Arcutis Launches ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5
Rhea-AI Summary
Arcutis (Nasdaq: ARQT) announced the commercial launch of ZORYVE cream 0.05% for treatment of mild to moderate atopic dermatitis in children ages 2 to 5 in the U.S. The product received FDA approval on October 6, 2025 and is becoming available in pharmacies the week of October 30, 2025. Clinical trials reported significant clearance of signs and symptoms and meaningful itch improvement. ZORYVE is a once-daily, steroid-free topical that can be used anywhere on the body for any duration, and Arcutis is offering patient support via the ZORYVE Direct Program, a copay savings card, and the Arcutis Cares patient assistance program.
Positive
- FDA approval for ages 2–5 (Oct 6, 2025)
- Commercial launch in pharmacies the week of Oct 30, 2025
- Once-daily, steroid-free topical usable anywhere on body
- Clinical trials showed significant clearance and itch improvement
- Patient access programs include copay savings and PAP
Negative
- Commercial coverage under pharmacy benefit managers is still being reviewed
News Market Reaction – ARQT
In the Oct 30 session, ARQT declined 1.46%, reflecting a mild negative market reaction. Argus tracked a peak move of +2.2% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Once-daily, effective, safe, and well-tolerated ZORYVE cream
0.05% now commercially available for children as young as age 2 - ZORYVE cream
0.05% provides rapid clearance of atopic dermatitis - ZORYVE can be used anywhere on the body for any duration and is not a steroid
- Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children in the U.S.
WESTLAKE VILLAGE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the commercial launch of ZORYVE® (roflumilast) cream
ZORYVE cream
“Atopic dermatitis is one of the most common chronic skin conditions in young children, yet safe and effective long-term treatment options have been limited, especially for children ages 2 to 5,” said Todd Edwards, chief commercial officer at Arcutis. “With ZORYVE cream
ZORYVE cream
“In my practice, I’ve seen firsthand how challenging atopic dermatitis can be for young children who deal with discomfort from the itch and rash, which can disrupt daily activities and sleep at night. In addition, parents and caregivers are looking for treatments that are not a steroid and are easy to apply,” said Latanya Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University’s Charles E. Schmidt College of Medicine. “I look forward to being able to offer ZORYVE cream
Arcutis is dedicated to ensuring predictable access for the ZORYVE portfolio of products, with one simple copay card and fulfillment process. The ZORYVE® Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed ZORYVE to navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients.† Arcutis will also continue to offer the Arcutis Cares™ patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.‡
On October 6, 2025, Arcutis announced that the U.S. Food and Drug Administration (FDA) had approved ZORYVE cream
A Media Snippet accompanying this announcement is available by clicking on this link.
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 recently 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
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.
INDICATIONS
ZORYVE cream,
ZORYVE cream,
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 (≥
The most common adverse reactions reported (≥
Please see full Prescribing Information for ZORYVE.
ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.
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 for ZORYVE cream to advance the standard of care in atopic dermatitis, including patients ages 2 to 5 years. 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, 2025, 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
† 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.
