A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of QLG1074 With Placebo in Achieving Renal Remission in Subjects With Active Lupus Nephritis

The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis.

开始日期2023-12-25

申办/合作机构

齐鲁制药有限公司

100 项与伏环孢素相关的临床结果

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100 项与伏环孢素相关的转化医学

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100 项与伏环孢素相关的专利（医药）

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116

项与伏环孢素相关的文献（医药）

2024-12-31·RENAL FAILURE

Efficacy and safety of biologics, multitarget therapy, and standard therapy for lupus nephritis: a systematic review and network meta-analysis

Review

作者: Li, Zhen-Qiong ; Tian, Gui-Qing

OBJECTIVE:

This study aimed to compare the efficacy and safety of biologics, multitarget therapy, and standard therapy for the induction of lupus nephritis.

METHODS:

A systematic search of electronic databases (EMBASE, Web of Science, PubMed, Cochrane Library, and ClinicalTrials.gov) was conducted from inception to 30 August 2023. Our study included randomized controlled trials enrolling adult lupus nephritis patients treated with biologics or multitarget therapy, in comparison with standard therapy. The primary outcomes were the rates of complete renal remission (CRR) and serious adverse events (SAE). Stata 15.0 was used to conduct the network meta-analysis.

RESULTS:

Ten randomized controlled trials with a total of 1989 patients met the inclusion criteria. The network meta-analysis indicated that compared with standard therapy, multitarget therapy, obinutuzumab, belimumab, and voclosporin therapy demonstrated superior efficacy in achieving complete renal remission. Among these options, multitarget therapy had the greatest effect (OR = 2.78, 95% CI = 1.81-4.26). Regarding safety, it was observed that there were no significant statistical differences among the various treatment options. Cluster analysis revealed that both obinutuzumab and belimumab exhibited good efficacy and safety.

CONCLUSIONS:

belimumab and obinutuzumab stood out as promising treatments due to their good performance in terms of efficacy and safety. Multitarget therapy may be the most effective approach for treating lupus nephritis. However, since the study population consists exclusively of Asian patients, further research is needed to verify the efficacy of multitarget therapy in lupus nephritis patients of non-Asian descent.

2024-12-01·Drug Metabolism and Pharmacokinetics

Understanding mechanisms of negative food effect for voclosporin using physiologically based pharmacokinetic modeling

Article

作者: Fujiu, Motohiro ; Akazawa, Takanori ; Watanabe, Ayahisa

Negative food effect refers to a reduction in bioavailability, when a drug is taken with food. Voclosporin, a highly lipophilic cyclic peptide drug for treatment of active lupus nephritis, has shown negative food effect in clinical trials. Here, the cause of the negative food effect of voclosporin was investigated using physiologically based pharmacokinetic (PBPK) modeling to understand the mechanism responsible for oral absorption of voclosporin. Voclosporin is a substrate for P-glycoprotein and CYP3A4, and it has been evaluated for intestinal membrane permeability in human induced pluripotent stem cell-derived intestinal epithelial cells (hiPSC-IECs). The membrane permeability in hiPSC-IECs is integrated into the PBPK model for simulating permeability accurately. The PBPK model simulated the systemic PK profile in fasted state in human. Then, the PBPK model with in vitro adsorption of voclosporin onto food simulated the systemic PK profile in fed state for food effect. In addition, the PBPK model for rats also simulated the plasma profile of voclosporin for the food effect. These results suggest that a possible cause of the negative food effect of voclosporin is the adsorption of voclosporin to food in gastrointestinal tract. These approaches could facilitate understanding of the mechanisms responsible for oral absorption of cyclic peptides.

2024-11-01·Lupus Science & Medicine

Comparison of a voclosporin-based triple immunosuppressive therapy to high-dose glucocorticoid-based immunosuppressive therapy: a propensity analysis of the AURA-LV and AURORA 1 studies and ALMS

Article

作者: Hodge, Lucy S ; Dall'Era, Maria ; Truman, Matt ; Solomons, Neil ; Kalunian, Kenneth ; Askanase, Anca D ; Yap, Ernie

Introduction:

High-dose glucocorticoid (GC)-based dual immunosuppressive treatment regimens are still frequently used in active lupus nephritis (LN) despite their known association with dose-dependent toxicities and incomplete efficacy. We hypothesised that the addition of voclosporin to low-dose GCs and mycophenolate mofetil (MMF) would reduce exposure to the toxicities of high-dose GC-based dual immunosuppressive therapy regimens, resulting in an improved safety profile without compromising efficacy.

Methods:

Propensity score matching generated two groups of matched participants from the voclosporin arms (in combination with MMF (2 g/day) and low-dose GCs) of the Phase 2 AURA-LV and Phase 3 AURORA 1 studies and the MMF (3 g/day) and intravenous cyclophosphamide (IVC) arms (both in combination with high-dose GCs) of the Aspreva Lupus Management Study (ALMS) induction study. Safety and efficacy outcomes were assessed over 6 months.

Results:

There were 179 matched participants identified between the AURA-LV/AURORA 1 studies and ALMS. The overall incidence of adverse events (AEs) was higher in IVC- and MMF-treated participants of ALMS; more voclosporin-treated participants reported AEs by preferred term of glomerular filtration rate decreased, hypertension and anaemia. The incidence of serious AEs was similar across treatments. There were four (2.2%) deaths in IVC- and MMF-treated participants of ALMS compared with seven (3.9%) deaths in voclosporin-treated participants. Significantly more voclosporin-treated participants achieved a ≥25% reduction in urine protein creatinine ratio (UPCR) from baseline at 3 months and ≥50% reduction in UPCR from baseline at 6 months.

Conclusions:

Compared with the high-dose GC-based regimens used in ALMS, voclosporin-based triple immunosuppressive therapy resulted in fewer AEs overall and greater and earlier reductions in proteinuria over the first 6 months of treatment. These data reinforce the feasibility of using low doses of GCs and MMF to treat LN when combined with voclosporin as a third agent.

172

项与伏环孢素相关的新闻（医药）

2024-12-11

·药渡

11月，20家生物医药公司裁员

受全球经济下行压力和生物制药资本寒冬影响，生物医药行业裁员现象日益普遍。裁员原因包括被并购、产品开发失利、业务重组、降低管理成本等多方面。 2024年11月，有20家公司宣布裁员；其中23andMe在1个月内进行了2次裁员。以下，对各公司裁员情况进行汇总。 11月27日 KronosBio宣布，为了削减成本，将在今年年底前将其员工人数削减约83%。裁员后，这家总部位于加利福尼亚州的生物技术公司将剩下大约10名员工。由于此前在铂类耐药高级别浆液性卵巢癌I/II期数据令人失望，该公司还终止了其CDK9抑制剂istisociclib的开发。 11月27日诺华宣布将从其新泽西州工厂裁员近140名人。裁员将从2025年2月开始，一直持续到8月。这将主要影响Xolair、Tafinlar和Mekinist的商业现场销售团队。裁员之际，诺华加大了其产品线投资，包括可能以11亿美元收购基因治疗专家Kate Therapeutics以深化其神经肌肉专业知识，以及与Ratio Therapeutics的放射性制药交易，交易金额可能高达7.45亿美元。 11月27日据STAT News报道，在宣布与人工智能领导者Exscientia合并仅几个月后，Recursion Therapeutics宣布将裁员数十人。 Recursion和Exscientia于2024年8月首次宣布合并，拥有约8.5亿美元的现金和现金等价物，外加1亿美元的年度协同效应，这可以支持合并后的公司运营到2027年。除了10个高级发现项目和10多个合作项目外，合并后的公司正在考虑10多个临床和临床前管线项目。预计在未来18个月内将公布其临床候选药物的试验结果。 11月26日为了寻找资源支持其到2026年的运营，Medigene启动了一项广泛的组织重组活动，这家德国生物技术公司约40%的员工将在2025年被解雇。根据公司的新闻稿，该公司将保留那些对其新方向至关重要的员工，这些员工专注于具有最大投资回报潜力的研发活动。 2025年，Medigene将集中资源开发T细胞受体（TCR）引导的疗法，针对灵敏度、特异性和安全性进行了优化。该生物技术公司还将优先与药明生物合作，开发其TCR引导的T细胞接合MDG3010。 11月26日 Alector公布了其阿尔茨海默病抗体AL002令人失望的II期研究结果，41名员工面临解雇，约占其总员工人数的17%。裁员将于2025年上半年进行。裁员是全面重组计划的一部分，Alector将其资源与新的战略重点保持一致，未来，这家生物技术公司将专注于颗粒蛋白前体项目latozinemab和AL101/GSK4527226，这两个项目分别针对额颞叶痴呆和阿尔茨海默病而开发。 11月26日为了2025年将支出减少约15亿美元，百时美施贵宝宣布计划从新泽西州劳伦斯维尔工厂再裁员约195名员工。裁员将从2025年2月13日开始，一直持续到明年年底。 BMS于2024年4月在其第一季度收益报告中首次宣布了其全面的战略计划，这一举措的核心是到今年年底裁员约2,200人。首席执行官ChrisBoerner当时表示，这些业务调整将帮助BMS变得“更加敏捷”并“提高整个公司的效率”。 11月22日据Fierce Biotech报道，Sonata Therapeutics将为了围绕其最紧迫及优先事项精简其组织，裁员约20名员工。该公司一直在开发一类新的疗法，称为网络药物，旨在对患病细胞进行重新编程以释放治疗信号。今年3月，Sonata宣布与Champalimaud基金会合作开发SNT-3012，这是该生物技术公司的新型网络药物，旨在治疗胰腺癌和结直肠癌。 11月22日在宣布裁员200多名员工后不久，23andMe将解雇加州的153名员工并关闭其在南旧金山的分厂。裁员可能是之前宣布的裁员的一部分。这家基因检测公司将从1月10日起在桑尼维尔裁员122名员工，在南旧金山裁员31名员工。 11月21日由于来自中国的竞争日益激烈，强生和默克正在解雇该国的员工，J&J的裁员主要影响到一个销售外科产品的部门，而默克正在削减其糖尿病部门。中国媒体报道称，强生的裁员将影响该制药公司多达五分之一的大陆员工。默克受影响的员工人数目前没有报道。此外，J&J还解雇了新泽西州新不伦瑞克省总部的231名员工。这些削减将于12月27日生效。 11月18日根据WARN通知，吉利德科学公司和子公司Kite Pharma正在裁员72人。自1月17日起，吉利德西雅图工厂将关闭。 2025年3月14日起解雇其位于加利福尼亚州福斯特城的总部的104名员工。Kite Pharma将在2025年年中关闭其费城工厂。裁员原因为企业调整以进一步使资源与长期战略目标保持一致。 11月18日 Adaptimmune宣布将在2025年第一季度裁员约33%，以将其总运营费用降低约25%。此外，Adaptimmune还将结束uza-cel的II期SURPASS-3试验的招募，uza-cel是其下一代研究性TCRT细胞疗法，正在针对铂类耐药卵巢癌进行试验。从2025年到2028年，Adaptimmune预计将节省约3亿美元，这笔资金将使这家生物技术公司能够专注于其滑膜肉瘤业务，包括推出Tecelra和lete-cel的开发。 11月14日 11月14日，临床阶段生物技术公司Sensei Biotherapeutics宣布，为了集中资源推进免疫检查点抑制剂SNS-101的临床开发，该公司将裁员46%。大部分裁员将来自其临床前研发团队。这家总部位于马里兰州罗克维尔的公司,也将关闭其位于罗克维尔的研究基地。预计这些举措将使Sensei的现金流延长至2026年第二季度。 Sensei的SNS-101抑制剂是一种条件活性抗体，旨在选择性靶向肿瘤微环境中的免疫检查点VISTA（T细胞活化的V结构域Ig抑制因子）。该公司正在进行SNS-101作为单一疗法以及与再生元的PD-1抑制剂Libtayo联合治疗晚期实体瘤患者的多中心I/II期临床试验。 11月14日 Marinus Pharmaceuticals宣布，由于ganaxolone治疗与结节性硬化症相关的癫痫发作的III期结果未达预期，公司解雇了约45%的员工。这是今年已知的第二次裁员。今年5月，Marinus透露将裁员约20%。由于5月和11月的裁员，该公司可能还剩下大约73名员工。 11月13日据STAT News报道，Orna Therapeutics在一年内二次裁员，但没有透露裁员人数。同时重新调整了产品线。 Orna的体内CAR平台panCAR旨在治疗自身免疫和肿瘤疾病，将其oRNA技术与专有的脂质纳米颗粒相结合，制造出修饰免疫细胞的疗法。根据其网站，该公司希望到2026年将其panCAR候选药物引入临床试验。 11月12日基因检测公司23andMe宣布，将裁员200多名员工，约占其员工总数的40%。原因为停止开发新疗法，转而专注于其基因检测服务和产品，以简化其运营并降低成本。裁员将使企业损失高达1200万美元，包括遣散费、过渡期和结束聘用相关成本。作为回报，23andMe预计每年可节省超过3500万美元。 11月11日总部位于威尔明顿的公司赛默飞世尔科技将于2025年1月6日至2026年11月6日期间在马萨诸塞州的列克星敦、普兰维尔和剑桥的三个地点裁员160名。赛默飞世尔将关闭列克星敦工厂。并将项目从列克星敦转移到普兰维尔。 11月7日 Aurinia Pharmaceuticals宣布，为发展其狼疮性肾炎药物Lupkynis并快速开发其自身免疫性疾病候选药物AUR200，公司战略重组将裁员约45%。这是Aurinia今年已知的第二次裁员。2月，该公司宣布将在第一季度裁员至少25%。 Aurinia在11月7日的公告中表示，重组将提高运营效率，并将为公司节省超过4000万美元的年化现金运营费用。 11月7日为了更加专注于淋巴瘤患者的主要候选产品nana-val。位于加州卡迪夫的生物技术公司Viracta Therapeutics宣布裁员42%。裁员于10月31日生效。另10名董事中有4名自愿辞职。裁员后这家生物技术公司拥有约18名员工。 11月6日根据WARN的通知，安斯泰来基因疗法公司继续逐步关闭其旧金山的生物制造工厂，安斯泰来将于1月1日裁员10名员工。该设施的关闭预计将于2025年3月完成，影响约100名员工。目前尚不清楚其中有多少员工被解雇，但裁员可以追溯到几个月前。10月21日裁员7人，6月19日裁员10人。 11月5日 Sana Biotechnology宣布，由于管线转移和其他旨在延长其现金流的计划，该公司将裁员。人数不详。2023年由于将资源集中在其低免疫平台上，Sana裁员约120名员工（29%）。参考资料： https://www.biospace.com/biospace-layoff-tracker 来源：药事纵横幻目翻译 *声明：“药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。 10亿美金！映恩生物新型ADC药物独家授权GSK MNC加速扫货中国创新药，狂掀“买买买”热潮！ KRAS家族再添“强将”！百济神州Pan-KRAS抑制剂临床获批

高管变更基因疗法并购临床1期

2024-12-08

·医药投资部落

11月，有20家生物医药公司裁员

受全球经济下行压力和生物制药资本寒冬影响，生物医药行业裁员现象日益普遍。裁员原因包括被并购、产品开发失利、业务重组、降低管理成本等多方面。 2024年11月，有20家公司宣布裁员；其中23andMe在1个月内进行了2次裁员。以下，对各公司裁员情况进行汇总。 11月27日 KronosBio宣布，为了削减成本，将在今年年底前将其员工人数削减约83%。裁员后，这家总部位于加利福尼亚州的生物技术公司将剩下大约10名员工。由于此前在铂类耐药高级别浆液性卵巢癌I/II期数据令人失望，该公司还终止了其CDK9抑制剂istisociclib的开发。 11月27日诺华宣布将从其新泽西州工厂裁员近140名人。裁员将从2025年2月开始，一直持续到8月。这将主要影响Xolair、Tafinlar和Mekinist的商业现场销售团队。裁员之际，诺华加大了其产品线投资，包括可能以11亿美元收购基因治疗专家Kate Therapeutics以深化其神经肌肉专业知识，以及与Ratio Therapeutics的放射性制药交易，交易金额可能高达7.45亿美元。 11月27日据STAT News报道，在宣布与人工智能领导者Exscientia合并仅几个月后，Recursion Therapeutics宣布将裁员数十人。 Recursion和Exscientia于2024年8月首次宣布合并，拥有约8.5亿美元的现金和现金等价物，外加1亿美元的年度协同效应，这可以支持合并后的公司运营到2027年。除了10个高级发现项目和10多个合作项目外，合并后的公司正在考虑10多个临床和临床前管线项目。预计在未来18个月内将公布其临床候选药物的试验结果。 11月26日为了寻找资源支持其到2026年的运营，Medigene启动了一项广泛的组织重组活动，这家德国生物技术公司约40%的员工将在2025年被解雇。根据公司的新闻稿，该公司将保留那些对其新方向至关重要的员工，这些员工专注于具有最大投资回报潜力的研发活动。 2025年，Medigene将集中资源开发T细胞受体（TCR）引导的疗法，针对灵敏度、特异性和安全性进行了优化。该生物技术公司还将优先与药明生物合作，开发其TCR引导的T细胞接合MDG3010。 11月26日 Alector公布了其阿尔茨海默病抗体AL002令人失望的II期研究结果，41名员工面临解雇，约占其总员工人数的17%。裁员将于2025年上半年进行。裁员是全面重组计划的一部分，Alector将其资源与新的战略重点保持一致，未来，这家生物技术公司将专注于颗粒蛋白前体项目latozinemab和AL101/GSK4527226，这两个项目分别针对额颞叶痴呆和阿尔茨海默病而开发。 11月26日为了2025年将支出减少约15亿美元，百时美施贵宝宣布计划从新泽西州劳伦斯维尔工厂再裁员约195名员工。裁员将从2025年2月13日开始，一直持续到明年年底。 BMS于2024年4月在其第一季度收益报告中首次宣布了其全面的战略计划，这一举措的核心是到今年年底裁员约2,200人。首席执行官ChrisBoerner当时表示，这些业务调整将帮助BMS变得“更加敏捷”并“提高整个公司的效率”。 11月22日据Fierce Biotech报道，Sonata Therapeutics将为了围绕其最紧迫及优先事项精简其组织，裁员约20名员工。该公司一直在开发一类新的疗法，称为网络药物，旨在对患病细胞进行重新编程以释放治疗信号。今年3月，Sonata宣布与Champalimaud基金会合作开发SNT-3012，这是该生物技术公司的新型网络药物，旨在治疗胰腺癌和结直肠癌。 11月22日在宣布裁员200多名员工后不久，23andMe将解雇加州的153名员工并关闭其在南旧金山的分厂。裁员可能是之前宣布的裁员的一部分。这家基因检测公司将从1月10日起在桑尼维尔裁员122名员工，在南旧金山裁员31名员工。 11月21日由于来自中国的竞争日益激烈，强生和默克正在解雇该国的员工，J&J的裁员主要影响到一个销售外科产品的部门，而默克正在削减其糖尿病部门。中国媒体报道称，强生的裁员将影响该制药公司多达五分之一的大陆员工。默克受影响的员工人数目前没有报道。此外，J&J还解雇了新泽西州新不伦瑞克省总部的231名员工。这些削减将于12月27日生效。 11月18日根据WARN通知，吉利德科学公司和子公司Kite Pharma正在裁员72人。自1月17日起，吉利德西雅图工厂将关闭。 2025年3月14日起解雇其位于加利福尼亚州福斯特城的总部的104名员工。Kite Pharma将在2025年年中关闭其费城工厂。裁员原因为企业调整以进一步使资源与长期战略目标保持一致。 11月18日 Adaptimmune宣布将在2025年第一季度裁员约33%，以将其总运营费用降低约25%。此外，Adaptimmune还将结束uza-cel的II期SURPASS-3试验的招募，uza-cel是其下一代研究性TCRT细胞疗法，正在针对铂类耐药卵巢癌进行试验。从2025年到2028年，Adaptimmune预计将节省约3亿美元，这笔资金将使这家生物技术公司能够专注于其滑膜肉瘤业务，包括推出Tecelra和lete-cel的开发。 11月14日 11月14日，临床阶段生物技术公司Sensei Biotherapeutics宣布，为了集中资源推进免疫检查点抑制剂SNS-101的临床开发，该公司将裁员46%。大部分裁员将来自其临床前研发团队。这家总部位于马里兰州罗克维尔的公司,也将关闭其位于罗克维尔的研究基地。预计这些举措将使Sensei的现金流延长至2026年第二季度。 Sensei的SNS-101抑制剂是一种条件活性抗体，旨在选择性靶向肿瘤微环境中的免疫检查点VISTA（T细胞活化的V结构域Ig抑制因子）。该公司正在进行SNS-101作为单一疗法以及与再生元的PD-1抑制剂Libtayo联合治疗晚期实体瘤患者的多中心I/II期临床试验。 11月14日 Marinus Pharmaceuticals宣布，由于ganaxolone治疗与结节性硬化症相关的癫痫发作的III期结果未达预期，公司解雇了约45%的员工。这是今年已知的第二次裁员。今年5月，Marinus透露将裁员约20%。由于5月和11月的裁员，该公司可能还剩下大约73名员工。 11月13日据STAT News报道，Orna Therapeutics在一年内二次裁员，但没有透露裁员人数。同时重新调整了产品线。 Orna的体内CAR平台panCAR旨在治疗自身免疫和肿瘤疾病，将其oRNA技术与专有的脂质纳米颗粒相结合，制造出修饰免疫细胞的疗法。根据其网站，该公司希望到2026年将其panCAR候选药物引入临床试验。 11月12日基因检测公司23andMe宣布，将裁员200多名员工，约占其员工总数的40%。原因为停止开发新疗法，转而专注于其基因检测服务和产品，以简化其运营并降低成本。裁员将使企业损失高达1200万美元，包括遣散费、过渡期和结束聘用相关成本。作为回报，23andMe预计每年可节省超过3500万美元。 11月11日总部位于威尔明顿的公司赛默飞世尔科技将于2025年1月6日至2026年11月6日期间在马萨诸塞州的列克星敦、普兰维尔和剑桥的三个地点裁员160名。赛默飞世尔将关闭列克星敦工厂。并将项目从列克星敦转移到普兰维尔。 11月7日 Aurinia Pharmaceuticals宣布，为发展其狼疮性肾炎药物Lupkynis并快速开发其自身免疫性疾病候选药物AUR200，公司战略重组将裁员约45%。这是Aurinia今年已知的第二次裁员。2月，该公司宣布将在第一季度裁员至少25%。 Aurinia在11月7日的公告中表示，重组将提高运营效率，并将为公司节省超过4000万美元的年化现金运营费用。 11月7日为了更加专注于淋巴瘤患者的主要候选产品nana-val。位于加州卡迪夫的生物技术公司Viracta Therapeutics宣布裁员42%。裁员于10月31日生效。另10名董事中有4名自愿辞职。裁员后这家生物技术公司拥有约18名员工。 11月6日根据WARN的通知，安斯泰来基因疗法公司继续逐步关闭其旧金山的生物制造工厂，安斯泰来将于1月1日裁员10名员工。该设施的关闭预计将于2025年3月完成，影响约100名员工。目前尚不清楚其中有多少员工被解雇，但裁员可以追溯到几个月前。10月21日裁员7人，6月19日裁员10人。 11月5日 Sana Biotechnology宣布，由于管线转移和其他旨在延长其现金流的计划，该公司将裁员。人数不详。2023年由于将资源集中在其低免疫平台上，Sana裁员约120名员工（29%）。来源：药事纵横医药研究报告分享营收集与分享全市场主流医药研究报告每天仅需0.8元畅享超过1900篇精选医药研究报告未来一年新增额外500篇

高管变更基因疗法细胞疗法并购

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 项与伏环孢素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09033	伏环孢素	L04AD03	DB11693

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
狼疮性肾炎	美国	Aurinia Pharmaceuticals, Inc.	2021-01-22

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
干眼综合征	临床3期	美国	Aurinia Pharmaceuticals, Inc.	2019-10-14
干燥综合征性角膜结膜炎	临床3期	美国	Aurinia Pharmaceuticals, Inc.	2019-10-14
肾移植急性排斥反应	临床3期	-	Aurinia Pharmaceuticals, Inc.	2013-03-01
葡萄膜炎	临床3期	美国	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	奥地利	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	巴西	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	加拿大	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	捷克	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	法国	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	德国	Lux Biosciences, Inc.	2011-02-01

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临床结果

适应症

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


EULAR2024	N/A	狼疮性肾炎	179	Voclosporin-based, triple immunosuppressive regimen	憲壓餘襯艱選憲夢網獵(鹽壓鬱範鹽鏇糧選醖襯) = The overall incidence of adverse events (AEs) was higher in IVC- and MMF-treated participants in ALMS over the 6-month period. More participants in AURA-LV and AURORA 1 reported hypertension and anemia. Due to the known hemodynamic effects of calcineurin inhibition, there was a small decrease in mean eGFR in the AURA-LV/AURORA 1 participants in the first few weeks of treatment after which mean eGFR remained stable; a greater number of events of GFR decreased were reported by AURA-LV/AURORA 1 participants. The incidence of serious AEs was similar across groups. 糧網簾餘餘選餘壓窪醖 (襯鏇醖範網築鹽齋齋築 ) 更多	积极	2024-06-05
				High-dose glucocorticoid and mycophenolate mofetil-based therapy
AURORA (Biospace) 人工标引	N/A	狼疮性肾炎	-	LUPKYNIS	繭網構壓願選鹹獵選簾(糧鑰網願築範鏇網構鑰) = 廠齋願襯積鬱繭淵鬱築網顧簾鬱襯鏇淵觸襯糧 (築淵夢衊鑰淵獵範鑰選 )	积极	2024-05-09
AURORA (Biospace) 人工标引	N/A	狼疮性肾炎	25	LUPKYNIS, MMF, and steroids	積夢簾窪醖網醖憲壓繭(衊鬱鏇積顧獵壓鬱獵製) = 襯簾積顧鏇齋衊簾膚構壓鑰鹹壓齋積顧構衊鬱 (構範獵鬱遞壓範鬱衊夢 )	积极	2024-05-09
				MMF and glucocorticoids	積夢簾窪醖網醖憲壓繭(衊鬱鏇積顧獵壓鬱獵製) = 選範餘廠齋願繭餘簾鹽壓鑰鹹壓齋積顧構衊鬱 (構範獵鬱遞壓範鬱衊夢 )
NCT03021499 (phase 3 study, Pubmed)	临床3期	狼疮性肾炎	148	Voclosporin	(遞膚鹽鹽壓襯蓋積衊遞) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms 鹹壓構網齋衊艱遞簾餘 (艱憲選餘顧艱範餘齋築 ) 更多	积极	2023-12-18
				Placebo
ACR2023	N/A	蛋白尿	-	Voclosporin	醖衊廠淵範廠衊鹹衊繭(廠鹽壓範壓範廠窪簾糧) = 窪願餘夢願鬱壓鹹獵窪醖壓網築齋蓋壓遞獵築 (遞襯顧醖餘鏇膚鹽壓範 ) 更多	-	2023-11-14
				Placebo	醖衊廠淵範廠衊鹹衊繭(廠鹽壓範壓範廠窪簾糧) = 蓋繭餘繭衊簾壓憲鹹簾醖壓網築齋蓋壓遞獵築 (遞襯顧醖餘鏇膚鹽壓範 ) 更多
AURORA 1 (Biospace) 人工标引	临床2/3期	狼疮性肾炎	-	LUPKYNIS® + MMF+ glucocorticoids (proteinuria >=2 g/day)	獵壓遞餘夢選製餘衊齋(鏇糧觸構醖製夢壓獵淵) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day 夢鹹簾築蓋繭願範衊壓 (構鹽構構襯醖構餘鹹餘 ) 更多	积极	2023-11-07
				LUPKYNIS® + MMF+ glucocorticoids (UPCR ≥2 g/g at baseline)
AURORA 2 (Biospace) 人工标引	临床3期	狼疮性肾炎	26	LUPKYNIS® in combination + MMF + glucocorticoids	獵鬱築壓鹹選艱繭願窪(餘鏇醖醖製壓構範顧鬱) = experienced numerically greater mean reductions 壓獵鏇襯窪憲餘廠遞窪 (壓鏇簾糧夢繭願簾蓋鹹 ) 更多	积极	2023-11-07
				MMF + glucocorticoids
AURORA (Biospace) 人工标引	N/A	狼疮性肾炎	-	LUPKYNIS + MMF + glucocorticoids (Black patients)	齋壓獵積選構觸憲遞淵(觸醖網鏇鏇選艱廠膚蓋) = 網積齋糧鏇窪觸窪齋壓齋繭憲築膚鏇淵願窪範 (觸鹽顧鏇鬱餘壓鹽襯餘 )	积极	2023-11-07
				MMF + glucocorticoids (Black patients)	齋壓獵積選構觸憲遞淵(觸醖網鏇鏇選艱廠膚蓋) = 網獵衊衊衊齋網淵鏇蓋齋繭憲築膚鏇淵願窪範 (觸鹽顧鏇鬱餘壓鹽襯餘 )
AURA-LV and AURORA 1 (EULAR2023)	临床2/3期	蛋白尿	-	Voclosporin	顧遞觸觸窪淵構鑰遞艱(鹽艱遞遞廠憲遞艱鹹鑰) = 夢艱鏇鏇壓齋鏇鹽鏇願鹹積鏇膚淵糧鑰襯襯夢 (窪憲簾廠夢築築範網觸 ) 更多	积极	2023-05-31
				Placebo	顧遞觸觸窪淵構鑰遞艱(鹽艱遞遞廠憲遞艱鹹鑰) = 蓋鑰構廠膚築衊鬱齋淵鹹積鏇膚淵糧鑰襯襯夢 (窪憲簾廠夢築築範網觸 ) 更多