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

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

FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5 (GlobeNewswire) - "The FDA has set a PDUFA target action date of June 29, 2026, for this application....This sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range."

FDA filing • PDUFA • Psoriasis

Long-term Roflumilast Cream 0.05% for Atopic Dermatitis in Patients Aged 2-5 Years (INTEGUMENT-OLE): Patient-reported Outcomes (ACAAI 2025) - P3 | "IDQOL and DFI also improved, by means of 7.1 and 6.5 points, respectively. Conclusion Use of roflumilast cream 0.05% for up to 56 weeks provided sustained, meaningful improvements in PROs for 2-5-year-olds (at baseline) with AD."

Clinical • Patient reported outcomes • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term Roflumilast Cream 0.15% for Atopic Dermatitis in Patients Aged 6+ Years (INTEGUMENT-OLE): Patient-reported Outcomes (ACAAI 2025) - P3 | "DFI scores improved by a mean of 3.4 points. Conclusion Meaningful improvements in patient-reported AD signs/symptoms (including itch), patient QoL, and family impact were maintained/continued to improve with roflumilast cream 0.15% for up to 56 weeks in ≥6-year-olds with AD."

Clinical • Patient reported outcomes • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Roflumilast Cream 0.15% and 0.05% Effects on Sleep in Patients with Atopic Dermatitis (Arcutis Press Release) - "ZORYVE cream reduced the impact of atopic dermatitis on sleep loss/disturbance for study participants and families as compared to vehicle across multiple patient-reported outcome measurements. In addition, the reduced impact of atopic dermatitis on sleep for individuals with atopic dermatitis (and their family, in patients aged ≤17 years) was similar among the ≥6-year and 2–5-year-old age groups...Improvements from baseline were greater with ZORYVE cream versus vehicle throughout the trials including at Week 4 (INTEGUMENT-1/2: 2.6 vs 1.6; P<0.001; INTEGUMENT-PED: 2.6 vs 1.6; P<0.01). On average, there was a greater reduction in mean WI-NRS scores within 24 hours of the first application among patients treated with ZORYVE compared to patients treated with vehicle (P<0.005) in both INTEGUMENT-1/2 and INTEGUMENT-PED."

P3 data • Atopic Dermatitis

Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Roflumilast-treated patients experienced greater improvements in disease severity than vehicle-treated patients. The PASI-HD can more accurately assess disease changes compared with PASI."

Journal • P3 data • Dermatology • Immunology • Psoriasis

Once-Daily Roflumilast Cream 0.15% and 0.05% Improve Atopic Dermatitis Signs and Symptoms that Can be Maintained with Proactive Twice-Weekly Treatment: Results From the 52-Week Phase 3 INTEGUMENT-OLE Trial in Patients Aged ≥2 Years (Arcutis Press Release) - "...ZORYVE cream 0.15% and 0.05% were well tolerated, decreased signs and symptoms of atopic dermatitis, and maintained or increased improvements through up to 56 weeks of treatment in individuals aged ≥2 years....Starting at Week 4 of INTEGUMENT-OLE, participants who achieved a vIGA-AD score of ‘Clear’ (0), switched to proactive twice-weekly application (ZORYVE cream 0.05% n=170; 30.2% of 562 children ages 2-5; ZORYVE cream 0.15% n=130; 19.8% of 658 adults and children ≥6). For participants who switched to twice-weekly application, the median duration of disease control (maintaining vIGA-AD of ‘Clear’ or ‘Almost Clear’, with adequate control of signs and symptoms on the twice-weekly schedule application) was 238 days in children 2-5 and 281 days in adults and children 6 years of age and older."

P3 data • Atopic Dermatitis

Commercial Highlights (GlobeNewswire) - "ZORYVE net product sales for the third quarter of 2025 were $99.2 million, reflecting 22% sequential growth over the second quarter of 2025 and 122% year-over-year growth. Sequential growth was driven by increasing demand across products, the launch of ZORYVE foam 0.3% in plaque psoriasis of the scalp and body, and improved gross-to-net (GTN) pricing; Following FDA approval in early October, the Company will launch ZORYVE cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5 by the end of October."

Launch US • Sales • Atopic Dermatitis • Psoriasis

Arcutis Launches ZORYVE (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5 (GlobeNewswire) - "ZORYVE cream 0.05% will be available in pharmacies this week."

Launch US • Atopic Dermatitis

FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5 (GlobeNewswire) - "Commercial product expected to be available by the end of October 2025....The FDA approval of ZORYVE cream 0.05% is based on results from the INTEGUMENT-PED Phase 3 trial (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis), the INTEGUMENT-OLE long-term extension study, and a Phase 1 pharmacokinetic study."

FDA approval • Launch US • Atopic Dermatitis

Arcutis Biotherapeutics to Host Virtual Investor Day and Report Third Quarter 2025 Financial Results on October 28, 2025 (Arcutis Press Release) - "In addition to discussing third quarter 2025 financial results, the Investor Day will feature: An in-depth look into the Company’s strategy for long-term, sustained growth for ZORYVE (roflumilast); A detailed review of clinical development activities and advancements for new ZORYVE indications and ARQ-234; An overview of the Company’s capital allocation strategy and financial outlook."

Clinical • Atopic Dermatitis • Immunology

Efficacy and Tolerability of Roflumilast Cream 0.3% and Foam 0.3% in Patients With Plaque Psoriasis Involving the Face and/or Genitals: Outcomes From the Phase 3 DERMIS-1/2 and ARRECTOR Trials (EADV 2025) - "Overall, treatment-related AEs from DERMIS-1/2 were reported for 4.0% and 3.6% of patients in the roflumilast cream and vehicle groups, respectively, and for 5.7% and 2.0% of patients in the roflumilast foam and vehicle groups from ARRECTOR. Both roflumilast cream 0.3% and foam 0.3% were well tolerated and improved psoriasis across several efficacy assessments after 8 weeks. Observed improvements in disease were consistent between the formulations in the overall populations and in patient subpopulations who had psoriasis with baseline facial and/or genital involvement."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Caregiver-Reported Outcomes From the Phase 3 INTEGUMENT-PED Trial of Children Aged 2–5 Years With Atopic Dermatitis and Treated With Roflumilast Cream 0.05% (EADV 2025) - P3 | "Once-daily roflumilast cream 0.05% significantly improved AD as measured by multiple PROs, compared with vehicle cream, after 4 weeks of treatment in patients aged 2–​5 years with AD. Outcomes were consistent with those reported for patients aged ≥6 years with AD."

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

Efficacy and Tolerability of Roflumilast Cream 0.3% and Foam 0.3% in Patients with Plaque Psoriasis Involving the Face and/or Genitals: Outcomes from the Phase 3 DERMIS-1/2 and ARRECTOR Trials (GlobeNewswire) - "Additionally, 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% were both well tolerated and 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."

P3 data • Psoriasis

Caregiver-Reported Outcomes from the Phase 3 INTEGUMENT-PED Trial of Children Aged 2–5 Years with Atopic Dermatitis and Treated with Roflumilast Cream 0.05% (GlobeNewswire) - "An additional presentation highlights patient-reported outcomes (PROs), as reported by caregivers, from the INTEGUMENT-PED Phase 3 trial in children aged 2–5 years with atopic dermatitis. Data demonstrate that children who received a once-daily application of investigational ZORYVE cream 0.05% had greater improvements versus vehicle across various PROs assessing signs, symptoms, and severity of atopic dermatitis, as well as improved quality of life (QoL) and decreased negative impact on the family after 4 weeks. Improvements were observed in SCORing Atopic Dermatitis (SCORAD) total and component scores (i.e., itch, sleep loss, and dryness intensity) and in disease severity and impact questions (as measured by Patient-Oriented Eczema Measure, or POEM)."

P3 data • Patient reported outcomes • Atopic Dermatitis

Arcutis Submits Supplemental New Drug Application for ZORYVE (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5 (GlobeNewswire) - "The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study."

FDA filing • Psoriasis

Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=354 | Completed | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. (PubMed, Pediatr Dermatol) - P2 | "Under maximal use conditions, once-daily roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis in children aged 2-11 years, consistent with phase 3 results in adults and adolescents. Trial Registration: Clinicaltrials.gov listing: 215: NCT04655313; 216: NCT04746911."

Journal • PK/PD data • Dermatology • Immunology • Psoriasis

Revise Phase III Trial Protocol For Roflumilast Cream: CDSCO Panel Tells Sun Pharma (Medical Dialogues) - "This came after Sun Pharmaceuticals presented its proposal for the grant of permission to manufacture and marketing of Roflumilast cream 0.3% w/w with a Phase III clinical trial protocol for the proposed indication of an effective alternative for the treatment of plaque psoriasis, along with a bioequivalence (BE) study waiver."

Clinical protocol • Psoriasis

Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "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."

Sales • Atopic Dermatitis • Psoriasis