醋酸地非法林(Difelikefalin acetate) - 药物靶点：κ opioid receptor_在研适应症：慢性肾病相关瘙痒，瘙痒，疼痛_专利_临床

概要

基本信息

药物类型

小分子化药

别名

+ [10]

靶点

κ opioid receptor

作用机制

κ opioid receptor激动剂(κ-阿片受体激动剂)

治疗领域

皮肤和肌肉骨骼疾病神经系统疾病泌尿生殖系统疾病+ [1]

在研适应症

慢性肾病相关瘙痒瘙痒疼痛+ [2]

非在研适应症

急性疼痛背痛胆汁淤积性瘙痒+ [7]

原研机构

CARA Therapeutics, Inc.

在研机构

Vifor Fresenius Medical Care Renal Pharma France S.A.S.

CARA Therapeutics, Inc.

成都国为生物医药有限公司

+ [6]

非在研机构

Kissei Pharmaceutical Co., Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2021-08-23),

瘙痒

最高研发阶段(中国)临床3期

特殊审评-

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结构

分子式C36H53N7O6

InChIKeyFWMNVWWHGCHHJJ-SKKKGAJSSA-N

CAS号1024828-77-0

查看全部结构式(2)

序列信息

Sequence Code 319389768

关联

40

项与醋酸地非法林相关的临床试验

NCT06593392 / Not yet recruiting临床2期

KOR-PED-202 an Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis with Moderate-to-Severe Pruritus

Rationale:
* People with long term kidney disease who are on haemodialysis (a procedure for removing waste products from the blood) commonly develop a condition that makes their skin very itchy.
* Difelikefalin is a medicine that can treat the itching related to long term kidney disease.
* Clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis, while being safe and tolerable.
* The current study is being done in adolescents aged 12 to 17 years on haemodialysis who have moderate to severe itching related to long term kidney disease to assess if difelikefalin is safe in this age group.
The aims of the study are:
Main aim: To assess the safety of difelikefalin in adolescents who are on haemodialysis and have itching related to long term kidney disease
Secondary aim: To measure the amount of difelikefalin that enters the blood in adolescents who are on haemodialysis and have itching related to long term kidney disease
Study Design At least 18 adolescents, aged 12 to 17 years, who are on haemodialysis and have itching related to long term kidney disease will take part in this study.
All study participants will receive difelikefalin 3 (or up to 4) times weekly for up to 12 weeks. The study duration for a participant is up to 17 to 18 weeks; during this period, participants will visit the clinic 3 times weekly (during their haemodialysis visits).

开始日期2025-01-31

申办/合作机构

Vifor Fresenius Medical Care Renal Pharma Ltd.

NCT06446310 / Recruiting临床3期

A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus

This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.

开始日期2024-06-18

申办/合作机构

齐鲁制药有限公司

CTR20241840 / Recruiting临床3期

评价醋酸地非法林注射液（QLG2198）治疗血液透析成人受试者慢性肾脏病相关性中度至重度瘙痒有效性和安全性的多中心、随机、双盲、安慰剂平行对照III期临床研究

主要目的：与安慰剂相比，评价醋酸地非法林注射液（QLG2198）治疗血液透析成人受试者慢性肾脏病相关性中度至重度瘙痒的有效性。次要目的：与安慰剂相比，评价醋酸地非法林注射液（QLG2198）治疗血液透析成人受试者慢性肾脏病相关性中度至重度瘙痒的安全性。与安慰剂相比，评价醋酸地非法林注射液（QLG2198）治疗伴有慢性肾脏病相关性中度至重度瘙痒的血液透析成人受试者在改善瘙痒相关生活质量（QoL）方面的有效性。

开始日期2024-06-11

申办/合作机构

齐鲁制药（海南）有限公司

100 项与醋酸地非法林相关的临床结果

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100 项与醋酸地非法林相关的转化医学

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100 项与醋酸地非法林相关的专利（医药）

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64

项与醋酸地非法林相关的文献（医药）

2024-12-31·Renal Failure

The efficacy and safety of difelikefalin for pruritus in hemodialysis patients: a systematic review and meta-analysis of randomized controlled trials

Review

作者: Alsaid, Abdullah ; Kamal, Mariam ; Hamdi, Mahmoud ; Radwan, Radwa ; Abuelazm, Mohamed ; Elshnoudy, Iman Abdelhady ; Saeed, Abdallah ; Turkmani, Mustafa ; Khlidj, Yehya

BACKGROUNDChronic kidney disease-associated pruritus (CKD-ap) is a common complication that negatively affects the quality of life. Difelikefalin has emerged as a novel FDA-approved drug to manage CKD-ap. This systematic review and meta-analysis will assess the efficacy and safety of Difelikefalin versus placebo to manage CKD-ap.METHODSPubMed, Scopus, WOS, Central, and Embase were systematically searched until November 2023. RevMan was used to perform meta-analysis. Quality assessment was conducted using the Cochrane RoB 2.0 tool. Results were reported as risk ratio (RR) and mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: (CRD42023485979).RESULTSFive RCTs with a total of 896 participants were included. Difelikefalin significantly decreased the weekly mean WI-NRS score (MD: -0.99 [-1.22, -0.75], p ˂ .00001), 5-D itch scale total score (MD: -1.51 [-2.26, -0.76], p > .0001), and Skindex-10 total score (MD: -7.39 [-12.51, -2.28], p = .005), but showed significantly higher adverse events (RR: 1.26 [1.03, 1.55], p = .03), versus placebo. However, there was no significant difference between both groups in serious adverse events (RR: 1.42 [0.78, 2.57], p = .25) or death (RR: 0.81 [0.19, 3.34], p = .77).CONCLUSIONDifelikefalin appears to be a promising agent for the management of CKD-induced pruritus in patients with end-stage renal disease. However, evidence is still underpowered due to the paucity of the current data; therefore, more robust RCTs are required to confirm the benefit of Difelikefalin.

2024-12-31·Journal of Dermatological Treatment

Association of pruritus and chronic cough: an all of us database study

Article

作者: Kim, Brian ; Wang, Zhen ; Sharma, Divija ; Pulsinelli, Juliana ; Ungar, Benjamin ; Correa da Rosa, Joel

PURPOSEBased on a potential shared pathophysiology tied to mast cell activity and neurogenic inflammation that may link pruritus and chronic cough (CC), this study, leveraging the All of Us database, examines the association between the two conditions.MATERIALS AND METHODSA nested case-control comparison was used to examine the association, identifying cases with SNOMED codes 418363000 (pruritus) and 68154008 (CC). Matching was performed on a 1:4 ratio by age, sex, and ethnicity using the MatchIt package in R, followed by maximum likelihood method to estimate odds ratios (ORs) and 95% confidence intervals from 2x2 contingency tables.RESULTSCC patients (n = 2,388) were more than twice as likely to be diagnosed with pruritus (OR: 2.65) and pruritus patients (n = 22,496) were more than twice as likely to be diagnosed with CC (OR: 2.57), than respective matched controls.CONCLUSIONSThese results highlight the potential bidirectional relationship between CC and pruritus, suggesting possible shared immune and neural pathways. Treatments like difelikefalin and nalbuphine that modulate these pathways, alongside P2X3 targeting agents, are emerging as potential therapeutic approaches for itch and chronic cough given the possible interconnected pathophysiology. This study's insights into the associations between pruritus and CC may pave the way for targeted therapeutic strategies that address their shared mechanisms.

2024-12-01·Neuropharmacology

Conorphin-66 produces peripherally restricted antinociception via the kappa-opioid receptor with limited side effects

Article

作者: Zhang, Run ; Xu, Biao ; Zhang, Mengna ; Zhang, Qinqin ; Zhang, Nan ; Xu, Kangtai ; Li, Ning ; Chen, Dan ; Fang, Quan ; Hu, Xuanran

With the current unmet demand for effective pain relief, analgesics without major central adverse effects are highly appealing, such as peripherally restricted kappa-opioid receptor (KOR) agonists. In this study, Conorphin-66, an analog of the selective KOR peptide agonist Conorphin T, was pharmacologically characterized in a series of experiments, with CR845 serving as the reference compound. Firstly, in vitro functional assay indicated that Conorphin-66 selectively activates KOR and exhibits weak β-arrestin2 signaling bias (-1.54 versus -4.35 for CR845). Additionally, subcutaneous Conorphin-66 produced potent antinociception in mouse pain models with ED₅₀ values ranged from 0.02 to 3.28 μmol/kg, including tail-flick test, post-operative pain, formalin pain, and acetic acid-induced visceral pain. Similarly, CR845 exert potent antinociception in mouse pain models ranged from 0.15 to 1.47 μmol/kg. Notably, antagonism studies revealed that the analgesic effects of Conorphin-66 were mainly mediated by the peripheral KOR. Furthermore, Conorphin-66 produced non-tolerance-forming antinociception over 8 days. Unlike CR845, subcutaneous Conorphin-66 did not promote the sedation, anxiogenic effects, depressive-like effects, but did exhibit diuretic activity. Further study showed that Conorphin-66 does not have apparent antipruritic effects in an acute itch model. Overall, Conorphin-66 emerges as a novel peripherally restricted KOR agonist that produced potent antinociception with reduced side effects.

88

项与醋酸地非法林相关的新闻（医药）

2024-09-24

·米内网

【聚焦】齐鲁入局17亿注射剂

精彩内容近日，CDE官网显示，齐鲁制药的注射用硫酸多黏菌素B以仿制3类报产获受理，该产品2023年在中国公立医疗机构终端的销售额超过17亿元。今年以来，齐鲁制药有25个品种以新注册分类提交上市/临床申请，其中12个暂无首仿（含剂型首仿）获批。硫酸多黏菌素B是一组从多黏芽孢杆菌中分离出的抗菌性多肽，通过改变细菌细胞膜通透性导致细菌死亡，主要用于绿脓杆菌及其他假单胞菌引起的创面、尿路以及眼、耳、气管等部位感染，也可用于败血症、腹膜炎等。米内网数据显示，注射用硫酸多黏菌素B已被纳入国家医保乙类目录，目前仅上药第一生化拥有生产批文。该产品近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端迅速放量，2021年突破10亿元，2022-2023年均超过17亿元。近年来中国公立医疗机构终端注射用硫酸多黏菌素B销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局仿制药申报方面，有10家企业的注射用硫酸多黏菌素B以新注册分类报产在审，包括倍特药业、汇宇制药、利泰尔药业、亿帆生物、华北制药、齐鲁制药、健康元药业、Xellia制药、四川上善六经医药、湖南埃威格林医药。米内网数据显示，今年以来，齐鲁制药已有25个品种以新注册分类提交上市/临床申请，涵盖10个治疗大类，集中在神经系统药物（6个）、全身用抗感染药物（5个）、心脑血管系统药物（4个）等治疗领域。 2024年至今齐鲁制药以新分类申报的品种来源：米内网中国申报进度（MED）数据库 25个品种中，瑞卢戈利片、奥氮平萨米多芬片、来特莫韦注射液、阿巴帕肽注射液、芦曲泊帕片、布瑞哌唑片、布瑞哌唑口崩片、丙酸氟替卡松鼻喷雾剂、醋酸地非法林注射液、注射用奥氮平、立他司特滴眼液、西尼莫德片12个品种暂无仿制药（以药品名称计）获批；注射用硫酸多黏菌素B、来特莫韦片、美阿沙坦钾片、丁酸氯维地平脂肪乳注射液等品种目前拥有生产批文的国内企业仅有1家。资料来源：米内网数据库、CDE官网等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至9月24日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

专利侵权

2024-09-05

·维健医药

维健医药持证地非法林注射液中国III期临床研究中显著改善血液透析患者慢性肾病相关瘙痒

2024年9月3日，维健医药公布了KOR-CHINA-301研究最新研究数据，该研究旨在评估地非法林注射液改善血液透析患者慢性肾病相关瘙痒的有效性和安全性。该中国III期确证性临床研究结果达到主要终点指标，显著优于安慰剂（P=0.0003）。地非法林耐受性良好，其安全性特征与产品已知安全性特征基本一致. 地非法林已在美国和欧盟等多个国家上市，如果未来该药在中国获批上市，将为国内饱受瘙痒折磨的血液透析患者们带来安全有效、给药方式更方便的新治疗选择。研究结果重点如下：主要终点：地非法林组第4周时每日24小时最大瘙痒程度数字化评定量表（WI-NRS）的周平均值较基线改善程度显著高于安慰剂组（地非法林组减安慰剂组，最小二乘法均值差异（SE）为 -0.81（0.223），95%CI (-1.25, -0.37), P=0.0003）。次要终点：地非法林快速起效，从第2周时开始WI-NRS改善程度显著优于安慰剂（P＜0.05）。安全性：在中度至重度瘙痒的中国血液透析患者中，地非法林的安全性令人满意，且与产品已知安全性特征基本一致。 Vifor Fresenius Medical Care Renal Pharma 为该试验申办方，维健医药为中国的合作开发方，泰格医药为CRO，在三方与各研究中心共同努力下完成该研究的双盲阶段。本研究结果将会作为地非法林在中国获批上市的重要参考，希望该药在顺利完成后相关审批后能尽快获批上市。维健医药将为中国血液透析瘙痒患者提供新的治疗选择，更好满足患者的临床治疗需求。截至2024年2月22日，地非法林注射液已在美国、欧盟（包括冰岛、挪威和列支敦士登）、英国、加拿大、瑞士、新加坡、澳大利亚和日本等41个国家获批用于治疗患有CKD相关瘙痒症的成人血液透析患者，全球上市商标包括KORSUVA®/KAPRUVIA® 。是该适应在中国即将获批的首个肽类kappa阿片受体（KOR）激动剂。地非法林是一种KOR激动剂，通过与受体结合，抑制瘙痒感的产生 [1] 。地非法林的亲水性肽结构限制了它进入中枢神经系统(CNS)，使其有别于具有中枢活性的KOR激动剂。与大多数阿片类药物相比，地非法林不是受管制药品，也不会引起呼吸抑制等阿片类药物不良反应 [2-4] 。该药在常规透析后，通过透析通路静脉给药，有效解决血液透析患者高口服片剂负荷大带来的长期依从性问题。维健医药和Vifor Fresenius Medical Care Renal Pharma 于2023年1月16日签署了地非法林注射剂开发和商业化的长期独家许可协议，用于国内血液透析成人患者中重度瘙痒症的治疗。维健医药拥有地非法林注射液在中国开发和商业化的独家权益。慢性肾病相关瘙痒表现为全身性和持续性瘙痒，对患者生存质量有巨大的负面影响，可能导致抑郁、焦虑、睡眠失调和死亡率升高。在中国分别有约42%、21%、11%和 8%的血液透析患者正在遭受轻度、中度、重度或极重度瘙痒症的困扰[5]。其他研究也报告了透析患者瘙痒患病率高达36%~80% [6，7]。当前已有治疗方案各不相同，包括对症状轻微或患局部性症状的患者使用局部治疗（润肤剂、类固醇镇痛剂、局部麻醉剂），对更严重或全身瘙痒的患者优化透析参数和系统治疗[8]。但现有治疗（外用或内用）并不能完全满足临床需求，仍有许多患者对仍受着瘙痒的困扰。香港维健医药集团是一家总部位于香港的领先生物制药公司，在大中华地区开展商业运营，并在亚洲和欧洲区域不断扩展业务。公司专注于创新药物的商业化，致力于为心肾疾病、胃肠疾病、罕见病以及其他未满足和严重未被满足的医疗需求患者提供突破性疗法。维健医药与众多世界领先的制药和生物技术公司建立了成功的长期合作伙伴关系，创造了一个独特而有意义的多元化产品组合，包括15种以上的专科产品，覆盖商业和后期临床阶段。维健医药始终以患者为中心，坚守对合作伙伴的承诺，不断扩展其产品组合，寻求通过其全球合作伙伴网络引进更多的变革性疗法。参考文献 1.https://www.ema.europa.eu/en/medicines/human/EPAR/kapruvia 2.https://ir.caratherapeutics.com/static-files/62d3f790-49dc-4882-952b-023e92329efd Presented at the 8th World Congress on Itch; September 27-29, 2015; Nara, Japan 3.https://ir.caratherapeutics.com/static-files/a713f5b9-f084-4982-bcac-fd2d47490013 4.New England Journal of Medicine 2020; 382:222-232 5. Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, et al. International comparisons of prevalence, awareness, and treatment of pruritus in people on hemodialysis. Clin J Am Soc Nephrol. 2017 Dec; 12:2000-7. 6. Li J, Guo Q, Lin J, Yi C, Yang C, Yang X, Yu X. Prevalence and associated factors of uraemic pruritus in continuous ambulatory peritoneal dialysis patients. Intern Med. 2015 Mar 1; 54:2827-33. 7. Wen Y, Liu C, Lin Z, Zhang Z, Sun W, Qin X, et al. Uremic pruritus in Chinese chronic haemodialysis population: a single-centre series study. Acta Medica Mediterranea. 2020; 36:1569. 8. Weisshaar E, Szepietowski JC, Dalgard F, Garcovich S, Gieler U, Giménez -Arnau A, et al. European S2k guideline on chronic pruritus. Acta Derm Venereol. 2019; 99:469- 506. 内容来源于网络，如有侵权，请联系删除。

上市批准临床结果

2024-07-11

·BioSpace

Cara Therapeutics Announces Exploration of Strategic Alternatives

STAMFORD, Conn., July 11, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that it has engaged Piper Sandler & Co. to act as its financial advisor for the process of exploring and reviewing strategic alternatives. “We are committed to evaluating a range of strategic options to maximize value for our shareholders,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “As part of this effort, our Board of Directors has approved a streamlined operating plan focused on cost-containment and cash conservation.” There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. Cara Therapeutics does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law. As of March 31, 2024, the Company had approximately $70 million in cash, cash equivalents, and marketable securities. About Cara Therapeutics Cara Therapeutics is a biopharmaceutical company focused on transforming the way pruritus is treated. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit . Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the Company’s exploration and review of strategic alternatives, its ability to identify and complete a transaction as a result of the strategic review process, and its plans to reduce costs and conserve cash. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include the risk that the Company may not be successful in exploring strategic alternatives and consummating one or more strategic transactions on attractive terms, if at all; the Company’s actual reductions in spending as compared to anticipated cost reductions; the Company’s costs of continuing to operate as a public company; and the other risks described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. INVESTOR CONTACT investor@caratherapeutics.com

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100 项与醋酸地非法林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10890 D11111	醋酸地非法林	-	DB11938

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性肾病相关瘙痒	冰岛	Vifor Fresenius Medical Care Renal Pharma France S.A.S.	2022-04-25
慢性肾病相关瘙痒	欧盟	Vifor Fresenius Medical Care Renal Pharma France S.A.S.	2022-04-25
慢性肾病相关瘙痒	挪威	Vifor Fresenius Medical Care Renal Pharma France S.A.S.	2022-04-25
慢性肾病相关瘙痒	列支敦士登	Vifor Fresenius Medical Care Renal Pharma France S.A.S.	2022-04-25
瘙痒	美国	CARA Therapeutics, Inc.	2021-08-23

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适应症	最高研发状态	国家/地区	公司	日期
疼痛	临床3期	美国	CARA Therapeutics, Inc.	2022-01-30
疼痛	临床3期	韩国	Chong Kun Dang Pharmaceutical Corp.	2022-01-30
瘙痒	临床2期	波兰	CARA Therapeutics, Inc.	2022-08-26
特应性皮炎	临床2期	美国	CARA Therapeutics, Inc.	2022-08-16
慢性肾病	临床2期	美国	CARA Therapeutics, Inc.	2022-05-17
瘙痒	药物发现	波兰	CARA Therapeutics, Inc.	2022-08-26
特应性皮炎	药物发现	美国	CARA Therapeutics, Inc.	2022-08-16
尿毒症瘙痒	药物发现	美国	CARA Therapeutics, Inc.	2017-08-14
尿毒症瘙痒	药物发现	波多黎各	CARA Therapeutics, Inc.	2017-08-14
术后疼痛	药物发现	美国	CARA Therapeutics, Inc.	2015-09-01

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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


NCT05885737 (KOR-CHINA-301, NEWS) 人工标引	临床3期	慢性肾病相关瘙痒	-	地非法林注射液	(繭齋築願網夢簾艱膚鹽): Difference = -0.81 (95% CI, -1.25 ~ -0.37), P-Value = 0.0003 达到更多	积极	2024-09-04
				安慰剂
NCT03617536 (CTgov)	临床2期	瘙痒 \| 慢性肾病	269	CR845 0.25 mg Oral Tablet (CR845 0.25 mg Oral Tablet)	築醖鏇鑰窪簾獵餘獵遞(膚顧鏇壓壓繭餘廠遞網) = 鏇鬱鏇繭製觸淵遞顧觸選鬱憲鏇鹽壓製襯顧鹹 (繭壓繭構積願顧鏇遞蓋, 積觸壓艱艱顧積襯餘糧 ~ 衊壓夢膚觸觸顧築範鹽) 更多	-	2024-01-24
				CR845 0.5 mg Oral Tablet (CR845 0.5 mg Oral Tablet)	築醖鏇鑰窪簾獵餘獵遞(膚顧鏇壓壓繭餘廠遞網) = 鏇鑰夢鏇夢艱構鏇遞選選鬱憲鏇鹽壓製襯顧鹹 (繭壓繭構積願顧鏇遞蓋, 蓋觸獵遞襯廠網顧積窪 ~ 憲願醖餘範糧繭艱糧獵) 更多
KIND 1 (Biospace) 人工标引	临床3期	特应性皮炎辅助	287	difelikefalin+TCS	(製鏇壓鹹窪鹹繭鏇醖製) = Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone. 繭範簾繭壓繭願鹹製築 (願餘糧餘簾憲範觸壓鏇 ) 更多	不佳	2023-12-18
				placebo +TCS
NCT03636269 \| NCT03422653 \| NCT03998163 (Pubmed \| Nephrol Dial Transplant)	临床3期	血液透析并发症	-	Difelikefalin 0.5 µg/kg	鑰範鑰繭鹽夢鏇網憲獵(淵範觸製繭範鹽簾憲廠) = 遞遞餘構範鹽衊繭壓鏇遞選憲齋製構鹽遞膚願 (淵鏇襯蓋獵艱選鏇願鏇 )	积极	2023-11-15
3105 (ASN2022)	N/A	慢性肾病	222	Difelikefalin 0.5 µg/kg	鏇遞獵壓選簾觸艱鹹範(淵築蓋繭鏇襯襯齋範獵) = 襯廠獵遞製醖淵艱糧願選醖範顧鬱積積憲鹹築 (繭鏇製觸繭蓋鑰膚蓋憲, 2.0)	积极	2022-11-05
				Difelikefalin	鏇遞獵壓選簾觸艱鹹範(淵築蓋繭鏇襯襯齋範獵) = 醖艱鏇觸鏇積鹹鹹窪襯選醖範顧鬱積積憲鹹築 (繭鏇製觸繭蓋鑰膚蓋憲, 2.0)
NCT04706975 (KOMFORT, Biospace) 人工标引	临床2期	瘙痒	125	Difelikefalin	(築獵鹽鹽夢積齋構製範) = 膚積淵網憲糧膚願衊醖鏇醖範衊膚夢製鑰窪鏇 (鏇壓襯壓鏇鹹廠鑰獵鑰 ) 更多	积极	2022-09-08
				Placebo	(築獵鹽鹽夢積齋構製範) = 淵憲遞醖鑰積築衊餘糧鏇醖範衊膚夢製鑰窪鏇 (鏇壓襯壓鏇鹹廠鑰獵鑰 ) 更多
NCT03998163 (Study 3105 \| CR845-CLIN3105, Pubmed) 人工标引	临床3期	瘙痒	222	Difelikefalin	(積獵壓艱衊範繭鹽壓願) = 憲蓋鬱鏇遞鏇繭觸製醖艱齋鹹願網襯糧積憲餘 (網艱遞願鏇選醖鏇廠壓 ) 更多	积极	2022-08-24
NCT03281538 \| NCT03636269 \| NCT03422653 \| NCT03998163 (CR845-CLIN3105, Pubmed)	临床3期	尿毒症瘙痒	-	Difelikefalin	(繭簾醖鹽積鹽範蓋遞範) = 範鑰夢顧鬱鬱夢鏇憲衊鑰齋膚壓窪構構餘鏇憲 (構鏇築廠鹹夢蓋壓顧積 ) 更多	积极	2022-08-01
				Placebo	(繭簾醖鹽積鹽範蓋遞範) = 觸選選憲膚膚鹹膚觸鑰鑰齋膚壓窪構構餘鏇憲 (構鏇築廠鹹夢蓋壓顧積 ) 更多
NCT03636269 \| NCT03422653 (KALM-1 \| KALM-2, Pubmed) 人工标引	临床3期	瘙痒	851	Difelikefalin	(積醖簾獵選構構願製蓋) = 鬱獵淵淵築醖範顧選齋壓餘製獵鹹衊簾鏇膚餘 (遞鏇鹽範衊遞窪鏇鏇鹹 ) 更多	积极	2022-06-28
				Placebo	(積醖簾獵選構構願製蓋) = 製鏇鬱製齋衊蓋壓襯鬱壓餘製獵鹹衊簾鏇膚餘 (遞鏇鹽範衊遞窪鏇鏇鹹 ) 更多
NCT03422653 (KALM-1, CTgov)	临床3期	尿毒症瘙痒	378	CR845 0.5 mcg/kg (CR845 0.5mcg/kg)	遞觸製餘選簾網壓顧觸(壓鏇糧糧壓鏇鬱廠憲鏇) = 醖選廠構簾觸夢顧獵鑰鹽膚範蓋築窪艱廠繭積 (窪廠鏇醖獵夢選襯窪壓, 襯餘構鏇構醖選齋觸廠 ~ 窪鏇齋製獵窪衊鏇糧蓋)	-	2022-04-26
				Placebo (Placebo)	遞觸製餘選簾網壓顧觸(壓鏇糧糧壓鏇鬱廠憲鏇) = 夢構觸鑰壓網窪糧艱壓鹽膚範蓋築窪艱廠繭積 (窪廠鏇醖獵夢選襯窪壓, 鹹鹹繭餘艱艱餘襯簾糧 ~ 顧網構鬱願鏇鹽獵遞窪)