This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of California, San Francisco

NCT07340216

/ RecruitingPhase 1

An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis

This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.

Start Date15 Dec 2025

Sponsor / Collaborator

Arcutis Biotherapeutics, Inc.

100 Clinical Results associated with Roflumilast

100 Translational Medicine associated with Roflumilast

100 Patents (Medical) associated with Roflumilast

1,049

Literatures (Medical) associated with Roflumilast

01 Apr 2026·Actas Dermo-Sifiliograficas

Oral Roflumilast for Long-term Management of Behçet Spectrum Disorders: A Multicenter Observational Analysis

Article

Author: Zaragoza Ninet, V ; González García, Á ; Blaya Imbernon, D ; Bagan, J ; Peñuelas Leal, R ; Bagan, L ; Pérez Pastor, G ; Finello, M ; Perez Zafrilla, E ; Grau Echevarría, A ; Linares Barrios, M ; Marti Cabrera, M ; Alegre De Miquel, V ; García Fernández, L ; Peñuelas Ruiz, J A ; Diez Recio, E ; Labrandero Hoyos, C

BACKGROUND:

Recurrent aphthous stomatitis (RAS) and Behçet's disease (BD) are part of the Behçet spectrum disorders (BSD), sharing genetic traits and characterized by recurrent ulcers. No systemic treatment is approved for RAS or incomplete BD, despite significant quality-of-life impacts.

OBJECTIVE:

To evaluate the efficacy of roflumilast, a PDE4 inhibitor, in BSD patients and compare responses between RAS and BD.

METHODS:

This analytical observational study included a total of 33 patients with BSD (22, RAS; 11, BD) from 5 Spanish centers, followed over 52 weeks. Data were collected retrospectively and prospectively, assessing flare-ups, ulcers, pain, and duration. Statistical models compared outcomes across treatment periods.

RESULTS:

Roflumilast significantly reduced all studied response variables, with no loss of long-term efficacy. Differences between RAS and BD were minimal and clinically irrelevant. Adverse events occurred in 63% of patients, mostly mild and self-limiting, with tolerability improved through dose adjustments. Two patients (6.25%) dropped out due to adverse events.

CONCLUSION:

Roflumilast is effective for managing BSD, offering a safe option to address unmet needs in RAS and BD. Its favorable safety profile and long-term efficacy support its use in the routine clinical practice.

01 Feb 2026·ANNALS OF PHARMACOTHERAPY

Roflumilast and the Changing Landscape of Seborrheic Dermatitis Treatment

Review

Author: Xie, Joy ; Dhillon, Jimmy ; Tchack, Madeline ; Rao, Babar K. ; Mahajan, Aryan

Objective::

This article reviews clinical trial data that assess the safety, efficacy, and clinical application of roflumilast, a phosphodiesterase-4 inhibitor, for the treatment of seborrheic dermatitis.

Data Sources::

A review of the literature was conducted in MEDLINE (Pubmed) and Clinicaltrials.gov from January 1, 1950 to April 13, 2025 using the search terms: “Roflumilast” and “seborrheic dermatitis.”

Study selection and data extraction::

Relevant articles in English relating to the safety, efficacy, pharmacodynamics, and pharmacokinetics were included.

Data Synthesis::

In one phase IIa clinical trial, 73.8% of patients treated with roflumilast achieved Investigator Global Assessment (IGA) success, compared with 40.9% in the vehicle group at 8 weeks ( P < 0.001). A phase III trial found 79.5% of patients in the roflumilast group achieved IGA success at week 8, compared with 58.0% in the vehicle group ( P < 0.001). Furthermore, there were statistically significant reductions in erythema, scaling, and itch severity in the roflumilast group. Roflumilast was well tolerated, with adverse events comparable with vehicle foam.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

Roflumilast is the first phosphodiesterase-4 inhibitor approved by the Food and Drug Administration for the treatment of seborrheic dermatitis. Based on 2 clinical trials, roflumilast has a positive safety profile, is efficacious, and is easy to apply, highlighting its utility in treating seborrheic dermatitis.

Conclusion::

Roflumilast is effective in treating seborrheic dermatitis. Future trials should compare its safety and efficacy with other drugs.

01 Feb 2026·RESPIRATORY MEDICINE

Beyond corticosteroids: A systematic review and meta-analysis of novel therapies for hypersensitivity pneumonitis

Article

Author: Gabr, Rana Kamal El Said ; Ahmed Abd Elaleem, Fatma Elzahraa ; Nabeh, Omnia Azmy ; Elkholy, Emad ; Elkorashy, Reem Ibrahim ; Lewandowska, Katarzyna B ; Elmorsy, Soha Aly ; Akl, Yosri ; Ahmed Mohamed Hassan, Mennatullah Abdelhaleem ; Soliman, Youssef Mohamed Amin

INTRODUCTION:

Hypersensitivity pneumonitis (HP) is a complex immune-mediated interstitial lung disease triggered by inhaled antigens. While corticosteroids remain the mainstay of therapy, their benefit is limited in fibrotic HP. Several novel agents-including pirfenidone, nintedanib, rituximab, azathioprine, mycophenolate mofetil (MMF), leflunomide, and roflumilast-have been investigated as alternatives.

METHODS:

This meta-analysis followed PRISMA guidelines and was registered on PROSPERO (CRD42023428070). Eligible studies included clinical and non-clinical trials assessing both traditional and novel therapies in HP. Primary outcomes were mean difference from baseline (MDB) and percentage change from baseline (PCB) in forced vital capacity (FVC%) and diffusing capacity for carbon monoxide (DLCO%). Meta-analyses were performed using fixed- and random-effects models, with heterogeneity assessed via I². Sensitivity analyses and publication bias assessments were also conducted. Risk of bias was evaluated using CASP and RoB-2 tools.

RESULTS:

Twenty-three studies comprising 975 patients (aged 39.3-83 years) were included. Rituximab, azathioprine, MMF, and corticosteroids showed non-significant pooled MDBs in FVC%, with MDB of -0.87 %, 2.49 %,1.96 %, and 2.03 %, respectively. For DLCO%, rituximab and MMF showed positive effects, with a MDB of 6.69 and 5.98, respectively, while azathioprine had minimal impact. Single-study analyses suggested that pirfenidone and nintedanib may stabilize lung function; their combination improved DLCO% but not FVC%. Leflunomide and roflumilast demonstrated promising effects in single reports.

CONCLUSION:

Due to heterogeneity and limited high-quality evidence, definitive conclusions about novel therapies in HP remain elusive. However, rituximab and MMF showed promising results. Long-term randomized trials with standardized endpoints are needed to guide therapeutic decisions.

211

News (Medical) associated with Roflumilast

26 Jan 2026

·investors.arcutis.com

Arcutis Biotherapeutics, Inc. Announces Termination of Promotion Agreement with Kowa

WESTLAKE VILLAGE, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that on January 23, 2026, the Company and Kowa Pharmaceuticals America, Inc. mutually agreed to terminate their promotion agreement. The agreement covered sales and promotion of ZORYVE® (roflumilast) by Kowa to primary care physicians and pediatricians in the United States. Following the termination, Arcutis plans to assume responsibility for sales and promotion of ZORYVE in the pediatric and primary care settings. The Company is finalizing its plans for promotion to these clinicians and will provide further updates during the Q4 earnings call on February 25, 2026. This initiative is distinct from and in addition to the targeted expansion of the Company’s dermatology salesforce, which will remain focused on serving dermatology clinicians and growing prescriptions of ZORYVE in dermatology practices. “Our promotion agreement with Kowa has laid important groundwork for the promotion of ZORYVE in the primary care and pediatric markets,” said Frank Watanabe, president and CEO of Arcutis. “As a once-daily topical that can be used anywhere on the body and for any duration, ZORYVE has the potential to simplify disease management across three major inflammatory skin diseases. In 2026, we are well-positioned to drive adoption and growth of ZORYVE in the primary care market through incremental investments that we will scale over time, while maximizing the growth of ZORYVE in dermatology.” Under the terms of the Termination Agreement, Kowa will cease all sales and promotions of ZORYVE and Arcutis will not be required to make any further payments. The Company expects to remain cash flow break even and does not expect this change to negatively affect 2026 net product sales guidance. INDICATIONSZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. 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, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 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. 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 0.05% 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%). 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 0.3% 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%). ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use. 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 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 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 Arcutis’ plans to promote ZORYVE and further penetrate the primary care and pediatric segments, as well as expectations regarding the adoption, growth, and commercial success of ZORYVE. 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:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

Drug Approval

12 Jan 2026

·investors.arcutis.com

Arcutis Highlights 2026 Strategic Priorities and Anticipated Milestones

Continued strong growth of ZORYVE® (roflumilast) in 2026 with full-year net product sales guidance of $455–$470 million Advancement of ZORYVE indication-expansion strategy beginning with ongoing Phase 2 proof-of-concept trials in vitiligo and hidradenitis suppurativa Initiation of clinical development program for ARQ-234 in atopic dermatitis Transition to positive cash flows enables investment to both accelerate growth of ZORYVE franchise and advance pipeline WESTLAKE VILLAGE, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, today announced its strategic priorities for 2026. “2025 was a transformative year as we solidified ZORYVE’s position as an advanced targeted topical with the potential to redefine the standard of care for chronic inflammatory skin diseases,” said Frank Watanabe, president and chief executive officer of Arcutis. “In 2026, we will build on this momentum by driving ZORYVE growth across approved indications and investing in our commercial capabilities to accelerate the conversion from topical corticosteroids. At the same time, we will advance our innovative pipeline, including ZORYVE life cycle initiatives and ARQ-234, our biologic for atopic dermatitis. With strong operating leverage, we are well positioned to pursue new opportunities and reinforce our leadership in medical dermatology drug development and commercialization.” 2026 Strategic Priorities Grow our core ZORYVE business as we establish ZORYVE as the foundational therapy for adults and children who need long-term therapeutic solutions for managing their plaque psoriasis, seborrheic dermatitis, and atopic dermatitis. Sustainable momentum of ZORYVE franchise with 2026 net product sales expected in the $455–$470 million range. Targeted ~20% expansion of dermatology sales force to optimize prescriber targeting and call frequency, deepening adoption of ZORYVE. Continued label expansion efforts to progress ZORYVE for the treatment of pediatric patients: Expect to announce topline results from INTEGUMENT-INFANT Phase 2 study of ZORYVE cream 0.05% in infants age 3 months to less than 24 months in the first quarter of 2026 and submission of a supplemental New Drug Application (sNDA) in the third quarter of 2026. U.S. Food and Drug Administration (FDA) review ongoing of sNDA for ZORYVE cream 0.3% for the treatment of plaque psoriasis in children ages 2-5; Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026. Expect to announce topline results from INTEGUMENT-INFANT Phase 2 study of ZORYVE cream 0.05% in infants age 3 months to less than 24 months in the first quarter of 2026 and submission of a supplemental New Drug Application (sNDA) in the third quarter of 2026. U.S. Food and Drug Administration (FDA) review ongoing of sNDA for ZORYVE cream 0.3% for the treatment of plaque psoriasis in children ages 2-5; Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026. Expand the ZORYVE franchise into additional indications through strategic life cycle management beginning with proof-of-concept studies in vitiligo and hidradenitis suppurativa. Expect to report decision on program advancement for investigational ZORYVE foam 0.3% for the treatment of vitiligo in the fourth quarter of 2026. Expect to report decision on program advancement for investigational ZORYVE foam 0.3% for the treatment of hidradenitis suppurativa in the first quarter of 2027. Build our pipeline by advancing innovative medicines for patients, leveraging industry-leading clinical development and commercialization capabilities that we have developed at Arcutis. Begin enrolling patients in the Phase 1 study of ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor, being developed as a potential biologic treatment for atopic dermatitis, in the first quarter of 2026. 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. INDICATIONSZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. 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, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 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. 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 0.05% 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%). 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 0.3% 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%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.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. Such forward-looking statements include, but are not limited to, statements regarding the potential results of clinical trials and associated timelines, and statements regarding forward-looking financial results. These statements are based on the Company’s current beliefs and expectations and 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. ContactsMediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

Phase 2Clinical ResultPhase 1Phase 3Drug Approval

08 Dec 2025

·investors.arcutis.com

Arcutis Strengthens Board of Directors with New Appointment of Amit Munshi and Honors Retirement of Bhaskar Chaudhuri

WESTLAKE VILLAGE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Amit Munshi has been appointed to the Arcutis Board of Directors effective December 4, 2025, and announced the retirement of founder and long-serving Board member Bhaskar Chaudhuri, PhD. Dr. Chaudhuri will continue as a consultant for the Company. “As Arcutis looks to continue to grow in this next chapter, we are delighted to welcome Amit, an exceptional and visionary biopharmaceutical leader, to the Arcutis Board,” said Frank Watanabe, president and chief executive officer of Arcutis. “Amit’s deep expertise in financing, portfolio optimization, and strategic corporate transactions—combined with his experience advising diverse biotech companies and leading investment firms—will be invaluable for Arcutis as we broaden commercialization of ZORYVE® (roflumilast), advance our expanding pipeline, and reinforce our leadership in medical dermatology.” “As one of the founders of Arcutis, our former chairman, and member of the board for nine years, Bhaskar has been instrumental in the successful development of ZORYVE—now the number one prescribed branded topical across three indications—and the growth of Arcutis from the first Series A financing to a now multibillion-dollar market cap company,” said Keith R. Leonard, chairman of the Board of Arcutis. “We are deeply grateful and thank him for his vision, dedication, and significant contributions in shaping what Arcutis is today.” “Arcutis is entering a significant phase of growth, evolving its commercial presence and progress, and building an innovative pipeline that addresses real unmet needs,” said Amit Munshi. “I’m honored to join the Board and contribute my experience to support the Company as it strengthens its foundation, extends its impact, and brings forward meaningful solutions for people with chronic skin conditions.” Amit Munshi is a proven biopharmaceutical leader with a track record of transforming companies and driving multibillion-dollar outcomes. Most recently, as president and CEO of Orna Therapeutics LLC, he spearheaded the merger of Orna and ReNAgade Therapeutics LLC, as well as its Series A financing and operational build-out. Previously, as CEO of Arena Pharmaceuticals, Inc., he led a dramatic turnaround, which included revamping the Company’s strategy and raising over $900M in equity and $800M in partnerships, and culminated in Pfizer’s $6.7B acquisition, in addition to progressing four therapeutics in 11 indications with 37 trials at 600+ clinical sites around the world. Munshi serves on multiple boards, advises leading investment firms and has also held leadership roles at EPIRUS Biopharmaceuticals, Inc., Percivia LLC, Kythera Biopharmaceuticals, Inc. and Amgen Inc., where he drove global launches, optimized product portfolios, and led strategic transactions. He holds an MBA from Claremont Graduate University and dual degrees from The University of California, Riverside. About ArcutisArcutis 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. INDICATIONSZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. 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, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 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. 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 0.05% 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%). 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 0.3% 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%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. 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 Company’s financial position and potential growth. 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:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9ecc2657-94a4-424c-9221-6ec36bbd15ca

Executive ChangeAcquisitionDrug 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.

to view more data

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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Mild Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	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

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04845620 (INTEGUMENT-PED, CTgov)	Phase 3	Dermatitis, Atopic	652	Roflumilast Cream 0.05% (Roflumilast Cream 0.05%)	qmldjijxci = mhovwpslat rbomvuywtc (sqpbyzxvqv, avxsxnijtf - gghqejysmm) View more	-	23 Dec 2025
				Vehicle Cream (Vehicle Cream)	qmldjijxci = uepdkautte rbomvuywtc (sqpbyzxvqv, liokcrlvqb - ovudwirrra) View more
NCT04804605 (INTEGUMENT-OLE, CTgov)	Phase 3	Dermatitis, Atopic	1,220	roflumilast cream (ARQ-151-311/312: RC/RC 0.15% Group)	emlkrgfgxy = ckdwctumfr tzipfhzqxm (xpsbipgwib, kzchlqsivo - gnfksvrcce) View more	-	23 Dec 2025
				roflumilast (ARQ-151-311/312: VC/RC 0.15% Group)	emlkrgfgxy = rruacssxmf tzipfhzqxm (xpsbipgwib, pmzwamujji - vrkowzldfe) View more
NCT04211363 \| NCT04211389 (DERMIS-1, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Plaque psoriasis	398	Roflumilast cream 0.3%	ayxvbnhksl(duzeyhurac) = yrnlltoors jjohtenujs (wmvyxovowl ) View more	Positive	24 Oct 2025
				Vehicle	ayxvbnhksl(duzeyhurac) = ivbjplxevl jjohtenujs (wmvyxovowl ) View more
NCT04211363 \| NCT04211389 \| NCT05028582 (ARRECTOR, Company_Website) Manual	Phase 3	Plaque psoriasis	-	ZORYVE cream 0.3%	ppxkkafgjc(hmmbwmrcbb) = Data from the Phase 3 DERMIS-1/2 and ARRECTOR trials demonstrated that, at Week 8, ZORYVE cream 0.3% and ZORYVE foam 0.3% both improved signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement. Improvements in subgroups with facial and/or genital involvement were comparable with those in the overall population and consistent between the cream and foam formulations. drlgzhlzhr (srwaywjrtd ) View more	Positive	17 Sep 2025
				ZORYVE foam 0.3%
NCT04845620 (INTEGUMENT-PED, Company_Website) Manual	Phase 3	Dermatitis, Atopic	-	ZORYVE cream 0.05%	fabzmqkjpl(flieigqwnc) = Children who received a once-daily application of ZORYVE cream 0.05% had greater improvements versus vehicle across various PROs assessing signs and symptoms of atopic dermatitis after 4 weeks. Improvements were observed in SCORing Atopic Dermatitis (SCORAD) total and component scores (i.e., itch, sleep loss, and dryness intensity). pwhrijract (zedyjrfsin ) View more	Positive	17 Sep 2025
				Vehicle
NCT04973228 (STRATUM, Company_Website) Manual	Phase 3	Dermatitis, Seborrheic	-	ZORYVE foam 0.3%	wpplbwldpp(nparuwgiwx) = qrozxkcyxw aswcvslvbu (yzwvvoqnpd ) View more	Positive	17 Sep 2025
				Vehicle	wpplbwldpp(nparuwgiwx) = yzjlhmgfdy aswcvslvbu (yzwvvoqnpd ) View more
NCT06631170 (NEWS) Manual	Phase 3	Moderate Atopic Dermatitis \| Dermatitis, Atopic	354	0.15%罗氟司特	psbyqdpwpn(lqndxakbld) = uxgxuipnaj fmjfratjzj (ttmnpvzkjp ) Met View more	Positive	30 Jul 2025
				赋形剂	psbyqdpwpn(lqndxakbld) = frqajgxjgx fmjfratjzj (ttmnpvzkjp ) Met View more
NCT05028582 (ARRECTOR, CTgov)	Phase 3	Psoriasis of scalp	432	Roflumilast Foam 0.3% (Roflumilast Foam 0.3%)	gertcomgpm = hyxnwmbypx qvzaekzdeu (yweifdreun, tnsvepglaa - bakpbkgepi) View more	-	17 Jul 2025
				Vehicle Foam (Vehicle Foam)	gertcomgpm = jcncdmyopv qvzaekzdeu (yweifdreun, ugxtbpnxsi - ozuobvhkfb) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-2, AAD2025 \| Company_Website) Manual	Phase 3	Dermatitis, Atopic	1,337	Roflumilast creamRoflumilast cream 0.15%	nslllxarch(gwjphumzuq) = skokkeyasg basnisswsn (mshjaehjsu ) View more	Positive	07 Mar 2025
				Vehicle cream	nslllxarch(gwjphumzuq) = zybhbcqcak basnisswsn (mshjaehjsu ) View more
NCT05028582 (ARRECTOR, AAD2025) Manual	Phase 3	Psoriasis	432	roflumilast foam 0.3%roflumilast foam 0.3%	axjhckgrst(qkhdxhjbif) = bquntsxcqw bpypjskzvs (rvexjrfoed ) View more	Positive	07 Mar 2025
				vehicle	axjhckgrst(qkhdxhjbif) = edbxvcnqoj bpypjskzvs (rvexjrfoed ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis