Zoryve (roflumilast cream) / Arcutis, Huadong Medicine, Sato Pharma - LARVOL DELTA

The treatment of bullous pemphigoid with topical roflumilast 0.3% cream case study. (PubMed, JAAD Case Rep) - No abstract available

Journal • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology

Efficacy and Safety of Roflumilast Cream 0.3% in Chinese Adult and Pediatric Patients with Plaque Psoriasis: Results From a Phase 3 Trial (AAD 2026) - "Once-daily roflumilast cream 0.3% was effective and well tolerated in Chinese patients aged ≥6 years with plaque psoriasis with no new safety signals, extending the favourable benefit–risk profile observed in previous phase 3 trials."

Clinical • P3 data • Dermatology • Immunology • Pediatrics • Psoriasis

Roflumilast Cream 0.15% for Mild-to-Moderate Atopic Dermatitis: A Multicenter, Vehicle-Controlled Phase?3 Bridging Study in China (AAD 2026) - P3 | "Roflumilast cream 0.15% demonstrated rapid and robust efficacy and a favourable safety profile in Chinese patients, consistent with results from previous studies."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

INTEGUMENT-INFANT: Once-Daily Roflumilast Cream 0.05% in Infants Aged 3–<24 Months With Atopic Dermatitis (AAD 2026) - No abstract available

Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% Provides Improvements in Caregiver-Reported Outcomes That are Maintained Long Term: Results for Patients Aged 2–5 years With Mild-to-Moderate Atopic Dermatitis in the INTEGUMENT-OLE Trial (AAD 2026) - P3 | "Mean improvements were observed across individual component scores, including those assessing sleep loss (SCORAD=2.9; POEM=1.4; CDLQI=0.9; IDQoL=0.7; DFI=0.9) and pruritus (SCORAD=4.2; POEM=1.9; CDLQI=1.1; IDQoL=1.1). Roflumilast cream 0.05% provided clinically meaningful improvements in signs/symptoms of AD and disease severity that were maintained/continued to improve over 52 weeks, and improved the quality of life, including pruritus in children aged 2–5 years and sleep loss for these children and their families."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Roflumilast Cream 0.3% and Foam 0.3% Provide Improvement Across Psoriasis Area and Severity Index Body Regions and Clinical Signs for Patients With Plaque Psoriasis (AAD 2026) - "Improvements were reflected in component scores for desquamation, erythema, and infiltration, across regions. Roflumilast cream 0.3% and foam 0.3% (versus vehicle) each improved signs/symptoms and severity of psoriasis across body regions."

Clinical • Dermatology • Immunology • Psoriasis

Arcutis to Present New Clinical Data in a Late-Breaking Podium Presentation and Scientific Posters at the 2026 American Academy of Dermatology Annual Meeting (Arcutis Press Release) - "In an AAD late-breaking podium presentation, the Company will share new efficacy, safety, and tolerability results from its INTEGUMENT-INFANT Phase 2 trial...In addition, a five-minute poster presentation will highlight long-term caregiver-reported outcomes from its INTEGUMENT-OLE Phase 3 trial of ZORYVE cream 0.05% in children aged 2 to 5 years with mild to moderate atopic dermatitis. Additional results will be presented in two e-posters from a STRATUM Phase 3 trial subgroup analysis in individuals with seborrheic dermatitis with face and scalp involvement, and Psoriasis Area and Severity Index (PASI) outcomes from the Phase 3 DERMIS-1/2 and ARRECTOR trials in individuals with plaque psoriasis."

Clinical data • Atopic Dermatitis • Psoriasis • Seborrheic Dermatitis

Topical PDE4 Inhibition with Roflumilast Cream for Rapid Symptomatic Control of Urticaria (AAAAI 2026) - "Patients undergoing treatment for urticaria experience flares despite standard systemic therapies, identifying an unmet need for rapid, targeted therapies. We trialed topical roflumilast cream, a potent phosphodiesterase-4 (PDE4) inhibitor, for symptomatic control of urticaria, given its specificity for PDE4 in mast cells and favorable vehicle."

Dermatology • Immunology • Urticaria

Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology (Arcutis Press Release) - "During the 52-week OLE study, all participants (n=562) initially applied ZORYVE cream 0.05% once daily as a monotherapy to all areas of the body impacted by atopic dermatitis, excluding the scalp. Per study protocol, children who achieved clear skin, or a Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) = 0 at or after Week 4, were transitioned to a proactive twice-weekly (BIW) regimen, and the efficacy results reported in this publication include data from both once-daily and BIW participants...The primary endpoint of the OLE study was safety. Treatment-Emergent Adverse Events (TEAEs) were reported for 280 (49.8%) participants, and most events were mild (n=139; 24.7%) or moderate (n=125; 22.2%). "

P3 data • Atopic Dermatitis

Drugs for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-Term Safety and Efficacy of Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% for Mild-to-Moderate Atopic Dermatitis in Children Aged 2-5 Years From a 52-Week, Phase 3 Trial (INTEGUMENT-OLE). (PubMed, Pediatr Dermatol) - P3 | "Roflumilast cream 0.05% demonstrated a favorable long-term safety profile and durable efficacy for up to 56 weeks of treatment in children aged 2-5 years with AD, and "disease control" was maintained with BIW application. These results are consistent with previous studies, including patients aged ≥ 6 years from INTEGUMENT-OLE."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain • Pruritus

COMPARING 1.5% RUXOLITINIB CREAM AND OTHER THERAPIES FOR PEDIATRIC PATIENTS WITH ATOPIC DERMATITIS: A SYSTEMATIC LITERATURE REVIEW AND NETWORK META-ANALYSIS (ISPOR 2026) - "For each outcome, all treatments for which outcome data were reported, apart from dupilumab + TCS, could be connected in a network to 1.5% ruxolitinib cream through a common comparator (vehicle). Results of NMAs indicate 1.5% ruxolitinib cream offers similar or better disease control than that of available topical therapies for pediatric AD based on IGA-TS, EASI-75, and Itch NRS4 and similar safety in terms of TEAEs."

Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

Improvement in Atopic Dermatitis Signs and Symptoms With Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.15% or 0.05%: Results From the 52-Week Phase 3 INTEGUMENT-OLE Trial in Patients Aged ≥2 Years (AAAAI 2026) - P3 | "Treatment-related adverse events were reported for 4.7% and 2.5% of patients from INTEGUMENT-1/2 and INTEGUMENT-PED, respectively, and application-site pain adverse events for <1% of patients overall. Conclusions Roflumilast cream was well tolerated and provided long-term decreases in AD signs/symptoms for patients aged ≥2 years, supporting the use of roflumilast cream for long-term AD control, including proactive BIW application, without topical corticosteroids."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Roflumilast Cream Provides Long-Term Improvements in Atopic Dermatitis: Subgroup Analysis of Patients With Other Atopic Conditions (AAAAI 2026) - P3 | "Outcomes were consistent among subgroups of patients with 0, 1, or ≥2 additional atopic conditions. Conclusions Roflumilast cream improved AD signs/symptoms in subgroups of patients with other atopic conditions providing an opportunity to reduce overall corticosteroid burden."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Ophthalmology • Respiratory Diseases

Comparison chart: Topical nonsteroidal drugs for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Safety and Efficacy of Roflumilast Foam in HS (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Beth Israel Deaconess Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

Arcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis (GlobeNewswire) - "58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4. Investigational ZORYVE cream 0.05% was well tolerated and demonstrated a safety profile consistent with previous studies, with no new safety signals identified through 4 weeks of treatment....The Company plans to submit a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for this age group in Q2 2026."

FDA filing • P2 data • Atopic Dermatitis

Arcutis Biotherapeutics, Inc. Announces Termination of Promotion Agreement with Kowa (GlobeNewswire) - "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....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."

Commercial • Atopic Dermatitis • Psoriasis • Seborrheic Dermatitis

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. (The Manila Times) - "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."

Sales projection • Atopic Dermatitis • Psoriasis • Seborrheic Dermatitis

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=101 | Completed | Sponsor: Arcutis Biotherapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: Jun 2026 ➔ Dec 2025

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Safety and Efficacy of Roflumilast Foam in HS (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Beth Israel Deaconess Medical Center

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Arcutis Completes Enrollment in INTEGUMENT-INFANT Phase 2 Study Evaluating ZORYVE (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis (GlobeNewswire) - "The INTEGUMENT-INFANT Phase 2, open-label, multicenter study is evaluating the safety and tolerability of ZORYVE cream 0.05% applied once daily over a four-week period in 101 infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis....Topline results from the study are expected to be reported in Q1 2026."

Enrollment closed • P2 data • Atopic Dermatitis

Announcement Regarding the Receipt of Drug Registration Acceptance Notice by a Wholly-Owned Subsidiary [Google translation] (Huadong Medicine Press Release) - "On November 10, 2025, Hangzhou Sino-American East China Pharmaceutical Co., Ltd...a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as 'the Company'), received an Acceptance Notice (Acceptance No.: JXHS2500126) issued by the National Medical Products Administration (NMPA) for the acceptance of its marketing authorization application for Roflumilast Cream (ZORYVE) 0.15%...Results from a Phase III clinical trial in China showed that roflumilast cream (ZORYVE) 0.15% demonstrated positive efficacy and good safety in subjects aged 6 years and older with mild to moderate atopic dermatitis, meeting the primary endpoint of the study. The overall efficacy and safety data were similar to those from overseas studies conducted by the collaborating company Arcutis, supporting its application for marketing approval in China."

China filing • Atopic Dermatitis

Roflumilast Cream 0.15% Provides Improvement Across Eczema Area and Severity Index Body Regions and Clinical Signs in Patients Aged ≥6 Years with Mild-to-Moderate Atopic Dermatitis (ISDS 2025) - P3 | "Roflumilast cream 0.15% improved the clinical signs of AD, reducing EASI total and component scores more than vehicle cream throughout the INTEGUMENT-1/2 studies. These results support that roflumilast provides rapid and consistent benefit across body regions affected by AD."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Improvement in Atopic Dermatitis Signs and Symptoms With Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.15% or 0.05%: the 52-Week Phase 3 INTEGUMENT-OLE Trial in ≥2-year-olds (ISDS 2025) - P3 | "Among patients who achieved clear skin, proactive BIW application maintained 'disease control' for >200 days. Roflumilast cream was well tolerated and is an appropriate alternative to traditional topical AD treatments."

P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology