An Open Label Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam as a Mono or add-on Therapy in the Treatment of Hidradenitis Suppurativa With Correlative Analysis.

This is a phase 2a, open label study.
As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.

Start Date01 Sep 2025

Sponsor / Collaborator

Arcutis Biotherapeutics, Inc.

NCT07105254

/ Not yet recruitingNot ApplicableIIT

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)

An open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% in pediatric subjects with Non-Segmental Vitiligo (NSV)

Start Date01 Aug 2025

Sponsor / Collaborator-

NCT06977711

/ RecruitingPhase 1IIT

Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants.
The aims are:
1. To assess the safety and how well the participants tolerate the treatment
2. Assess the response of the tumor to treatment to estimate complete response
3. Assess the response of the tumor to treatment to estimate progression-free survival

Start Date20 Jun 2025

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

100 Clinical Results associated with Roflumilast

100 Translational Medicine associated with Roflumilast

100 Patents (Medical) associated with Roflumilast

1,136

Literatures (Medical) associated with Roflumilast

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study

Article

Author: Yilmaz, Orhan ; Torres, Tiago ; Lé, Ana Maria ; Luz, Martim

OBJECTIVE:

Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.

METHODS:

Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.

RESULTS:

Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.

CONCLUSION:

Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.

01 Dec 2025·INFLAMMATION RESEARCH

Selective phosphodiesterase 4 inhibitor roflumilast reduces inflammation and lung injury in models of betacoronavirus infection in mice

Article

Author: Lacerda, Larisse de Souza Barbosa ; da Silva, Walison Nunes ; Martins, Débora Gonzaga ; Martins, Flávia Rayssa Braga ; Soriani, Frederico Marianetti ; Guimaraes, Pedro Pires Goulart ; Pinho, Vanessa ; Félix, Franciel Batista ; Costa, Vivian Vasconcelos ; Teixeira, Mauro Martins ; Costa, Victor Rodrigues de Melo ; Beltrami, Vinícius Amorim ; Queiroz-Junior, Celso Martins ; Santos, Felipe Rocha da Silva ; Resende, Letícia Cassiano ; Guimaraes, Goulart

OBJECTIVE:

We aimed to understand the potential therapeutic and anti-inflammatory effects of the phosphodiesterase-4 (PDE4) inhibitor roflumilast in models of pulmonary infection caused by betacoronaviruses.

METHODS:

Mice were infected intranasally with murine hepatitis virus (MHV-3) or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Roflumilast was given to MHV-3-infected mice therapeutically at doses of 1 mg/kg or 10 mg/kg, or prophylactically at 10 mg/kg. In SARS-CoV-2-infected mice, roflumilast was given therapeutically at a dose of 10 mg/kg. Lung histopathology, chemokines (CXCL-1 and CCL2), cytokines (IL-1β, IL-6, TNF, IFN-γ, IL-10 and TGFβ), neutrophil immunohistochemical staining (Ly6G⁺ cells), macrophage immunofluorescence staining (F4/80⁺ cells), viral titration plaque assay, real-time PCR virus detection, and blood cell counts were examined.

RESULTS:

Therapeutic treatment with roflumilast at 10 mg/kg reduced lung injury in SARS-CoV-2 or MHV-3-infected mice without compromising viral clearance. In MHV-3-infected mice, reduced lung injury was associated with decreased chemokines levels, prevention of neutrophil aggregates and reduced macrophage accumulation in the lung tissue. However, the prophylactic treatment strategy with roflumilast increased lung injury in MHV-3-infected mice.

CONCLUSION:

Our findings indicate that therapeutic treatment with roflumilast reduced lung injury in MHV-3 and SARS-CoV-2 lung infections. Given the protection induced by roflumilast in inflammation, PDE4 targeting could be a promising therapeutic avenue worth exploring following severe viral infections of the lung.

01 Oct 2025·CELLULAR SIGNALLING

Roflumilast inhibits neuronal ferroptosis via AMPK/Nrf2/HO-1 signaling and promotes motor function recovery after spinal cord injury in rats

Article

Author: Han, YaoNan ; Yu, DeShui ; Wang, XingTong

Spinal cord injury (SCI) is a serious central nervous system disease. Ferroptosis is one of the major causes of spinal cord neurological loss, and targeting ferroptosis is a promising therapeutic strategy. Roflumilast has shown promising applications in the treatment of neurological diseases due to its potent anti-inflammatory and anti-oxidative stress effects. This study aimed to investigate whether roflumilast could inhibit neuronal ferroptosis to improve motor function after SCI in rats. In vitro experiments, we found that roflumilast significantly increased cell survival in an in vitro ferroptosis model, improved mitochondrial function, reduced intracellular iron, reactive oxygen species (ROS), and lipid peroxides accumulation as well as the expression of the pro-ferroptosis proteins, long-chain acyl-coenzyme A synthase 4 (ACSL4), and prostaglandin-endoperoxide synthase 2 (PTGS2), and increased the expression of ferroptosis-inhibitory protein glutathione peroxidase 4 (GPX4), and ferritin heavy chain 1 (FTH1) expression. Mechanistically, these protective effects were achieved by activating AMP-dependent protein kinase (AMPK)/nuclear factor E2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling and were attenuated when AMPK signaling was blocked. In vivo experiments, roflumilast attenuated spinal cord tissue damage, increased the number of motor neuron survivors, and improved motor function after SCI in rats. Overall, activation of AMPK/Nrf2/HO-1 signaling by roflumilast attenuated neuronal ferroptosis and improved motor function after SCI in rats.

196

News (Medical) associated with Roflumilast

06 Aug 2025

·investors.arcutis.com

Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update

Q2 2025 net product revenue for ZORYVE® (roflumilast) was $81.5 million, a 164% increase compared to Q2 of 2024, and a 28% increase compared to Q1 of 2025, driven by strong portfolio demand growth ZORYVE foam 0.3% received U.S. Food and Drug Administration (FDA) approval for the treatment of plaque psoriasis of the scalp and body in adults and adolescents 12 years of age and older Initiated INTEGUMENT-INFANT study to evaluate the safety and efficacy of ZORYVE cream 0.05% in infants with atopic dermatitis ages 3 months to 24 months Submitted Investigational New Drug Application (IND) for ARQ-234, a novel fusion protein for the potential treatment of patients with atopic dermatitis WESTLAKE VILLAGE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update. “We continue to advance our strategy to become the leading medical dermatology company. This quarter, we generated strong net product revenues of $81.5 million from our ZORYVE portfolio, launched a new indication for ZORYVE foam for scalp and body psoriasis, and continued to advance our pipeline. Demand for ZORYVE continues to grow steadily, and we recently surpassed 1 million prescriptions dispensed, underscoring clinicians’ trust in ZORYVE as their preferred steroid-free topical treatment across our four approved indications, thanks to its consistent, robust efficacy and favorable safety and tolerability,” said Frank Watanabe, president and chief executive officer. “Looking ahead, we remain focused on expanding the approved uses of ZORYVE to the youngest patients, with the potential Q4 approval of ZORYVE cream 0.05% for 2 to 5 year olds with atopic dermatitis and the initiation of an infant atopic dermatitis study. Together with our efforts to evaluate potential further indications for ZORYVE and the continued advancement of ARQ-234, we are well positioned for long-term, sustainable growth.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis. U.S. demand for ZORYVE cream 0.3% in plaque psoriasis continues to grow, with over 439,000 prescriptions filled since launch, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. Launch of ZORYVE cream 0.15% in atopic dermatitis continues to gain momentum with over 99,000 prescriptions filled since launch. ZORYVE cream 0.15% received a strong recommendation from the American Association of Dermatology (AAD) in its recently updated guidelines for atopic dermatitis treatments for adults. The Company has been assigned a Prescription Drug User Fee Act (PDUFA) action date of October 13, 2025 for the supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5 years old. In addition, the Company commenced a four-week Phase 2 study to evaluate investigational, once-daily ZORYVE cream 0.05% in infants as young as 3 months to less than 2 years with atopic dermatitis, which could potentially be the basis for further indication expansion. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis and plaque psoriasis of the scalp and body. The Company received FDA approval for its sNDA for ZORYVE foam for scalp and body psoriasis in adult and adolescents 12 years of age and older in May 2025 and commenced sales in June 2025. Demand for ZORYVE foam 0.3% in seborrheic dermatitis and plaque psoriasis of the scalp and body continues to grow robustly each quarter, with over 405,000 prescriptions filled since launch, reflecting the high unmet need in these diseases. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis. The Company submitted its IND for ARQ-234 in July 2025. Other Pipeline Updates Following the evaluation of results from the Phase 1b trial of ARQ-255, a penetrating topical formulation of ivarmacitinib for the treatment of alopecia areata, the Company has elected to halt further development of this program. While clinical and biomarker results indicated some level of efficacy, the results did not meet the Company's threshold for advancement, and the Company has deprioritized the program given other R&D priorities across its portfolio. The Company has begun to investigate further indication expansion opportunities for ZORYVE, beginning with two recently initiated Phase 2 studies. Recent Corporate Highlights ZORYVE cream and ZORYVE foam received the Seal of Recognition from the National Psoriasis Foundation (NPF) in June 2025, the first time that the NPF has recognized a prescription product. ZORYVE cream 0.15% received a strong recommendation in the updated AAD guidelines for atopic dermatitis treatments for adults. The Company's successful pivotal Phase 3 ARRECTOR trial for ZORYVE foam 0.3% in scalp and body psoriasis was published in the Journal of the American Medical Association Dermatology in May 2025. Obtained three new U.S. patents in Q2 2025 related to topical roflumilast compositions. Second Quarter 2025 Summary Financial Results Product revenues for the quarter ended June 30, 2025 were $81.5 million compared to $30.9 million for the corresponding period in 2024. Revenues for the quarter were $27.7 million for ZORYVE cream 0.3%, $14.6 million for ZORYVE cream 0.15%, and $39.2 million for ZORYVE topical foam 0.3%. Year-over-year and quarter-over-quarter increases were due to increased unit demand. Gross-to-net (GTN) rates remain favorable for ZORYVE, driven by a high percentage of prescriptions being reimbursed. Cost of sales for the quarter ended June 30, 2025 were $7.5 million compared to $3.5 million for the corresponding period in 2024 due to increasing ZORYVE sales. Research and development (R&D) expenses for the quarter ended June 30, 2025 were $19.5 million compared to $19.3 million for the corresponding period in 2024. Expenses remained consistent year-over-year as decreased development costs for roflumilast in adult atopic dermatitis and plaque psoriasis were partially offset by an increase in development costs for pediatric atopic dermatitis and continued medical affairs investments to support medical education. Selling, general, and administrative (SG&A) expenses for the quarter ended June 30, 2025 were $69.2 million compared to $58.2 million for the corresponding period in 2024. The year-over-year increase was primarily driven by increased sales and marketing and personnel-related expenses due to our continued commercialization efforts for ZORYVE. Net loss was $15.9 million, or $0.13 per basic and diluted share, for the quarter ended June 30, 2025 compared to $52.3 million, or $0.42 per basic and diluted share, for the corresponding period in 2024. Cash, cash equivalents, restricted cash, and marketable securities were $191.1 million as of June 30, 2025, compared to $228.6 million as of December 31, 2024. Net cash provided by operating activities was $0.3 million during the second quarter as increased gross profit and timing changes in net working capital reduced cash used in operations. The company made the $10.0 million cash milestone payment to AstraZeneca for reaching a sales milestone of $250 million that was incurred in the first quarter of 2025, which is included as an investing activity. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. 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 invent differentiated therapies against biologically validated targets, and has produced a robust pipeline for inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. Forward Looking StatementsThis 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 to address large markets with significant unmet need; the development, approval, and potential commercialization of product candidates; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve 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 and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with 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:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

Clinical ResultDrug ApprovalPhase 3Phase 2Phase 1

26 Jun 2025

·investors.arcutis.com

Arcutis’ ZORYVE® (roflumilast) Cream 0.15% Receives Strong Recommendation in American Academy of Dermatology Updated Guidelines for Adult Atopic Dermatitis

The American Academy of Dermatology (AAD) provided evidence-based recommendation for the use of ZORYVE® (roflumilast) cream 0.15% in adults with mild to moderate atopic dermatitis (AD) Recommendation reflects ZORYVE’s proven efficacy, safety, and tolerability as a next-generation, steroid-free, topical phosphodiesterase-4 (PDE4) inhibitor Among newly evaluated branded topical therapies, ZORYVE is the only treatment with a strong recommendation for adults with mild to moderate atopic dermatitis in AAD’s focused guideline update ZORYVE is the first FDA-approved branded topical PDE4 inhibitor indicated for AD, plaque psoriasis, and seborrheic dermatitis AD impacts over 16 million adults in the United States WESTLAKE VILLAGE, Calif, June 26, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream 0.15% has received a strong recommendation in the focused guideline update for the management of adult AD from AAD. The recommendation highlights ZORYVE’s ability to deliver clinically meaningful improvements in pruritus and disease severity, its favorable tolerability profile, and low rates of treatment discontinuation, offering adults and pediatric patients 6 years of age and older with mild to moderate AD an effective, non-steroid option for daily disease management. “The AAD’s focused update highlights therapies that meet rigorous standards for efficacy, safety, and tolerability for adults living with AD,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “The inclusion of ZORYVE in these recommendations validates what healthcare professionals have already experienced with ZORYVE in their practice – a next-generation, steroid-free topical that delivers meaningful improvement for people with AD. It marks important progress in providing individuals with AD and their healthcare providers evidence-based choices that are suitable for all areas, including sensitive and hard-to-treat areas of the body.” The AAD’s strong recommendation helps guide clinicians and patients toward treatments that deliver clinically meaningful improvements in disease severity while being safe and well tolerated for long-term use. The focused update incorporates newly Food and Drug Administration (FDA)-approved topical and biologic therapies into existing guidelines to ensure that the dermatology community has access to the most current, evidence-based recommendations for managing this chronic condition. For more information on ZORYVE, including full prescribing information, please visit www.zoryve.com. About Atopic DermatitisAD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. AD is a chronic, relapsing, and genetically predisposed inflammatory skin disease that has unique clinical presentations across the lifespan. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. It presents differently in infants, children, and adults. About ZORYVE® (roflumilast) ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses — AD, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a next generation topical PDE4 inhibitor. PDE4, an established target in dermatology, is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. ZORYVE (roflumilast) cream 0.3% is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate AD in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. Recently, both ZORYVE cream 0.3% and ZORYVE foam 0.3% were awarded the National Psoriasis Foundation’s Seal of Recognition —the first FDA-approved product to receive the honor. Investigational ZORYVE (roflumilast) cream 0.05% for the topical treatment of mild to moderate AD in children 2 years to 5 years old is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025. INDICATIONS 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, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 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. 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 (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include 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 (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. 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 invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including AD and alopecia areata. 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 for ZORYVE cream 0.15% as a treatment for adult AD patients. 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 Relationsir@arcutis.com

Drug Approval

10 Jun 2025

·www.globenewswire.com

Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis

Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitisAtopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily over a four-week period. ZORYVE cream is a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor formulated for topical use. “AD is a lifelong chronic condition in children that can 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,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Despite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants, making new clinical research for tolerable and effective treatments that can be used over a lifetime and can reduce or replace steroids, critically important for this age group. Enrolling the first child in this study is a meaningful step forward and builds on our mission to address unmet needs in pediatric dermatology.” About INTEGUMENT-INFANTThis Phase 2, open-label, multicenter study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate AD involving at least 3% body surface area. The study’s primary objective is to evaluate the safety and tolerability of roflumilast cream 0.05% applied once daily over four weeks in this age group. This study builds on the successful results of the ARQ-151-105 (MUSE) study, which evaluated roflumilast cream 0.05% in infants aged 3 months to 24 months with AD. About Atopic DermatitisAD is a chronic, relapsing and genetically predisposed inflammatory skin disease that has unique clinical presentations across the lifespan. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. It presents differently in infants, children, and adults. AD, also known as eczema, is one of the most common chronic inflammatory skin conditions in infants and children, with approximately 9.6 million children diagnosed in the United States. Studies estimate that up to 60% of children with AD develop symptoms within their first year, often manifesting as red, scaly patches on the cheeks, chin, and scalp. About ZORYVE (roflumilast) ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses — atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a next generation topical PDE4 inhibitor. PDE4, an established target in dermatology, is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. ZORYVE® (roflumilast) cream 0.3% is approved by the Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. Investigational ZORYVE (roflumilast) cream 0.05% for the topical treatment of mild to moderate AD in children 2 years to 5 years old is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025. INDICATIONS 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, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 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. 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 (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include 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 (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. 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 invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. 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 for ZORYVE cream 0.05% as a treatment for AD in infants. 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. ContactsMedia Amanda Sheldon, Head of Corporate Communications media@arcutis.com Investors Latha Vairavan, Chief Financial Officerir@arcutis.com

Clinical ResultPhase 2Drug Approval

100 Deals associated with Roflumilast

External Link

KEGG	Wiki	ATC	Drug Bank
D05744	Roflumilast	R03DX07	DB01656

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	United States	Arcutis Biotherapeutics, Inc.	10 Jul 2024
Dermatitis, Seborrheic	United States	Arcutis Biotherapeutics, Inc.	15 Dec 2023
Plaque psoriasis	Canada	Arcutis Biotherapeutics, Inc.	20 Dec 2019
Pulmonary Disease, Chronic Obstructive	European Union	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Iceland	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Liechtenstein	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Norway	AstraZeneca AB	05 Jul 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	21 Nov 2024
Mild Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	21 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Psoriasis of scalp	Phase 3	United States	Arcutis Biotherapeutics, Inc.	24 Aug 2021
Psoriasis of scalp	Phase 3	Canada	Arcutis Biotherapeutics, Inc.	24 Aug 2021
Chronic large plaque psoriasis	Phase 3	United States	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Chronic large plaque psoriasis	Phase 3	Canada	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Chronic large plaque psoriasis	Phase 3	Dominican Republic	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Asthma	Phase 3	United States	AstraZeneca PLC	01 Nov 2003

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06631170 (NEWS) Manual	Phase 3	Dermatitis, Atopic	354	0.15%罗氟司特	rbaeqnbtky(vbcijemxlm) = kthfeblylx ghwtzgdpak (crwccnkite ) Met View more	Positive	30 Jul 2025
				赋形剂	rbaeqnbtky(vbcijemxlm) = kfkniwbpqn ghwtzgdpak (crwccnkite ) Met View more
NCT05028582 (ARRECTOR, CTgov)	Phase 3	Psoriasis of scalp	432	Roflumilast Foam 0.3% (Roflumilast Foam 0.3%)	iimlibytmq = zirjmuvgko flwryrgfmv (mnvmcthykz, smckkzohxa - dxxaakwgzw) View more	-	17 Jul 2025
				Vehicle Foam (Vehicle Foam)	iimlibytmq = mpifgdwrft flwryrgfmv (mnvmcthykz, homtizagmh - trpukqqhfm) View more
NCT05028582 (ARRECTOR, AAD2025) Manual	Phase 3	Psoriasis	432	roflumilast foam 0.3%	ewrwquqrfk(fzruqkqbog) = tdrkmhjbly ckofcujjkp (aswtlgnwqb ) View more	Positive	07 Mar 2025
				vehicle	ewrwquqrfk(fzruqkqbog) = efzfwqnxmd ckofcujjkp (aswtlgnwqb ) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-2, AAD2025 \| Company_Website) Manual	Phase 3	Dermatitis, Atopic	1,337	Roflumilast cream 0.15%	nffrdevgfs(nkmuluujbf) = uurobwguop bvobfksclp (vsdjvrufoo ) View more	Positive	07 Mar 2025
				Vehicle cream	nffrdevgfs(nkmuluujbf) = vsyepzksyp bvobfksclp (vsdjvrufoo ) View more
NCT04845620 (INTEGUMENT-PED, Company_Website) Manual	Phase 3	Dermatitis, Atopic	652	0.05% ZORYVE	rzvfnksysv(ewrwvmlsqg) = unwahhggrf braqqgogdo (zkdxmsqywv ) View more	Positive	24 Feb 2025
				vehicle-controlled	rzvfnksysv(ewrwvmlsqg) = jprbrveggv braqqgogdo (zkdxmsqywv ) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-2, ACAAI2024 \| GlobeNewswire) Manual	Phase 3	Dermatitis, Atopic	-	Roflumilast cream 0.15%	snhfalusyu(tplshnxdge) = abrncmhwoj rzdextpwxm (uqctvmhdpf ) View more	Positive	24 Oct 2024
				Vehicle	snhfalusyu(tplshnxdge) = yneakqafre rzdextpwxm (uqctvmhdpf ) View more
NCT04773587 (INTEGUMENT-I \| INTEGUMENT-1 \| INTEGUMENT-1, CTgov)	Phase 3	Dermatitis, Atopic	654	Roflumilast Cream 0.15% (Roflumilast Cream 0.15%)	skcmkzrueh = ttgrsmkyxa loeokzljou (amyduleyjx, ahwzpcjtzq - bgvhgqudnc) View more	-	09 Oct 2024
				Vehicle Cream (Vehicle Cream)	skcmkzrueh = gfiqkcfiuv loeokzljou (amyduleyjx, mlmzsxdace - iqoddgnanp) View more
NCT04773600 (INTEGUMENT-II \| INTEGUMENT-2, CTgov)	Phase 3	Dermatitis, Atopic	683	Roflumilast Cream (Roflumilast Cream 0.15%)	wdnyqbuuxh = oqhlgfuays tctksjhdvn (jbwsmivscd, kbunonlelx - ypuriuwcyr) View more	-	04 Oct 2024
				Vehicle cream (Vehicle Cream)	wdnyqbuuxh = qtmnxmqcfn tctksjhdvn (jbwsmivscd, qpoumlfitq - tslaumrgeq) View more
NCT04773587 \| NCT04773600 (Literature) Manual	Phase 3	Dermatitis, Atopic	1,337	Roflumilast cream, 0.15% (INTEGUMENT-1)	ufnxjtjxyt(vekdlqqmat) = omjzkprvus itvrczhcrl (qerciekjsg ) View more	Positive	18 Sep 2024
				Vehicle cream (INTEGUMENT-1)	ufnxjtjxyt(vekdlqqmat) = ksdinhxyeq itvrczhcrl (qerciekjsg ) View more
NCT04445987 (phase 2, CTgov)	Phase 2	Dermatitis, Seborrheic	408	ARQ-154-203 Roflumilast Foam (Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap)	odxfehaqed = dxidpiwwgb zmerduugbj (qdzawkngsg, rwaxzokvjq - zffuourbir) View more	-	11 Jun 2024
				ARQ-154-203 Roflumilast Foam (Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap)	odxfehaqed = dltfmpizxi zmerduugbj (qdzawkngsg, nmwnadudtm - olqfygoeth)

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