A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 Mg or 60 Mg with Placebo in Patients with Active Lupus Nephritis

The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

开始日期2023-11-03

申办/合作机构

Kezar Life Sciences, Inc.

NCT05569759 / Active, not recruiting临床2期

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With Open-label Extension to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis

This is a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis will receive zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allows patients to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.

开始日期2023-05-23

申办/合作机构

Kezar Life Sciences, Inc.

100 项与泽托佐米相关的临床结果

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100 项与泽托佐米相关的转化医学

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100 项与泽托佐米相关的专利（医药）

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项与泽托佐米相关的文献（医药）

2023-01-01·Frontiers in immunology

Zetomipzomib (KZR-616) attenuates lupus in mice via modulation of innate and adaptive immune responses.

Article

作者: Kirk, Christopher J. ; Fan, R. Andrea ; Muchamuel, Tony ; Anderl, Janet L. ; McMinn, Dustin L. ; Lowe, Eric ; Johnson, Henry W. B. ; Tuch, Brian B. ; Bomba, Darrin J. ; Millare, Beatriz

Zetomipzomib (KZR-616) is a selective inhibitor of the immunoproteasome currently undergoing clinical investigation in autoimmune disorders. Here, we characterized KZR-616 in vitro and in vivo using multiplexed cytokine analysis, lymphocyte activation and differentiation, and differential gene expression analysis. KZR-616 blocked production of >30 pro-inflammatory cytokines in human peripheral blood mononuclear cells (PBMCs), polarization of T helper (Th) cells, and formation of plasmablasts. In the NZB/W F1 mouse model of lupus nephritis (LN), KZR-616 treatment resulted in complete resolution of proteinuria that was maintained at least 8 weeks after the cessation of dosing and was mediated in part by alterations in T and B cell activation, including reduced numbers of short and long-lived plasma cells. Gene expression analysis of human PBMCs and tissues from diseased mice revealed a consistent and broad response focused on inhibition of T, B, and plasma cell function and the Type I interferon pathway and promotion of hematopoietic cell lineages and tissue remodeling. In healthy volunteers, KZR-616 administration resulted in selective inhibition of the immunoproteasome and blockade of cytokine production following ex vivo stimulation. These data support the ongoing development of KZR-616 in autoimmune disorders such as systemic lupus erythematosus (SLE)/LN.

2022-09-01·European journal of immunology

Effective therapy of polymyositis in mice via selective inhibition of the immunoproteasome

Article

作者: Kirk, Christopher J ; Basler, Michael ; del Rio Oliva, Marta ; Groettrup, Marcus

Abstract:

Polymyositis (PM) is a chronic autoimmune inflammatory myopathy resulting in muscle weakness. The limited approved therapies and their poor efficacy contribute to its comorbidity. We investigated the therapeutic use of ONX 0914 and KZR‐616, selective inhibitors of the immunoproteasome, in C protein‐induced myositis (CIM), a mouse model of PM that closely resembles the human disease. Diseased mice (day 13 postimmunization) were treated with 10 mg/kg ONX 0914, KZR‐616, or vehicle on alternate days until day 28. Endpoints included muscle strength assessed by a grip strength meter, serum creatine kinase activity, histology, and immunohistochemistry analysis. Treatment with ONX 0914 or KZR‐616 prevented the loss of grip strength in mice after CIM induction, while vehicle‐treated animals displayed progressive muscle weakness. Immunoproteasome inhibition lowered PM‐associated leukocyte infiltration of the muscle and prevented increased serum creatine kinase levels. LMP7‐deficient mice were resistant to CIM induction, as they showed no alterations in grip strength or creatine kinase (CK) levels or muscular alterations. In conclusion, selective inhibition of the immunoproteasome displays therapeutic efficacy in a preclinical mouse model of PM with suppression of muscle inflammation and preservation of muscle strength. Positive results from this study support the rationale for using KZR‐616 in clinical studies.

2022-08-01·Current opinion in pharmacology

Current and new targets for treating myositis

Review

作者: Oddis, Chester V ; Moghadam-Kia, Siamak

As treatment of refractory idiopathic inflammatory myopathies (IIM) has been challenging, there is growing interest in assessing new therapies that target various pathways implicated in the pathogenesis of IIM. In the largest clinical trial to date, rituximab was studied in adult and juvenile myositis, but the primary outcome was not met despite 83 percent of subjects with refractory myositis meeting the definition of improvement. The U.S. Food and Drug Administration (FDA) has recently granted approval to Octagam 10% immune globulin intravenous (IVIg), for the treatment of adult dermatomyositis based on impressive results from a double-blind placebo-controlled trial. Anti-tumor necrosis factor (anti-TNF) utility in IIM is not recommended and recent reports suggest this therapy may induce systemic autoimmune disease including myositis. Further, anti-IL6 therapy cannot be recommended as a recent trial of tocilizumab failed to reach its primary endpoint. Further studies are needed to assess the role of newer therapies such as abatacept (inhibition of T cell co-stimulation), sifalimumab (anti-IFNα), Janus kinase [JAK] inhibitors, apremilast (phosphodiesterase 4 inhibitor), and KZR-616 (selective inhibitor of the immunoproteasome) given their biological plausibility and encouraging recent small-case series results. The future of IIM therapy will depend on exploring biomarkers implicated in the etiopathogenesis of IIM, improvements in myositis classification based on serological and histopathological features, and well-designed controlled clinical trials using validated consensus outcome measures.

123

项与泽托佐米相关的新闻（医药）

2024-12-12

·求实药社

累涨近130%！这家港股Biotech有点东西

在临床需求未被充分满足的肾脏病领域，国内头部创新药企正在加速布局，以确立其在全球市场的竞争优势。近期，云顶新耀在核心商业化产品和突破性研究方面取得了一系列重要的里程碑式进展: 11月28日，国家医保局正式公布2024年国家医保目录，其中全球首个IgA肾病对因治疗药物耐赋康被纳入新版药品目录，并将在2025年1月1日正式生效。根据公开数据，包括IgA肾病在内的整个肾病领域长期缺乏对因药物，耐赋康的出现预计将IgA肾病发生肾功能衰竭平均时间推迟12.8年。 12月2日，云顶新耀宣布伊曲莫德（VELSIPITY）用于治疗中重度活动性溃疡性结肠炎成人患者的新药上市许可申请。 12月4日，云顶新耀公布的数据显示，其BTK抑制剂EVER001胶囊，在治疗原发性膜性肾病的1b/2a期临床试验中显示出积极效果，有潜力成为肾病市场的颠覆者。受一系列利好影响，云顶新耀近日来股价持续上扬。拉长周期看，自8月下旬至今，该股走势颇为陡峭，区间累计涨幅达1.5倍；年内累涨近130%，表现优于同行，引发市场广泛关注。这背后，公司产品商业化前景已经愈发明朗，多个里程碑事件在持续增强市场的投资信心。不过，回到业绩层面，扭亏为盈仍是云顶新耀肩头的重担。 IgA肾病救星进医保耐赋康®（布地奈德肠溶胶囊，NEFECON®）是全球首个获批的IgA肾病对因治疗药物。它通过特殊的制作工艺，将布地奈德靶向释放于回肠末端的Peyer's淋巴结，针对病因起效，从源头减少致病性IgA1(Gd-IgA1)水平，降低66%肾功能下降，预计延缓IgA肾病进展至肾衰竭12.8年！布地奈德肠溶胶囊适用于所有确诊为IgA肾病的患者，无论尿蛋白水平或肾功能状况（未透析）如何。尤其适合24小时尿蛋白定量超过0.5克、具有进展风险的IgA肾病患者。具体用药请遵医嘱。需要注意的是该药物不适用于未确诊为IgA肾病的患者，以及其他类型的肾病，如微小病变性肾病、膜性肾病和FSGS等。 NefIgArd研究中国亚组分析显示，在2年的治疗和观察期内，使用16mg/天剂量的耐赋康® NEFECON®（布地奈德肠溶胶囊）的患者在24个月时eGFR下降了7.09 mL/min/1.73 m²，而安慰剂组下降了20.97 mL/min/1.73 m²。这表明，在2年期间（9个月治疗期和15个月停药观察期），耐赋康® NEFECON® 组患者的肾功能恶化程度比安慰剂组减少了约66%。作为全球首个免疫球蛋白A（IgA）肾病的对因治疗药物，耐赋康®的获批填补了国内从疾病源头治疗IgA肾病的空白，为临床医生和相关患者提供了创新的治疗选择。随着此番“跑步”进入新版国家医保药品目录，耐赋康®将更好地满足日益增长的临床治疗需求，使更多肾病患者能够用得上这一创新药物，更早地开启对因治疗，从而进一步推动临床规范化治疗的实施。肾病创新领域取得突破 12月4日，云顶新耀宣布其自主研发且拥有全球权益的新一代共价可逆布鲁顿酪氨酸激酶（BTK）抑制剂EVER001，在1b/2a期临床试验阶段性数据中取得积极结果。本次试验聚焦原发性膜性肾病（pMN），是成人原发性肾病综合征的主要原因，存在未被满足的医疗需求。近年来，中国pMN的发病率持续上升，成为继IgA肾病（IgAN）后的第二大肾病综合征常见的病理类型，且目前全球没有获批此适应症的药物。不同于传统的共价不可逆BTK抑制剂，EVER001采用独特的共价可逆机制，结合其强大的靶点结合力与良好的安全性特征，避免持续抑制带来的毒副作用。试验结果显示，抗-PLA2R自身抗体水平在数据截止日期时已达到接近100%的下降，而早在低剂量组的24周和高剂量组的12周，抗-PLA2R自身抗体下降已超过90%。此外，在已完成36周治疗的低剂量组患者中，81.8%的患者实现临床缓解，高剂量组中已完成24周治疗的患者已有85.7%实现临床缓解。除低剂量组的1例患者外，其他所有完成36周治疗的低剂量组患者，以及所有经24周治疗的高剂量组患者分别在36周和24周都实现了免疫学完全缓解。 EVER001作为一款潜在的同类最佳产品，该结果不仅显示了EVER001在pMN治疗中的高选择性、优异的药代动力学特征、良好的安全性特征以及强大的靶点结合力，还凸显了其在其他自身免疫性肾病，如狼疮性肾炎（LN）、IgA肾病、微小病变病（MCD）和局部节段性肾小球硬化（FSGS）中的广阔适应症前景。凭借广泛的适应症前景、日益增加的疾病发病率以及全球范围内的开发权益，EVER001有望成为云顶新耀针对全球疾病领域蓝海赛道的深刻洞察和合理布局的重磅管线。另一重磅药物也取得进展云顶新耀在自免疫领域的重磅药品——伊曲莫德（VELSIPITY）也即将迎来收获期。近日，云顶新耀宣布伊曲莫德（VELSIPITY）用于治疗中重度活动性溃疡性结肠炎成人患者的新药上市许可申请，已获得香港卫生署正式受理。该产品已于今年4月获得澳门药物监督管理局批准上市，并于10月份通过"港澳药械通"政策在大湾区落地。伊曲莫德，是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中重度活动性溃疡性结肠炎药物，也是目前唯一在全球Ⅲ期临床试验中证实对孤立性直肠炎有疗效的药物。近年来，溃疡性结肠炎在我国发病率明显增加，预计到2030年，中国的溃疡性结肠炎患者人数预计将达到约100万人，存在迫切且巨大的未被满足的临床需求。华福证券表示，伊曲莫德很大潜力成为中国中度至重度溃疡性结肠炎的一线治疗药物，可口服给药，无安全性黑框标签，展现出与生物制剂相当的临床疗效，预计24 年内在中国内地递交NDA 申请。收入大幅增加尚未扭亏为盈虽然云顶新耀在产品线方面频频迎来好消息，但其依旧未摆脱亏损，且上半年亏损进一步扩大。根据财务数据显示，2024年上半年，云顶新耀收入3.02亿元，同比增长高达32.9倍。尽管公司收入大幅增长，但其仍深陷亏损泥淖。期内，其录得归母净亏损约6.32亿元，而上年同期则亏损4.24亿元，亏损进一步扩大。不过，对于生物医药企业而言，早期往往依赖于大量的研发投入，初期亏损并不代表未来业绩不会改善。随着产品销售规模持续打开，其扭亏的希望还是挺大的。云顶新耀执行董事兼首席执行官罗永庆也表示：“要力争在2025年底前实现盈亏平衡的战略目标。” 为了扩大利润空间，公司也正在积极压缩运营费用支出。财报显示，2024年上半年，云顶新耀运营费用占收入比重大幅减少249%，使得亏损显著收窄35%。不过，追求盈利道路上，云顶新耀必然要克服诸多创新药开发难关。创新药市场存在较为激烈的博弈，给企业的产品研发带来较大压力。比如看向云顶新耀瞄准的BTK抑制剂领域，据不完全统计，目前近十款BTK药物正聚焦肾病相关的适应症，其中百济神州的泽布替尼已经展现出迅猛增势。当然，无论是药物研发风险高还是市场竞争激烈，几乎是每个创新药企发展过程中都会遇到的问题，这种情况下，只看药企的产品开发效率和质量。在提质增效道路上，云顶新耀的“弹药”还算充足。财报显示，2024年上半年，公司现金储备达19.3亿元，可支持多项战略目标的实现。结语云顶新耀在肾病领域已经搭建了包括耐赋康、BTK抑制剂EVER001和泽托佐米在内的管线矩阵，可为约1000万肾小球肾病患者带来创新的治疗选择。展望后市，伴随着多款重磅产品商业化持续提速，市场普遍认为，云顶新耀的业绩有望迎来持续增长，逐渐实现扭亏为盈。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。国内唯一！深度聚焦自免药物开发的峰会联系我们 AIM 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

基因疗法临床结果临床研究

2024-12-04

·凯莱英药闻

打造肾病“三驾马车”！云顶新耀潜在“同类最佳”新一代肾病药物取得1b/2a期临床试验积极结果

欢迎关注凯莱英药闻今日，云顶新耀宣布，公司在研药物EVER001在治疗原发性膜性肾病（pMN）的1b/2a期临床试验阶段性数据取得积极结果。 EVER001是新一代共价可逆布鲁顿酪氨酸激酶（BTK）抑制剂，正在全球范围内开发用于治疗肾病；该药物在保持高活性的同时具有高选择性，能够避免持续抑制带来的毒副作用，具有同类最佳的潜力。关于1b/2a期临床试验此项1b/2a期临床试验旨在评价EVER001在蛋白尿为特征的肾小球疾病的中国患者中的安全性、疗效、药代动力学和药效学。31名经肾脏活检证实的抗-PLA2R自身抗体阳性的原发性膜性肾病患者，分别入组低剂量组和高剂量组，接受EVER001 共36周的治疗。截至2024年9月13日，已完成36周治疗的低剂量组患者中，81.8%（9/11）的患者实现临床缓解，高剂量组中已完成24周治疗的患者已有85.7%（6/7）实现临床缓解。除低剂量组的1例患者外，其他所有完成36周治疗的低剂量组患者，以及所有经24周治疗的高剂量组患者分别在36周和24周都实现了免疫学完全缓解。低剂量组的24小时蛋白尿几何平均值（最小二乘法）在36周相较于基线下降78.3%，而高剂量组在24周即出现73.8%的下降。在数据截止日期时，抗-PLA2R自身抗体水平已达到接近100%的下降；早在低剂量组的24周和高剂量组的12周，抗-PLA2R自身抗体下降已超过90%。未见在其他共价非可逆BTK抑制剂上观察到的有临床意义的不良事件，如出血、心律失常、严重感染、白细胞减少、血小板减少、严重肝功能损伤等。关于EVER001 EVER001（XNW1011）是新一代共价可逆的BTK抑制剂；BTK 是B 细胞受体信号通路的重要组成部分，可调节B 淋巴细胞的存活、激活、增殖和分化。应用小分子抑制剂靶向BTK 是治疗B 细胞淋巴瘤和自身免疫性疾病的有效选择。根据2021 年9 月与信诺维医药和中国抗体制药达成的独家许可协议，云顶新耀拥有在全球开发、生产和商业化EVER001 用于治疗肾病的权利。在中国健康受试者中进行的I 期研究结果表明，EVER001 具有高选择性、优异的药代动力学特征、良好的安全性特征以及强大的靶点参与性。关于BTK抑制剂 BTK 是一种非受体酪氨酸激酶，在各种细胞表面受体（主要包括BCR）的信号转导中发挥核心作用，在B 细胞癌变后，BTK 会变得异常活跃，BTK 信号传导通路的激活会发出启动B 细胞恶性肿瘤细胞生长的信号，并在生长、迁移中发挥着重要作用。 BTK 抑制剂通过作用于BCR信号通路，与BTK 特异性结合而抑制BTK 自身磷酸化，阻止BTK 激活，从而阻断信号传导并诱导细胞凋亡，达到对B 细胞肿瘤发展的控制作用。目前，全球范围内上市的BTK 抑制剂共6 种，第一代BTK 抑制剂伊布替尼2013年获FDA 批准上市，为血液肿瘤的治疗带来新进展。不过第一代BTK抑制剂由于选择性较差，除了抑制BTK 外，还会对EGFR、TEC、BMX 等多个靶点产生抑制作用，导致脱靶效应相关不良事件发生。第二代BTK 抑制剂提高了选择性，减轻脱靶效应，目前全球有四款BTK 抑制剂属于第二代BTK 抑制剂。目前，伊布替尼仍是全球BTK 市场中最畅销的品种，第二代BTK抑制剂阿可替尼和泽布替尼销售增长迅速。根据Deutsche Bank Report 2022 数据，BTK 抑制剂全球市场规模仍在增长中，预测2026 年BTK 抑制剂市场规模可达到204 亿美元。据不完全统计，目前仅近十款BTK药物正开发用于肾病相关的适应症。关于原发性膜性肾病 PMN是一种自身免疫性肾小球疾病，主要临床表现为蛋白尿，是引起成人肾病综合征（NS）最常见的原发性原因。作为成人肾病综合征常见的病理类型，PMN在我国的患病率呈逐年升高的趋势，是发病率仅次于IgA肾病的原发性肾小球肾炎。据统计，我国目前有约200万原发性膜性肾病患者，超过30%的患者对目前的标准治疗没有应答，约30%达到缓解的患者会复发。目前，全球没有获批用于PMN的药物；因此，亟需研发能提高治疗缓解率、降低高复发率、减少慢性肾毒性风险的治疗药物。关于云顶新耀云顶新耀成立于2017 年，从成功的授权引进模式逐步发展到兼具强大的自主研发和商业化的双轮驱动模式。目前，公司在肾科疾病、感染性和传染性疾病、自身免疫性疾病、mRNA 平台等领域已建立全球同类首创或者同类最佳的药物组成的顶级的产品管线。 2024上半年，公司主营收入达3 亿元，研发开支为人民币2.53 亿元，分销及销售开支为人民币2 亿元；2024 年维持人民币7 亿元的全年营业收入指引。截至2024 年6 月30 日，公司现金及现金等价物及银行存款为人民币19 亿元。在肾病领域，云顶新耀以肾小球类疾病为焦点建立产品管线，拳头产品耐赋康(NEFECON)是治疗IgA肾病的首款创新药，现已在美国、欧盟、中国澳门等地上市；同时，公司持续通过内部发现和授权引进扩大管线，联合泽托佐米、EVER001，打造肾病“三驾马车”。参考资料 1、公司官网 2、华福证券、财通证券、长城证券感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

临床1期临床结果临床2期

2024-12-03

·PRNewswire

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床申请

100 项与泽托佐米相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16070

研发状态

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
自身免疫性肝炎	临床2期	美国	Kezar Life Sciences, Inc.	2023-05-23
自身免疫性溶血性贫血	临床2期	美国	Kezar Life Sciences, Inc.	2020-07-01
自身免疫性溶血性贫血	临床2期	澳大利亚	Kezar Life Sciences, Inc.	2020-07-01
自身免疫性溶血性贫血	临床2期	意大利	Kezar Life Sciences, Inc.	2020-07-01
自身免疫性溶血性贫血	临床2期	波兰	Kezar Life Sciences, Inc.	2020-07-01
自身免疫性溶血性贫血	临床2期	俄罗斯	Kezar Life Sciences, Inc.	2020-07-01
免疫性血小板减少症	临床2期	美国	Kezar Life Sciences, Inc.	2020-07-01
免疫性血小板减少症	临床2期	澳大利亚	Kezar Life Sciences, Inc.	2020-07-01
免疫性血小板减少症	临床2期	意大利	Kezar Life Sciences, Inc.	2020-07-01
免疫性血小板减少症	临床2期	波兰	Kezar Life Sciences, Inc.	2020-07-01

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临床结果

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分期

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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


NCT05781750 (PALIZADE, Company_Website) 人工标引	临床2期	狼疮性肾炎	-	zetomipzomib 30 mg	壓膚齋艱窪膚鬱窪網鑰(衊蓋鏇願製網艱鏇夢簾) = four fatal, or grade 5, serious adverse events among participants in the Philippines and Argentina, according to the release. 願積夢製鹽築鹽範鏇膚 (獵襯積簾範獵鑰憲糧選 )	不佳	2024-10-01
NCT05781750 (PALIZADE, Company_Website) 人工标引	临床2期	狼疮性肾炎	-	zetomipzomib 60 mg		不佳	2024-10-01
NCT04628936 (CTgov)	临床2期	皮肌炎	18	KZR-616	選憲壓獵觸範繭網築築(淵餘範衊繭餘築憲餘簾) = 襯壓壓憲窪製鹽淵廠鬱憲衊觸願廠鹽餘網鬱選 (選獵糧艱壓膚艱積築艱, 齋繭襯選淵網簾遞糧壓 ~ 齋襯壓壓積膚壓遞鬱鹹) 更多	-	2024-06-05
NCT04033926 (PRESIDIO, CTgov)	临床2期	皮肌炎	25	Zetomipzomib (Arm A: Period 1 (Zetomipzomib))	夢壓網憲製廠繭構糧繭(簾鏇夢齋獵積鹽簾製艱) = 襯糧獵鏇鑰淵鏇衊顧齋窪糧鑰夢積窪鑰選簾構 (獵繭鑰築選壓衊醖觸築, 繭襯繭襯淵顧積範鹽襯 ~ 獵艱窪願獵鏇鹽構淵膚) 更多	-	2024-01-03
NCT04033926 (PRESIDIO, CTgov)	临床2期	皮肌炎	25	Placebo (Arm B: Period 1 (Placebo))	夢壓網憲製廠繭構糧繭(簾鏇夢齋獵積鹽簾製艱) = 網窪窪製憲簾繭選遞鑰窪糧鑰夢積窪鑰選簾構 (獵繭鑰築選壓衊醖觸築, 鹽膚築鑰醖鏇衊齋範醖 ~ 繭壓膚膚鬱醖糧獵鬱構) 更多	-	2024-01-03
MISSION (EULAR2023)	临床2期	狼疮性肾炎 uCD163	21	Zetomipzomib 60mg	襯願窪衊齋繭鹽夢簾網(遞鹹願鹹淵鹽網窪築蓋) = 糧遞夢構淵淵遞範顧鏇築襯築衊鹹繭鏇顧窪餘 (憲糧醖廠鏇遞衊夢艱選 )	积极	2023-05-31
NCT03393013 (MISSION, EULAR2023)	临床2期	狼疮性肾炎 proteinuria \| urinary CD163	21	Zetomipzomib 60 mg SC QW	鹹選簾鬱顧憲鹹繭願觸(簾壓顧築齋遞願積憲齋) = 齋鏇鏇淵齋醖膚窪遞製壓簾憲膚襯遞夢網願選 (積糧憲糧廠糧觸艱鑰網 ) 更多	-	2023-05-31
NCT03393013 (MISSION, ASN2022) 人工标引	临床2期	狼疮性肾炎	5	KZR-616	遞衊鹽淵網膚艱觸繭願(願觸衊餘製網範遞選鹽) = 襯齋艱蓋淵鏇製齋廠艱遞糧築鏇襯遞衊夢簾餘 (構鬱製壓憲襯廠糧夢構 ) 更多	积极	2022-11-03
NCT03393013 (MISSION, Biospace) 人工标引	临床2期	狼疮性肾炎	17	Zetomipzomib	艱壓壓衊築膚構獵觸齋(齋餘願醖獵廠蓋壓積醖) = 齋膚醖鏇膚鹽網鹽齋糧壓構廠憲窪夢遞顧獵艱 (鏇餘齋網鹽蓋繭製獵廠 ) 更多	积极	2022-06-27
NCT04033926 (PRESIDIO, BusinessWire) 人工标引	临床2期	皮肌炎 \| 多发性肌炎	25	Zetomipzomib (Zetomipzomib+Zetomipzomib+placebo)	醖觸鏇鹹鏇繭願遞鑰鑰(製鏇製醖齋遞願簾壓壓) = 憲簾鹽顧糧憲獵壓構淵窪襯憲壓願獵積繭範積 (選夢願壓艱襯糧築餘遞 ) 更多	不佳	2022-05-03
NCT04033926 (PRESIDIO, BusinessWire) 人工标引	临床2期	皮肌炎 \| 多发性肌炎	25	Zetomipzomib (Zetomipzomib+placebo+Zetomipzomib)	醖觸鏇鹹鏇繭願遞鑰鑰(製鏇製醖齋遞願簾壓壓) = 範窪糧艱蓋窪艱範繭夢窪襯憲壓願獵積繭範積 (選夢願壓艱襯糧築餘遞 ) 更多	不佳	2022-05-03
NCT03393013 (MISSION, BusinessWire) 人工标引	临床1期	系统性红斑狼疮	47	Zetomipzomib	蓋壓遞憲積蓋壓淵願醖(餘獵壓製築製襯鬱鏇蓋) = 夢網鹽廠製鬱醖壓夢獵壓觸網鹽構鬱壓餘膚衊 (遞艱廠淵襯積窪壓淵鹹 ) 更多	积极	2021-06-02
NZB/W Lupus Nephritis Model (ACR2019)	N/A	狼疮性肾炎	-	KZR-616	鏇獵窪壓選襯鏇製蓋窪(衊獵觸鹽繭窪網齋蓋餘) = 範獵醖範製廠獵積範壓窪製積築糧淵願築艱襯 (窪衊鹹夢積鹽醖鑰鹽顧 )	积极	2019-11-10