This section highlights FDA-related milestones and regulatory updates for drugs developed by Arcutis Biotherapeutics (ARQT).
Over the past two years, Arcutis Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ZORYVE™, roflumilast, ARQ-234, and ARQ-255. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ZORYVE™ (roflumilast) FDA Regulatory Timeline and Events
ZORYVE™ (roflumilast) is a drug developed by Arcutis Biotherapeutics for the following indication: Inhibitor of phosphodiesterase-4 (PDE4).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- April 27, 2026
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication for ZORYVE® (roflumilast) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months.
AI Summary
Arcutis Biotherapeutics announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration to expand the use of ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in infants as young as 3 months. The company is seeking clearance to offer this non-steroidal topical option for very young patients.
Atopic dermatitis often starts in infancy and can be widespread on a baby’s body. Because infants have a higher body surface area relative to their mass, they may be more likely to absorb topical medicines and experience side effects. The condition also causes major sleep disruption, raises infection risk, and creates emotional and developmental strain for both children and caregivers. If approved, the expanded indication could address an unmet need, but safety data in infants will be central to the FDA’s review.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- March 28, 2026
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced new data from the INTEGUMENT-INFANT Phase 2 trial demonstrating that ZORYVE® (roflumilast) cream 0.05% reduced signs and symptoms of atopic dermatitis, the most common form of eczema, in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis.
AI Summary
Arcutis Biotherapeutics reported Phase 2 INTEGUMENT-INFANT results showing that ZORYVE (roflumilast) cream 0.05% reduced signs and symptoms of atopic dermatitis in infants aged 3 months to less than 24 months with mild to moderate disease. In the trial, topical roflumilast was well tolerated and produced meaningful improvements in common inflammatory skin symptoms of eczema, supporting its potential use in very young patients. The data add to evidence that ZORYVE can be effective across different ages, body areas, and disease severities.
Arcutis said these findings will support a planned supplemental New Drug Application for ZORYVE cream 0.05% in this infant age group, which the company expects to submit in the second quarter of 2026. If approved, the result could expand treatment options for infants with mild to moderate atopic dermatitis.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- March 10, 2026
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced that Pediatric Dermatology published data from the Phase 3 open-label extension (INTEGUMENT-OLE) study evaluating once-daily ZORYVE® (roflumilast) cream 0.05% in children aged 2 to 5 years with mild-to-moderate atopic dermatitis.
AI Summary
Arcutis Biotherapeutics reported Pediatric Dermatology publication of Phase 3 open‑label extension (INTEGUMENT‑OLE) data on once‑daily ZORYVE® (roflumilast) cream 0.05% in children 2–5 years with mild‑to‑moderate atopic dermatitis. The cream was safe and well tolerated, and treatment effects were maintained and improved over time through 56 weeks, showing continued control of signs and symptoms in this young group.
Children who reached clear skin and switched to a proactive twice‑weekly maintenance regimen sustained disease control for a median of about eight months. Of the study population, 170 children (30.2%) entered the twice‑weekly dosing phase; the Kaplan‑Meier median duration of control on this schedule was 238 days.
These findings support Arcutis’s focus on expanding pediatric treatment options. Considering atopic dermatitis often starts in early childhood and can disrupt sleep and well‑being, longer‑term, well‑tolerated topical options for young children are clinically meaningful.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- February 2, 2026
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced positive topline results from the INTEGUMENT-INFANT Phase 2 study evaluating the safety, tolerability, and efficacy of ZORYVE® (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis.
AI Summary
Arcutis Biotherapeutics announced positive topline results from the INTEGUMENT-INFANT Phase 2 study of ZORYVE® (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The open-label, multicenter trial treated 101 infants once daily for four weeks to assess safety, tolerability, and efficacy. Results reinforced a consistent safety and tolerability profile. The most frequently reported adverse events (≥3%) were diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Only one participant discontinued due to an adverse event, and there were no serious adverse events reported.
The study builds on an earlier maximal usage pharmacokinetics trial (ARQ-151-105) and supports the safety findings of prior pediatric research. Because atopic dermatitis often begins in infancy and can disrupt sleep and increase infection risk, these results are important for evaluating treatment options for very young children.Read Announcement
- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- November 13, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Canada, Inc is pleased to announce that Health Canada has approved PrZORYVE® (roflumilast foam 0.3%) for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older.
AI Summary
Arcutis Canada, Inc. announced that Health Canada has approved PrZORYVE® (roflumilast foam 0.3%) for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older. The approval covers use on both scalp and body plaques, giving clinicians and patients in Canada a newly authorized option for managing this chronic inflammatory skin condition. PrZORYVE is a topical formulation of roflumilast administered as a foam.
This regulatory nod means Canadian teens and adults can now access PrZORYVE for plaque psoriasis in the approved age group. Arcutis Canada highlighted the approval as an important step toward expanding treatment choices for people living with psoriasis and said it looks forward to making the product available to patients and healthcare providers in Canada.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- October 28, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. today outlined its strategy to achieve sustainable growth and reported financial results for the quarter ended September 30, 2025. Arcutis will review both topics at its Investor Day, which begins today at 10:30 a.m. Eastern Time (ET).
AI Summary
Arcutis Biotherapeutics, Inc. outlined its strategy for sustainable growth and reported financial results for the quarter ended September 30, 2025. In Q3, ZORYVE net product revenue reached $99.2 million, a 122% increase year-over-year and 22% sequential growth. The company provided initial 2026 net product sales guidance of $455–$470 million. Arcutis will review these results and its growth plan at its Investor Day today at 10:30 a.m. Eastern Time.
The company plans to expand ZORYVE by converting topical corticosteroid prescriptions. It is running Phase 2 trials in vitiligo and hidradenitis suppurativa. Arcutis also plans to advance its pipeline with ARQ-234.
The company aims for peak ZORYVE sales of $2.6–$3.5 billion annually by capturing 15%–20% of the topical corticosteroid market. This supports long-term growth and reinvestment.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- October 24, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced that new data demonstrating ZORYVE® (roflumilast) cream 0.15% and 0.05% improved quality of life, specifically by helping to reduce sleep disruptions, and provided long-term, durable disease control for individuals with atopic dermatitis aged 2 years and older will be presented at the 2025 Fall Clinical Dermatology Conference, taking place October 23–26, 2025, in Las Vegas.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- October 6, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age.
AI Summary
Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration approved its supplemental new drug application for ZORYVE (roflumilast) cream 0.05%. This once‐daily, steroid‐free topical treatment is now approved for children aged 2 to 5 with mild to moderate atopic dermatitis and can be applied anywhere on the body.
Clinical trials showed rapid improvement, with about 40% of participants achieving at least 75% clearance of symptoms by week 4. More than one-third of children also saw a meaningful reduction in itch within four weeks. ZORYVE was generally well tolerated, with most adverse reactions being mild, such as upper respiratory infections and headache.
The company expects to launch commercially by October 2025. This approval gives parents and providers a steroid-free option to manage atopic dermatitis in young children. Arcutis aims to improve quality of life for families affected by this skin condition.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- September 17, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced that new data on ZORYVE (roflumilast) efficacy across three common skin conditions—seborrheic dermatitis, atopic dermatitis, and psoriasis—will be presented at the 34th Annual European Academy of Dermatology and Venereology (EADV) Congress, which is taking place September 17–20, 2025, in Paris.
AI Summary
Arcutis Biotherapeutics, Inc. will present new efficacy data for its topical therapy ZORYVE (roflumilast) at the 34th Annual European Academy of Dermatology and Venereology (EADV) Congress in Paris, September 17–20, 2025. The company will share findings across three common inflammatory skin disorders: seborrheic dermatitis, atopic dermatitis, and plaque psoriasis.
A subgroup analysis from the Phase 3 STRATUM trial will show that ZORYVE foam 0.3% significantly reduced signs, symptoms, redness, scaling, and itch in seborrheic dermatitis patients with diverse skin types. Results were consistent across race, ethnicity, and Fitzpatrick skin type subgroups.
Data from the INTEGUMENT-PED trial in children aged 2–5 with atopic dermatitis will highlight that once-daily ZORYVE cream 0.05% improved patient- and caregiver-reported outcomes, quality of life, and disease severity measures after four weeks.
Finally, pooled results from the Phase 3 DERMIS-1/2 and ARRECTOR studies will demonstrate that both ZORYVE cream 0.3% and foam 0.3% improved facial and genital plaque psoriasis symptoms and were well tolerated.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- September 16, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced that ZORYVE was presented with a 2025 Best of Beauty Breakthrough Award by Allure magazine, which is globally recognized as the most distinguished beauty award by industry professionals and consumers.
AI Summary
Arcutis Biotherapeutics, Inc. announced that ZORYVE was presented with a 2025 Best of Beauty Breakthrough Award by Allure magazine, which is globally recognized as the most distinguished beauty honor by industry professionals and consumers. ZORYVE is the first prescription topical therapy for eczema, plaque psoriasis, and seborrheic dermatitis to win this prestigious award.
It is the number one prescribed branded topical therapy across these three inflammatory skin conditions. ZORYVE comes as a cream and a leave-in foam, each used once per day anywhere on the body. Its unique formulas work on all skin and hair types and provide safe, well-tolerated relief with rapid results. Healthcare providers have chosen it over one million times.
Arcutis says this award underscores its innovative approach in dermatology and its commitment to meeting patients’ unmet needs. The recognition highlights the team’s dedication to developing targeted topical treatments that redefine care for inflammatory skin diseases.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- June 10, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc 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.
AI Summary
Arcutis Biotherapeutics announced that the first child has been enrolled in the Phase 2 open-label study, INTEGUMENT-INFANT. This trial evaluates the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis. The cream will be applied once daily over a four‐week period. Approximately 35 infants with mild to moderate atopic dermatitis, affecting at least 3% of their body, are expected to participate. Dr. Patrick Burnett noted that atopic dermatitis poses significant challenges for young patients and their families, including sleep disruption and increased risk of skin infections. The study is a key step in developing more suitable treatment options for infants, potentially offering a steroid-sparing alternative for managing this chronic condition.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- June 6, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced that it will present five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, which is taking place in Nashville, TN, from June 6-7, 2025.
AI Summary
Arcutis Biotherapeutics, Inc. announced it will present five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, TN, scheduled for June 6-7, 2025. The company aims to share new data from its INTEGUMENT-OLE study, which focuses on the long-term safety and effectiveness of its investigational ZORYVE cream 0.05% in young children aged 2 to 5 with atopic dermatitis. One key finding is that children who switched to a proactive twice-weekly application achieved a median of 238 days of disease control. These results help demonstrate that ZORYVE cream may offer a promising, steroid-free treatment option for managing the symptoms of atopic dermatitis in a sensitive population.
This conference presence highlights Arcutis’ commitment to advancing treatments in immuno-dermatology and further supports the potential of their innovative topical therapies for atopic dermatitis.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- March 17, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Canada, Inc announced that Health Canada has approved PrZORYVE® (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older.
AI Summary
Arcutis Canada, Inc announced that Health Canada has approved PrZORYVE® (roflumilast cream 0.15%) for treating mild to moderate atopic dermatitis in adults and children aged six years and older. This new, once‐daily, steroid‐free topical cream is designed to offer rapid relief from itch and inflammation while supporting long-term disease control. Clinical trials demonstrated significant improvements in skin clearance with benefits visible as early as one week and sustained control for up to 56 weeks. The formulation, which leverages HydroARQ Technology™, is non-greasy, absorbs quickly, and is gentle on the skin barrier. This approval provides a new treatment option for those managing atopic dermatitis, a condition that significantly affects quality of life, by reducing symptoms without the use of traditional steroids. PrZORYVE aims to give patients and healthcare providers an effective alternative in managing this common and challenging skin disorder.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- March 7, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced new data from two posters shared at the 2025 American Academy of Dermatology Annual Meeting (AAD).
AI Summary
Arcutis Biotherapeutics, Inc. presented new data at the 2025 American Academy of Dermatology Annual Meeting (AAD) through two poster presentations. One poster highlighted the favorable safety profile and efficacy of ZORYVE® cream 0.15% in treating mild to moderate atopic dermatitis (AD) in adults and children aged 6 and older who had an inadequate response, intolerance, or contraindications to topical treatments. In this study, over 91% of patients reported no or mild sensations at the application site, while investigators noted minimal irritation in almost all cases over a four-week period.
The second poster showed that investigational ZORYVE® foam 0.3% provided significant patient-reported improvements for scalp and body psoriasis in individuals aged 12 and older. Patients experienced better symptom control and a notable improvement in quality of life, supporting ZORYVE formulations as effective alternatives for common dermatological conditions.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- February 26, 2025
- Target Action Date:
- October 13, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced that The FDA has set a PDUFA target action date of October 13, 2025 for this application.
AI Summary
Arcutis Biotherapeutics announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 for its supplemental New Drug Application (sNDA). The application is for ZORYVE cream 0.05%, a once-daily topical treatment aimed at children ages 2 to 5 with mild to moderate atopic dermatitis. The company highlighted that pivotal clinical trials have shown the cream to be both effective and safe, key factors when treating young children with a chronic condition.
If approved, ZORYVE cream 0.05% would offer a new non-steroid treatment option for approximately 1.8 million children in the United States suffering from atopic dermatitis. The positive trial results suggest the cream may provide long-term relief for children and improve the quality of life for both patients and caregivers.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- February 26, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced the FDA's acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old.
AI Summary
Arcutis Biotherapeutics, Inc. announced that the FDA has accepted their supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily topical therapy for mild to moderate atopic dermatitis in children aged 2 to 5. The cream is a next generation phosphodiesterase-4 (PDE4) inhibitor designed to reduce inflammation while offering a safe and effective long-term treatment option for young patients whose condition often affects sensitive areas like the face and neck. Clinical trials have shown significant improvements in skin clearance and itch relief, with a favorable safety and tolerability profile. If approved, ZORYVE cream 0.05% could offer a new treatment option and potentially benefit about 1.8 million children with atopic dermatitis in the United States. The FDA has set a PDUFA target action date of October 13, 2025 for this application.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- September 25, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials showing that ZORYVE cream 0.15% provided consistent and meaningful improvements in signs and symptoms of AD in individuals regardless of race, ethnicity, and Fitzpatrick skin types.
AI Summary
Arcutis Biotherapeutics, Inc. announced new subgroup analysis results from its Phase 3 INTEGUMENT-1 and -2 trials for ZORYVE cream 0.15%. The studies showed that the treatment provided consistent and meaningful improvements in signs and symptoms of atopic dermatitis (AD) regardless of race, ethnicity, or Fitzpatrick skin type. Patients treated with ZORYVE experienced greater skin clearance and significant itch reduction compared to those receiving a placebo.
The data, presented at the 2024 European Academy of Dermatology & Venereology Congress, highlighted that higher percentages of ZORYVE-treated patients reached a validated improvement in AD, whether they were White, Black or African American, Asian, or described by other racial groups, and regardless of whether their skin type was lighter or darker. The cream was safe and well tolerated across all subgroups, giving clinicians confidence in its effective use for diverse individuals with AD.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- September 24, 2024
- Target Action Date:
- May 22, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced that The FDA assigned the application a PDUFA target action date of May 22, 2025.
AI Summary
Arcutis Biotherapeutics recently announced that the FDA accepted its supplemental New Drug Application (sNDA) for ZORYVE foam, a once-daily topical treatment aimed at addressing scalp and body psoriasis. Notably, the FDA set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025, highlighting a key upcoming milestone in the approval process. The sNDA is supported by strong data from Phase 2b and pivotal Phase 3 clinical trials. These studies demonstrated significant improvements in the signs and symptoms of psoriasis, including rapid relief of scalp itch. Scalp psoriasis poses unique challenges due to the difficulties of applying traditional creams or ointments in hair-bearing areas. If approved, ZORYVE foam could become a transformative option for adults and adolescents suffering from both scalp and body psoriasis.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- September 24, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.
AI Summary
Arcutis Biotherapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%. This once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor is intended for adults and adolescents aged 12 and older suffering from scalp and body psoriasis. The sNDA, supported by strong efficacy and safety data from Phase 2b and pivotal Phase 3 trials, represents a promising new treatment option for those facing the challenges of applying traditional creams or ointments on hair-bearing areas.
Clinical studies showed that ZORYVE foam significantly improved psoriasis signs and symptoms on both the scalp and the body compared to a vehicle. With the FDA assigning a PDUFA target action date of May 22, 2025, Arcutis hopes this innovative formulation will greatly improve the quality of life for millions of psoriasis patients.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- September 19, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc. announced that the Journal of American Medical Association Dermatology (JAMA Dermatology) published the positive results from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) evaluating the efficacy and safety of ZORYVE® (roflumilast) cream 0.15% as a once-daily, steroid-free treatment for mild to moderate AD.
AI Summary
Arcutis Biotherapeutics recently announced that JAMA Dermatology published positive findings from two pivotal Phase 3 studies—INTEGUMENT-1 and INTEGUMENT-2—evaluating ZORYVE® (roflumilast) cream 0.15% for mild to moderate atopic dermatitis (AD). The studies showed that around 31% of patients treated with ZORYVE achieved Investigator Global Assessment (IGA) Success at Week 4 compared to 14% for those receiving the vehicle. Participants also experienced rapid and significant itch relief, with improvements observed as early as Week 1. The trials confirmed that this once-daily, steroid-free cream is both effective and well tolerated across adults and children aged 6 years and older. These compelling results, published in a leading medical journal, highlight ZORYVE’s potential to offer a new, reliable treatment option for patients suffering from the burdensome symptoms of AD.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- August 28, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 for roflumilast cream 0.05%
AI Summary
Arcutis Biotherapeutics announced plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025. The application will focus on roflumilast cream 0.05% for treating atopic dermatitis (AD) in children aged 2 to 5 years.
The long-term study results highlight that the cream was well-tolerated with no new safety signals noted over 56 weeks, and many patients continued to see improvements. These findings support the potential for a safe and effective treatment for AD, particularly for younger patients who need both rapid and sustained relief. Arcutis aims to build on these positive outcomes with the upcoming sNDA submission to expand treatment options for this vulnerable population.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- August 28, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced announced results from the INTEGUMENT-OLE long-term open-label study of once-daily roflumilast cream 0.05% demonstrating the durable efficacy and favorable safety profile of roflumilast cream 0.05% in the treatment of mild to moderate AD in children 2 to 5 years old.
AI Summary
Arcutis Biotherapeutics recently announced positive results from the INTEGUMENT-OLE long-term open-label study evaluating once-daily roflumilast cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years. Over 56 weeks, the treatment maintained durable efficacy with a favorable safety profile and no new safety signals were observed. Notably, 71.9% of participants who rolled over from the previous INTEGUMENT-PED trial achieved a 75% improvement in their Eczema Area and Severity Index (EASI-75), demonstrating that the cream not only provided rapid relief but also improved over time.
Based on these encouraging findings, Arcutis plans to submit a supplemental New Drug Application (sNDA) to the FDA in the first quarter of 2025. The results reinforce that roflumilast cream 0.05% could be a safe and effective long-term treatment option for young children with atopic dermatitis.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- July 29, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
- Arcutis Biotherapeutics, Inc. announced the commercial launch of ZORYVE® (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6 in the United States. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch, and was developed to provide long-term disease control.
AI Summary
Arcutis Biotherapeutics, Inc. announced the U.S. commercial launch of ZORYVE® (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis in adults and children aged 6 and older. This new, once-daily, steroid-free cream quickly clears visible signs of the condition while significantly reducing itch, providing relief that supports long-term disease control.
Developed with the challenges of chronic eczema in mind, ZORYVE is designed for continuous use with a formulation that avoids common irritants associated with other topical therapies. Patients can safely apply it anywhere on the body, using it for as long as needed without the limitations often seen with conventional treatments. This launch marks a significant step forward in offering a rapid and effective treatment option for millions suffering from atopic dermatitis across the United States.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- July 23, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.
AI Summary
Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for ZORYVE (roflumilast) foam 0.3%. This once-daily, next generation PDE4 inhibitor is developed to treat scalp and body psoriasis in adults and adolescents aged 12 and older. The foam is designed to work on difficult-to-treat, hair-bearing areas where traditional creams and ointments may not be effective. In clinical studies, ZORYVE foam showed significant improvements in both scalp and body psoriasis, with many patients experiencing reduced itch within 24 hours. The pivotal Phase 3 ARRECTOR trial reported that a high percentage of participants achieved successes in scalp and body clearance. The favorable safety profile and ease of use of the foam offer hope for a new treatment option for the millions of people suffering from psoriasis, addressing both visible plaques and uncomfortable symptoms.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- July 23, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics, Inc announced that Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial
AI Summary
Arcutis Biotherapeutics announced that once-daily ZORYVE foam significantly improved both scalp and body psoriasis in its Phase 2b and pivotal Phase 3 trials. The treatment cleared psoriasis plaques effectively on both areas, with 67% of participants reaching success on scalp assessments after eight weeks. The foam also provided fast relief, with some patients noticing reduced scalp itch within 24 hours after the first application.
In addition to its strong efficacy results, ZORYVE foam demonstrated a favorable safety and tolerability profile. These positive outcomes suggest that, if approved, ZORYVE foam could become an important new option for adults and adolescents with scalp and body psoriasis. This advancement highlights the potential benefits of a steroid-free, easy-to-apply treatment that works well even in challenging hair-bearing areas.
Read Announcement- Drug:
- ZORYVE™ (roflumilast)
- Announced Date:
- July 9, 2024
- Indication:
- Inhibitor of phosphodiesterase-4 (PDE4)
Announcement
Arcutis Biotherapeutics announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control.
AI Summary
Arcutis Biotherapeutics has received FDA approval for its supplemental new drug application for ZORYVE (roflumilast) cream, 0.15%. This approval is for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients aged 6 years and older. The cream is a once-daily, steroid-free option designed to provide rapid disease clearance and significant itch relief, addressing one of the most bothersome symptoms of atopic dermatitis.
ZORYVE cream is formulated to be safe for use on any part of the body and is developed specifically for long-term disease control. This new treatment option offers an innovative alternative for patients who need effective management of the condition without the side effects commonly associated with steroids. Arcutis plans to make ZORYVE cream widely available through key channels in the near future.
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Roflumilast FDA Regulatory Timeline and Events
Roflumilast is a drug developed by Arcutis Biotherapeutics for the following indication: To treat inflammatory dermatoses.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- roflumilast
- Announced Date:
- March 18, 2026
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc announced that it will present new data from its clinical development program and marketed ZORYVE® (roflumilast) portfolio during the 2026 American Academy of Dermatology (AAD) Annual Meeting taking place March 27-31 in Denver.
AI Summary
Arcutis Biotherapeutics will present new clinical and product data at the 2026 American Academy of Dermatology Annual Meeting, March 27–31 in Denver. The company said it will share findings from its clinical development program alongside results for its marketed ZORYVE® (roflumilast) portfolio.
Key live presentations include a podium late‑breaking session, “INTEGUMENT‑INFANT,” on once‑daily roflumilast cream 0.05% in infants aged 3 to <24 months (abstract #79891), presented by Lawrence F. Eichenfield, MD, on Saturday, March 28. Dr. Eichenfield will also present a 35‑minute poster on long‑term caregiver‑reported outcomes for 2–5 year‑olds from the INTEGUMENT‑OLE trial on Friday, March 27.
Electronic posters will cover roflumilast foam 0.3% for seborrheic dermatitis (face/scalp subgroup, STRATUM trial; Laura Ferris, MD) and roflumilast cream and foam 0.3% for plaque psoriasis across body regions and signs (Melinda Gooderham, MD). These presentations span pediatric and adult uses across atopic dermatitis, plaque psoriasis, and seborrheic dermatitis within the ZORYVE portfolio.
Read Announcement- Drug:
- roflumilast
- Announced Date:
- November 17, 2025
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%, a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old.
AI Summary
Arcutis announced that the FDA has accepted a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3% to expand its plaque psoriasis indication to include children ages 2 to 5. The FDA set a PDUFA target action date of June 29, 2026. If approved, ZORYVE cream 0.3% would be the first and only topical phosphodiesterase-4 (PDE4) inhibitor indicated for plaque psoriasis in children as young as two, offering a steroid-free, once-daily treatment option that could be used on sensitive areas such as the face and skin folds.
The sNDA is supported by a 4-week Maximal Usage Systemic Exposure (MUSE) study in 2- to 5-year-olds and data from a long-term open-label study that included this age group. Those studies showed favorable long-term safety, tolerability, and persistence of efficacy, suggesting potential benefits for young children and their families in managing plaque psoriasis. Arcutis says this filing advances care for pediatric patients with immune-mediated skin disease.
Read Announcement- Drug:
- roflumilast
- Announced Date:
- September 3, 2025
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc. announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2.
AI Summary
Arcutis Biotherapeutics announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration to expand the use of ZORYVE® (roflumilast) cream 0.3% for treating plaque psoriasis in children as young as 2. If approved, ZORYVE would become the first topical PDE4 inhibitor approved for this age group, offering an alternative to topical steroids and vitamin-D analogs.
Current FDA-approved options for children under 6 are limited, especially for sensitive areas like the face and skin folds. ZORYVE cream is once-daily, steroid-free, non-greasy, and free of common irritants. The sNDA is backed by data from a 4-week maximal usage study in 2- to 5-year-olds and a long-term open-label study showing consistent safety, tolerability, and sustained efficacy.
By expanding ZORYVE’s label, Arcutis aims to address an unmet need in pediatric dermatology, providing young patients and caregivers a safer, effective, non-steroidal treatment for plaque psoriasis.
Read Announcement- Drug:
- roflumilast
- Announced Date:
- May 22, 2025
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.
AI Summary
Arcutis Biotherapeutics, Inc. has received FDA approval for the supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) topical foam 0.3%. This approval allows the treatment of plaque psoriasis on both the scalp and body in patients 12 years of age and older. ZORYVE foam is a once-daily, steroid-free topical treatment that offers patients powerful clearance and rapid relief from itch—a common and challenging symptom of psoriasis, especially on the scalp. The foam formulation is designed to be convenient for use on hair-bearing areas, addressing a major difficulty when using creams or ointments. This approval expands treatment options for nearly 9 million Americans with plaque psoriasis, many of whom suffer from scalp involvement, and marks a significant step in the availability of effective, long-term management for this chronic condition.
Read Announcement- Drug:
- roflumilast
- Announced Date:
- July 22, 2024
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc announced that it will host a virtual Key Opinion Leader (KOL) event featuring a leading dermatology and immune-mediated skin disease expert to discuss the unmet need and current treatment landscape for individuals with mild to moderate atopic dermatitis (AD).
AI Summary
Arcutis Biotherapeutics, Inc. has announced that it will host a virtual Key Opinion Leader (KOL) event focused on the treatment of atopic dermatitis (AD). A leading expert in dermatology and immune-mediated skin diseases will join the session to discuss the unmet need among individuals with mild to moderate AD and review the current treatment landscape.
This online event aims to provide valuable insights into how existing therapies are meeting—or not meeting—the needs of AD patients. Attendees will learn about gaps in treatment options and the challenges that remain in effectively managing this condition. By facilitating expert discussion, Arcutis Biotherapeutics intends to inform healthcare professionals and stakeholders, ultimately helping to drive progress in the development of improved treatment strategies for those affected by mild to moderate atopic dermatitis.
Read Announcement- Drug:
- roflumilast
- Announced Date:
- June 10, 2024
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc. announced new results from the INTEGUMENT-OLE long-term open-label study of investigational once-daily roflumilast cream 0.15% in adults and children ages 6 years and older with AD presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference.
AI Summary
Arcutis Biotherapeutics, Inc. presented new findings from its INTEGUMENT-OLE long-term open-label study at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. The study evaluated once-daily roflumilast cream 0.15% in adults and children ages 6 and older with atopic dermatitis (AD). Over 56 weeks of treatment, the investigational cream showed continued improvements in AD signs and symptoms, including itch. Notably, 66.2% of participants who maintained treatment achieved a 75% improvement in the Eczema Area and Severity Index, while a subgroup switching to proactive twice-weekly dosing maintained disease control for a median of 281 days. The cream was well tolerated with no new safety signals reported. These results support the potential of roflumilast cream 0.15% as an effective, long-term, steroid-free treatment option for individuals with AD, providing meaningful improvements in managing chronic symptoms and maintaining a flare-free condition.
Read Announcement- Drug:
- roflumilast
- Announced Date:
- June 5, 2024
- Indication:
- To treat inflammatory dermatoses
Announcement
Arcutis Biotherapeutics, Inc. announced that five abstracts will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, which will take place in Chicago, IL from June 8-10, 2024. Among these presentations will be new long-term safety and efficacy data for roflumilast cream 0.15% in patients ≥6 years of age with mild to moderate atopic dermatitis, and an encore of preclinical data on ARQ-234, a CD200 receptor agonist the Company is investigating for atopic dermatitis.
AI Summary
Arcutis Biotherapeutics, Inc. announced that it will present five abstracts at the upcoming Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference in Chicago, IL, from June 8-10, 2024. Notably, one presentation will share new long-term safety and efficacy data for roflumilast cream 0.15% in patients aged 6 years and older with mild to moderate atopic dermatitis. This data comes from a Phase 3, 52-week study and could offer important insights into managing this common skin condition.
Additionally, the company will present preclinical data on ARQ-234, a CD200 receptor agonist now under investigation for atopic dermatitis treatment. These presentations underline Arcutis’ commitment to advancing innovative therapeutic options in immuno-dermatology, aiming to improve care and outcomes for patients facing chronic, immune-mediated dermatological conditions.
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ARQ-234 FDA Regulatory Events
ARQ-234 is a drug developed by Arcutis Biotherapeutics for the following indication: in Healthy Volunteers and Adults With Atopic Dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARQ-234
- Announced Date:
- March 3, 2026
- Indication:
- in Healthy Volunteers and Adults With Atopic Dermatitis
Announcement
Arcutis Biotherapeutics, Inc. announced that the first participant has been enrolled in a Phase 1a/1b, double-blind, randomized, placebo-controlled study, ARQ-234-131, evaluating the safety and tolerability of ARQ-234.
AI Summary
Arcutis Biotherapeutics announced that the first participant has been enrolled in ARQ-234-131, a Phase 1a/1b, first-in-human, double-blind, randomized, placebo-controlled study. The trial will test ARQ-234 in healthy volunteers and adults with moderate to severe atopic dermatitis to gather early human safety data.
ARQ-234 is a fusion-protein agonist of the CD200 receptor (CD200R), an immune-regulatory checkpoint. By binding CD200R, ARQ-234 is intended to trigger inhibitory signals in immune cells, reduce overactive immune responses, and help restore immune balance. This checkpoint agonism is an emerging approach to calm unwanted inflammation.
The study’s primary goals are to evaluate safety, tolerability, and clinical improvement in adults with moderate to severe atopic dermatitis. A key secondary goal is to measure pharmacokinetics across single and multiple dose levels. Findings will guide further development of ARQ-234 as a potential new treatment for atopic dermatitis.
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ARQ-255 FDA Regulatory Events
ARQ-255 is a drug developed by Arcutis Biotherapeutics for the following indication: JAK1 inhibitor therapy for alopecia areata.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARQ-255
- Announced Date:
- September 5, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- JAK1 inhibitor therapy for alopecia areata
Announcement
Arcutis Biotherapeutics, Inc announced that Phase 1b results expected first half of 2025
AI Summary
Arcutis Biotherapeutics announced that enrollment is complete for its Phase 1b clinical trial of ARQ‑255. ARQ‑255 is a novel topical suspension containing the potent JAK1 inhibitor ivarmacitinib, designed to target alopecia areata by delivering the medication deep into the skin using the company's proprietary 4D technology. The unique formulation aims to reach the base of the hair follicle where inflammation occurs, offering a new approach for a condition that currently lacks FDA-approved topical treatments. Results from this vehicle-controlled, double-blind study, which includes healthy volunteers and patients with patchy alopecia areata, are anticipated in the first half of 2025. This phase of the trial will assess safety, tolerability, pharmacodynamics, and pharmacokinetics, and is a key step in Arcutis’ broader plan to bring innovative therapies to those affected by immune-mediated skin conditions.
Read Announcement- Drug:
- ARQ-255
- Announced Date:
- September 5, 2024
- Indication:
- JAK1 inhibitor therapy for alopecia areata
Announcement
Arcutis Biotherapeutics, Inc announced the enrollment of the last subject in the Phase 1b study evaluating ARQ-255, a topical suspension of ivarmacitinib, a potent and selective JAK1 inhibitor, for the treatment of alopecia areata.
AI Summary
Arcutis Biotherapeutics recently announced the enrollment of the final subject in its Phase 1b study for ARQ-255. This study is testing ARQ-255, a topical suspension of ivarmacitinib—a potent and selective inhibitor of JAK1—for its safety, tolerability, pharmacodynamics, and pharmacokinetics in both healthy volunteers and individuals with patchy alopecia areata.
The drug is uniquely formulated using the company’s proprietary Deep Dermal Drug Delivery (4D) technology. This technology is designed to deliver the drug deep into the skin, reaching the base of the hair follicle where the inflammation associated with alopecia areata occurs. Results from this study are expected in the first half of 2025, potentially paving the way for a new, FDA-approved topical treatment for this challenging condition.
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