盐酸依特卡肽(Etelcalcetide) - 药物靶点：CaSR_在研适应症：慢性肾病，继发性甲状旁腺功能亢进症_专利_临床

概要

基本信息

药物类型

合成多肽

别名

etelcalcetide hydrochloride、Parsabiv、Telcalcetide

+ [8]

靶点

CaSR

作用方式

激动剂

作用机制

CaSR激动剂(钙敏感受体激动剂)

治疗领域

内分泌与代谢疾病泌尿生殖系统疾病

在研适应症

慢性肾病继发性甲状旁腺功能亢进症

非在研适应症

慢性肾病-矿物质和骨骼疾病心源性水肿终末期肾脏病

原研机构

Amgen, Inc.

在研机构

Amgen, Inc.Amgen Europe BV

Ono Pharmaceutical Co., Ltd.

+ [1]

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2016-11-11),

慢性肾病继发性甲状旁腺功能亢进症

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C38H73N21O10S2.ClH

InChIKeyKHQMSZGKHGQUHG-WZDHWKSBSA-N

CAS号1334237-71-6

Sequence Code 1167865364

来源: *****

关联

41

项与盐酸依特卡肽相关的临床试验

JPRN-UMIN000053361

/ RecruitingN/AIIT

A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients. - A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients.

开始日期2024-01-15

申办/合作机构-

NCT03969329

/ Recruiting临床3期

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

开始日期2019-12-20

申办/合作机构

Amgen, Inc.

NCT03795558

/ Completed临床2期IIT

A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.

开始日期2019-05-01

申办/合作机构

Krankenhaus der Elisabethinen Linz GmbH

[+1]

100 项与盐酸依特卡肽相关的临床结果

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100 项与盐酸依特卡肽相关的转化医学

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100 项与盐酸依特卡肽相关的专利（医药）

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159

项与盐酸依特卡肽相关的文献（医药）

2025-02-01·Clinical Journal of the American Society of Nephrology

Incorporation of Calcimimetics into End-Stage Kidney Disease Bundle

Article

作者: Ma, Junjie ; Pecoits-Filho, Roberto ; Karaboyas, Angelo ; Sprague, Stuart M. ; Pisoni, Ronald L ; Saleem, Najma ; Martin, Kevin J. ; Smerdon, Caroline ; Zhao, Junhui ; Moore, Carol

Key Points:

After incorporation into the bundle in 2021, etelcalcetide use decreased substantially, reflecting financial incentives to restrict access.Etelcalcetide discontinuers had a swift and sustained increase in parathyroid hormone and loss of secondary hyperparathyroidism control, despite most switching to cinacalcet.These findings have US policy implications not only for etelcalcetide and parathyroid hormone but also for future development of innovative therapies in dialysis.

Background:

Calcimimetics, including intravenous etelcalcetide and oral cinacalcet, are often prescribed to hemodialysis patients to prevent complications of elevated parathyroid hormone (PTH) levels. In January 2021, US dialysis reimbursement policy switched from the transitional drug add-on payment adjustment (TDAPA) to an increased bundled payment, with $10.09 per session added for all hemodialysis patients to cover the expense for calcimimetics, whether or not patients are administered etelcalcetide. We leveraged this natural experiment to investigate the effect of this policy change.

Methods:

This analysis included 713 US in-center hemodialysis patients enrolled in the United States Dialysis Outcomes and Practice Patterns Study who discontinued etelcalcetide during the TDAPA transition period (December 2020–April 2021). Within a self-matched longitudinal design, within-patient changes in mean PTH, calcium, and phosphorus were assessed in the 6 months before versus after etelcalcetide discontinuation, using linear regression adjusted for potential confounders.

Results:

Etelcalcetide use in the United States Dialysis Outcomes and Practice Patterns Study decreased by 58%, from 12% to 5% from July 2020 to 2021; 73% of etelcalcetide discontinuers switched to cinacalcet within 6 months. Comparing the 6 months before versus after etelcalcetide discontinuation, the mean PTH levels increased by 107 (95% CI; 80 to 133) pg/ml, and the prevalence of PTH >600 pg/ml increased by 15% (95% CI; 11% to 19%), from 28% to 43% overall, and increased from 26% to 49% among Black patients. The mean serum calcium and phosphorus levels increased by 0.42 and 0.16 mg/dl, respectively.

Conclusions:

Etelcalcetide use decreased substantially after TDAPA ended in January 2021, with most patients switching to cinacalcet. The subsequent increase in PTH levels was swift and sustained and especially pronounced among Black patients, raising concerns about disparities and potential downstream effects on clinical outcomes. Despite the spirit of the policy change, the flat per-treatment increased payment may have inadvertently created a financial incentive to restrict patient access to a more effective therapy and potentially stifle drug innovation.

2025-02-01·Nefrologia

Etelcalcetide: What we know eight years since its approval

Review

作者: Freitas, Pedro ; Pereira, Luciano

INTRODUCTION AND OBJECTIVES:

The impact of etelcalcetide on patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) has been studied since its introduction in 2016/2017. However, only a handful of studies reported clinically relevant outcomes. This narrative review aims to summarize the published data about etelcalcetide, focusing on biochemical, cardiovascular (CV) and bone endpoints, as well as adverse effects and all-cause mortality.

MATERIALS AND METHODS:

A literature review of the use of etelcalcetide in hemodialysis patients with SHPT was conducted. Several sources were used, such as PubMed, Google Scholar and Cochrane Library.

RESULTS:

Regarding bone and mineral metabolism, etelcalcetide is effective in reducing serum levels of parathormone (PTH), calcium, phosphate and fibroblast growth factor 23 (FGF23). Preliminary data have highlighted its role in reducing bone turnover and improving mineralization and preservation of bone structure, indicating a possible positive impact on renal osteodystrophy. From a CV perspective, etelcalcetide is associated with a significant reduction in left ventricular hypertrophy. In addition, etelcalcetide reduces FGF23 and increases sclerostin serum levels. This data suggests a possible CV beneficial effect.

CONCLUSIONS:

Etelcalcetide is effective in controlling SHPT. Promising data is available for some bone and surrogate cardiovascular endpoints, suggesting a possible beneficial effect. There is a lack of studies specifically designed to evaluate its role in reducing fractures, CV and all-cause mortality.

2024-11-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Etelcalcetide ameliorates bone loss in chronic kidney disease-mineral and bone disorder by activation of IRF7 and necroptosis pathways

Article

作者: Lu, Kuo-Cheng ; Chiu, Hui-Wen ; Zheng, Cai-Mei ; Chen, Yi-Jie ; Lin, Yen-Chung ; Chiu, Yu-Jhe ; Hou, Yi-Chou ; Liao, Min-Tser

Chronic kidney disease-mineral and bone disorder (CKD-MBD) is a multifaceted clinical syndrome characterized by mineral imbalances, abnormalities in bone metabolism, chronic inflammation and vascular calcification. Etelcalcetide, a second-generation intravenous calcimimetic agent, has been approved for treating high-turnover renal osteodystrophy, effectively targeting the pathophysiological mechanisms underlying this condition. We investigate the impacts of etelcalcetide on osteoclast (OC) differentiation and functionality in CKD-MBD via three critical mechanisms: inflammation initiated by interferon regulatory factor 7 (IRF7), receptor-interacting protein (RIP)-mediated necroptosis and apoptosis-induced cell death. The low-dose (CKD + L) or high-dose (CKD + H) of etelcalcetide groups significantly improved biochemical markers compared to the CKD control mice. Additionally, etelcalcetide-treated CKD mice significantly improved cortical and trabecular bone parameters. In an in vitro study, etelcalcetide was observed to bolster the IRF7-mediated IFNβ response in OC differentiation. Furthermore, it stimulated RIP-mediated necroptosis via RIP and MLKL activation, inhibiting bone resorption. Moreover, the drug increased levels of caspases 3 and 9, inducing cell death in OCs. These findings suggest that etelcalcetide regulates bone metabolism and reduces skeletal issues in CKD-MBD. Etelcalcetide likely enhances bone parameters in CKD-MBD mice by regulating IRF7 pathways and inhibiting OC differentiation. It also improves bone health and promotes RIP-mediated necroptosis and apoptosis pathways within OCs.

66

项与盐酸依特卡肽相关的新闻（医药）

2025-03-03

·医药地理

【凤采鸾章·博文集】慢性肾脏病-矿物质骨紊乱治疗中降全段甲状旁腺激素药物研究进展

慢性肾脏病-矿物质骨紊乱治疗中降全段甲状旁腺激素药物研究进展 Research progress of drugs to reduce whole intact parathyroid hormone in the treatment of chronic kidney disease-mineral and bone disorder 张倩楠1 ，汪年松2* ，李军辉1* (1. 同济大学附属普陀人民医院肾内科，上海 200060；2. 上海交通大学医学院附属第六人民医院肾内科，上海 200233) 引用张倩楠, 汪年松, 李军辉. 慢性肾脏病-矿物质骨紊乱治疗中降全段甲状旁腺激素药物研究进展[J]. 世界临床药物, 2025, 46(1): 23-28. DOI:10.13683/j.wph.2025.01.005 作者简介张倩楠，主治医师，研究方向：慢性肾脏病的诊治。通信作者：汪年松，主任医师，教授，博士生导师，研究方向：糖尿病肾病、急性肾损伤发病机制和防治。李军辉，副主任医师，副教授，研究方向：慢性肾脏病诊治。基金项目：上海市普陀区科委课题(ptkwws202412)；上海市普陀区人民医院院级课题(2022rmky12) 摘要继发性甲状旁腺功能亢进 (secondary hyperparathyroidism，SHPT) 是慢性肾脏病 - 矿物质骨紊乱 (chronic kidney disease-mineral and bone disorder，CKD-MBD) 的重要并发症之一，可显著增加患者骨骼畸形、心血管事件及死亡的发生风险。在目前 CKD-MBD SHPT 的临床治疗中，磷结合剂、拟钙剂、多核铁 - 氢氧化物及 tenapanor 等药物均展现出一定优势；新型活性维生素 D 类似物可有效降低全段甲状旁腺激素 (intact parathyroid hormone，iPTH) 水平。该文对近年来降 iPTH CKD 的 MBD 治疗药物进展作一综述，旨在为临床用药提供参考。关键词慢性肾脏病 - 矿物质骨紊乱；继发性甲状旁腺功能亢进症；全段甲状旁腺激素章节导览 1 磷结合剂 1.1 含钙磷结合剂 1.2 非含钙磷结合剂 1.2.1 司维拉姆 1.2.2 碳酸镧 2 其他降磷药物 2.1 含铁磷结合剂 2.2 tenapanor 3 活性维生素 D 及其类似物 3.1 骨化三醇 3.2 帕立骨化醇 3.3 阿法骨化醇与度骨化醇 4 拟钙剂 4.1 西那卡塞 4.2 依特卡肽 4.3 依沃卡塞 (evocalcet) 5 调节肠道菌群治疗 6 联合用药 7 结语文章节选慢性肾脏病 (chronic kidney disease，CKD) 是目前全球范围内的重要公共卫生问题。我国CKD患者约有 1.32 亿例，患病率高达10.8%。CKD- 矿物质骨紊乱(chronic kidney disease-mineral and bone disorder，CKD-MBD) 是一种肾功能减退导致的矿物质及骨代谢异常综合征，主要表现为钙和磷代谢异常、全段甲状旁腺激素(intact parathyroid hormone，iPTH) 水平升高、骨质疏松及血管钙化等，是引发CKD患者致残、致死等不良事件的重要原因之一。近年研究显示，肾脏排泄、内分泌功能异常等可诱发 CKD 患者甲状旁腺过度增生及iPTH 分泌增加，最终引发继发性甲状旁腺功能亢进 (secondary hyperparathyroidism，SHPT)，而 SHPT 又进一步加重矿物质、骨代谢异常和异位钙化，影响预后，加重社会医疗经济负担。CKD 患者约从 3b 期开始出现 iPTH 水平进行性升高；CKD 患者骨骼对 PTH 的反应性低，且调整轻中度 CKD 患者的 PTH 至正常范围可能诱发高磷血症 (hyperphosphatemia) 。因此，CKD-MBD 患者降 iPTH 的治疗目标应为将 iPTH 水平控制于高于正常参考范围的合理区间，但目前对不同 CKD 分期、不同治疗情况者 PTH 的精准控制目标尚未统一。现将对 CKD-MBD 患者降 iPTH 治疗药物的研究进展作一综述，旨在为临床提供参考。 ↑长按二维码阅读原文聚焦药物综合评价促进临床合理用药请看《世界临床药物》！本刊为月刊，大16开。邮发代号4-302，全国各地邮局均可订阅。定价：26元，全年312元。订阅电话：021-62790477-751 订阅传真：021-62473200 订阅邮箱：guohx@pharmadl.com END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

临床研究临床终止

2025-02-24

·麦科奥特

MICOT（麦科奥特）全球首创新药MT1013多中心、随机与依特卡肽阳性对照临床试验-入组圆满完成

点击蓝字关注我们 MICOT（麦科奥特）全球首创新药MT1013 多中心、随机与依特卡肽阳性对照临床试验-入组圆满完成陕西麦科奥特医药科技股份有限公司自主研发的全球首创新药MT1013多中心、随机与依特卡肽阳性对照临床试验，以高效且精准的节奏完成了全部受试者入组工作。这一成就不仅标志着麦科奥特在肾病治疗领域迈出了关键一步，更是公司创新实力的重要体现。 MT1013是麦科奥特针对慢性肾脏病伴继发性甲状旁腺功能亢进（SHPT）患者精心研发的全球首创新药。作为一款双靶点多肽创新药，MT1013采用独特的单分子设计，能够同时作用于两个关键靶点。它不仅能有效控制SHPT病情，还能促进成骨，改善骨质疏松，从而显著降低患者骨痛、骨骼畸形等并发症的风险。这种创新的治疗机制为SHPT患者带来了全新的治疗思路和希望。在中美临床I期研究中，MT1013的安全性和有效性得到了充分验证。研究结果显示，该药物能够显著降低血清iPTH水平，且未出现症状性低血钙或胃肠道不良反应，展现出良好的耐受性。此次临床试验由陕西麦科奥特科技有限公司申办，是一项多中心、随机、与依特卡肽阳性对照的研究。试验在全国45家研究中心同步开展，旨在全面评估MT1013治疗接受维持性血液透析（MHD）的慢性肾脏病伴继发性甲状旁腺功能亢进（SHPT）患者的疗效和安全性。该研究以依特卡肽为阳性对照，通过科学严谨的设计和执行，为MT1013的上市申请提供了坚实的临床依据。完成受试者入组是临床试验的关键一步，这不仅为后续数据收集和分析奠定了基础，也为MT1013的进一步研发和市场推广提供了有力支持。麦科奥特凭借其在创新药物研发领域的深厚积累和强大实力，成功推动了这一项目的高效进展，展现了公司在医药创新领域的卓越能力。随着临床试验的顺利推进，MT1013有望为慢性肾脏病伴继发性甲状旁腺功能亢进患者带来更安全、更有效的治疗选择，为肾病治疗领域注入新的活力，开启新的篇章。欢迎关注麦科奥特｜MICOT

临床1期

2025-02-13

·医药地理

第九十批参比制剂目录发布

2月12日，国家药监局发布《关于发布仿制药参比制剂目录（第九十批）的通告》，其中新增品规42个，变更及增加持证商品规9个。涉及品种：氟轻松玻璃体内植入剂、盐酸依特卡肽注射液、甲磺酸酚妥拉明滴眼液、沙库巴曲缬沙坦钠胶囊、赖诺普利口服溶液等。附：化学仿制药参比制剂目录（第九十批）来源:易联招采 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

带量采购

100 项与盐酸依特卡肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	盐酸依特卡肽	H05BX04	DB12865

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
慢性肾病	欧盟	Amgen Europe BV	2016-11-11
慢性肾病	冰岛	Amgen Europe BV	2016-11-11
慢性肾病	列支敦士登	Amgen Europe BV	2016-11-11
慢性肾病	挪威	Amgen Europe BV	2016-11-11
继发性甲状旁腺功能亢进症	欧盟	Amgen Europe BV	2016-11-11
继发性甲状旁腺功能亢进症	冰岛	Amgen Europe BV	2016-11-11
继发性甲状旁腺功能亢进症	列支敦士登	Amgen Europe BV	2016-11-11
继发性甲状旁腺功能亢进症	挪威	Amgen Europe BV	2016-11-11

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
终末期肾脏病	临床2期	奥地利	Amgen, Inc.	2019-05-01
慢性肾病-矿物质和骨骼疾病	临床2期	-	KAI Pharmaceuticals, Inc.	2012-03-01
心源性水肿	临床1期	美国	Amgen, Inc.	2017-03-14
心源性水肿	临床1期	比利时	Amgen, Inc.	2017-03-14
心源性水肿	临床1期	德国	Amgen, Inc.	2017-03-14
心源性水肿	临床1期	立陶宛	Amgen, Inc.	2017-03-14
心源性水肿	临床1期	波兰	Amgen, Inc.	2017-03-14
心源性水肿	临床1期	英国	Amgen, Inc.	2017-03-14

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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


NCT03960437 (The Effect of Etelcalcetide on CKD-MBD (Parsabiv-MBD), Pubmed \| Clin J Am Soc Nephrol)	临床2期	-	-	Etelcalcetide	廠觸廠範繭糧繭構窪淵(壓鏇襯構構觸膚網鹹鹽) = 鏇觸顧蓋醖網衊廠襯繭選鑰膚憲願遞壓糧衊窪 (鏇齋壓繭壓醖餘鹹鏇襯 ) 更多	积极	2023-11-01
NCT03960437 (Parsabiv-MBD \| The Effect of Etelcalcetide on CKD-MBD (Parsabiv-MBD), CTgov)	临床2期	慢性肾病-矿物质和骨骼疾病 \| 血管钙化 \| 终末期肾脏病	22	Etelcalcetide	築餘製顧積顧夢獵襯範(鹽顧願積淵願淵遞鑰壓) = 膚顧鹽製鹹夢繭鬱淵選簾顧簾艱選廠夢廠觸築 (築鑰觸膚淵憲鹽窪艱蓋, 0) 更多	-	2023-09-21
ISN WCN2023	N/A	继发性甲状旁腺功能亢进症	92	Etelcalcetide 7.5-15 mg/week	糧網膚繭範鏇願範餘壓(膚築窪簾廠觸選網願衊) = Only 1 Patient (3.8%) had GI side effects which didn’t necessitate to stop the medication 艱網繭膚夢夢齋鹽蓋願 (範鹽網齋鬱艱糧夢鹽夢 ) 更多	积极	2023-03-01
ISN WCN2023	N/A	继发性甲状旁腺功能亢进症	92	Cinacalcet		积极	2023-03-01
ASN2022	N/A	继发性甲状旁腺功能亢进症	414	Cinacalcet (CIN)	齋選糧繭鏇齋選範鹹衊(蓋製襯憲遞繭願鹽蓋構) = 鏇鏇獵蓋簾壓獵淵願憲鬱繭襯餘鑰廠觸夢齋簾 (鏇積壓繭範蓋蓋顧憲淵 )	-	2022-11-05
ERA2022	N/A	贫血	-	Etelcalcetide	製廠壓淵鏇鏇襯願餘憲(鏇襯衊廠淵窪遞壓憲鑰) = 積鹽襯觸鹽艱廠築蓋顧窪構壓構鹽築鹹蓋蓋願 (蓋鑰鑰醖窪鑰遞憲鑰鹹, 207) 更多	-	2022-05-03
NCT03283098 (Pubmed \| Med Lett Drugs Ther \| Clin Ther) 人工标引	临床1期	慢性肾病	33	etelcalcetide	餘憲夢鬱艱鏇襯鹽淵膚(製繭繭糧構築鬱蓋壓簾) = 鹽願衊鏇範願築鏇衊襯衊襯餘積鏇觸糧簾鹽憲 (遞網鹽餘膚獵窪鑰鹽衊 ) 更多	积极	2021-11-10
NCT03283098 (Pubmed \| Med Lett Drugs Ther \| Clin Ther) 人工标引	临床1期	慢性肾病	33	Placebo	製壓鑰鏇築積鬱積鏇壓(築選範艱範範簾廠鏇糧) = 鬱齋築構鹹艱選簾膚製鹽襯膚範窪艱鑰夢艱壓 (遞簾簾遞繭憲壓製衊顧 ) 更多	积极	2021-11-10
ASN2021	N/A	慢性肾病 parathyroid hormone	-	Etelcalcetide	積襯艱蓋積襯鹽選醖鹽(襯憲憲選積衊襯淵鬱顧) = 鏇廠獵醖鑰獵觸夢醖網遞鏇鏇鏇窪夢衊齋淵艱 (鹽構簾淵鹽鏇網繭淵顧 ) 更多	积极	2021-10-27
ASN2021	N/A	慢性肾病 parathyroid hormone	-	Placebo	蓋顧窪築鹽鹹獵窪簾鹽(構齋顧鹹築鹹齋鹹糧鹽) = 淵蓋艱膚選糧鹹衊衊鹹簾窪積廠築觸簾積構淵 (鹽膚糧廠鑰網簾選蓋鑰 )	积极	2021-10-27
ASN2021	N/A	终末期肾脏病 serum PTH	5	Etelcalcetide	繭廠壓範選製範願齋夢(簾鬱襯觸製鹽襯繭鑰鏇) = 鬱齋選鑰蓋鹽糧顧廠繭餘簾顧鏇齋襯鹹艱網糧 (齋簾獵淵築鬱願願鬱醖 ) 更多	积极	2021-10-27
ASN2021	N/A	维持	22	Etelcalcetide	觸顧齋獵艱齋網窪憲衊(鏇艱網選鬱鹽構顧壓夢) = 構齋齋衊積憲鹽簾選築餘齋網範選遞願遞願艱 (遞築遞糧襯積鏇鬱選糧 ) 更多	积极	2021-10-27
ASN2021	N/A	继发性甲状旁腺功能亢进症维持 parathyroid hormone (PTH) \| calcium (Ca) \| phosphate (P)	974	Cinacalcet (CIN)	窪選網淵積襯鏇齋窪壓(觸廠壓鏇顧憲襯淵鑰壓) = 膚製觸壓襯顧鏇廠觸窪製齋壓憲壓襯膚憲衊繭 (鏇齋觸製繭製衊遞願獵 ) 更多	积极	2021-10-27
ASN2021	N/A		974	Etelcalcetide (ETEL)	窪選網淵積襯鏇齋窪壓(觸廠壓鏇顧憲襯淵鑰壓) = 齋繭艱蓋膚鬱壓鏇醖鬱製齋壓憲壓襯膚憲衊繭 (鏇齋觸製繭製衊遞願獵 ) 更多	积极	2021-10-27