,” said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and INTEGUMENT-INFANT clinical trial investigator. “Because their immune system and skin barrier are still developing, infants are particularly vulnerable to the burdensome symptoms of atopic dermatitis, including visible disease and intense itch that can disrupt sleep and significantly impact both infants and their caregivers. Safe and effective long-term therapies suitable for use anywhere on the body, including sensitive regions such as the face and skin folds, remain an important unmet need for infants with atopic dermatitis. If approved, ZORYVE cream 0.05% could offer a much-needed, non-steroidal treatment option developed specifically for very young children, including infants.”
Atopic dermatitis is the most common form of eczema and frequently presents during infancy, contributing to significant child and caregiver burden and impaired quality of life. In infants, atopic dermatitis can have more widespread presentation on the body and infants demonstrate a higher body surface area-to-body mass ratio, which may increase the risk of side effects from topical treatment.
“This sNDA submission represents an important milestone in our effort to expand treatment options for infants as young as 3 months living with atopic dermatitis, an age group with very limited treatment options today,” said Frank Watanabe, president and CEO of Arcutis. “If approved, investigational ZORYVE cream 0.05% could offer an effective and well-tolerated treatment option suitable for long-term use, helping infants and their families maintain clear skin and limit cumulative topical steroid exposure. This potential age expansion supports our strategy to broaden ZORYVE’s reach and reinforces its role as a foundational therapy across age groups.”
The sNDA is supported by positive results from a Phase 1 open-label pharmacokinetic (PK) trial and a Phase 2 open-label trial (INTEGUMENT-INFANT), both of which evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The Phase 1 study enrolled 19 infants and demonstrated PK, safety and efficacy profiles over four weeks that were consistent with those from prior pediatric atopic dermatitis studies in older children. The INTEGUMENT-INFANT study enrolled 101 infants and assessed safety, tolerability, and efficacy over four weeks, and in this study, ZORYVE cream 0.05% was well tolerated in infants. The safety and tolerability profile observed in the INTEGUMENT-INFANT study was consistent with prior pediatric experience across the INTEGUMENT program. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.
Among infants who completed four weeks of treatment in INTEGUMENT-INFANT (n=96), 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as a score of 0 (Clear) or 1 (Almost Clear) with a ≥2-grade improvement from baseline. In addition, 49% of infants achieved a vIGA-AD score of Clear or Almost Clear at Week 4, with 24% achieving vIGA-AD score of Clear or Almost Clear at Week 2, and improvements were observed as early as Week 1. Among infants with at least mild scalp involvement at baseline, 67.5% (27/40) achieved vIGA-scalp success at Week 4. In the study, 58.3% of infants achieved at least a 75% reduction from baseline in Eczema Area and Severity Index (EASI-75) at Week 4, with 34% achieving EASI-75 at Week 2.
Caregiver-reported assessments also demonstrated rapid improvement in itch, with 72.7% of infants achieving Worst Scratch Itch Numeric Rating Scale (WSI-NRS) success, defined as a ≥4-point improvement at Week 4 (end of study, n=77), and 60.3% at Week 2 (n=73). Furthermore, 66.7% of infants achieved at least a 25% improvement from baseline in pruritus based on the Dynamic Pruritus Scale (DPS-25) at four hours (n=87), 58.6% at one hour (n=87), and 46.6% at 10 minutes (n=88).
ZORYVE cream 0.05% was intentionally formulated for atopic dermatitis and is suitable for children and infants with atopic dermatitis whose immune system and skin barrier are still developing. The 0.05% dose was specifically selected for children ≤5 years of age, in part based on the understanding of the skin barrier dysfunction associated with atopic dermatitis, which is especially important because the skin of infants and younger children is still developing. ZORYVE cream 0.05% is a once-daily, steroid-free, non-greasy topical treatment that does not contain sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. ZORYVE cream 0.05% is already approved for the treatment of mild to moderate atopic dermatitis in patients aged 2-5 years.
About Atopic Dermatitis Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Atopic dermatitis is a chronic, relapsing, and genetically predisposed inflammatory skin disease. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. Younger children may have especially widespread atopic dermatitis, including on the face and neck.
Atopic dermatitis is often initially diagnosed during childhood with approximately 90% of people with atopic dermatitis developing symptoms by age 5 and up to 60% of children developing symptoms within their first year. Pediatric atopic dermatitis can negatively impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers.
About ZORYVE® (roflumilast) ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE cream is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.
Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition — the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025, as well as a strong recommendation for the use of ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis from the AAD’s first-ever pediatric atopic dermatitis guidelines published in April 2026. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”
INDICATION ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.
IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).
About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on The Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential FDA approval of ZORYVE cream 0.05% for infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis, that clinical trial results will translate to real-world use of ZORYVE cream, and the potential for ZORYVE cream to advance the standard of care in atopic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com
Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com
FAQ
What did Arcutis (ARQT) file with the FDA on April 27, 2026 regarding ZORYVE cream 0.05%?
Arcutis submitted a supplemental NDA to expand ZORYVE cream 0.05% for infants aged 3 months to <24 months. According to the company, the filing is supported by a Phase 1 PK study (n=19) and the Phase 2 INTEGUMENT-INFANT study (n=101) showing tolerability and efficacy endpoints.
How effective was ZORYVE (ARQT) in the INTEGUMENT-INFANT Phase 2 study at Week 4?
In INTEGUMENT-INFANT, 58.3% of infants achieved EASI-75 and 34.4% achieved vIGA-AD success at Week 4. According to the company, additional measures showed 49% with vIGA-AD of Clear or Almost Clear at Week 4 and rapid itch improvements.
What safety findings did Arcutis (ARQT) report for ZORYVE cream 0.05% in infants?
ZORYVE cream 0.05% was reported as well tolerated with a pediatric-consistent safety profile. According to the company, the most frequent adverse events were diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting over four weeks.
If approved, how would ZORYVE (ARQT) differ from other infant topical options for atopic dermatitis?
If approved, ZORYVE would provide a non-steroidal, once-daily topical option formulated for infants and young children. According to the company, it contains no propylene glycol, polyethylene glycol, ethanol, or fragrances and targets long-term, body-wide use.
What limitations of the ARQT infant data should investors consider regarding the sNDA?
Key limitations include open-label study design and short four-week duration for safety and efficacy assessment. According to the company, the Phase 2 data are supportive but were not randomized placebo-controlled trials in this age group.
