罗氟司特(Roflumilast) - 药物靶点：PDE4_在研适应症：特应性皮炎，脂溢性皮炎，斑块状银屑病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ARQ-151 Cream 0.3%、ARQ-154 Foam、Roflumilast (JAN/USAN/INN)

+ [16]

靶点

PDE4

作用方式

抑制剂

作用机制

PDE4抑制剂(磷酸二酯酶4抑制剂)

治疗领域

免疫系统疾病呼吸系统疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

特应性皮炎脂溢性皮炎斑块状银屑病+ [5]

非在研适应症

气道病变过敏性哮喘阿尔茨海默症+ [9]

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构

Arcutis Biotherapeutics, Inc.AstraZeneca ABAstraZeneca Pharmaceuticals LP

+ [1]

非在研机构

AstraZeneca PLC

Takeda Pharmaceutical Co., Ltd.

Sol-Gel Technologies Ltd.

最高研发阶段批准上市

首次获批日期

欧盟 (2010-07-05),

慢性阻塞性肺疾病

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

分子式C17H14Cl2F2N2O3

InChIKeyMNDBXUUTURYVHR-UHFFFAOYSA-N

CAS号162401-32-3

关联

158

项与罗氟司特相关的临床试验

NCT06860958

/ Recruiting临床3期IIT

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

开始日期2025-03-01

申办/合作机构

Tanta University

CTR20243893

/ Recruiting临床3期

评价0.15%罗氟司特乳膏（ZORYVE®）在轻中度特应性皮炎患者中有效性和安全性的多中心、随机、双盲、赋形剂对照的Ⅲ期桥接研究

主要目的：？评估罗氟司特乳膏在轻中度AD受试者中的有效性。次要目的：？评估罗氟司特乳膏在轻中度AD受试者中的其他疗效指标；？评估罗氟司特乳膏在轻中度AD受试者中的安全性；？评估罗氟司特乳膏在轻中度AD受试者中的药代动力学特征。

开始日期2024-11-21

申办/合作机构

Arcutis Biotherapeutics, Inc.

[+2]

NCT06631170

/ Recruiting临床3期

A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients with Mild to Moderate Atopic Dermatitis

This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

开始日期2024-11-21

申办/合作机构

杭州中美华东制药有限公司

100 项与罗氟司特相关的临床结果

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100 项与罗氟司特相关的转化医学

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100 项与罗氟司特相关的专利（医药）

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1,250

项与罗氟司特相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

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

Article

作者: 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.

2025-12-01·INFLAMMATION RESEARCH

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

Article

作者: 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 ; Costa, Victor Rodrigues de Melo ; Teixeira, Mauro Martins ; Beltrami, Vinícius Amorim ; Queiroz-Junior, Celso Martins ; Santos, Felipe Rocha da Silva ; Guimaraes, Goulart ; Resende, Letícia Cassiano

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.

2025-07-01·RESPIRATORY PHYSIOLOGY & NEUROBIOLOGY

Roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, induces respiratory frequency plasticity that is resistant to inflammation in neonatal rat in vitro preparations

Article

作者: Watters, Jyoti J ; Johnson, Stephen M ; Rastas, Jacob P ; Desai, Pujal S ; Baker, Tracy L

Premature and newborn infants often have prolonged apneas and are susceptible to bacterial infections that further disrupt breathing. Phoshodiesterase-4 (PDE4) inhibitor drugs increase inspiratory motor activity and appear to induce a long-lasting increase in inspiratory frequency ("frequency plasticity"). To test whether a PDE4 inhibitor drug induces frequency plasticity, neonatal rat brainstem-spinal cords were isolated and exposed to bath-applied roflumilast (10 min, 0.02-1.0 µM). Roflumilast acutely increased burst frequency and induced frequency plasticity in a concentration-dependent manner. Blockade of protein kinase A (PKA) or exchange protein activated by cAMP (EPAC) signaling pathways abolished the induction, but not the maintenance, of roflumilast-induced frequency plasticity. Brainstem-spinal cords isolated from neonatal rats injected with lipopolysaccharide (LPS, 0.1 mg/kg, 3 h prior) expressed frequency plasticity following bath-applied roflumilast at 0.05-0.5 µM, but not at lower concentrations. This shows that roflumilast-induced frequency plasticity is largely resistant to LPS-induced inflammation. Thus, roflumilast increases inspiratory burst frequency acutely and induces frequency plasticity even during ongoing inflammation, which could have important clinical implications.

273

项与罗氟司特相关的新闻（医药）

2025-04-30

·药事纵横

4款重磅药物有望获FDA批准上市|2025年5月

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。在5月，将有4款重磅药物有望获得批准，其中包括：潜在首个获批用于COPD患者每月给药的生物制剂mepolizumab；罗氟司特泡沫（0.3%）新适应症，用于头皮和全身银屑病；潜在用于治疗符合资格的晚期PPGL患者的首款疗法Welireg以及Moderna下一代COVID-19疫苗mRNA-1283。Mepolizumab适应症：嗜酸性慢性阻塞性肺疾病PDUFA日期：2025年5月7日12月9日，GSK宣布，FDA已接受MATINEE研究数据的审查，以支持美泊利珠单抗（Nucala，mepolizumab）作为嗜酸性表型慢性阻塞性肺病（COPD）患者的附加维持治疗药物获得新适应症的监管审查程序，PDUFA日期为2025年5月7日。该药物有望成为首个获批用于COPD患者每月给药的生物制剂。Mepolizumab（美泊利珠单抗）于2015年11月获FDA批准上市，是一种抗IL-5的人源化单克隆抗体，可阻断IL-5与嗜酸粒细胞表面上IL-5受体α链的相互作用，进而阻断IL-5对嗜酸性粒细胞等效应细胞的作用。BLA得到了3期MATINEE试验(NCT04133909)数据的支持，该研究是一项为期52-104周的多中心、随机、双盲、安慰剂对照临床试验（n=806），评估了美泊利珠单抗（100mg，每4周1次，皮下注射）对比安慰剂作为疾病频繁恶化且血嗜酸性粒细胞水平升高的中度至重度COPD患者在维持治疗之外的附加治疗方案的有效性和安全性。研究的主要终点为中度至重度COPD的年恶化率。结果显示，治疗104周后，美泊利珠单抗组患者的年恶化率低于安慰剂组，数据具有统计学意义和临床意义。罗氟司特泡沫（0.3%）适应症：头皮和身体牛皮癣PDUFA日期：2025年5月22日7月23日，Arcutis Biotherapeutics宣布罗氟司特泡沫（0.3%，每日1次）治疗头皮银屑病和全身银屑病的新药补充申请（sNDA）获FDA受理。罗氟司特泡沫（0.3%）是Arcutis开发的一种改良型新药，于2023年12月在美国获批上市，用于治疗脂溢性皮炎。Arcutis还开发了一款罗氟司特乳膏（0.3%），该产品已于2022年7月获FDA批准上市，适应症为斑块状银屑病。2023年8月，华东医药与Arcutis达成合作，引进了罗氟司特泡沫和罗氟司特乳膏在大中华区和东南亚地区的开发、注册、生产和商业化权益。此次sNDA主要是基于III期ARRECTOR研究的积极结果。该研究是一项随机、双盲、安慰剂对照临床试验（N=432），评估了罗氟司特泡沫（0.3%）治疗12岁及以上青少年和成人头皮银屑病和全身银屑病患者的疗效和安全性。研究结果显示，与安慰剂相比，罗氟司特泡沫（0.3%）在头皮和身体银屑病症状方面有统计学显著改善。据报道，使用罗氟司特泡沫（0.3%）后，头皮和身体瘙痒明显减轻。Welireg适应症：晚期嗜铬细胞瘤和副神经节瘤PDUFA日期：2025年5月26日2025年1月27日，默沙东宣布美国FDA已受理其缺氧诱导因子-2α（HIF-2α）抑制剂Welireg（belzutifan）的补充新药申请（sNDA），并授予优先审评资格，用以治疗12岁及以上的晚期、不可切除或转移性嗜铬细胞瘤和副神经节瘤（PPGL）患者。此次申请基于LITESPARK-015临床2期研究的客观缓解率（ORR）和缓解持续时间（DOR）数据。该申请的PDUFA日期为2025年5月26日。根据新闻稿，如果获批，Welireg可能成为美国FDA批准用于治疗符合资格的晚期PPGL患者的首款疗法。Welireg是FDA加速批准的首个HIF-2α抑制剂，用于需要治疗的成人von Hippel-Lindau（VHL）疾病患者，特别是那些伴有相关透明细胞肾细胞癌（RCC）、中枢神经系统血管母细胞瘤或胰腺神经内分泌肿瘤且不需要立即手术的情况。2023年12月，Welireg获美国FDA批准成为首个获批用于晚期RCC患者的HIF-2α抑制剂。Welireg的获批标志着自2015年以来，晚期RCC首次有新机制疗法获得批准。mRNA-1283适应症：COVID-19PDUFA日期：2025年5月31日FDA已接受Moderna下一代COVID-19疫苗mRNA-1283的生物制品许可申请 (BLA)，并指定了PDUFA 目标日期为2025年5月31日。mRNA-1283 的设计旨在增强冷藏条件下的稳定性，并将采用预充式注射器包装，这为流感和新冠联合疫苗的研发铺平了道路，从而增强了公司的整体呼吸系统产品组合。根据第3阶段NextCOVE研究(NCT05815498)的结果，mRNA-1283与 Spikevax 相比表现出非劣效的相对疫苗效力 (rVE）。Spikevax是Moderna已批准上市的一款mRNA新冠疫苗，能编码全长SARS-CoV-2 S蛋白。该疫苗在2020年的关键性试验中达到了94.5%的有效率。然而，实际使用表明Spikevax还有提升空间，尤其是在对抗新变异株方面，另外其还需简化物流。mRNA-1283疫苗则是Moderna尝试实现这些改进的下一代新冠疫苗。参考资料：各公司公告

上市批准临床结果信使RNA临床3期疫苗

2025-04-05

·药通社

化药3类梳理：哪些该BE，哪些要临床？

化药3类，指境内申请人仿制境外上市但境内未上市原研药品的药品。3类药物此前的处境一直比较尴尬，虽然是仿制药范畴，但是又有“真、假、半真3类”多种不同情况，不同的分类有不同的临床要求，企业常常搞不清区别，今天就来探讨一下关于3类仿制的区别和临床申报策略。化药3类在业内人士口中常分真假三类。通常根据实际情况可分为真3类（全新的化合物进入国内）、半真3类（国内有其他剂型产品）、假3类（国内有同品种上市多年）。也可以直接按照是否需要进行验证性临床分为真3类和假3类，本文介绍的是实际情况的分类模式。不同类别化药3类对应不同的临床策略：从3类的临床策略中，3类的临床要求并不能很好的区分，还是具体情况具体分析，以下细分一下情况和举一些具体例子进行分析。No.1剂量探索（I期）+确证性临床研究有种族差异的，需以新药临床思路进行仿制药临床研究。根据BE试验中的PK数据，可以结合原研公布的PK数据进行对比，多角度分析其是否具有PK方面的种族差异，若无PK差异，则可考虑直接开展验证性临床；若有种族差异，按照临床评价的基本逻辑则还应考察中国人群的剂量探索性试验，为验证性临床提供剂量依据。举例：罗氟司特片罗氟司特为PED4抑制剂，作为首个口服的COPD药物备受关注，2010年EMA首次批准，2011年获得FDA批准上市，原研一直未在中国上市，所以该品种作为3类由国内企业申报。但是有研究提示中国受试者药物暴露量明显高于白种人，需首先进行药代研究，根据人种间PK结果考虑开展剂量探索研究，之后再进行验证性临床试验。目前国内欲开发该品种的企业均先行进行了药代动力学临床登记，比如天津红日、北京九洲济康等，但是后续未见继续登记验证性临床，猜测可能由于剂量探索不理想重新评估是否继续开发，也可能由于罗氟司特片原研的销售与预期有差距，仿制企业重新评估是否投入剂量探索+验证性临床开发。No.2BE+验证性临床试验BE证实与原研生物等效，验证性临床确证疗效及安全性。举例1：氟比洛芬酯注射液在氟比洛芬酯注射液上市之前，国内氟比洛芬有片剂和贴剂，所以注射液为改变给药途径，需要证明有效性与安全性，需要验证性临床。同时脂质体作为复杂制剂，具有长效作用，药代动力学不同于普通注射剂，需要进行BE证明与原研等效。所以需要BE+验证性临床。广东嘉博2018年完成BE，2020年完成验证性临床，已批准。后续有2家企业通过BE+验证性临床试验后批准，其他未进行验证性临床的均未批准。举例2：泊马度胺胶囊该品种原研企业为新基，未进口中国上市。国内企业首仿是正大天晴，以验证性临床+BE的申请获得批准。后续齐鲁申报同样做了BE以及验证性临床。No.3验证性临床试验无法或无需进行BE试验的品种，通过验证性临床试验证实有效及安全性。举例1：兰地洛尔注射液原研2002年在日本上市，一直未在中国进口上市，属于真3类，南京海辰做了验证性临床试验，2020年以3类首仿批准生产。举例2：酮洛芬凝胶贴膏原研为日本日本久光，一直未在中国上市，为真3类，九典为首仿，以验证性临床批准，但是因为凝胶贴膏不易做BE试验，所以仅以验证性临床批准。No.4BE试验可豁免验证性临床试验仅以BE试验申请注册。举例1：布比卡因脂质体注射液恒瑞2020年获批，以BE试验批准。国内已有布比卡因注射液上市，所以布比卡因脂质体注射液为假3类，因为已有普通注射液在国内上市多年，该品种免临床，仅需证明与原研的生物等效。举例2：苯扎贝特缓释片苯扎贝特缓释片原研为ACTAVIS，未在中国上市，但是苯扎贝特片，苯扎贝特胶囊、苯扎贝特分散片等剂型国内企业已经上市多年，在中国人群中有明确的有效性与安全性数据，所以苯扎贝特缓释片属于假3类，所以做BE证明与原研等效即可上市。盐酸美金刚缓释胶囊也属于上述情况由于普通胶囊已在国内上市多年，该品种属于半真3类，因此仅需BE试验证明与原研等效，豁免验证性临床。No.5豁免BE及其他临床试验由境内外临床数据支持，通过体外评价证实与原研一致。这一类主要是真溶液，二羟丙茶碱注射液、氯化钾口服溶液等等，数量多不具体举例，此种3类最为简单，豁免BE及其他临床试验。No.6总结从以上实际案例可以看出，3类药物确定临床方案还是得具体情况具体分析，基于有效性与安全性以及国内有没有用药人群的数据等。在《药品试验数据保护实施办法（征求意见稿）》落地之后，企业对3类药物的临床策略变动会较大，但对想要冲击首仿的企业而言，变动并不会大，3类药的临床策略主要依据以下两点：1、根据境外原研药品临床安全性和有效性、以及种族因素影响的基础；2、基于中国患者获益/风险评估的需要，评价中国患者临床需求确定其在境内上市需开展的临床试验技术要求。↓ 扫码加入药通社交流群 ↓投稿/内容沟通：华籍美人（Ww_150525）

上市批准临床1期

2025-04-02

·investors.arcutis.com

Arcutis and Padagis Agree to Stay Patent Lawsuit

WESTLAKE VILLAGE, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, is pleased to announce that Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC (Padagis) have requested a stay to the ongoing patent litigation between Padagis and the Company, and the Company has agreed to enter a joint stipulation to stay the case, which was filed in the U.S. District Court for the District of Delaware on April 2, 2025. After the Court enters the joint stipulation, all calendared dates and trial for the patent litigation will be vacated. As part of the joint stipulation agreement, Padagis is required to report to Arcutis any U.S. Food and Drug Administration (FDA) correspondence regarding their Abbreviated New Drug Application (ANDA) for their potential generic alternative to Arcutis’ patented product, ZORYVE® (roflumilast) cream 0.3% for plaque psoriasis. In addition, the parties agreed to extend the 30-month Hatch-Waxman stay of regulatory approval by one day for every day the litigation is stayed as of March 24, 2025, such that in the event the litigation resumes in the future, Arcutis will still benefit from the entirety of the stay afforded to it under the Hatch-Waxman Act. “This joint stipulation is a positive development for Arcutis that fully preserves our ability to assert our intellectual property while also preserving the Hatch-Waxman stay. As we have previously communicated, we maintain confidence in the strength of our broad patent portfolio that protects the innovative aspects of ZORYVE and in our legal position against Padagis. If and when the stay is lifted, we will continue to vigorously defend our intellectual property rights as appropriate, and to fight against any attempts by Padagis to infringe our patents,” said Frank Watanabe, president and CEO, Arcutis. “Our focus is to continue to build upon the strong adoption of ZORYVE as a safe and effective therapy and alternative to steroids for three major inflammatory dermatoses and continue to deliver meaningful innovation to millions of individuals impacted by plaque psoriasis, seborrheic dermatitis and atopic dermatitis.” Patent protection for ZORYVE cream 0.3% extends until at least 2037. ZORYVE cream 0.3% is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. About ArcutisArcutis 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. INDICATIONSZORYVE 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 INFORMATION ZORYVE 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. 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 Arcutis’ patent portfolio, regulatory processes and litigation and related proceedings, as well as adoption of ZORYVE. 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:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com

专利侵权

100 项与罗氟司特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05744	罗氟司特	R03DX07	DB01656

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
特应性皮炎	美国	Arcutis Biotherapeutics, Inc.	2024-07-10
脂溢性皮炎	美国	Arcutis Biotherapeutics, Inc.	2023-12-15
斑块状银屑病	加拿大	Arcutis Biotherapeutics, Inc.	2019-12-20
慢性阻塞性肺疾病	欧盟	AstraZeneca AB	2010-07-05
慢性阻塞性肺疾病	冰岛	AstraZeneca AB	2010-07-05
慢性阻塞性肺疾病	列支敦士登	AstraZeneca AB	2010-07-05
慢性阻塞性肺疾病	挪威	AstraZeneca AB	2010-07-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
轻度特应性皮炎	临床3期	中国	杭州中美华东制药有限公司	2024-11-21
轻度特应性皮炎	临床3期	中国	Arcutis Biotherapeutics, Inc.	2024-11-21
中度特应性皮炎	临床3期	中国	杭州中美华东制药有限公司	2024-11-21
中度特应性皮炎	临床3期	中国	Arcutis Biotherapeutics, Inc.	2024-11-21
头皮银屑病	临床3期	美国	Arcutis Biotherapeutics, Inc.	2021-08-24
头皮银屑病	临床3期	加拿大	Arcutis Biotherapeutics, Inc.	2021-08-24
慢性大斑块银屑病	临床3期	美国	Arcutis Biotherapeutics, Inc.	2020-02-12
慢性大斑块银屑病	临床3期	加拿大	Arcutis Biotherapeutics, Inc.	2020-02-12
慢性大斑块银屑病	临床3期	多米尼加共和国	Arcutis Biotherapeutics, Inc.	2020-02-12
哮喘	临床3期	美国	AstraZeneca PLC	2003-11-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05028582 (ARRECTOR, AAD2025) 人工标引	临床3期	银屑病	432	roflumilast foam 0.3%	壓襯繭簾選糧廠憲願廠(鑰廠範蓋齋製繭簾醖鬱) = 餘顧壓範壓鑰範蓋構蓋衊衊艱壓鹽構鑰窪網鑰 (選願願蓋簾鬱艱鬱鑰遞 ) 更多	积极	2025-03-07
				vehicle	壓襯繭簾選糧廠憲願廠(鑰廠範蓋齋製繭簾醖鬱) = 簾鏇糧蓋鹹願窪艱窪積衊衊艱壓鹽構鑰窪網鑰 (選願願蓋簾鬱艱鬱鑰遞 ) 更多
NCT04773587 \| NCT04773600 (INTEGUMENT-2, AAD2025 \| Company_Website) 人工标引	临床3期	特应性皮炎	1,337	Roflumilast cream 0.15%	膚選壓膚壓醖獵顧艱淵(壓襯獵構襯範鏇廠襯觸) = 壓壓範廠齋鬱鑰壓憲鏇膚選淵鹽艱製築積鹹顧 (衊選觸繭壓簾衊鬱窪鑰 ) 更多	积极	2025-03-07
				Vehicle cream	膚選壓膚壓醖獵顧艱淵(壓襯獵構襯範鏇廠襯觸) = 齋鹽顧鏇衊醖鹹糧製憲膚選淵鹽艱製築積鹹顧 (衊選觸繭壓簾衊鬱窪鑰 ) 更多
NCT04845620 (INTEGUMENT-PED, Company_Website) 人工标引	临床3期	特应性皮炎	652	0.05% ZORYVE	網淵憲淵淵蓋觸鏇醖繭(廠窪積繭網鹹顧憲顧憲) = 壓積鹹鹹醖繭艱衊廠獵淵醖範構鏇範淵顧襯窪 (窪憲醖餘窪憲鬱糧願選 ) 更多	积极	2025-02-24
				vehicle-controlled	網淵憲淵淵蓋觸鏇醖繭(廠窪積繭網鹹顧憲顧憲) = 簾鏇遞鬱淵製艱獵糧選淵醖範構鏇範淵顧襯窪 (窪憲醖餘窪憲鬱糧願選 ) 更多
NCT04773587 \| NCT04773600 (INTEGUMENT-2, ACAAI2024 \| GlobeNewswire) 人工标引	临床3期	特应性皮炎	-	Roflumilast cream 0.15%	範淵壓遞廠糧鏇襯範襯(淵觸艱窪鑰糧構繭淵齋) = 構獵蓋蓋積衊窪鏇鹹顧壓顧憲觸窪獵築鹹鬱齋 (餘醖壓構顧醖鏇選醖積 ) 更多	积极	2024-10-24
				Vehicle	範淵壓遞廠糧鏇襯範襯(淵觸艱窪鑰糧構繭淵齋) = 鹽範觸憲構壓衊繭遞繭壓顧憲觸窪獵築鹹鬱齋 (餘醖壓構顧醖鏇選醖積 ) 更多
NCT04773587 (INTEGUMENT-I \| INTEGUMENT-1 \| INTEGUMENT-1, CTgov)	临床3期	特应性皮炎	654	Roflumilast Cream 0.15% (Roflumilast Cream 0.15%)	廠簾鏇鹽構膚鹹選壓鹽 = 壓齋襯網獵醖積壓簾鑰艱襯鏇齋積遞艱鹽願襯 (糧齋簾醖醖顧夢淵淵網, 憲鹽憲餘憲構網觸顧廠 ~ 蓋窪憲糧憲膚淵繭憲簾) 更多	-	2024-10-09
				Vehicle Cream (Vehicle Cream)	廠簾鏇鹽構膚鹹選壓鹽 = 餘鏇醖蓋夢膚顧餘繭廠艱襯鏇齋積遞艱鹽願襯 (糧齋簾醖醖顧夢淵淵網, 餘壓蓋範簾憲醖繭壓顧 ~ 憲糧築範鏇齋簾遞憲壓) 更多
NCT04773600 (INTEGUMENT-II \| INTEGUMENT-2, CTgov)	临床3期	特应性皮炎	683	Roflumilast Cream (Roflumilast Cream 0.15%)	範築餘選選觸壓顧壓淵 = 衊鬱壓繭膚餘襯夢醖築糧範糧餘夢築艱願鹽獵 (鹹窪鹹醖壓襯鹽網蓋蓋, 選壓鏇獵構廠範憲鏇獵 ~ 鹽鏇齋觸糧網窪顧窪鹽) 更多	-	2024-10-04
				Vehicle cream (Vehicle Cream)	範築餘選選觸壓顧壓淵 = 鏇積淵積餘鏇願鹽鹽壓糧範糧餘夢築艱願鹽獵 (鹹窪鹹醖壓襯鹽網蓋蓋, 鑰膚選鏇鏇壓壓遞簾醖 ~ 積糧壓選觸積範壓蓋獵) 更多
NCT04773587 \| NCT04773600 (Literature) 人工标引	临床3期	特应性皮炎	1,337	Roflumilast cream, 0.15% (INTEGUMENT-1)	築鏇廠積廠鹹餘膚網獵(構衊遞觸鹽窪鬱顧選憲) = 蓋構廠壓壓醖糧鑰獵觸鬱簾築鏇憲膚糧築艱衊 (夢壓簾襯鏇顧顧鹹願顧 ) 更多	积极	2024-09-18
				Vehicle cream (INTEGUMENT-1)	築鏇廠積廠鹹餘膚網獵(構衊遞觸鹽窪鬱顧選憲) = 顧膚鏇廠壓鏇範醖獵鹽鬱簾築鏇憲膚糧築艱衊 (夢壓簾襯鏇顧顧鹹願顧 ) 更多
NCT04445987 (phase 2, CTgov)	临床2期	脂溢性皮炎	408	ARQ-154-203 Roflumilast Foam (Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap)	衊夢襯餘齋餘憲鏇構觸 = 獵衊艱選糧鹽簾蓋選願觸鑰齋繭鑰夢積觸窪簾 (鹹遞網鏇窪簾鹹淵膚糧, 積願獵齋選淵簾顧壓艱 ~ 範糧糧糧鏇鹽淵簾衊鏇) 更多	-	2024-06-11
				ARQ-154-203 Roflumilast Foam (Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap)	衊夢襯餘齋餘憲鏇構觸 = 膚憲積選製膚構艱鑰廠觸鑰齋繭鑰夢積觸窪簾 (鹹遞網鏇窪簾鹹淵膚糧, 選製願獵壓獵積願廠憲 ~ 網衊壓齋醖淵憲窪齋蓋)
NCT04804605 (INTEGUMENT-OLE, GlobeNewswire) 人工标引	临床3期	特应性皮炎	658	Roflumilast cream 0.15% (INTEGUMENT-1)	願網鑰醖願壓積簾選糧(艱鹹構餘壓艱鹹鏇鹽簾) = 壓夢製網廠鹹鹽襯醖鬱積顧鑰選糧夢鹽齋顧襯 (壓夢積積遞願鹽蓋築夢 ) 更多	积极	2024-06-10
				Roflumilast cream 0.15% (INTEGUMENT-2)	願網鑰醖願壓積簾選糧(艱鹹構餘壓艱鹹鏇鹽簾) = 範遞鹽淵鹽製遞壓鬱餘積顧鑰選糧夢鹽齋顧襯 (壓夢積積遞願鹽蓋築夢 ) 更多
Literature 人工标引	N/A	脂溢性皮炎	-	roflumilast foam formulation	-	积极	2024-05-13