FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

Arcutis (Nasdaq:ARQT) received FDA approval to expand ZORYVE (roflumilast) cream 0.3% for plaque psoriasis to children as young as age 2, including intertriginous areas.

Rhea-AI Summary

Arcutis (Nasdaq:ARQT) received FDA approval to expand ZORYVE (roflumilast) cream 0.3% for plaque psoriasis to children as young as age 2, including intertriginous areas. ZORYVE is a once-daily, non-steroidal topical for use anywhere on the body, with no duration limits.

The decision is based on a 4-week MUSE study and a 24-week extension in children 2–5, which showed safety and efficacy consistent with prior adolescent and adult trials. This is the seventh FDA approval for ZORYVE in four years. Arcutis highlights broad availability and access programs, including ZORYVE Direct savings and Arcutis Cares assistance.

Positive

• FDA expands ZORYVE cream 0.3% approval to children aged 2–5 years
• First once-daily, steroid-free plaque psoriasis cream approved down to age 2
• Seventh FDA approval for the ZORYVE franchise in four years
• Pediatric studies up to 24 weeks show safety consistent with adult Phase 3 trials
• ZORYVE cream widely available through key wholesalers and dermatology pharmacies
• ZORYVE Direct and Arcutis Cares programs aim to reduce patient out-of-pocket costs

Negative

• None.

Argus Jun 30 session

-2.02% close to close Open Argus

Details

News Market Reaction – ARQT

In the Jun 30 session, ARQT declined 2.02%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement extends ZORYVE 0.3% to children as young as 2 years, adding a seventh FDA approval...

Analysis

This announcement extends ZORYVE 0.3% to children as young as 2 years, adding a seventh FDA approval in four years. Prior FDA events showed mixed share responses; elevated short interest and an effective shelf mean financing and volatility remain key watchpoints.

Key Figures

Cream strength: 0.3% Minimum treatment age: 2 years Pediatric age range: 2 to 5 years +5 more

Cream strength

0.3%

ZORYVE (roflumilast) cream concentration in approved pediatric plaque psoriasis use

Minimum treatment age

2 years

New lower age limit for plaque psoriasis indication with ZORYVE cream 0.3%

Pediatric age range

2 to 5 years

Ages enrolled in MUSE study ARQ-151-216 for plaque psoriasis

MUSE study duration

4 weeks

Maximal Usage Systemic Exposure (MUSE) trial period in children 2–5

Body surface area

≥2% BSA

Minimum plaque psoriasis involvement for enrollment in MUSE study

Long-term extension

up to 24 weeks

Duration of open-label extension study ARQ-151-306 in ages 2–5

Total ZORYVE approvals

7 FDA approvals

Cumulative ZORYVE regulatory milestones achieved over four years

Dosing frequency

once-daily

Topical dosing schedule for ZORYVE cream 0.3% in plaque psoriasis

Previous Fda approval Reports

5 past events · Latest: Oct 06

Same Type 5 events

1. Oct 06

   FDA approval

   24h Move

   -0.8%

   FDA approval of ZORYVE 0.05% cream for atopic dermatitis ages 2–5.

2. May 22

   FDA approval

   24h Move

   -0.7%

   FDA approval of ZORYVE 0.3% foam for plaque psoriasis age 12+.

3. Dec 16

   sNDA submission

   24h Move

   +6.9%

   sNDA submission for ZORYVE 0.05% cream in children 2–5 with AD.

4. Jul 23

   sNDA submission

   24h Move

   +3.5%

   sNDA for ZORYVE foam in scalp and body psoriasis age 12+.

5. Jul 09

   FDA approval

   24h Move

   -2.1%

   FDA approval of ZORYVE 0.15% cream for atopic dermatitis age 6+.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

plaque psoriasis, intertriginous areas, maximal usage systemic exposure, pharmacokinetics, +1 more

5 terms

plaque psoriasis medical

"for the topical treatment of plaque psoriasis, including intertriginous areas, to children"

A chronic autoimmune skin condition that causes raised, red, scaly patches where the skin sheds too quickly, like a tree producing bark in clumps instead of renewing smoothly. It matters to investors because prevalence, severity, and treatment options drive demand for therapies, shape clinical trial design and regulatory review, and affect potential market size, pricing and reimbursement for drugs or devices aimed at relieving symptoms or altering the underlying immune response.

intertriginous areas medical

"for the topical treatment of plaque psoriasis, including intertriginous areas, to children"

Intertriginous areas are parts of the body where skin rubs against skin—for example, armpits, groin, under the breasts, and skin folds behind knees—similar to where fabric creases and traps heat and moisture. For investors, these sites matter because medications, creams, and medical devices intended for those spots face special formulation, safety and testing requirements due to higher irritation and infection risk, which can affect regulatory approval, labeling and market demand.

maximal usage systemic exposure medical

"based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216)"

Maximal usage systemic exposure describes the greatest amount of a drug or chemical that can enter the bloodstream when a product is used exactly as intended at the highest realistic frequency, dose, or body area. Think of it as testing how full a cup gets when you pour at the fastest safe rate; regulators use it to assess risk, and investors care because high systemic exposure can trigger safety warnings, tighter labeling, additional studies, or reduced market potential.

pharmacokinetics medical

"This open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pde4 inhibitor medical

"ZORYVE cream 0.3%, a potent and selective PDE4 inhibitor, directly addresses this treatment gap"

A PDE4 inhibitor is a drug that blocks an enzyme (PDE4) involved in turning off certain cell signals linked to inflammation and brain activity; blocking it lets those signals persist and can reduce inflammation or alter nerve-cell behavior. Investors care because this drug class underlies treatments for conditions like chronic inflammatory and neurological disorders, so clinical trial results, regulatory decisions, or patent news can strongly affect a company’s drug pipeline value and stock outlook.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Add on Google Not now

• ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for children with plaque psoriasis as young as 2 years of age
• ZORYVE cream 0.3% is safe, effective, and well-tolerated for use anywhere on the body with no restrictions on duration of use
• Seventh FDA approval for ZORYVE in four years
  

WESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for ZORYVE^® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. ZORYVE cream 0.3% is a once-daily, steroid-free topical that is safe, effective, and well tolerated, and is suitable for use anywhere on the body with no limitations on duration of use. 

Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease that can begin early in life and persist for decades. Plaque psoriasis can appear as raised, red, or discolored areas of skin covered with silvery scales.

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds. Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use,” said Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator, Ada West Dermatology. “In clinical studies, ZORYVE cream 0.3% 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. This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time.”

“Parents and caregivers of young children with plaque psoriasis have faced a significant treatment gap for years, with very limited options, even though this skin condition can have a profound impact on the child and the entire family,” said Leah Howard, president and chief executive officer, National Psoriasis Foundation. “The FDA approval of a once-daily, steroid-free topical treatment for children as young as 2 introduces an important new treatment option for a largely overlooked population and represents a significant advancement in pediatric psoriasis care.”

A Media Snippet accompanying this announcement is available by clicking on this link.

ZORYVE cream 0.3% was previously approved for the treatment of plaque psoriasis in adults and children down to age 6. The approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216) evaluating ZORYVE cream 0.3% in children ages 2 to 5 years with plaque psoriasis. This open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy in children with plaque psoriasis involving at least 2% body surface area. Supportive long-term safety data were derived from an open-label extension study (ARQ-151-306), which evaluated the long-term safety, tolerability, and efficacy of ZORYVE cream 0.3% in individuals ages 2 to 5 years with plaque psoriasis for up to 24 weeks of treatment. Results demonstrated safety and efficacy profiles that were generally consistent with those observed in the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adolescents and adults.

“Children with plaque psoriasis under age 6 have historically had few treatment options that are appropriate for long‑term use, forcing families and clinicians to navigate care for a chronic, progressive skin condition with limited choices,” said Frank Watanabe, president and chief executive officer of Arcutis. “ZORYVE cream 0.3%, a potent and selective PDE4 inhibitor, directly addresses this treatment gap and is the first once-daily steroid-free treatment for plaque psoriasis approved down to age 2. This seventh FDA approval for ZORYVE in four years demonstrates Arcutis’ commitment to delivering meaningful innovation to the youngest children and their families.”

ZORYVE cream is widely available today via key wholesaler and dermatology pharmacy channels. Arcutis is committed to ensuring predictable access across the ZORYVE portfolio through a simplified copay and fulfillment process. The ZORYVE^® Direct Program supports patients who have been prescribed ZORYVE by helping navigate the insurance process, assisting with adherence, and providing access to the ZORYVE Direct Savings Card Program to help reduce out-of-pocket costs for eligible commercially insured patients.^† The Company also offers the Arcutis Cares™ patient assistance program, which provides ZORYVE at no cost to financially eligible patients who are uninsured or underinsured.^‡

For more information about ZORYVE, including full Prescribing Information, please visit www.zoryve.com.

About Plaque Psoriasis
Psoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, and flaking. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin area.

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 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 adults 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.”

INDICATIONS
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. 

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. 

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).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. 

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). 

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). 

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). 

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

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%).

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company delivering meaningful innovation to address the needs of individuals living with chronic inflammatory skin diseases. Over the past decade, Arcutis has successfully developed a robust portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases, driven by a commitment to solving the most persistent patient challenges in dermatology. Arcutis’ unique dermatology development platform, built on established scientific pathways and coupled with deep clinical dermatology and commercial expertise, enables us to efficiently develop, scale, and deliver our differentiated therapies while advancing a growing pipeline across 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 real-world use results of ZORYVE cream 0.3%, and the potential for ZORYVE cream to advance the standard of care in plaque psoriasis including this young patient population. 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.

† Subject to eligibility criteria and maximum program limitation. This offer is not valid for patients without commercial drug insurance or whose prescription claims are eligible to be reimbursed, in whole or in part, by any government program.

‡ Subject to financial eligibility requirements. Other terms and restrictions apply.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA approve for Arcutis ZORYVE (ARQT) on June 29, 2026?

The FDA approved an expanded indication for ZORYVE cream 0.3% to treat plaque psoriasis in children as young as age 2. According to Arcutis, the approval covers topical treatment, including intertriginous areas, with once-daily, steroid-free use anywhere on the body.

Why is the new ZORYVE cream 0.3% approval important for pediatric plaque psoriasis (ARQT)?

The approval gives young children a once-daily, steroid-free option usable on sensitive skin and for long-term treatment. According to Arcutis, it addresses a longstanding treatment gap for ages 2–5, where topical steroids have limitations on sensitive areas and continuous use.

What clinical data supported FDA approval of ZORYVE cream 0.3% for ages 2 to 5 (ARQT)?

Approval is based on a 4-week MUSE study in children 2–5 with plaque psoriasis and a 24-week extension trial. According to Arcutis, safety and efficacy in these studies were generally consistent with DERMIS-1 and DERMIS-2 Phase 3 trials in adolescents and adults.

How does ZORYVE cream 0.3% differ from topical steroids for children with plaque psoriasis?

ZORYVE cream 0.3% is a once-daily, non-steroidal PDE4 inhibitor approved for use anywhere on the body with no duration limits. According to Arcutis, topical steroids are not recommended for long-term, continuous use, especially on sensitive areas like the face and skin folds.

What age ranges is ZORYVE cream 0.3% now approved to treat for plaque psoriasis (ARQT)?

ZORYVE cream 0.3% is approved for plaque psoriasis in adults and children starting at age 2. According to Arcutis, this expands prior approval, which began at age 6, and now includes young children with disease on any body area, including intertriginous regions.

How can patients access ZORYVE cream 0.3% and savings programs for plaque psoriasis?

ZORYVE cream is available through major wholesalers and dermatology pharmacy channels in the United States. According to Arcutis, the ZORYVE Direct Program and Arcutis Cares offer insurance navigation, adherence support, savings cards, and free product for eligible uninsured or underinsured patients.