[Translation] A multicenter, randomized, double-blind, parallel, vehicle-controlled phase II clinical study to evaluate the efficacy and safety of SHR0302 alkaline gel in subjects with non-segmental vitiligo

主要目的：评价在非节段型白癜风受试者中SHR0302碱凝胶治疗的有效性。次要目的：评价在非节段型白癜风受试者中SHR0302碱凝胶治疗其他的疗效终点和受试者报告结局的影响；评价在非节段型白癜风受试者中SHR0302碱凝胶治疗的安全性及耐受性；评价SHR0302碱凝胶的药代动力学和药效学特征。

[Translation]

Primary objective: To evaluate the efficacy of SHR0302 alkaline gel treatment in subjects with non-segmental vitiligo. Secondary objectives: To evaluate the effects of SHR0302 alkaline gel treatment on other efficacy endpoints and subject-reported outcomes in subjects with non-segmental vitiligo; To evaluate the safety and tolerability of SHR0302 alkaline gel treatment in subjects with non-segmental vitiligo; To evaluate the pharmacokinetic and pharmacodynamic characteristics of SHR0302 alkaline gel.

Start Date11 Feb 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT06790862

/ RecruitingPhase 2

A Multicenter, Randomized, Double-blind, Parallel, Excipient-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR0302Base in Subjects With Nonsegmental Vitiligo

The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.

Start Date11 Feb 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT06731153

/ Not yet recruitingPhase 2IIT

A Randomized, Controlled, Open-label, Phase II Clinical Study Evaluating the JAK1 Inhibitor Ivarmacitinib to Reverse Immunotherapy Resistance in Triple-negative Breast Cancer

This is a prospective, open-label, randomized phase II clinical study which recruits unresectable recurrent or metastatic triple-negative breast cancer resistant to immunotherapy.

Start Date01 Dec 2024

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Ivarmacitinib

100 Translational Medicine associated with Ivarmacitinib

100 Patents (Medical) associated with Ivarmacitinib

Literatures (Medical) associated with Ivarmacitinib

01 Apr 2025·Indian Journal of Clinical Biochemistry

SHR0302 Improves Treg/Th17 Imbalance in Patients with Systemic Lupus Erythematosus

Article

Author: Jaafar, Halmat M ; Maroof, Avin Mohammad Arif ; Mohammad, Talar Ahmad Merza

IL-6-mediated JAK1/STAT3 signaling pathway is involved in the development of Th17 cells, which play an essential role in the pathogenesis of various autoimmune diseases such as systemic lupus erythematosus (SLE). To evaluation of the regulatory and anti-inflammatory effects of the JAK1/STAT3 inhibition in SLE, we evaluated the effects of SHR0302 on regulatory T cell (Treg)/Th17 balance. Thirty-two patients with SLE and twenty-nine healthy subjects were enrolled in this study. The mRNA expression levels of anti- and pro-inflammatory cytokines, such as FOXP3, ROR-γt, IL-10, IL-17A, IL-21, and IRF-4, were determined using real-time PCR, and the cytokine levels of IL-6, IL-10, IL-17A, TNF-α, and IFN-γ were analyzed by ELISA. The frequency and in vitro development of CD4+ CD25+ Foxp3+ Treg and Th17 cells were evaluated by flow cytometry. SHR0302 could increase the mRNA expression and cytokine level of Treg-related molecules. Furthermore, numbers of Treg cells were increased, after treatment with SHR0302. In contrast, the mRNA expression level of Th17-related molecules, ROR-γt, IL-17A, and IL-21, were decreased. Reduction of inflammatory cytokine levels was a confirmation of the modulating effect of the SHR0302, including IL-6, IL-17, TNF-α, and IFN-γ. In addition, frequency of Th17 cells were reduced by SHR0302. Our study shows that SHR0302 regulating the JAK1/STAT3 pathway can be a new treatment option for SLE.

01 Feb 2025·MedComm

Butyrolactone I blocks the transition of acute kidney injury to chronic kidney disease in mice by targeting JAK1

Article

Author: Zhang, Xiaotian ; Chen, Xia ; Zou, Yu ; Huang, Jianzheng ; Zhao, Ziming ; Tong, Qingyi ; Xiao, Yang ; Xiang, Ming ; Chen, Chengjuan ; Zhang, Yonghui ; Zhang, Tiantai ; Gu, Lianghu ; Huang, Kun ; Qi, Changxing ; Zhang, Zijun

Abstract:

Chronic kidney disease (CKD) is a disease that affects more than 850 million people. Acute kidney injury (AKI) is a common cause of CKD, and blocking the AKI–CKD transition shows promising therapeutic potential. Herein, we found that butyrolactone I (BLI), a natural product, exerts significant nephroprotective effects, including maintenance of kidney function, inhibition of inflammatory response, and prevention of fibrosis, in both folic acid‐ and ureteral obstruction‐induced AKI–CKD transition mouse models. Notably, BLI showed greater blood urea nitrogen reduction and anti‐inflammatory effects than telmisartan. Bioinformatics analysis and target confirmation assays suggested that BLI directly binds to JAK1, and kinase inhibition assay confirmed it is a potent JAK1inhibitor with an IC50 of 0.376 µM. Experiments in JAK1‐knockdown mice also proved that BLI targets JAK1 to work. Furthermore, BLI demonstrated nephroprotective effects and safety comparable to ivarmacitinib, the well‐known JAK1 inhibitor. Mechanistically, BLI targets JAK1 and inhibits its phosphorylation and JAK‐STAT activation, subsequently regulating the downstream signaling pathways to inhibit reactive oxygen species production, inflammation, and ferroptosis, thereby preventing the occurrence of kidney fibrosis and blocking the AKI–CKD transition process. This study demonstrates for the first time that BLI is a JAK1 inhibitor and a promising candidate for delaying CKD progression, which warrants further investigation.

01 Feb 2025·ANNALS OF THE RHEUMATIC DISEASES

Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial

Article

Author: Li, Yasong ; He, Xiaohong ; Jiang, Zhenyu ; Lin, Changsong ; Zhan, Feng ; Xie, Xi ; Duan, Xinwang ; Chen, Lin ; Yang, Lei ; Sun, Yuqi ; Jin, Hongtao ; Qian, Long ; Zeng, Xiaofeng ; Du, Zhengfu ; Zheng, Zhaohui ; Xu, Shengqian ; Gong, Huiping ; Liu, Jinjing ; Mi, Cundong ; Liu, Shengyun ; Dong, Guangchao ; Zhang, Shangzhu ; Su, Jingbo ; Wei, Hua ; Liu, Jing ; Wang, Jian ; Zhang, Ning ; Zhu, Jing ; Luo, Hui ; Xie, Qibing ; Shi, Xiaofei ; Wu, Rui ; Jiang, Ying ; Geng, Xiuqin ; Liu, Huaxiang

OBJECTIVE:

To assess the efficacy/safety of ivarmacitinib, a selective Janus kinase (JAK) 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

METHODS:

Patients were randomised (1:1:1) to receive either placebo (n=188), ivarmacitinib 4 mg (n=189) or ivarmacitinib 8 mg (n=189) once daily, with background csDMARDs allowed. After 24 weeks, patients on placebo switched to ivarmacitinib 4 mg for an additional 28 weeks, while those on ivarmacitinib continued their initial dosage. The primary endpoint was the proportion of patients achieving a 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24.

RESULTS:

At week 24, ACR20 response rates were significantly higher in the ivarmacitinib 4 mg (70.4%) and 8 mg (75.1%) groups compared with the placebo group (40.4%; both p<0.0001). Both ivarmacitinib doses achieved numerically higher Disease Activity Score 28-joint count C reactive protein of <2.6/≤3.2 response rates compared with placebo. Improvements in efficacy and patient-reported outcomes were sustained through 52 weeks and were noted in patients who switched from placebo after week 24. During the placebo-controlled period, treatment-emergent adverse events (TEAEs) occurred in 81.5% and 90.5% of patients in the ivarmacitinib 4 mg and 8 mg groups, versus 79.3% in the placebo group. Infection-related TEAEs were slightly higher in the ivarmacitinib groups.

CONCLUSIONS:

Ivarmacitinib may offer a potential therapeutic option for patients with RA who have an inadequate response to csDMARDs, with a safety profile that was generally manageable over 1 year of treatment and similar to other JAK inhibitors.

TRIAL REGISTRATION NUMBER:

NCT04333771.

News (Medical) associated with Ivarmacitinib

19 Mar 2025

·www.drugs.com

American Academy of Dermatology, March 7 to 11

The annual meeting of the American Academy of Dermatology was held from March 7 to 11 in Orlando, Florida, and attracted clinicians, academicians, allied health professionals, and others interested in dermatology. The conference highlighted recent advances in the diagnosis and management of dermatological conditions. During one presentation, Joshua Cook, M.D., of the Columbia University Irving Medical Center in New York City, noted that targeting insulin resistance and hyperinsulinemia is important not only for the treatment of obesity and diabetes, but potentially also independently for improving metabolism-related inflammatory skin diseases like psoriasis and hidradenitis suppurativa. Cook discussed the tight epidemiologic connection between obesity, type 2 diabetes, and inflammatory skin diseases, especially psoriasis. The mechanistic basis of this connection is likely due to insulin resistance and/or hyperinsulinemia. Cook noted that hyperinsulinemia likely drives excessive proliferation and inflammation of skin lesions in psoriasis and other inflammatory skin diseases, even in the setting of systemic insulin resistance. "We are currently performing clinical studies to better understand the role of insulin action in psoriasis," Cook said. "Health care providers should strongly consider screening patients with overweight/obesity and inflammatory skin diseases with hemoglobin A1c, fasting glucose, and lipid profiles. Treatment of obesity and type 2 diabetes with glucagon-like peptide-1 receptor agonists may improve inflammatory skin disease activity (an area of active research). There may also be roles for metformin and pioglitazone in inflammatory skin disease treatment in select patients." Abstract During another presentation, Daniel Charles Butler, M.D., of the University of Arizona College of Medicine in Tucson, discussed the connection between itch and aging. Butler discussed how itch is very common in the older adult population. He noted there are many etiologic contributors to itch, including the immune system, the skin barrier, and the cutaneous nerves, all of which are uniquely impacted by aging. "As practicing clinicians, we need to substantiate itch as a real, impactful but targetable symptom and disease," Butler said. "The connection between age and itching allows us to target contributing etiologies with available treatments. For example, itch in older adults is often multifactorial with immunologic changes and neuropathic changes. This allows us to use treatment to target multiple contributors." Butler disclosed financial ties to the pharmaceutical industry. Abstract Adam J. Friedman, M.D., of the George Washington School of Medicine and Health Sciences in Washington, D.C., discussed how food allergy is an extremely rare cause of chronic urticaria with no identifiable cause (CSU), and some food intolerances may contribute, but responses are highly individualized and elimination diets should only be done in a structured way. Friedman provided insight into how urticaria, both acute and chronic, is a common condition, affecting as many as 80 percent of people at some point in their lives. For approximately 1 percent of individuals who develop chronic urticaria, this condition can last for years, significantly impacting quality of life. While patients often search for a clear trigger, more than two-thirds of cases occur without an identifiable cause. Although food allergies can trigger acute urticaria, particularly in children, when it comes to CSU, food allergy is rarely a culprit. Friedman noted that, instead, he often sees food intolerances or pseudoallergic reactions, which may contribute to symptoms in some individuals. This distinction is important because a true food allergy involves an immune response, and food intolerances tend to be more variable, harder to predict, and less understood. A number of studies have explored dietary interventions in CSU, but the results so far have been mixed at best. "At the end of the day, lifestyle modifications are cost-effective, noninvasive, and worth exploring, but they require proper education and guidance -- both for patients and physicians. This remains an underfunded and underresearched area, but as interest grows, we may gain clearer insights into how diet influences CSU," Friedman said. "While it's tempting to believe that cutting out a few foods might be a silver bullet, CSU is a complex, multifactorial condition. And as with most things in dermatology, there's rarely a one-size-fits-all approach." Friedman disclosed financial ties to the pharmaceutical industry. Abstract Peggy A. Wu, M.D., of the University of California Davis in Sacramento, discussed how systemic contact dermatitis (SCD) is a diagnosis to consider in the setting of a chronic, recalcitrant rash in the right clinical setting, although the diagnosis is not common. Wu discussed how SCD represents a small subset of allergic contact dermatitis (ACD) diagnoses. Like ACD, SCD is thought to be a delayed hypersensitivity reaction, and as such, reactions follow exposures in hours to days. SCD can present in a myriad of ways, including, most commonly, vesicular bilateral hand dermatitis, generalized dermatitis, and periorificial dermatitis. Frequent causes of SCD include exposure to nickel, balsam of Peru, and fragrance. The diagnosis is usually made in the setting of a chronic rash with positive patch test results to an allergen with plausible, relevant dietary sources and following topical avoidance of identified allergens. "Physicians should consider the diagnosis of SCD in the setting of a recalcitrant chronic rash with certain phenotypes (vesicular bilateral hand dermatitis, generalized dermatitis, periorificial) and positive patch test reactions to allergen(s) with a possible relevant dietary source," Wu said. "A recommended approach to SCD is to start with a one-month trial of dietary modification. Longer courses of dietary modification may benefit from working with a dietitian to maintain nutritional need." Abstract AAD: Baricitinib Efficacious for Hair Regrowth in Teens With Severe Alopecia Areata TUESDAY, March 18, 2025 -- For adolescents with severe alopecia areata, baricitinib is efficacious for hair regrowth, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text AAD: Maintenance of Low Eczema Activity Seen After About 80 Days Off Tapinarof FRIDAY, March 14, 2025 -- Patients with atopic dermatitis who achieve completely clear skin with tapinarof ( Vtama ) cream maintain low disease activity after about 80 days off treatment, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text AAD: Ivarmacitinib 4 mg, 8 mg Efficacious for Adults With Severe Alopecia Areata THURSDAY, March 13, 2025 -- For adults with severe alopecia areata, ivarmacitinib, a selective Janus kinase 1 inhibitor, at doses of 4 and 8 mg is efficacious and tolerable, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

13 Mar 2025

·www.drugs.com

AAD: Ivarmacitinib 4 mg, 8 mg Efficacious for Adults With Severe Alopecia Areata

THURSDAY, March 13, 2025 -- For adults with severe alopecia areata (AA), ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, at doses of 4 and 8 mg is efficacious and tolerable, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Jianzhong Zhang, M.D., of the Peking University People's Hospital in Beijing, and colleagues examined the efficacy and safety of ivarmacitinib in adults with severe AA (≥50 percent scalp hair loss, including alopecia totalis/universalis) in a phase 3 trial. Three hundred thirty patients were randomly assigned to receive either daily oral ivarmacitinib (4 or 8 mg) or placebo for 24 weeks (109, 111, and 110 patients, respectively), followed by a double-blind extension phase of 28 weeks. After 24 weeks, patients receiving placebo were re-randomly assigned to ivarmacitinib 4 or 8 mg. The researchers found that 34.9, 40.6, and 9.0 percent of those assigned to ivarmacitinib 4 mg, 8 mg, and placebo, respectively, achieved a Severity of Alopecia Tool score ≤20 at week 24. The response rate difference versus placebo was 25.6 and 31.6 percent, respectively, for ivarmacitinib 4 mg and 8 mg. Treatment-emergent adverse events occurred in 77.1, 84.7, and 75.5 percent of those assigned to ivarmacitinib 4 mg, 8 mg, and placebo, respectively, during the placebo-controlled period. No new safety signals emerged. No deaths, thromboembolic events, or major cardiovascular events were reported; one stage III follicular lymphoma case and one thyroid cancer case were reported with ivarmacitinib 4 mg and 8 mg, respectively. "Ivarmacitinib, at 4-mg and 8-mg doses, demonstrated significant efficacy and tolerability in patients with severe AA," the authors write. The study was funded by Jiangsu Hengrui Pharmaceuticals, the developer of ivarmacitinib. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 3AACRASH

25 Feb 2025

·investors.arcutis.com

Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Q4 2024 net product revenue for ZORYVE® (roflumilast) was $69.4 million, a 413% increase compared to Q4 of 2023 and a 55% increase compared to Q3 of 2024; driven by strong portfolio demand growth and including a non-recurring adjustment of $4.1 million due to a reduction in reserves for product returns Full Year 2024 net product revenue for ZORYVE was $166.5 million, an increase of 471% over the prior year, setting the stage for sustained growth and strong financial position in 2025 ZORYVE is now the most prescribed branded non-steroidal topical treatment across three major inflammatory skin conditions combined in the United States Supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream, 0.05%, submitted to the Food and Drug Administration (FDA) for the treatment of atopic dermatitis in children ages 2 to 5 Made a partial prepayment of $100 million of principal on $200 million of then outstanding debt with the ability to re-draw it in whole or in part WESTLAKE VILLAGE, Calif., Feb. 25, 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 and year ended December 31, 2024, and provided a business update. “Our success in 2024 was driven by growing ZORYVE momentum, including commercial launches for two new indications for ZORYVE, and our pricing and access strategy that led to strong commercial and government reimbursement. ZORYVE is the number one prescribed branded non-steroidal topical, due to its compelling value proposition of effectively and safely relieving multiple inflammatory skin conditions anywhere on the body for any duration,” said Frank Watanabe, president and chief executive officer. “We are also continuing to advance our product pipeline and, along with strong stewardship of our financial resources and management of expenses, we believe we are well positioned to realize our mission of addressing unmet needs and the lack of innovation in medical dermatology.” 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 360,000 prescriptions filled since launch by over 14,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. ZORYVE cream is covered by the three largest Pharmacy Benefit Managers (PBMs) and multiple other commercial insurers, and during the quarter the Company expanded its Medicaid coverage to two additional states, Ohio and Illinois. The Company aims to obtain Medicaid coverage in additional states, as well as some Medicare coverage, during 2025. ZORYVE cream 0.3% saw significant gross-to-net (GTN) improvement in 2024 and has reached its steady state GTN. Initial launch of ZORYVE cream 0.15% in atopic dermatitis has been strong with over 33,000 prescriptions filled since launch, and is covered as a line extension by two of the largest national PBMs. The Company anticipates continued improvement in coverage during 2025. The Company submitted an sNDA for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5 with an anticipated target action date in Q4 of 2025, if accepted as submitted. 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 246,000 prescriptions filled since launch, reflecting the high unmet need in this disease. ZORYVE foam is also covered by the three largest PBMs and has steadily improved coverage over the course of 2024. ZORYVE foam has gained Medicaid coverage in line with ZORYVE cream 0.3% and is nearing a 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, which was accepted by the FDA in September with a PDUFA action date set for 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 H1 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 In October 2024, the Company made a partial prepayment of $100 million of principal on $200 million of then outstanding debt. The Company amended the $200 million term-loan with SLR Investment Corp. in August 2024, obtaining an option to prepay up to $100 million of the principal and re-draw it in whole or in part, at the Company’s discretion. In October 2024, Health Canada approved ZORYVE® (roflumilast) foam 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older, and the Company commenced sales in December. In November 2024, ZORYVE cream 0.15% received Glamour’s 2024 Health and Wellness Award for "Best Eczema Product". Obtained one new U.S. patent in Q4 2024 related to topical roflumilast compositions. In February 2025, announced a partnership with the iconic professional football player Odell Beckham Jr., to help raise awareness of seborrheic dermatitis and share his positive experience with ZORYVE foam. Fourth Quarter and Full Year 2024 Summary Financial Results Total revenues for the quarter ended December 31, 2024 were $71.4 million compared to $13.5 million for the corresponding period in 2023. The quarter ended December 31, 2024 included Other revenue of $2.0 million and a non-recurring adjustment of $4.1 million due to a reduction in reserves for product returns. Total revenues for the year ended December 31, 2024 were $196.5 million compared to $59.6 million for the corresponding period in 2023. These year-over-year increases were due to strong unit demand growth as well as improvements in GTN sales deductions. In addition, 2024 and 2023 include Other revenue of $5.0 million and $30.0 million, respectively, related to the Huadong License and Collaboration Agreement. 2024 also includes Other revenue of $25.0 million from an upfront payment in connection with the Sato License Agreement, bringing Other revenue in 2024 to $30.0 million. Cost of sales for the quarter ended December 31, 2024 were $6.9 million compared to $2.2 million for the corresponding period in 2023. Cost of sales for the year ended December 31, 2024 were $19.1 million compared to $5.0 million for the corresponding period in 2023. Research and development (R&D) expenses for the quarter ended December 31, 2024 were $14.5 million compared to $23.8 million for the corresponding period in 2023. R&D expenses for the year ended December 31, 2024 were $76.4 million compared to $110.6 million for the corresponding period in 2023. These year-over-year decreases were due to decreased clinical development costs related to our topical roflumilast programs. Selling, general, and administrative (SG&A) expenses for the quarter ended December 31, 2024 were $57.6 million compared to $48.7 million for the corresponding period in 2023. SG&A expenses for the year ended December 31, 2024 were $229.4 million compared to $185.1 million for the corresponding period in 2023. These year-over-year increases were primarily due to higher sales force headcount and sales and marketing expenses related to the launches of ZORYVE. Net loss was $10.8 million, or $0.09 per basic and diluted share, for the quarter ended December 31, 2024 compared to $66.3 million, or $0.72 per basic and diluted share, for the corresponding period in 2023. Net loss was $140.0 million, or $1.16 per basic and diluted share, for the year ended December 31, 2024 compared to $262.1 million, or $3.78 per basic and diluted share, for the corresponding period in 2023. Cash, cash equivalents, restricted cash, and marketable securities were $228.6 million as of December 31, 2024, compared to $272.8 million as of December 31, 2023. Net cash used in operating activities was $0.7 million during the fourth quarter and $112.2 million during the full year 2024. Conference Call and Webcast Arcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and year 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 including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, 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 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: MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, VP Finance and Corporate Controllerir@arcutis.com

Clinical ResultDrug ApprovalPhase 1Phase 3Phase 2

100 Deals associated with Ivarmacitinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	25 Mar 2025
Ankylosing Spondylitis	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Mar 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alopecia Areata	NDA/BLA	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	05 Sep 2024
Dermatitis, Atopic	NDA/BLA	China	Reistone Biopharma Co. Ltd.Startup	09 Jun 2023
Dermatitis, Atopic	NDA/BLA	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	09 Jun 2023
Axial Spondyloarthritis	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Aug 2022
Non-radiographic axial spondyloarthritis	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Aug 2022
Colitis, Ulcerative	Phase 3	United States	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	China	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	Georgia	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	Poland	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	Ukraine	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05470413 (NEWS) Manual	Phase 3	Alopecia Areata	330	艾玛昔替尼 4 mg QD	pdmnqryhxa(wsikyxmizo) = jgmbdslbvy qhleerunxf (stnetlcwrk ) View more	Positive	11 Mar 2025
				艾玛昔替尼 8 mg QD	pdmnqryhxa(wsikyxmizo) = gxrfcgobxu qhleerunxf (stnetlcwrk ) View more
NCT04333771 (phase III, Pubmed \| Ann Rheum Dis)	Phase 3	Rheumatoid Arthritis	-	Ivarmacitinib 4 mg	iavdyvbubr(wihwxgzjgy) = aeqmjcovwl dagjigecpq (mmzpntyaix )	Positive	01 Feb 2025
				Ivarmacitinib 8 mg	iavdyvbubr(wihwxgzjgy) = bzsgxkqsjg dagjigecpq (mmzpntyaix )
NCT04811131 (CTgov)	Phase 2	Nonsegmental vitiligo	114	NB-UVB phototherapy active treatment+ARQ-252 cream 0.3% (Active IP and Active Phototherapy)	xxqfibwhob(otorhirqcg) = wxfmpzfvrx wdvlxbtein (ayftdownkk, 25.0121) View more	-	12 Jul 2024
				NB-UVB phototherapy sham treatment+ARQ-252 cream 0.3% (Active IP and Sham Phototherapy)	xxqfibwhob(otorhirqcg) = lqdfarjuef wdvlxbtein (ayftdownkk, 11.8841) View more
NEWS Manual	Phase 2/3	Ankylosing Spondylitis	373	SHR0302 4mg	nkdnisfqfq(jcozsrhkpf) = gwecejwnew iekojmymex (pfyvtbtnsd ) View more	Positive	15 Jun 2024
				Placebo	nkdnisfqfq(jcozsrhkpf) = alrmmijkye iekojmymex (pfyvtbtnsd ) View more
NCT04333771 (EULAR 12024 \| EULAR 22024) Manual	Phase 3	Rheumatoid Arthritis	566	SHR0302 4mg	bubfzwzpmq(xodqjvcspy) = dpscmfodiz wycwsfgwmm (rzmsbpeynx ) View more	Positive	12 Jun 2024
				SHR0302 8mg	bubfzwzpmq(xodqjvcspy) = maursxgljz wycwsfgwmm (rzmsbpeynx ) View more
NCT04481139 (EULAR2024) Manual	Phase 2/3	Ankylosing Spondylitis	350	SHR0302 4 mg	rbllfqdefq(zipvposuft) = msjsemktjc ghgeiwwbgv (vtdytfvtkt ) View more	Positive	05 Jun 2024
				Placebo	rbllfqdefq(zipvposuft) = yydmdkrldc ghgeiwwbgv (vtdytfvtkt ) View more
NCT04378569 (CTgov)	Phase 1/2	Chronic eczema	230	ARQ-252 Cream (Cohort 1: ARQ-252 Cream 0.3% QD)	izvmhuchvu = oyghufimkn mrykngomcd (lqtoidhmni, qsnnvuwwgv - jcovqksjga) View more	-	05 Apr 2024
				ARQ-252 Cream (Cohort 2: ARQ-252 Cream 0.3% QD)	uuubqxphbn = tmbphfvkmr mskkkbfhys (yrjuxbhsgr, upniozvcdq - sluefgnkxr) View more
ASH2023	Phase 1	Chronic graft-versus-host disease First line	18	SHR0302	hwlmnbspvw(lozlegwppz) = ohcidcikma iempatinob (owhfycyfed ) View more	-	10 Dec 2023
NCT04162899 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis \| Dermatitis, Atopic	105	Drug: SHR0302 (Active Comparator: SHR0302 Dose A)	zargunzdrs = ledjhdxqcd sqitbebvmb (limvfabvvo, xtfzajarfp - qosbtyeiwc) View more	-	09 May 2023
				Drug: SHR0302 (Active Comparator: SHR0302 Dose B)	zargunzdrs = qjdnzqxkcd sqitbebvmb (limvfabvvo, ebborakpuj - sighzeyqls) View more
NCT04875169 (QUARTZ3, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	336	Ivarmacitinib 8 mg	nstrjsjmpi(bbhaxqtfhn) = nefqjgtaom jtyntkkubw (sjgxcpdcmc ) Met View more	Positive	18 Mar 2023
				Ivarmacitinib 4 mg	nstrjsjmpi(bbhaxqtfhn) = vbntztabfx jtyntkkubw (sjgxcpdcmc ) Met View more

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