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

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

Start Date20 May 2025

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

CTRI/2025/04/084479

/ Not yet recruitingNot ApplicableIIT

Study comparing efficacy and safety of oral Roflumilast and Apremilast for treatment of chronic plaque psoriasis a randomized control trial - NIL

Start Date25 Apr 2025

Sponsor / Collaborator-

NCT06860958

/ RecruitingPhase 3IIT

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients

Start Date01 Mar 2025

Sponsor / Collaborator

Tanta University

100 Clinical Results associated with Roflumilast

100 Translational Medicine associated with Roflumilast

100 Patents (Medical) associated with Roflumilast

1,254

Literatures (Medical) associated with Roflumilast

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

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

Article

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

OBJECTIVE:

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

METHODS:

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

RESULTS:

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

CONCLUSION:

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

01 Dec 2025·INFLAMMATION RESEARCH

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

Article

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

OBJECTIVE:

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

METHODS:

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

RESULTS:

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

CONCLUSION:

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

01 Jul 2025·BIOORGANIC CHEMISTRY

Dialkyloxyphenyl hybrids as PDE4B inhibitors: Design, synthesis, in vitro/in vivo anti-inflammatory activity and in silico insights

Article

Author: Aboutaleb, Mohamed H ; Hamdi, Abdelrahman ; Salem, Mohamed S H ; Elnagar, Mohamed R ; Ibrahim, Tarek S ; El-Sayed, Magda A-A ; Almatary, Aya M

A series of novel dialkyloxyphenyl hybrids 11a-11h and 12a-12c were designed and synthesized as PDE4 inhibitors with anti-inflammatory activity. All compounds demonstrated nanomolar-range inhibitory activity against both PDE4B and PDE4D isoforms with notable selectivity for PDE4B. The 3,4-dimethoxyphenyl derivative 11e exhibited superior PDE4B inhibitory activity (IC₅₀ = 2.82 nM), with nine-fold selectivity compared to 1.5 of Rolipram. In TNF-α inhibition assays, 11e demonstrated remarkable potency (IC₅₀ = 7.20 nM), comparable to roflumilast, followed by 11d (IC₅₀ = 15.54 nM) and 11b (IC₅₀ = 28.52 nM). In vivo evaluation using LPS-induced sepsis model revealed that 11e achieved the highest inhibition of both TNF-α (52.19 %) and neutrophilia (56.47 %) compared to reference compounds. Molecular docking and dynamics studies revealed that hybrids 11b, 11d, and 11e exhibit a characteristic binding mode within the PDE4 active sites, rationalizing their activity through specific interactions, and demonstrating higher stability in the active site compared to Roflumilast.

190

News (Medical) associated with Roflumilast

07 May 2025

·investors.arcutis.com

Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE® (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology

Once-daily, investigational ZORYVE foam 0.3%, rapidly improved psoriasis of the scalp and body, including itch, when used as a monotherapy 66.4% of individuals treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at Week 8 45.5% of individuals treated with ZORYVE foam achieved Body-Investigator Global Assessment (B-IGA) Success at Week 8 Efficacy and safety results were consistent with Phase 2 results of ZORYVE foam 0.3% in adults and adolescents 12 years of age and older Supplemental New Drug Application (sNDA) for investigational ZORYVE foam 0.3% for psoriasis is under review with U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025 More than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvement WESTLAKE VILLAGE, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Medical Association (JAMA) Dermatology published the positive results from a pivotal Phase 3 study evaluating the efficacy and safety of ZORYVE® (roflumilast) foam 0.3% as a once-daily monotherapy treatment for psoriasis of the scalp and body. The study showed that treatment with investigational ZORYVE foam resulted in significant improvements across multiple efficacy endpoints, including the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, as well as key secondary endpoints. The data also show improvement in pruritus (itch) was observed as early as 24 hours after the first application. “Plaque psoriasis is a chronic and burdensome disease that often leaves people searching for relief from thick scales, itch, and discomfort – especially when it affects the scalp, where treatment can be particularly challenging,” said Melinda Gooderham, MD, MSc, FRCPC, dermatologist and medical director at the SKiN Centre for Dermatology, principal investigator at the SKiN Research Centre, and lead author on the paper. “These compelling results demonstrate that ZORYVE foam 0.3% may provide rapid and significant relief of plaques anywhere on the body and is well-tolerated according to both investigator and patient-reported assessments. The foam formulation is particularly beneficial for its versatility in treating hair-bearing and non-hair-bearing skin, which could ultimately help patients adhere to their treatment.” A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis (ARRECTOR), was a Phase 3, randomized, double-blinded, vehicle-controlled trial which enrolled 432 adults and adolescents aged 12 years and older with plaque psoriasis affecting the scalp and body, across 49 sites in the United States and Canada. Significantly greater proportions of individuals treated with ZORYVE foam 0.3% achieved the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline. At Week 8, 66.4% of individuals treated with ZORYVE foam 0.3% achieved S-IGA success compared to 27.8% for vehicle (P<0.0001). At Week 8, 45.5% of patients treated with ZORYVE foam achieved B-IGA success compared to 20.1% for vehicle (P<0.0001). Other key findings include: ZORYVE foam provided a clinically meaningful improvement in scalp itch. 65.3% of individuals treated with ZORYVE achieved a clinically significant reduction in itch compared to 30.3% of individuals treated with vehicle at Week 8 (P<0.0001) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Significant improvement was seen in the ZORYVE treatment group as early as Week 2. The data also demonstrated improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) at Week 8, with 63.1% of those treated with ZORYVE foam 0.3% achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle (P<0.0001). Significant improvement was seen in the ZORYVE treatment group as early as Week 2. Importantly, there was a greater improvement in itch observed with ZORYVE within 24 hours after the first application compared to vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164). This improvement over vehicle within 24 hours after the first application was also observed in body itch (as measured by WI-NRS change from baseline, relative to vehicle; nominal P=0.0094). At Week 8, 70.9% of those treated with ZORYVE foam versus 31.3% treated with vehicle achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) (P<.001), another secondary endpoint. Similarly, 50.1% of people treated with ZORYVE foam 0.3% achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI-75), a key secondary endpoint, as compared to 16.8% of those treated with vehicle at Week 8 (P<.001). ZORYVE foam was well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar in both active treatment and vehicle arms. The most frequent adverse events in the ZORYVE foam arm (≥1%) included headache, diarrhea, and nausea. Investigator-rated application-site tolerability was similar between ZORYVE and vehicle groups, with investigators reporting no evidence of irritation for at least 99.2% of all patients at all time points. Patient-rated application-site tolerability was also similar between ZORYVE and vehicle with at least 94.4% of patients reporting no or mild sensation on local tolerability assessments at all time points. “We are thrilled that JAMA Dermatology, a premier medical journal, has published the positive results of our pivotal ARRECTOR study. These data demonstrate that investigational ZORYVE foam rapidly relieved psoriasis symptoms, including the most troublesome symptom of itch,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “As an effective, safe, and well-tolerated once-daily treatment, ZORYVE foam 0.3%, if approved, will offer those living with psoriasis a potential new treatment option for use anywhere on the body with no limitations on duration of use. Having a single agent that effectively treats psoriasis on both the scalp and body, with a safe and tolerable profile, is an important therapeutic benefit for both clinicians and the people they treat. We look forward to the FDA’s potential approval of ZORYVE foam 0.3% for the treatment of plaque psoriasis of the scalp and body anticipated later this month.” About Plaque Psoriasis Psoriasis is a common, chronic, inflammatory skin disease that affects approximately nine million people in the United States. Symptoms include itch, scaling, redness, and flaking. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso, and areas where the skin is thin, like the face, genitals, and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin area. In addition, scalp psoriasis occurs in more than half of all psoriasis sufferers, and sometimes extends to the forehead, back of the neck, or behind or inside the ears. About ZORYVE (roflumilast) ZORYVE is a next generation topical phosphodiesterase-4 (PDE4) inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. ZORYVE (roflumilast) topical foam 0.3% is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE foam is under review for the treatment of scalp and body psoriasis by the FDA with a PDUFA target action date of May 22, 2025. ZORYVE® (roflumilast) cream 0.3% is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE® (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” ZORYVE® (roflumilast) cream 0.05% is under review for the treatment of atopic dermatitis in children ages 2 to 5 by the FDA, with a PDUFA target action date of October 13, 2025. INDICATIONS ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATIONZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on The Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential real-world use results of ZORYVE foam in scalp and body psoriasis, the potential for ZORYVE foam to advance the standard of care in plaque psoriasis, atopic dermatitis and other inflammatory dermatological conditions, as well as potential regulatory approvals and associated timing of such approvals. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts: Media Amanda Sheldon, Head of Corporate Communications media@arcutis.com Investors Latha Vairavan, Chief Financial Officer ir@arcutis.com

Clinical ResultPhase 3Drug Approval

06 May 2025

·investors.arcutis.com

Arcutis Announces First Quarter 2025 Financial Results and Provides Business Update

Q1 2025 net product revenue for ZORYVE® (roflumilast) was $63.8 million, a 196% increase compared to Q1 of 2024, and a 2% decrease compared to Q4 of 2024, due to typical first-quarter deductible resets and insurance changes, and excluding the non-recurring reduction in reserves for product return of $4.1 million reported in Q4 2024 Continued demand growth for ZORYVE of 10%, solidifying its position as most prescribed branded non-steroidal topical treatment across three major inflammatory skin conditions All three largest national Pharmacy Benefit Managers (PBMs) covering entire ZORYVE portfolio and Medicaid coverage continues to expand On April 3, 2025, the patent litigation against Padagis was stayed and the court cancelled all case deadlines, including the trial May 22, 2025 Prescription Drug User Fee Act (PDUFA) action date for ZORYVE foam 0.3% for treatment of individuals with plaque psoriasis of the scalp and body, 12 years and older WESTLAKE VILLAGE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update. “In the first quarter we again delivered excellent performance driven by strong demand growth for our ZORYVE portfolio, which offers a distinct and compelling value proposition and provides healthcare providers and their patients with an effective and safe alternative to steroids. We have broad commercial coverage, are continuing to expand Medicaid coverage — with more than 1 in 2 recipients having coverage — and are maintaining our gross-to-net in the 50s,” said Frank Watanabe, president and chief executive officer. “With our team's execution of our strategy, strong financial position, multiple upcoming catalysts and market expansion opportunities, including additional indications and further coverage expansion for ZORYVE, as well as a promising pipeline, we are confident in our continued growth in 2025 and beyond.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis. U.S. demand for ZORYVE cream 0.3% in plaque psoriasis continues to grow, with over 425,000 prescriptions filled since launch by over 18,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. ZORYVE cream 0.3% has reached its steady state gross-to-net (GTN). Launch of ZORYVE cream 0.15% in atopic dermatitis continues to gain momentum with over 69,000 prescriptions filled since launch, with coverage by the three largest national PBMs. The Company anticipates continued improvement in GTN for ZORYVE cream 0.15% in 2025, converging on the GTN of our other products. The Company submitted a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5, and has been assigned a PDUFA action date of October 13, 2025. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis, and under FDA review for scalp and body psoriasis. Demand for ZORYVE foam 0.3% in seborrheic dermatitis continues to grow robustly each quarter, with over 343,000 prescriptions filled since launch, reflecting the high unmet need in this disease. ZORYVE foam has gained commercial and Medicaid coverage in line with ZORYVE cream 0.3% and is nearing its steady state GTN. The Company submitted an sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, and has been assigned a PDUFA action date of May 22, 2025. ARQ-255 - a topical suspension formulation of ivarmacitinib, a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor, designed to preferentially deliver the drug deep into the hair follicle, in order to potentially treat alopecia areata at the site of inflammation. In September 2024, the Company announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in the middle of 2025. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis. The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug application in 2025. Recent Corporate Highlights The Company appointed Latha Vairavan as Chief Financial Officer effective May 6, 2025. Obtained two new U.S. patents in Q1 2025 related to topical roflumilast compositions. In March 2025, at the request of Padagis, Arcutis agreed to a joint stipulation to stay the ongoing patent litigation with Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC (Padagis). On April 3, 2025, the court stayed the case and cancelled all case deadlines, including the trial. The 30-month stay will be extended for each day the stay is in place starting March 24, 2025, until the stay is lifted. The parties are not in settlement discussions. In March 2025, Health Canada approved ZORYVE® (roflumilast) cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age and older, and the Company commenced sales in April. The positive results from Arcutis's pivotal Phase 3 trial of the efficacy and safety of ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in children 2 to 5 years old was published in Pediatric Dermatology. First Quarter 2025 Summary Financial Results Product revenues for the quarter ended March 31, 2025 were $63.8 million compared to $21.6 million for the corresponding period in 2024. Revenues for the quarter were $23.4 million for ZORYVE (roflumilast) cream 0.3%, $30.2 million for ZORYVE (roflumilast) topical foam 0.3%, and $10.2 million for ZORYVE (roflumilast) cream 0.15%. Year-over-year increases were due to strong unit demand as well as improvements in GTN sales deductions. In addition, the first quarters of 2025 and 2024 included Other revenues of $2.0 million and $3.0 million, respectively, related to license revenues received in connection with the Huadong Pharmaceutical collaboration and licensing agreement. Q1 2024 also included Other revenues of $25.0 million from an upfront payment in connection with the Sato License Agreement. Cost of sales for the quarter ended March 31, 2025 were $8.8 million compared to $3.3 million for the corresponding period in 2024. The year-over-year increase was due to the cumulative catch-up adjustment related to the $10.0 million milestone payment to AstraZeneca achieved during the quarter, coupled with higher product revenues. Research and development (R&D) expenses for the quarter ended March 31, 2025 were $17.5 million compared to $23.1 million for the corresponding period in 2024. The year-over-year decrease was due to decreased clinical development costs related to our topical roflumilast program. Selling, general, and administrative (SG&A) expenses for the quarter ended March 31, 2025 were $64.0 million compared to $54.8 million for the corresponding period in 2024. The year-over-year increase was primarily due to compensation and personnel-related expenses for our continued commercialization efforts for ZORYVE. Net loss was $25.1 million, or $0.20 per basic and diluted share, for the quarter ended March 31, 2025 compared to $35.4 million, or $0.32 per basic and diluted share, for the corresponding period in 2024. Cash, cash equivalents, restricted cash, and marketable securities were $198.7 million as of March 31, 2025, compared to $228.6 million as of December 31, 2024. Net cash used in operating activities was $30.4 million during the first quarter. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, approval and potential commercialization of product candidates; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts:Media Amanda Sheldon, Head of Corporate Communications media@arcutis.com Investors Latha Vairavan, Chief Financial Officer ir@arcutis.com

Phase 3Phase 1Drug ApprovalFinancial StatementPhase 2

05 May 2025

·www.biospace.com

FDA Action Alert: GSK, Sanofi, Merck and More

Taylor Tieden for BioSpace On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors. Amid the growing macro-level headwinds in the vaccine space, the FDA this month is expected to decide on Moderna’s mRNA COVID-19 shot, alongside a handful of other big verdicts. Read below for more. GSK Asks FDA to Approve Asthma Injection Nucala for COPD GSK is proposing its subcutaneous biologic Nucala to treat adult patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The FDA’s decision is due on May 7. A pulmonary disease, COPD is characterized by inflammation in the lungs, manifesting as breathlessness, coughs and airflow obstruction. According to GSK, some 40% of patients suffer from disease exacerbations caused by type 2 inflammation, which in turn is linked to high eosinophil counts in the blood. Nucala , a monoclonal antibody, targets and blocks the IL-5 cytokine, which is crucial to maintain the activity of eosinophils. GSK is supporting Nucala’s COPD application with data from the Phase III MATINEE trial. The pharma released a topline readout from the study in September 2024, noting that Nucala elicited a “statistically significant and clinically meaningful reduction” in yearly rates of moderate or severe disease exacerbations as opposed to placebo. Nucala is currently approved for eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome, and as an add-on maintenance treatment for asthma and chronic rhinosinusitis with nasal polyps. Arcutis Seeks Zoryve Expansion into Body and Scalp Psoriasis By May 22, the FDA will release its verdict on Arcutis Biotherapeutics’ proposed expansion for Zoryve into body and scalp psoriasis. Arcutis is backing its expansion bid with data from the Phase III ARRECTOR trial, which found that 66.4% of Zoryve-treated patients achieved clear or almost-clear skin, as opposed to 27.8% in placebo patients. Results also showed that 65.3% of patients in the Zoryve arm saw significant improvements in itch, versus 30.3% in the placebo group. Arcutis also filed findings from a Phase IIb study as well as long-term efficacy and safety data for Zoryve in plaque psoriasis. Zoryve is a topical phosphodiesterase 4 inhibitor that works by helping to suppress inflammation in the skin. The drug won FDA approval in 2011 for the treatment of plaque psoriasis in patients aged 12 years and up. If approved for body and scalp psoriasis, Zoryve would be a “truly meaningful innovation” for patients who suffer from inadequately controlled symptoms, Arcutis CEO Frank Watanabe said in a September 2024 release. Sanofi Eyes Extension of Meningococcal Disease Shot to Infants, Toddlers Sanofi’s meningococcal disease vaccine MenQuadfi is currently approved for the primary immunization of children aged two years and up. As a booster, it can be used in those 13 years and older who continue to be at risk of meningococcal disease. Sanofi is seeking to expand MenQuadfi’s label to also include infants and toddlers from six weeks to 23 months of age. The FDA is currently reviewing this proposal and is due to release its decision on May 23. If approved, MenQuadfi could protect this younger population from the A, C, W and Y serogroups of Neisseria meningitidis . In an April presentation before the CDC’s Advisory Committee for Immunization Practices, Sanofi presented data from several trials, including the Phase III MET42 study. Results showed that MenQuadfi was safe to use in infants and toddlers, with most side effects being mild or moderate in severity. Efficacy-wise, MenQuadfi was able to match a commercially approved vaccine in immune response and seroprotection. Liquidia Awaits Final Yutrepia Approval in Interstitial Lung Disease On May 23, Liquidia is expecting to win final approval of its inhalation powder Yutrepia for the treatment of patients with pulmonary arterial hypertension associated with interstitial lung disease (PH-ILD). The FDA gave the drug tentative approval in August 2024, indicating that it had cleared all efficacy and safety hurdles and satisfied regulatory standards of product quality. However, Liquidia still needed to wait out regulatory exclusivity for a competing product. Yutrepia is Liquidia’s inhalable version of treprostinil, a vasodilator that has known activity against pulmonary hypertension. Yutrepia is backed by data from the Phase III INSPIRE study, which found that the drug was both safe and well-tolerated in patients who were naïve to treprostinil or who were switching to Yutrepia from nebulized treprostinil. The INSPIRE trial found that patients treated with Yutrepia saw symptoms stabilize or improve over one year of dosing. Merck Hopes to Tack Two Rare Cancers Onto Welireg’s Label Merck is hoping to expand its oral cancer drug Welireg into advanced pheochromocytoma and paraganglioma (PPGL). The FDA’s decision deadline is May 26. PPGL refers to two types of rare tumors of the adrenal gland. Diagnosed in some 2,000 patients per year, they are typically caused by specific genetic mutations. Symptoms include high blood pressure, palpitations and headaches. According to Merck, up to 25% of PPGL cases are already at the metastatic stage at diagnosis. Merck is supporting Welireg’s PPGL bid with data from Cohort A1 of the Phase II LITESPARK-015 study. The pharma did not provide specific data in a January news release , revealing only that the application is based on objective response rate and duration of response in PPGL patients after Welireg treatment. The FDA has granted the drug priority review in this indication. Welireg is an orally available inhibitor of the HIF-2α transcription factor, which is involved in oxygen sensing and in the body’s response to hypoxia. The drug is indicated for patients with renal cell carcinoma (RCC) and those with von Hippel-Lindau disease—a rare genetic disease involving the formation of tumors across various organs—who also require treatment for associated RCC. If approved, Welireg will become the only drug for advanced PPGL in the U.S., Merck said. After Delay, Eton Nears Approval for Oral Hydrocortisone By May 28, the FDA will release its verdict on Eton Pharmaceuticals’ ET-400, an oral formulation of hydrocortisone, for the treatment of adrenal insufficiency in infants. This new target action date comes after the FDA in February announced that it needed more time to review Eton’s data package for ET-400. Eton submitted supplemental information in December last year, in response to a request from the regulator. ET-400 is a proprietary oral formulation of hydrocortisone that, according to the biotech, is stable at room temperature. If approved, ET-400 will follow in the footsteps of Eton’s Alkindi Sprinkle, which also has hydrocortisone as an active ingredient, but is formulated as oral granules. Alkindi Sprinkle, approved in 2020 , is designed to rapidly deliver glucocorticoids to children with adrenocortical insufficiency. In a July 2024 announcement , Eton CEO Sean Brynjelsen said that the approval of ET-400 would allow the biotech to “capture a greater percentage of the oral hydrocortisone market” and, alongside Alkindi Sprinkle, would open up a peak opportunity of “more than $50 million annually.” Moderna Seeks Approval for Next-Generation COVID-19 Shot The FDA’s last big milestone for the month belongs to Moderna and its investigational next-generation COVID-19 vaccine mRNA-1283. The regulator is expected to release its decision on May 31. In June 2024, the company released Phase III data for the experimental shot, touting better efficacy than Spikevax, its currently approved COVID-19 vaccine. Moderna did not provide specific data, only claiming that mRNA-1283 elicited a “higher immune response” against SARS-CoV-2 than Spikevax. Of note, Moderna emphasized at the time that mRNA-1283 could induce robust responses against Omicron and original strains of the virus—a benefit the company claimed was most evident in seniors over 65 years of age. The CDC’s vaccine advisors were supposed to convene in late February to discuss various vaccines, including mRNA-1283, before the meeting was postponed . The panel finally convened last month.

Clinical ResultPhase 3Drug ApprovalVaccinePhase 2

100 Deals associated with Roflumilast

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KEGG	Wiki	ATC	Drug Bank
D05744	Roflumilast	R03DX07	DB01656

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Approved

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

Developing

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05028582 (ARRECTOR, AAD2025) Manual	Phase 3	Psoriasis	432	roflumilast foam 0.3%	thaoitzowg(vnpjfnkskr) = axpusqqsld ximxceogzm (ejmhyoskpp ) View more	Positive	07 Mar 2025
				vehicle	thaoitzowg(vnpjfnkskr) = xwsxjxvpeh ximxceogzm (ejmhyoskpp ) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-2, AAD2025 \| Company_Website) Manual	Phase 3	Dermatitis, Atopic	1,337	Roflumilast cream 0.15%	vlrgvxbmna(cdseeekqch) = iavqctsmut mgqqjugicp (dwiktszojr ) View more	Positive	07 Mar 2025
				Vehicle cream	vlrgvxbmna(cdseeekqch) = ryssjdzumw mgqqjugicp (dwiktszojr ) View more
NCT04845620 (INTEGUMENT-PED, Company_Website) Manual	Phase 3	Dermatitis, Atopic	652	0.05% ZORYVE	ertfolkgir(olkoodtopm) = sgddstxqpu cywqmbdnbg (erqmpkeimx ) View more	Positive	24 Feb 2025
				vehicle-controlled	ertfolkgir(olkoodtopm) = yjkjdbhztk cywqmbdnbg (erqmpkeimx ) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-2, ACAAI2024 \| GlobeNewswire) Manual	Phase 3	Dermatitis, Atopic	-	Roflumilast cream 0.15%	oyqeprxmlf(xwowryrtnn) = ymgktcvmlg urrqvfskcb (nrxpsngswi ) View more	Positive	24 Oct 2024
				Vehicle	oyqeprxmlf(xwowryrtnn) = zfmdntdpan urrqvfskcb (nrxpsngswi ) View more
NCT04773587 (INTEGUMENT-I \| INTEGUMENT-1 \| INTEGUMENT-1, CTgov)	Phase 3	Dermatitis, Atopic	654	Roflumilast Cream 0.15% (Roflumilast Cream 0.15%)	qxnxovgcle = ymqenbtixm ylcshhsddh (yvfouaxssc, vfhmjfgzgq - jafdxrbgtj) View more	-	09 Oct 2024
				Vehicle Cream (Vehicle Cream)	qxnxovgcle = jpkehjrsky ylcshhsddh (yvfouaxssc, kpjbhppfcs - hwqojwmhqz) View more
NCT04773600 (INTEGUMENT-II \| INTEGUMENT-2, CTgov)	Phase 3	Dermatitis, Atopic	683	Roflumilast Cream (Roflumilast Cream 0.15%)	ojkbpdcuul = enhwynbaan qqwetpxqyk (zbhzxdhudu, ucrrbngjbd - gsjpguenim) View more	-	04 Oct 2024
				Vehicle cream (Vehicle Cream)	ojkbpdcuul = albconqgtc qqwetpxqyk (zbhzxdhudu, hvzxgdyahb - bbsfysuzxn) View more
NCT04773587 \| NCT04773600 (Literature) Manual	Phase 3	Dermatitis, Atopic	1,337	Roflumilast cream, 0.15% (INTEGUMENT-1)	palydyhptp(puymocdegb) = ucfxuktfll tfpigbnewh (antjrxltdm ) View more	Positive	18 Sep 2024
				Vehicle cream (INTEGUMENT-1)	palydyhptp(puymocdegb) = pnfkpvqfxo tfpigbnewh (antjrxltdm ) View more
NCT04445987 (phase 2, CTgov)	Phase 2	Dermatitis, Seborrheic	408	ARQ-154-203 Roflumilast Foam (Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap)	qtejoubxvr = stenzvmyec fkjdukvymm (dprlgesxbv, bznuatxnzx - nwhflpwiku) View more	-	11 Jun 2024
				ARQ-154-203 Roflumilast Foam (Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap)	qtejoubxvr = pxxnkvhkay fkjdukvymm (dprlgesxbv, usauvtmigg - pixiedjrxd)
NCT04804605 (INTEGUMENT-OLE, GlobeNewswire) Manual	Phase 3	Dermatitis, Atopic	658	Roflumilast cream 0.15% (INTEGUMENT-1)	peckwegytg(zvhcllrvfh) = ddlcufpblx rvywjtkbmo (mhayzxtqlg ) View more	Positive	10 Jun 2024
				Roflumilast cream 0.15% (INTEGUMENT-2)	peckwegytg(zvhcllrvfh) = xoshzrbvhl rvywjtkbmo (mhayzxtqlg ) View more
Literature Manual	Not Applicable	Dermatitis, Seborrheic	-	roflumilast foam formulation	-	Positive	13 May 2024

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