A Bridging Trial to Compare the Pharmacokinetics of Glepaglutide (ZP1848) After Single Subcutaneous Adminstration by Vial/Syringe and by Autoinjector in Healthy Subjects

This is an open-label, randomized, single center, 2-treatment, 3-period, 3-sequence reference-replicated, crossover trial in healthy subjects to compare the PK of glepaglutide (ZP1848) after a single SC administration by vial/syringe and by autoinjector.

开始日期2020-03-04

申办/合作机构

Zealand Pharma US, Inc.

NL-OMON49360

/ CompletedN/A

A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial - Glepaglutide BE study: subcutaneous and autoinjector administration

开始日期2020-03-04

申办/合作机构

Zealand Pharma A/S

NCT04178447

/ Completed临床1期

An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function

This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) equation.

开始日期2019-12-10

申办/合作机构

Zealand Pharma US, Inc.

100 项与 Glepaglutide 相关的临床结果

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100 项与 Glepaglutide 相关的转化医学

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100 项与 Glepaglutide 相关的专利（医药）

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项与 Glepaglutide 相关的文献（医药）

2025-04-01·GASTROENTEROLOGY

Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial

Article

作者: Berner-Hansen, Mark ; Mercer, David F ; Subramanian, Sukanya ; Wanten, Geert ; Vanuytsel, Tim ; Rahman, Farooq ; Jeppesen, Palle B ; Nielsen, Thor S S ; Kunecki, Marek ; Joly, Francisca ; Pape, Ulrich-Frank ; Lamprecht, Georg

BACKGROUND & AIMS:

Glepaglutide is a long-acting glucagon-like peptide (GLP)-2 analogue developed to improve intestinal absorption in patients with short bowel syndrome (SBS). The authors conducted a trial to establish the efficacy and safety of glepaglutide in reducing parenteral support (PS) needs in patients with SBS with intestinal failure.

METHODS:

In an international, placebo-controlled, randomized, parallel-group, double-blind, phase 3 trial, patients with SBS with intestinal failure requiring PS ≥3 d/wk were randomized 1:1:1 to 24 weeks of glepaglutide 10 mg twice weekly or once weekly or placebo. PS volume was equivalently reduced if mean urine volume of a 48-hour balance period exceeded baseline values by >10%.

RESULTS:

One hundred six patients were randomized and dosed. Glepaglutide twice weekly significantly reduced weekly PS volumes from baseline to week 24 vs placebo (mean change, -5.13 vs -2.85 L/wk; P = .0039; primary end point). Results were similar across major anatomic subgroups. Glepaglutide twice weekly was also superior to placebo for key secondary end points of proportion of patients achieving clinical response, defined as ≥20% PS volume reduction from baseline to weeks 20 and 24 (65.7% vs 38.9%; P = .0243) and patients achieving a reduction in days on PS ≥1 d/wk from baseline to week 24 (51.4% vs 19.4%; P = .0043). Complete PS weaning ("enteral autonomy") was achieved for 5 patients (14%) receiving glepaglutide twice weekly vs 0 for patients receiving placebo. No statistically significant differences were found for glepaglutide once weekly vs placebo for primary or key secondary end points. Significant glepaglutide benefits on patient-reported outcome (Patient Global Impression of Change) were found. Glepaglutide was assessed to be safe and well tolerated.

CONCLUSIONS:

Glepaglutide treatment in patients with SBS with intestinal failure resulted in clinically relevant reductions in PS requirements and was well tolerated. (ClinicalTrials.gov, Number: NCT03690206; ClinicalTrialsRegister.eu, Number: 2017-004394-14.).

2025-03-01·Advanced Healthcare Materials

Glepaglutide‐Loaded Foam for the Induction of Mucosal Healing in the Treatment of Inflammatory Bowel Disease

Article

作者: Kambale, Espoir K ; Van den Bossche, William ; Guilbaud, Léo ; Saxena, Tanya ; Zhang, Wunan ; Yagoubi, Hafsa ; Messens, Joris ; Beloqui, Ana ; Moreels, Tom G. ; Wahni, Khadija

Abstract:

Glucagon‐like peptide 2 (GLP‐2) stimulates intestinal growth, repairs mucosa, and enhances epithelial integrity but has a short half‐life (7 min). Glepaglutide (GL), a GLP‐2 analog with an extended half‐life (50 h), is currently undergoing clinical trials for patients with short bowel syndrome. GL requires subcutaneous injection, which poses challenges for potential patient compliance. To address this challenge, GL was loaded into a rectal foam formulation using CO2 as a permeation enhancer to combine both the local and systemic effects of the GLP‐2 analog. In a dextran sodium sulfate (DSS)‐induced colitis model, the GL‐loaded foam (GLF) significantly mitigated the severity of colitis. GLF facilitated mucosal healing, as evidenced by colonoscopy images, increased plasma markers of mucosal healing, and increased crypt depth. To evaluate GL absorption in the colon, fluorescein dextran 4K (FD 4K) was employed. The foam formulation improved macromolecule absorption in the colon, with fast recovery of enhanced permeation that dissipated after 4 h. This study highlights GLF as a promising formulation for GL administration, balancing systemic and local anti‐inflammatory effects.

2025-02-13·JOURNAL OF MEDICINAL CHEMISTRY

Creating Glepaglutide, the First Long-Acting GLP-2 Analogue to Enable a Ready-to-Use Injection

Article

作者: Petersen, Yvette Miata ; Horn Møller, Eva ; Larsen, Bjarne Due ; Russell, Wayne ; Melander, Claes ; Skarbaliene, Jolanta ; Skodborg Villadsen, Jesper

Human glucagon-like peptide-2 (hGLP-2) receptor agonists have a benefit for the treatment of short bowel syndrome (SBS) and potentially other intestinal diseases (e.g., IBD). Native hGLP-2, a 33-amino acid gastrointestinal hormone, has a short half-life and is chemically and physically unstable, rendering it unsuitable for clinical use. In this paper, we describe the design of novel hGLP-2 peptide analogues with significantly improved chemical and physical properties, high in vitro hGLP-2 receptor potencies, and extended half-lives. Furthermore, synthesis yields were significantly improved by the addition of a C-terminal (lysine)₆ tail (Structure Inducing Probe technology, SIP). One hGLP-2 analogue described herein is glepaglutide ([Gly²Glu³Thr⁵Ser⁸Leu¹⁰Ala^11,16,24,28] hGLP-2[1-33]-NH-[Lys]6-NH₂), the first long-acting analogue with excellent physicochemical stability, making it suitable for liquid formulation. Glepaglutide is currently in phase 3 clinical trials as a potential new therapy for SBS and is the only hGLP-2 analogue in clinical testing that is dosed subcutaneously from a ready-to-use formulation in an autoinjector.

项与 Glepaglutide 相关的新闻（医药）

2025-06-09

·药时空

此前FDA拒绝批准！长效GLP-2类似物欧洲递交上市许可

6月2日（当地时间），丹麦制药公司Zealand Pharma A/S宣布向EMA（欧洲药品管理局）递交长效GLP-2(胰高血糖素样肽-2）类似物Glepaglutide上市许可申请（MAA），适应症：治疗短肠综合征（SBS )成人患者。新闻稿称，EMA递交MAA依据来自Glepaglutide每周二次治疗SBS的关键3期临床研究（EASE-1）和两项进行中长期扩展研究（EASE-2和EASE-3）以及机制研究（EASE-4）的支持。EASE-1研究（NCT03690206）是一项随机、双盲3期试验，共招募了106例每周至少3天依赖肠外支持（PS）肠衰竭SBS患者。患者随机接受10 mg Glepaglutide治疗（每周一次或两次）或安慰剂治疗。主要终点24周时每周肠外支持量相对于基线的绝对变化。研究结果显示，24周时每周两次Glepaglutide每周PS总体积减少5.13L/周，而安慰剂组每周减少2.85L/周（p=0.0039）。当每周给药一次时，Glepaglutide每周PS降低3.13L/周，较安慰剂未达到统计学意义。共有9例接受Glepaglutide治疗患者完全停用PS（实现肠内自主），而安慰剂组患者无法停止PS。对于每周两次接受Glepaglutide治疗患者，14%患者（n=5）实现肠自主。106例患者中102例完成EASE-1研究，其中96例继续为期两年的长期安全性和有效性扩展试验EASE-2研究。EASE-2研究（NCT03905707）是一项随机、双盲试验，其中SBS患者继续EASE-1治疗，Glepaglutide10 mg（每周一次或两次）。EASE-1研究安慰患者被重新随机分配接受10 mg Glepaglutide治疗（每周一次或每周两次）。治疗至少6个月后中期分析，关键疗效终点对Glepaglutide临床反应总体上保持不变或显示持续改善，包括更多两种剂量的停止PS患者。完成EASE-2研究患者有资格参加EASE-3 （NCT04881825），评估使用自动注射器每周给药一次Glepaglutide。首个57例从EASE-2研究转入EASE-3研究患者期中分析表明，PS减少保持不变。EASE-4研究（NCT04991311）是一项3b期试验，旨在评估Glepaglutide对肠液和能量摄取的机制影响，试验提供Glepaglutide在改善肠道吸收方面的药效学作用的证据。Glepaglutide为一款潜在治疗SBS的长效GLP-2类似物液体制剂，并将配备可皮下注射的自动给药装置，旨在降低或消除SBS患者的肠外营养支持，FDA曾授予孤儿药资格。2024年12月，其SBS的NDA被FDA出具完整回复函（CRL），FDA要求增加临床试验提供更多有效性和安全性证据。新闻稿中，Zealand Pharma A/S表示将于2025年下半年启动3期临床（EASE-5）以支持FDA的审批。2024年2月，日本武田制药注射用替度格鲁肽（Teduglutide）正式获得中国国家药品监督管理局（NMPA）批准（商品名：瑞唯抒/Revestive），适用于治疗短肠综合征（Short bowel syndrome，简称SBS）成人和1岁及以上儿童患者。此外，VectivBio和杭州泰格医药在2021年向CDE递交了GLP-2R激动剂注射用阿帕拉格鲁肽（Apraglutide）治疗SBS的IND申请（受理号：JXHL2100112），但未见开展临床试验信息。金赛生物和重庆派金生物在国内实施了3项针对SBS的临床试验，对应的产品分别为生长激素和重组替度格鲁肽（日本武田替度格鲁肽生物类似药）。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

孤儿药临床3期上市批准临床结果临床2期

2025-06-08

·药明康德

缓解率较标准治疗翻倍的多肽组合疗法；每周两次长效多肽向EMA递交上市申请…… | TIDES周报

近期，全球多肽和寡核苷酸（TIDES）领域迎来系列进展。Zealand Pharma公司宣布向欧洲药品管理局（EMA）递交其多肽疗法glepaglutide的上市申请，用于治疗短肠综合征（SBS）成人患者。用于治疗真性红细胞增多症（PV）的多肽疗法rusfertide达3期临床试验终点，需放血治疗的患者比例显著降低。治疗胶质母细胞瘤（GBM）的C/EBPβ拮抗剂lucicebtide（ST101）获积极2期临床试验结果。Glepaglutide：向EMA提交上市申请Zealand Pharma公司宣布向EMA递交其长效胰高血糖素样肽-2（GLP-2）类似物glepaglutide的上市许可申请（MAA），用于治疗SBS成人患者。Glepaglutide是一种装于自动注射器中的液体产品，设计用于每周两次的皮下给药，旨在减少或消除SBS患者对肠外营养支持（PS）的需求。美国FDA已授予该疗法治疗SBS的孤儿药资格。该递交主要是基于随机双盲关键3期试验EASE-1的结果，并得到两项正在进行的长期扩展试验EASE-2和EASE-3的中期结果和机制试验EASE-4的结果支持。EASE-1研究中，与安慰剂相比，每周两次glepaglutide给药在第24周显著降低患者每周PS所需总液体体积（P=0.0039）。第24周时，每周两次接受glepaglutide治疗患者的PS液体体积较基线平均降低5.13公升/周。安慰剂治疗仅导致所需PS液体体积降低2.85公升/周。对于接受每周两次glepaglutide治疗的患者，14%的患者（n=5）实现不再需要PS辅助治疗，而安慰剂治疗患者均不能停用PS。Rusfertide：公布3期临床试验的新数据Protagonist Therapeutics公司与武田（Takeda）公布了3期研究VERIFY的积极新结果。该试验主要评估每周一次的rusfertide自我给药皮下注射，在那些标准治疗下仍血容量控制不佳且依赖放血疗法的真性红细胞增多症患者中的疗效与安全性。Rusfertide是一种潜在“first-in-class”的在研天然激素铁调素的多肽模拟物，已获得美国FDA的孤儿药资格和快速通道资格。此次公布的分析结果显示，该研究达到了其主要终点，rusfertide联合当前标准治疗在高危和低危PV患者中使临床缓解率较安慰剂联合当前标准治疗组患者翻倍（76.9%对比32.9%），显著降低需放血治疗的患者比例。所有关键次要终点也均达到统计学显著差异，包括rusfertide联合治疗组需放血治疗的患者比例显著下降（27%对比78%），保持血细胞比容水平低于45%的患者比例显著提升（62.6%对比14.4%），患者报告的结局也有所改善。此外，未报告任何与rusfertide相关的严重不良事件。EO4010：公布1/2期联合治疗试验数据Enterome公司公布了其在研免疫疗法EO4010的1/2期临床试验AUDREY的积极数据。该研究旨在评估EO4010联合纳武利尤单抗（nivolumab）±贝伐珠单抗（bevacizumab）治疗微卫星稳定（MSS）/错配修复功能正常（pMMR）转移性结直肠癌（mCRC）的效果。EO4010是一种由五种微生物衍生肽组成的疫苗，这些肽模拟了五种常见于结直肠癌患者的肿瘤相关抗原（TAA）——BIRC5、FOXM1、UBE2C、CDC20和KIF2C，旨在激活患者的肿瘤特异性CD8阳性T细胞，引导其识别并杀死表达这些抗原的癌细胞。此次公布的结果显示，EO4010显示出良好的安全性和耐受性。中位随访时间为15.4个月时，20名MSS/pMMR mCRC患者的12个月生存率为40%，中位生存时间为11.3个月。目前，患者的生存曲线已趋于平稳，34%（7/20）的患者仍存活。此外，80%接受EO4010联合纳武利尤单抗治疗的患者体内检测到针对肿瘤相关抗原的特异性免疫反应。这些积极结果支持进一步开发EO4010治疗结直肠癌的潜力。Lucicebtide：公布2期临床试验结果Sapience Therapeutics公司公布了其潜在“first-in-class”的C/EBPβ拮抗剂lucicebtide治疗胶质母细胞瘤的2期临床试验数据。Lucicebtide已获得美国FDA授予用于治疗复发性GBM的快速通道资格，以及美国FDA和欧盟委员会授予的孤儿药资格，用以治疗神经胶质瘤。此次公布的结果显示，lucicebtide作为单一疗法和与标准护理（SoC）联合使用具有良好的耐受性。截至2025年5月6日的数据，新确诊的GBM队列中，9名患者中有5名尚未出现疾病进展（10-24+个月），6名患者在数据截止时仍然存活；复发性GBM队列中，9名患者中有4名获得疾病控制，其中2名为部分缓解（PR），3名患者在数据截止时仍然存活。[212Pb]VMT-α-NET：公布1/2a期临床试验的中期数据Perspective Therapeutics公司公布了其候选多肽偶联核素疗法[212Pb]VMT-α-NET的1/2a期临床试验的最新中期数据。该研究旨在评估[212Pb]VMT-α-NET在表达SSTR2的不可切除/转移性神经内分泌瘤（NET）患者中的疗效和安全性，这些患者既往未接受过放射性药物治疗（RPT），并且放射学证据显示其肿瘤在入组前12个月内已发生疾病进展。截至2025年4月30日的数据，该疗法安全性良好，在接受至少一种治疗的总共42名患者中，没有观察到剂量限制性毒性，也没有因不良事件而停药。在队列2的7名患者中，有4名达到了研究者评估的客观缓解，其中3名缓解已确认并持续维持，1名需进一步确认；而在队列1和2的共计9名患者中，有7名在超过一年的随访期内保持无疾病进展。ARO-ALK7：启动1/2a期临床试验Arrowhead Pharmaceuticals公司宣布，其用于治疗肥胖的在研小干扰RNA（siRNA）疗法ARO-ALK7的1/2a期临床试验已为第一批受试者给药。ARO-ALK7旨在沉默脂肪细胞中ACVR1C基因的表达，以减少激活素受体样激酶7（ALK7）的产生，ALK7在调节脂肪组织能量稳态的通路中充当受体。在临床前研究中，ARO-ALK7抑制了脂肪组织中ALK7的表达，从而能在保留瘦肌肉的同时减少体重和脂肪质量。新闻稿指出，ARO-ALK7是首个进入临床研究、靶向脂肪组织中表达基因的RNA干扰（RNAi）治疗药物。SC-102：IND申请获得FDA许可星联肽生物宣布，其EphA2靶向多肽偶联药物（PDC）SC-102的IND申请获得了美国FDA许可，可开展临床试验评估SC-102治疗表达EphA2的晚期或转移性实体瘤患者的安全性和有效性。SC-102通过特异性结合表达EphA2的肿瘤细胞，释放毒性载荷，从而抑制肿瘤生长。EphA2在多种肿瘤细胞表面高表达，SC-102有望治疗包括卵巢癌、乳腺癌、胰腺癌在内的多种实体瘤。此前，SC-102已在中国获批开展临床试验，目前正处于剂量递增研究阶段。已有临床数据显示，SC-102初步展现出良好的疗效和安全性。参考资料：[1] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-ALK7 for the Treatment of Obesity. Retrieved June 5, 2025, from https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-alk7[2] Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3091346/0/en/Perspective-Therapeutics-Highlights-Updated-Interim-Data-from-its-Ongoing-Phase-1-2a-Clinical-Trial-of-212Pb-VMT-%CE%B1-NET-at-the-2025-ASCO-Annual-Meeting.html[3] Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091534/0/en/Zealand-Pharma-submits-Marketing-Authorization-Application-to-the-European-Medicines-Agency-for-glepaglutide-in-short-bowel-syndrome.html[4] Protagonist and Takeda Announce ASCO Plenary Presentation Highlighting Full 32-Week Results from Phase 3 VERIFY Study of Rusfertide, Showing Reductions in Phlebotomy, Improved Hematocrit Control in Polycythemia Vera. Retrieved June 5, 2025, from https://www.takeda.com/newsroom/newsreleases/2025/polycythemia-vera-rusfertide-study/[5] Sapience Therapeutics Provides Data Update from Phase 2 Trial of Lucicebtide in Patients with Glioblastoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/sapience-therapeutics-provides-data-update-from-phase-2-trial-of-lucicebtide-in-patients-with-glioblastoma-at-the-2025-american-society-of-clinical-oncology-asco-annual-meeting-302470177.html[6] Enterome presents positive Phase 1/2 MSS/pMMR metastatic colorectal cancer data in patients treated with EO4010 OncoMimics™ immunotherapy plus nivolumab at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3090836/0/en/Enterome-presents-positive-Phase-1-2-MSS-pMMR-metastatic-colorectal-cancer-data-in-patients-treated-with-EO4010-OncoMimics-immunotherapy-plus-nivolumab-at-ASCO-2025.html[7] 星联肽EphA2靶向PDC药物SC-102获批美国临床. Retrieved June 5, 2025, from https://mp.weixin.qq.com/s/Z_VtQBFnZHfLUAs8ZmSNJw免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

孤儿药临床3期临床结果寡核苷酸快速通道

2025-06-02

·PipelineReview

Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome

COPENHAGEN, Denmark I June 2, 2025 I Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). “We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.” About glepaglutide Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial Program The Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand’s business and activities, please visit www.zealandpharma.com . SOURCE: Zealand Pharma

临床3期临床结果孤儿药申请上市

100 项与 Glepaglutide 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11337	-	-	DB14794

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适应症	最高研发状态	国家/地区	公司	日期
短肠综合征	申请上市	美国	Zealand Pharma A/S	2023-12-23
肾功能不全	临床1期	匈牙利	Zealand Pharma US, Inc.	2019-12-10
肾功能不全	临床1期	波兰	Zealand Pharma US, Inc.	2019-12-10
克罗恩病	临床1期	美国	Zealand Pharma US, Inc.	2009-01-01

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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


NCT03690206 (2017-004394-14, Pubmed \| Gastroenterology)	临床3期	短肠综合征	-	Glepaglutide 10 mg twice weekly	淵獵餘窪構獵觸顧淵遞(構齋構壓繭獵鹹餘製簾) = 獵衊繭壓遞鑰壓衊夢簾糧製鹹襯鏇廠衊夢醖鹽 (窪鏇築範艱願鑰選製簾 ) 更多	积极	2024-12-01
				Placebo	淵獵餘窪構獵觸顧淵遞(構齋構壓繭獵鹹餘製簾) = 壓廠憲廠築淵鹽餘壓獵糧製鹹襯鏇廠衊夢醖鹽 (窪鏇築範艱願鑰選製簾 )
NCT03690206 (EASE SBS 1 \| EASE-1 \| 2017-004394-14, CTgov)	临床3期	短肠综合征	106	glepaglutide (Glepaglutide SC Injections Twice Weekly)	繭鏇齋願壓餘醖窪夢餘(構窪簾壓憲艱鬱鹽製選) = 獵鹹觸餘顧築網顧憲淵築夢獵醖廠範壓獵蓋襯 (鬱積鑰糧醖壓築鏇糧醖, 築願範繭鏇窪選遞淵選 ~ 選築憲鬱壓製獵鏇遞蓋) 更多	-	2024-10-21
				Placebo+glepaglutide (Glepaglutide SC Injections Once Weekly and Placebo Once Weekly)	繭鏇齋願壓餘醖窪夢餘(構窪簾壓憲艱鬱鹽製選) = 齋願鹽衊顧繭淵繭獵願築夢獵醖廠範壓獵蓋襯 (鬱積鑰糧醖壓築鏇糧醖, 積蓋繭憲壓衊鑰構顧壓 ~ 願餘糧築衊壓鏇夢築鏇) 更多
UEGW2024	N/A	短肠综合征	-	Glepaglutide 10 mg	壓齋範窪鑰餘鏇衊艱範(夢願鹽衊觸窪網鑰餘積) = 齋簾願膚壓壓壓鏇願淵膚醖襯積積餘糧鹹夢網 (淵衊願網襯鹽鑰夢齋製, [-1337 ~ -382]) 更多	-	2024-10-13
EASE SBS-1 (DDW2024)	临床3期	短肠综合征 hepatic impairment \| renal impairment \| C-terminal telopeptide of type I collagen ... 更多	106	Glepaglutide 10 mg twice-weekly	齋膚膚簾鹽淵衊醖膚艱(網獵築築艱願衊蓋淵網) = No difference between active treatment and placebo was observed for change from baseline to Week 24 for the bone markers 蓋廠範顧廠壓遞簾鬱艱 (鏇鹽積夢選繭廠簾餘選 ) 更多	积极	2024-05-21
NCT03690206 (EASE-1, Biospace) 人工标引	临床3期	短肠综合征	106	Glepaglutide 10 mg	餘製獵窪簾積製糧觸構(醖網獵構憲齋壓觸鑰鏇) = 製憲夢艱鹽積窪範襯構鏇範艱鹽鑰願淵顧簾齋 (蓋餘範壓糧淵繭積夢廠 )	积极	2023-12-22
				Placebo	鏇築夢選壓鬱艱網窪廠(顧築膚齋觸鹽廠糧窪淵) = 窪築築膚積簾醖顧範衊蓋製齋窪鑰範鏇積鏇憲 (衊顧憲鹽膚範鬱顧構範 )
UEGW2023	N/A	-	-	Glepaglutide 10 mg twice-weekly	淵夢餘積構範鬱壓鹹獵(膚鑰願鏇繭廠窪遞醖廠) = more adverse events reported in glepaglutide treatment arms vs placebo, primarily attributable to mild injection site reactions 觸鹹齋築觸簾餘窪鬱鑰 (構鏇齋鹹積糧鑰繭鬱窪 )	-	2023-10-15
				Glepaglutide 10 mg once-weekly
NCT03279302 (Pubmed \| Clin Drug Investig)	临床1期	-	30	Glepaglutide 5 mg	廠積鏇膚憲鹽糧廠觸鏇(壓製獵廠襯襯齋獵範繭) = No safety issues were identified 願築簾廠糧夢積鏇醖膚 (鹹衊餘鑰鹹願顧壓遞糧 ) 更多	-	2022-11-02
				Glepaglutide 10 mg
UEGW2021	临床3期	-	18	Glepaglutide 0.1mg	淵餘膚夢製選鏇顧繭鑰(鏇憲獵艱鑰製衊鬱夢鏇) = 糧蓋憲廠窪製獵廠憲鹽簾衊憲蓋簾淵淵築選範 (簾範鏇鹽餘窪衊遞鏇壓 )	-	2021-10-02
				Glepaglutide 1.0mg	淵餘膚夢製選鏇顧繭鑰(鏇憲獵艱鑰製衊鬱夢鏇) = 繭築願鏇窪簾夢鹽醖積簾衊憲蓋簾淵淵築選範 (簾範鏇鹽餘窪衊遞鏇壓 )
NCT02690025 (Pubmed \| JPEN J Parenter Enteral Nutr)	临床2期	短肠综合征	18	Glepaglutide 10 mg	簾構鬱糧願積餘構鏇繭(壓遞壓醖願憲遞淵構廠) = 艱糧淵鬱選廠淵鏇網願衊憲構鹽鏇鏇憲積壓願 (構衊鹹窪簾窪積夢範願 )	-	2021-07-20
NCT02690025 (Pubmed \| Lancet Gastroenterol Hepatol)	临床2期	短肠综合征	18	Glepaglutide 10 mg	襯憲憲窪夢選餘壓餘窪(鹹製餘遞餘鹹簾鹹襯夢) = 觸夢鑰鹽窪窪網艱膚醖構膚鏇選簾衊襯簾艱鑰 (觸夢蓋獵廠鏇廠簾顧積 )	-	2019-05-01
				Glepaglutide 1 mg	襯憲憲窪夢選餘壓餘窪(鹹製餘遞餘鹹簾鹹襯夢) = 顧鏇構鏇網夢範鬱鏇鑰構膚鏇選簾衊襯簾艱鑰 (觸夢蓋獵廠鏇廠簾顧積 )