This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of Immune Checkpoint Inhibitor Diarrhea and Colitis (IMDC) CTCAE v5.0 grade ≥ 2 due to immune checkpoint inhibitors (ICI) therapy alone or combined with another ICI or ICI plus chemotherapy that in the opinion of the treating physician requires treatment with corticosteroid-based immunosuppression and does not require immediate secondary immune suppression.
The purpose of this study is to improve the treatment of IMDC in people taking ICIs and find out if etrasimod combined with corticosteroids is more effective than a placebo combined with corticosteroids at lowering the total number of corticosteroids needed to treat IMDC.
IMDC is one of the most common Immune Related Adverse Events (irAEs) from treatment with ICI. Current guidelines recommend steroid treatment for IMDC CTCAE grade ≥ 2, which requires that ICI therapy be stopped. Corticosteroids may interfere with ICIs and cannot be given at the same time, Strategies are needed to reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration that patients have to be off ICI therapy. (ICIs are a type of immunotherapy.)

开始日期2024-08-01

申办/合作机构

Yale University

[+1]

NCT06398626 / Not yet recruitingN/A

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod.
All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer.
The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

开始日期2024-07-22

申办/合作机构

Pfizer Inc.

NCT06294925 / RecruitingN/A

Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.
All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.
The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.
The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

开始日期2024-05-08

申办/合作机构

Pfizer Inc.

100 项与依曲莫德精氨酸相关的临床结果

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100 项与依曲莫德精氨酸相关的转化医学

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100 项与依曲莫德精氨酸相关的专利（医药）

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项与依曲莫德精氨酸相关的文献（医药）

2024-01-01·European journal of medicinal chemistry

Design and synthesis of etrasimod derivatives as potent antibacterial agents against Gram-positive bacteria

Article

作者: Hanski, Leena ; San-Martin-Galindo, Paola ; Fallarero, Adyary ; Yli-Kauhaluoma, Jari ; Reigada, Inés ; Zore, Matej ; Patel, Jayendra Z

The emergence of multidrug-resistant bacteria along with a declining pipeline of clinically useful antibiotics has led to the urgent need for the development of more effective antibacterial agents. Inspired by our recent report on the antibacterial activity of etrasimod, an immunomodulating drug candidate, we prepared a series of etrasimod derivatives by varying substituents on the phenyl ring, altering the central tricyclic aromatic ring, and modifying the carboxyl group. From this series of compounds, indole derivative 24f was identified as the most potent antibacterial compound, with the minimum inhibitory concentration (MIC) values between 2.5 and 10 μM against various Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), S. epidermidis and enterococci. Moreover, 24f exhibited rapid bactericidal activity against S. aureus, low toxicity and hemolytic activity, and a synergistic effect with gentamicin against S. aureus, MRSA, and Enterococcus faecalis. Furthermore, it was shown that neither etrasimod nor 24f affects S. aureus cell membranes. Importantly, 24f did not induce resistance in S. aureus, representing a significant improvement compared to etrasimod. Finally, the antibacterial activity of etrasimod and 24f against S. aureus and MRSA was confirmed in vivo in a Caenorhabditis elegans infection model. Taken together, our study highlights the value of etrasimod and its derivatives as potential antibacterial candidates for combating infections caused by Gram-positive bacteria.

2023-12-01·Nature reviews. Gastroenterology & hepatology

Author Correction: Etrasimod for ulcerative colitis: evaluating phase III results

作者: Matsuoka, Katsuyoshi ; Hibi, Toshifumi

2023-12-01·Nature reviews. Gastroenterology & hepatology

Etrasimod for ulcerative colitis: evaluating phase III results

Article

作者: Matsuoka, Katsuyoshi ; Hibi, Toshifumi

187

项与依曲莫德精氨酸相关的新闻（医药）

2024-07-15

·PRNewswire

SKYRIZI's Approval For Ulcerative Colitis Treatment Expands AbbVie's Portfolio Across Immune-mediated Inflammatory Diseases | DelveInsight

AbbVie's rapidly expanding Humira successor, SKYRIZI, is already achieving impressive sales growth. This IL-23 inhibitor is set to capture an even greater portion of Humira's diminishing market share with its crucial expansion into treating ulcerative colitis. LAS VEGAS, July 15, 2024 /PRNewswire/ -- Ulcerative colitis is an idiopathic inflammatory bowel disease affecting ~1.5 million patients in the US and with an unknown exact cause. It affects the colonic mucosa and is clinically characterized by diarrhea, stomach discomfort, pain, and hematochezia. The disease's extent varies, affecting either the rectum, the splenic flexure of the left side of the colon, or the whole of the rectum and bowel. As per DelveInsight analysis, the total ulcerative colitis diagnosed prevalent cases in the 7MM comprised approximately 3 million cases in 2023 and are projected to increase by 2034. Per analyst estimates, approximately 60% of cases accounted for moderate to severe cases of ulcerative colitis among the 7MM. The current treatments for ulcerative colitis depend on the severity of the disease and are broadly divided into six classes, comprising conventional therapies, Anti-TNFs, Anti-integrin agents, IL-12/IL-23 dual inhibitors, S1P-receptor modulators, and JAK inhibitors. The emergence of several mechanisms of action, like LANCL2 protein stimulators, miR-124 enhancers, tumor necrosis factor (TNF)-like ligand 1A inhibitors, toll-like receptor 9 agonists, and others will be expanding the treatment landscape of ulcerative colitis. There have been significant advancements in treating ulcerative colitis over the years. However, safety remains a major challenge. The lack of a safer and curative treatment option severely impacts patients' quality of life and daily activities. While current treatments are effective for some patients with ulcerative colitis, others need multiple lines of therapy, indicating a need for alternative treatments to achieve disease control. Several major pharmaceutical companies are collaborating to develop new solutions to address these issues. Learn more about the FDA-approved ulcerative colitis drugs @ Drugs for Ulcerative Colitis Treatment A few FDA-approved drugs for ulcerative colitis treatment include SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), OMVOH (Eli Lilly) VELSIPITY (Arena Pharmaceuticals/Pfizer), and SKYRIZI (AbbVie). SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein associated with inflammation and tissue damage in chronic inflammatory diseases. It is the first subcutaneous anti-TNF-alpha treatment administered every four weeks as maintenance therapy for ulcerative colitis. Approved for treating moderately to severely active ulcerative colitis in adults, SIMPONI is also being evaluated in ongoing trials for pediatric patients with the same condition. Vedolizumab is a humanized monoclonal antibody that targets and inhibits the alpha 4 beta 7 integrin, preventing it from binding to the intestinal mucosal addressing cell adhesion molecule 1 (MAdCAM-1). This integrin is found in a subset of circulating white blood cells that play a role in the inflammatory processes of ulcerative colitis and Crohn's disease. By blocking the alpha 4 beta 7 integrin, vedolizumab may reduce the infiltration of these white blood cells into gut tissues. It is currently approved as an IV and SC formulation for the treatment of moderately to severely active ulcerative colitis in adults who have not responded to, lost response to, or were intolerant to conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. VELSIPITY (Etrasimod) is an innovative, once-daily oral medication that acts as a highly selective modulator of the sphingosine 1-phosphate (S1P) receptor. Discovered by Arena, it is designed for optimized interaction with S1P receptors 1, 4, and 5, potentially offering better efficacy and safety. Etrasimod targets specific immune cells both systemically and locally and has the potential to treat various immune-mediated inflammatory diseases, such as Crohn's disease and ulcerative colitis. It is currently approved by the FDA and EMA for adults with moderately to severely active ulcerative colitis who have not responded adequately, lost response, or were intolerant to conventional or advanced therapies. Recently, on 18 June 2024, the FDA approved SKYRIZI for treating adult patients with moderately to severely active ulcerative colitis. This approval extends the drug's reach to approximately 1 million US patients and makes SKYRIZI the first IL-23 inhibitor approved for both UC and Crohn's disease, the two types of inflammatory bowel disease (IBD). After a 12-week induction period, patients can self-administer the medication at home using an on-body injector device, which AbbVie's press release describes as "designed with patients in mind." The device attaches to the body and delivers the medication in about five minutes. Since its approval for Crohn's in 2022, Skyrizi has emerged as a strong competitor to Johnson & Johnson's blockbuster drug STELARA in the IBD market. The AbbVie medication has captured a "significant share" of STELARA's sales. To know more about ulcerative colitis treatment options, visit @ New Treatment for Ulcerative Colitis The ulcerative colitis market is crowded with so many companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, and others are running clinical trials to improve the treatment space. The ulcerative colitis pipeline possesses potential drugs in mid-stage developments to be launched shortly. Some of the promising drugs in the pipeline include TREMFYA, ABX464, BT-11 (Omilancor), PRA023, Remestemcel-L, SHR0302 (Ivarmacitinib), and others that hold the potential to create a significant positive shift in the ulcerative colitis market size. Discover which therapies are expected to grab major ulcerative colitis market share @ Ulcerative Colitis Market Report TREMFYA (guselkumab) is a human monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, created by Janssen. IL-23 plays a crucial role in the pathogenesis of inflammatory diseases like ulcerative colitis and Crohn's disease. TREMFYA, an IL-23 inhibitor, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, produced in a mammalian cell line using recombinant DNA technology. It specifically binds to the p19 subunit of IL-23 and blocks its interaction with the IL-23 receptor. In May 2024, Johnson & Johnson released the initial data from the Phase III QUASAR maintenance study in ulcerative colitis, which achieved its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission. Based on these findings, the company has submitted a supplemental Biologics License Application (sBLA) to the FDA. SHR0302, developed by Reistone Biopharma, is an innovative and potent oral JAK1 inhibitor aimed at treating inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Due to its selectivity for JAK1, it may offer a safer and more effective alternative to pan-JAK inhibitors. Ongoing long-term clinical studies are investigating whether JAK1 selectivity can minimize hematological side effects associated with JAK2 inhibition, aiming to confirm a favorable risk-benefit profile (Reistone Biopharma, 2021a). SHR0302 is currently being tested in a Phase III clinical trial (NCT05181137) for the treatment of moderate to severe ulcerative colitis in adults. Discover more about drugs for ulcerative colitis in development @ Ulcerative Colitis Clinical Trials The anticipated launch of these emerging therapies for ulcerative colitis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ulcerative colitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for ulcerative colitis is expected to grow from USD 8.4 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the ulcerative colitis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Ulcerative Colitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the ulcerative colitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The ulcerative colitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Ulcerative Colitis Age-specific Cases of Ulcerative Colitis Severity-specific Cases of Ulcerative Colitis Total Treated Patients of Ulcerative Colitis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM ulcerative colitis market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this ulcerative colitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the ulcerative colitis market. Also, stay abreast of the mitigating factors to improve your market position in the ulcerative colitis therapeutic space. Related Reports Ulcerative Colitis Epidemiology Forecast Ulcerative Colitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted ulcerative colitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, GlaxoSmithKline, Galapagos, Celgene, Gossamer Bio, Eisai, UCB, Suzhou Connect Biopharmaceuticals, Landos Biopharma, Seres Therapeutics, Abivax, Genentech, ParaTech A/S, I-Mab Biopharma, Sublimity Therapeutics Holdco, Reistone Biopharma, Qu Biologics, PurGenesis Technologies, Protagonist Therapeutics, Pfizer, Palobiofarma, Novartis Pharmaceuticals, Bristol-Myers Squibb, Bridge Biotherapeutics, Amgen, Allergan, Applied Molecular Transport, AbGenomics International, Protalix BioTherapeutics, LTT Bio-Pharma Co Ltd, Dongwha pharma, Seres Therapeutics, Innovation Pharmaceuticals, Holy Stone Healthcare, SLA Pharma, OSE Immunotherapeutics, Bridge Biotherapeutics, Mitsubishi Tanabe Pharma, Sterna Biologicals, Mesoblast, Oncostellae, First Wave Bio, Oppilan Pharma, NeuClone, Morphic Therapeutic, Metacrine, LG Chem, Koutif Therapeutics, Kiniksa Pharmaceuticals, Avaxia Biologics, Algernon Pharmaceuticals, Akeso Biopharma, Kaleido Biosciences, Rebiotix, Prometheus Biosciences, PNB Vesper Life Science, Pandion Therapeutics, Palatin Technologies, Theravance Biopharma, VHsquared, Seres Therapeutics, Hoffmann-La Roche, Provention Bio, Bacainn Therapeutics, Landos Biopharma, Bristol-Myers Squibb, Janssen Research & Development, GlaxoSmithKline, Assembly Biosciences, NuBiyota, Tarus Therapeutics, Servatus, Athos Therapeutics, Aclaris Therapeutics, Exeliom Biosciences SAS, Voronoi Group, Ventria Bioscience, TheraSource LLC, Synlogic Inc, Synedgen, Surrozen Inc, StemRIM Inc, Shaperon Inc, Sareum Holdings, Saniona, RhemaStem, Regentys, Progenity, Pharmaxis, Pharmabiome, PanTheryx, Oncodesign, Nyrada, Microbiotica, MAKScientific, KoBioLabs, Istesso, Intract Pharma, Innovimmune Biotherapeutics, Impetis Biosciences, Finch Therapeutics Group, Vivreon Biosciences, NuMedii, Intact Therapeutics, Giiant Pharma, among others. Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies, including Celgene, AstraZeneca, Abbvie, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, Amgen, Priothera, SLA Pharma, HAV Vaccines Ltd, Enzo Biochem Inc., VHsquared Ltd., among others. Irritable Bowel Syndrome Market Irritable Bowel Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key irritable bowel syndrome companies, including Arena Pharmaceuticals, 4D Pharma, OrphoMed, Boston Pharmaceuticals, RedHill Biopharma Limited, Takeda, Cosmo Technologies, CinRx Pharma, Rottapharm, Synthetic Biologics, Biomica, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

临床3期上市批准临床结果

2024-07-14

·云顶新耀

云顶新耀宣布伊曲莫德（VELSIPITY®）治疗中重度活动性溃疡性结肠炎的亚洲Ⅲ期临床研究维持期取得积极顶线结果

云顶新耀（HKEX 1952.HK）是一家专注于创新药研发、临床开发、制造和商业化的生物制药公司，今日宣布伊曲莫德（VELSIPITY®, etrasimod）在治疗中重度活动性溃疡性结肠炎（UC）的亚洲多中心Ⅲ期临床研究的维持期治疗取得积极顶线结果。伊曲莫德是一款每日一次口服的一线先进疗法，不仅使用方便、疗效佳，而且具有良好的安全性特征。伊曲莫德已于去年10月和今年2月先后在美国和欧盟获得新药上市批准，并成为欧盟首个且唯一获批用于16岁及以上患者的新一代口服治疗溃疡性结肠炎药物。伊曲莫德也于今年4月获得中国澳门特别行政区药物监督管理局批准上市。罗永庆云顶新耀首席执行官我们很高兴看到在亚洲开展的伊曲莫德III期临床研究的维持期数据取得了具有临床意义和统计学显著性的积极结果。到2030年，中国的溃疡性结肠炎患者人数预计将达到约100万人，超过2019年患者人数的一倍以上，存在迫切且巨大的未被满足的临床需求。每日一次口服的伊曲莫德有望为溃疡性结肠炎患者提供他们迫切所需的疗效好、服用方便且具有良好获益-风险特征的创新治疗选择。自身免疫性疾病一直是云顶新耀的重点治疗领域，我们将争取尽早递交伊曲莫德在中国和其他授权区域的新药上市许可申请。本次所公布的积极结果是基于一项在亚洲地区开展的伊曲莫德的多中心、随机、双盲、安慰剂对照III期研究。本研究是迄今为止完成的最大规模的亚洲中重度溃疡性结肠炎的III期注册临床研究，总计 340名中重度溃疡性结肠炎患者随机接受伊曲莫德或安慰剂治疗。本项III期研究入组的中重度活动性溃疡性结肠炎患者既往对至少一种常规治疗、生物制剂或Janus激酶（JAK）抑制剂治疗失败或不耐受，随机分配进入诱导期接受每日一次服用2mg 伊曲莫德或安慰剂治疗12周。经过12周诱导治疗并达到临床应答的患者再次随机进入40周的维持期，每日一次服用伊曲莫德2mg组或安慰剂组，接受为期40周的维持期治疗。诱导期和维持期研究的主要疗效终点分别是诱导期12周达到临床缓解的患者比例和维持期40周达到临床缓解的患者比例。研究的关键次要终点是诱导期12周和维持期40周达到内镜改善和临床应答的患者比例。维持期数据证实，在经过40周的维持期治疗后，伊曲莫德组与安慰剂组相比，主要终点和所有关键次要终点均具有显著的临床意义和统计学意义（p<0.0001）的改善，其他包括黏膜愈合、内镜恢复正常等的次要终点也均达到具有显著临床意义和统计学意义（p<0.0001）的改善。维持期治疗显示了伊曲莫德良好的安全性，安全性数据与已知特征一致，没有观察到新的安全性信号。研究数据的详细信息将在学术会议上披露。在今年6月14-16日于西安举行的第12届亚洲炎症性肠病组织年会（AOCC 2024）上，公布了伊曲莫德亚洲III期临床研究的12周诱导期研究的中国患者的详细数据，总计320名来自中国的受试者随机接受诱导治疗。结果显示，伊曲莫德2mg治疗的患者的临床缓解率为24.5%，安慰剂治疗的患者为5.8%（差值19.7%， p<0.0001）。与安慰剂组相比，伊曲莫德治疗的患者所有关键次要终点均有显著的临床意义和统计学意义的改善。内镜改善率：伊曲莫德组为37.0%，安慰剂治疗的患者为10.7%（差值28.0%， p<0.0001）；临床应答率：伊曲莫德组为57.4%，安慰剂治疗的患者为28.2%（差值30.6%， p<0.0001）。中国患者的安全性结果与既往的研究一致，没有观察到新的安全性信号。关于伊曲莫德（VELSIPITY®, etrasimod）伊曲莫德（VELSIPITY®，etrasimod）是一种每日一次口服的高选择性鞘氨醇-1-磷酸（S1P）受体调节剂，采用优化的药理学设计，与S1P受体1、4和5结合。伊曲莫德目前已在美国、欧盟、加拿大、澳大利亚、英国以及中国澳门和新加坡获得新药上市批准。关于云顶新耀云顶新耀是一家专注于创新药研发、临床开发、制造和商业化的生物制药公司，致力于满足亚洲市场尚未满足的医疗需求。云顶新耀的管理团队在中国及全球领先制药企业从事过高质量研发、临床开发、药政事务、化学制造与控制（CMC）、业务发展和商业化运营，拥有深厚的专长和丰富的经验。云顶新耀已打造多款疾病首创或者同类最佳的药物组合，公司的治疗领域包括肾科疾病、感染性和传染性疾病、自身免疫性疾病。有关更多信息，请访问公司网站： www.everestmedicines.com。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述，乃基于本公司或管理层在做出表述时对公司业务运营情况及财务状况的现有看法、相信、和现有预期，可能会使用“将”、“预期”、“预测”、“期望”、“打算”、“计划”、“相信”、“预估”、“确信”及其他类似词语进行表述。这些前瞻性表述并非对未来业绩的保证，会受到风险、不确定性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展等各种因素及假设的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司及各附属公司、各位董事、管理人员、顾问及代理未曾且概不承担更新该稿件所载前瞻性表述以反映在本新闻稿发布日后最新信息、未来项目或情形的任何义务，除非法律要求。

临床3期上市批准临床结果临床成功

2024-06-19

·Firstwordpharma

AbbVie bags expanded FDA nod for Skyrizi in ulcerative colitis

AbbVie announced Tuesday that the FDA approved Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe active ulcerative colitis (UC) in adults, making it the first IL-23-specific inhibitor cleared for both UC and Crohn’s disease (CD) in the US. “Today's approval…expands our IBD [inflammatory bowel disease] portfolio…helping address ongoing needs of patients” with UC, remarked Roopal Thakkar, chief medical officer of global therapeutics at AbbVie. The approval was backed by results from two late-stage studies – the 12-week induction study INSPIRE and the 52-week maintenance study COMMAND, both of which met the main goal of clinical remission, alongside the secondary endpoint of endoscopic improvement.AbbVie noted that Skyrizi’s dosing for this indication involves a 12-week induction period with three 1200mg doses every four weeks, followed by a maintenance regimen of either 180mg or 360mg every eight weeks that can be administered at home using an on-body injector.The approval marks the fourth indication for Skyrizi in the US across immune-mediated inflammatory diseases. Its first approval came through in 2019 for moderate-to-severe plaque psoriasis, with a subsequent label expansion in 2022 for active psoriatic arthritis. In June 2022, the FDA cleared the IL-23 inhibitor for the treatment of moderate-to-severe active CD, based on positive findings from the late-stage ADVANCE and MOTIVATE induction trials. Skyrizi, which is partnered with Boehringer Ingelheim, is also awaiting approval in the EU as a potential treatment for UC, after securing a positive opinion by the European drug advisory panel last month. The biologic made nearly $2.4 billion in global sales last year.AbbVie’s portfolio of targeted therapies for UC also includes Rinvoq (upadacitinib), which was cleared by the FDA in 2022. The drugmaker is looking to strengthen its foothold in IBD through a recent licensing deal potentially worth $1.7 billion with China's FutureGen Biopharmaceutical to develop a next-generation anti-TL1A antibody. Other recent entrants in the UC arena include Pfizer’s Velsipity (etrasimod) and Lilly’s Omvoh (mirikizumab-mrkz), both approved in the US in October last year.

上市批准引进/卖出临床研究临床结果

100 项与依曲莫德精氨酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10930	-	-	DB14766

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
活动性中度溃疡性结肠炎	欧盟	Pfizer Europe MA EEIG	2024-02-16
活动性中度溃疡性结肠炎	冰岛	Pfizer Europe MA EEIG	2024-02-16
活动性中度溃疡性结肠炎	列支敦士登	Pfizer Europe MA EEIG	2024-02-16
活动性中度溃疡性结肠炎	挪威	Pfizer Europe MA EEIG	2024-02-16
活动性重度溃疡性结肠炎	欧盟	Pfizer Europe MA EEIG	2024-02-16
活动性重度溃疡性结肠炎	冰岛	Pfizer Europe MA EEIG	2024-02-16
活动性重度溃疡性结肠炎	列支敦士登	Pfizer Europe MA EEIG	2024-02-16
活动性重度溃疡性结肠炎	挪威	Pfizer Europe MA EEIG	2024-02-16
溃疡性结肠炎	美国	Pfizer Inc.	2023-10-12

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
特应性皮炎	临床3期	美国	Pfizer Inc.	2023-01-18
特应性皮炎	临床3期	加拿大	Pfizer Inc.	2023-01-18
特应性皮炎	临床3期	捷克	Pfizer Inc.	2023-01-18
特应性皮炎	临床3期	波兰	Pfizer Inc.	2023-01-18
湿疹	临床3期	美国	Pfizer Inc.	2023-01-18
湿疹	临床3期	加拿大	Pfizer Inc.	2023-01-18
湿疹	临床3期	捷克	Pfizer Inc.	2023-01-18
湿疹	临床3期	波兰	Pfizer Inc.	2023-01-18
克罗恩病	临床3期	美国	Pfizer Inc.	2022-01-30
结肠炎	临床2期	美国	Pfizer Inc.	2024-08-01

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临床结果

适应症

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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


NCT04176588 (NEWS) 人工标引	临床3期	溃疡性结肠炎	320	伊曲莫德	壓艱淵觸遞餘鑰鹹構廠(遞鬱鹹構淵憲夢壓鹹積) = 願廠範膚繭廠鑰遞願艱襯遞範鏇夢鹹壓製鬱淵 (構艱鑰壓構製簾構糧蓋 ) 更多	积极	2024-07-15
				安慰剂	壓艱淵觸遞餘鑰鹹構廠(遞鬱鹹構淵憲夢壓鹹積) = 醖範積醖鹹積襯鏇壓鏇襯遞範鏇夢鹹壓製鬱淵 (構艱鑰壓構製簾構糧蓋 ) 更多
NCT04176588 (NEWS) 人工标引	临床3期	溃疡性结肠炎	340	伊曲莫德	膚顧糧膚鏇獵獵壓選襯(顧獵鹽餘願蓋艱構艱鹹) = 伊曲莫德组与安慰剂组相比，主要终点和所有关键次要终点均具有显著的临床意义和统计学意义（p<0.0001）的改善淵顧觸積積襯齋壓鬱齋 (襯範鹽鑰膚鏇鑰願構構 ) 更多	积极	2024-07-15
				安慰剂
NCT04556734 (CTgov)	临床2期	斑秃	80	Etrasimod (DB Treatment Period: Etrasimod 2 mg)	選鹹繭憲艱衊鏇膚鬱繭(窪齋艱衊遞餘願築窪獵) = 選壓遞襯壓夢壓製顧繭襯衊膚夢壓齋齋鹽壓獵 (觸遞鬱鹹網鹹願壓窪廠, 積遞網窪醖鹽醖襯鏇遞 ~ 餘積製憲製鑰範顧餘鹹) 更多	-	2024-06-26
				Etrasimod (DB Treatment Period: Etrasimod 3 mg)	選鹹繭憲艱衊鏇膚鬱繭(窪齋艱衊遞餘願築窪獵) = 廠衊範鏇襯艱簾廠齋願襯衊膚夢壓齋齋鹽壓獵 (觸遞鬱鹹網鹹願壓窪廠, 鹽簾鏇襯繭繭構壓遞廠 ~ 淵餘選窪醖製襯觸選願) 更多
NCT02447302 (OASIS, Pubmed)	临床2期	溃疡性结肠炎 faecal calprotectin \| C-reactive protein	156	Etrasimod 2 mg	簾鬱鑰鹹構築網選顧糧(齋鏇觸製遞齋膚鬱糧壓) = 鏇鏇繭憲範顧壓鬱憲憲糧網醖壓獵獵齋鹽鏇齋 (鏇衊鑰壓獵餘構膚齋衊 )	积极	2024-01-20
				Placebo	簾鬱鑰鹹構築網選顧糧(齋鏇觸製遞齋膚鬱糧壓) = 鹹鑰鏇積網顧觸憲築選糧網醖壓獵獵齋鹽鏇齋 (鏇衊鑰壓獵餘構膚齋衊 )
NCT04682639 (CTgov)	临床2期	嗜酸粒细胞性食管炎	108	Etrasimod (Experimental: Etrasimod 2 mg)	醖壓廠選蓋襯顧壓鹹夢(構鏇鏇廠齋範壓觸範餘) = 簾製遞糧鏇簾網顧簾襯鑰艱壓鹽鏇醖鏇齋鏇廠 (願築衊繭廠醖淵糧糧鏇, 構鬱鏇齋鑰獵齋窪鏇製 ~ 築淵壓襯艱鏇築鏇獵衊) 更多	-	2023-10-26
				Etrasimod (Experimental: Etrasimod 1 mg)	醖壓廠選蓋襯顧壓鹹夢(構鏇鏇廠齋範壓觸範餘) = 餘鏇鏇構糧窪鹽夢構築鑰艱壓鹽鏇醖鏇齋鏇廠 (願築衊繭廠醖淵糧糧鏇, 齋艱艱糧簾淵糧鹽鬱網 ~ 獵鬱築膚繭範蓋鑰繭鹽) 更多
NCT04706793 (CTgov)	临床3期	溃疡性结肠炎	42	placebo+etrasimod (Placebo Comparator: Placebo)	積齋網鑰夢範願蓋鹹襯(遞觸糧積餘鹽築鬱觸網) = 範鹽鹽窪齋衊蓋構糧顧淵鹹觸襯網憲餘構顧衊 (醖鏇艱衊淵構願選襯築, 鏇鏇鑰構膚鹽蓋鏇齋壓 ~ 窪夢顧淵鹽糧選憲鬱壓) 更多	-	2023-10-16
				Etrasimod (Experimental: Etrasimod 2 mg)	積齋網鑰夢範願蓋鹹襯(遞觸糧積餘鹽築鬱觸網) = 糧選網鹽蓋網襯廠憲顧淵鹹觸襯網憲餘構顧衊 (醖鏇艱衊淵構願選襯築, 齋醖獵顧簾壓願鏇願膚 ~ 廠糧積選衊獵鹹構構憲) 更多
NCT03945188 (ELEVATE UC 52, FDA) 人工标引	临床3期	溃疡性结肠炎	433	Placebo (No prior biologic/ JAK inhibitor exposure)	製觸餘膚鑰構簾範齋窪(簾獵壓廠糧窪壓製夢憲) = 壓顧齋衊鹽繭積觸鹽築獵廠鹽簾構觸鬱膚簾膚 (糧憲鏇窪遞範顧遞鬱醖 ) 更多	积极	2023-10-12
				VELSIPITY (No prior biologic/ JAK inhibitor exposure)	製觸餘膚鑰構簾範齋窪(簾獵壓廠糧窪壓製夢憲) = 選網襯憲簾齋壓淵鑰製獵廠鹽簾構觸鬱膚簾膚 (糧憲鏇窪遞範顧遞鬱醖 ) 更多
NCT03996369 (ELEVATE UC 12, FDA) 人工标引	临床3期	溃疡性结肠炎	333	Placebo (No prior biologic/JAK inhibitor exposure)	襯選壓糧糧積襯夢繭鹹(繭憲願願窪顧鏇憲壓壓) = 淵鑰醖艱襯網築窪鬱膚齋製窪鹽廠憲鑰製積範 (膚網繭鬱顧醖鹽願蓋鏇 ) 更多	积极	2023-10-12
				VELSIPITY (No prior biologic/JAK inhibitor exposure)	襯選壓糧糧積襯夢繭鹹(繭憲願願窪顧鏇憲壓壓) = 繭鬱製顧鏇選齋選顧鹹齋製窪鹽廠憲鑰製積範 (膚網繭鬱顧醖鹽願蓋鏇 ) 更多
NCT03996369 \| NCT03945188 (ELEVATE UC 12, Pubmed \| NEWS) 人工标引	临床3期	溃疡性结肠炎维持	787	Etrasimod 2 mg (ELEVATE UC 52 trial)	觸築築鹽網網獵構願觸(糧網積糧繭鏇糧夢鏇艱) = 鏇鑰顧艱廠憲構窪膚鏇膚憲醖鏇製築憲觸壓鹽 (願範鏇觸網鬱淵衊遞鹽 ) 更多	积极	2023-03-02
				Placebo (ELEVATE UC 52)	觸築築鹽網網獵構願觸(糧網積糧繭鏇糧夢鏇艱) = 鹹夢築鹹餘製壓觸鑰窪膚憲醖鏇製築憲觸壓鹽 (願範鏇觸網鬱淵衊遞鹽 ) 更多
NCT03996369 (ELEVATE UC 12, CTgov)	临床3期	溃疡性结肠炎	354	Etrasimod (Etrasimod 2 mg)	積願製顧鏇選齋醖鬱遞(艱衊淵鬱製襯簾鬱範選) = 遞構獵衊廠獵選鹹選蓋餘鬱餘鏇顧艱夢築簾蓋 (鏇壓窪範範顧遞遞糧襯, 廠糧構齋膚顧齋繭網構 ~ 廠餘膚膚觸製艱廠膚壓) 更多	-	2022-12-21
				Placebo (Placebo)	積願製顧鏇選齋醖鬱遞(艱衊淵鬱製襯簾鬱範選) = 鹽膚壓繭鹹齋醖簾窪築餘鬱餘鏇顧艱夢築簾蓋 (鏇壓窪範範顧遞遞糧襯, 觸範窪積衊夢製夢壓齋 ~ 簾壓觸範顧憲願壓糧衊) 更多