A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

开始日期2025-01-01

申办/合作机构

University of Miami

[+1]

NCT05670379 / Not yet recruiting临床1期

A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant

The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.

开始日期2024-11-01

申办/合作机构

Vivani Medical, Inc.

[+1]

NCT05663515 / RecruitingN/A

EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs

EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up.

开始日期2024-09-30

申办/合作机构

AstraZeneca PLC

[+1]

100 项与艾塞那肽相关的临床结果

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100 项与艾塞那肽相关的转化医学

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100 项与艾塞那肽相关的专利（医药）

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3,982

项与艾塞那肽相关的文献（医药）

2025-02-01·BIOSENSORS & BIOELECTRONICS

Rational construction of porous cobalt nanoparticle integrated nitrogen doped hollow carbon nanostructures for peptide agonist exendin-4 biosensing

Article

作者: Medlín, Rostislav ; Natarajan, Bharathi ; Procházka, Michal ; Minar, Jan ; Nicolai, Laurent Christophe ; Zhang, Wei ; Subramanian, Palaniappan ; Kannan, Palanisamy

In this study, we designed a point-of-care (POC) testing electrochemical biosensor using an integrated biosensing assay based on hollow-like nitrogen-doped carbon nanostructures combined with cobalt nanoparticles (Co@HNCNs, Co₃O₄@HNCNs, and CoP@HNCNs). These are functionalized with Anti-Exendin-4 Antibodies (Anti-Ex-4-Abs) and Bovine Serum Albumin (BSA) to create sensitive probes (Co@HNCNs/Anti-Ex-4-Abs/BSA, Co₃O₄@HNCNs/Anti-Ex-4-Abs/BSA, and CoP@HNCNs/Anti-Ex-4-Abs/BSA) for the ultrasensitive detection of exendin-4 (Ex-4), a peptide agonist used in the treatment of type 2 diabetes mellitus (T2DM). Among the cobalt-based carbon nanostructures, the Co₃O₄@HNCNs/Anti-Ex-4-Abs/BSA nanoprobe demonstrated superior ability to specifically recognize Ex-4. This was indicated by a significant decrease in the chronoamperometric (CA) i-t current response, facilitating low-level detection of Ex-4. The nanoprobe was capable of detecting Ex-4 concentrations ranging from 1.0 to 90.0 pM, with a sensitivity of 0.60 μA/pM and a limit of detection (LOD) of 0.46 pM (S/N = 3). Furthermore, the Co₃O₄@HNCNs/Anti-Ex-4-Abs/BSA nanoprobes demonstrated the ability to detect nanomolar levels of Ex-4 in blood serum and urine samples, achieving satisfactory recovery rates of 96-104%. The proposed electrostatic interaction chemistry approach establishes a remarkable platform for constructing a peptide agonist biosensor that is effective for detecting Ex-4 in real human serum and urine samples.

2025-02-01·JOURNAL OF AFFECTIVE DISORDERS

A systematic review in effects of glucagon-like peptide-1 (GLP-1) mono-agonists on functional connectivity: Target engagement and rationale for the development in mental disorders

Review

作者: Au, Hezekiah C.T. ; Kwan, Angela T H ; Au, Hezekiah C T ; Teopiz, Kayla M. ; Ho, Roger ; Rosenblat, Joshua D ; McIntyre, Roger S ; Kwan, Angela T.H. ; Rosenblat, Joshua D. ; McIntyre, Roger S. ; Teopiz, Kayla M ; Zheng, Yang Jing ; Rhee, Taeho Greg ; Le, Gia Han ; Wong, Sabrina ; Phan, Lee

INTRODUCTION:

The mechanistic role of glucagon-like peptide-1 (GLP-1) and GLP-1 receptor agonists (GLP-1RAs) in modulating brain functional activity has been inadequately examined. Mental disorders are characterized by dysregulated functional connectivity in brain circuits that subserve phenomenology. We conducted a comprehensive synthesis of known effects of GLP-1 and GLP-1RAs on functional connectivity.

METHODS:

We conducted a systematic review examining studies that investigate changes in functional connectivity mediated by GLP-1 and GLP-1RAs in human adults. Relevant articles were retrieved from OVID (MedLine, Embase, AMED, PsychINFO, JBI EBP Database), PubMed, and Web of Science from database inception to April 26, 2024. Primary or secondary studies (n = 8) investigating the role of GLP-1 and GLP-1RAs on functional connectivity were included for analysis.

RESULTS:

GLP-1 and GLP-1RAs modulate functional connectivity within the dorsal default mode network (DMN), visuospatial network, right frontal parietal network, and the salience network. GLP-1 agonism is also associated with decreased functional connectivity within the hypothalamus, lateral orbitofrontal cortex, and amygdala. Contrastingly, some GLP-1RAs (e.g. exenatide) increase functional connectivity in the hypothalamus, nucleus tractus solitarius, and thalamus. Moreover, liraglutide is associated with increased functional connectivity within the hippocampus in healthy individuals suggesting that GLP-1RAs may have differential effects on brain functional connectivity.

DISCUSSION:

We observed that GLP-1 and GLP-1 RAs are associated with changes in functional connectivity known to subserve phenomenology of many mental disorders (e.g. anhedonia). Future research should aim to further examine neural circuits and networks affected by GLP-1 receptor activity and how they may affect cognitive and psychopathological domains in psychiatric disorders.

2025-01-01·CLINICAL NUCLEAR MEDICINE

Glucagon-Like Peptide-1 Receptor–Targeted PET/CT With 68Ga-HBED-CC-Exendin-4 in Localizing Insulinoma

Article

作者: Wang, Rongxi ; Zhu, Lin ; Pan, Qingqing ; Zhu, Zhaohui ; Wang, Guochang ; Ma, Heng ; Hong, Haiyan ; Wang, Jiarou ; Li, Linlin ; Chen, Jingci ; Luo, Yaping ; Kung, Hank F. ; Jin, Wenbin

Purpose:

Modifying glucagon-like peptide-1 receptor (GLP-1R)–targeted PET agent to achieve faster renal clearance and preserved high affinity to GLP-1R is clinically relevant. The aim of this study is to assess the performance of a newly developed GLP-1R–targeted agent, 68Ga-HBED-CC-exendin-4 in localizing insulinoma, and its biodistribution, as compared with previously introduced 68Ga-NOTA-exendin-4.

Patients and Methods:

Nineteen patients with endogenous hyperinsulinemic hypoglycemia were enrolled and referred for 68Ga-HBED-CC-exendin-4 PET/CT and 68Ga-NOTA-exendin-4 PET/CT within 2 consecutive days. Diagnostic performance of the 2 tracers in localizing insulinoma was evaluated, and SUV of the lesion, normal pancreas background, kidneys, and bladder were measured.

Results:

68Ga-HBED-CC-exendin-4 and 68Ga-NOTA-exendin-4 PET/CT exhibited an equivalent efficacy in detection rate (both sensitivity of 100%). Although SUVmax of the tumor in 68Ga-HBED-CC-exendin-4 was significantly lower than that in 68Ga-NOTA-exendin-4 (20.01 ± 9.41 vs 31.78 ± 15.46, P < 0.001) at 50 minutes postinjection, there was no significant difference in the tumor-to-background ratio between the 2 agents (8.61 ± 3.57 vs 8.18 ± 3.38, P = 0.326), and the lesions could be visible as early as 4 minutes postinjection for both agents in patients who underwent dynamic PET/CT. In addition, 68Ga-HBED-CC-exendin-4 exhibited approximately 30% decrease of the renal accumulation compared with 68Ga-NOTA-exendin-4 (SUVmean, 42.21 ± 5.79 vs 58.58 ± 10.06 at 50 minutes, P < 0.001).

Conclusions:

68Ga-HBED-CC-exendin-4 is an effective agent for localizing insulinoma showing similar detectability and tumor-to-background ratio compared with 68Ga-NOTA-exendin-4. Notably, 68Ga-HBED-CC-exendin-4 exhibits significantly lower renal uptake than 68Ga-NOTA-exendin-4, which might potentially benefit the detection of the tumors adjacent to the left kidneys.

317

项与艾塞那肽相关的新闻（医药）

2024-12-06

·精准药物

盘点11月FDA批准上市的重磅药物

来源：药渡撰文：幻目编辑：维他命到目前为止，FDA在2024年已经批准了一些重磅新药，包括礼来公司治疗阿尔茨海默病的Kisunla和Madrigal制药公司治疗代谢功能障碍相关脂肪性肝炎的Rezdiffra，BMS的35年来第一种新型精神分裂症药物KarXT等……相关内容拓展：35年来首款！FDA批准BMS新型精神分裂症药物，5款新药紧随其后…… 11月又有一些新药获批，以下汇总了11月FDA批准的药物相关信息。 1 Rapiblyk 研发企业：AOPOrphan Pharmaceuticals 适应症：重症监护中的心房颤动和心房扑动总部位于维也纳的AOPOrphan Pharmaceuticals获得了FDA对Rapiblyk（兰地洛尔）的批准，用于治疗重症监护环境中的心房颤动和心房扑动。Rapiblyk设计为静脉内给药，是一种超短效肾上腺素能受体拮抗剂，Rapiblyk可以“快速起效”，导致心率快速下降，而不会显著抑制患者的血压。 FDA的批准得到了五项随机安慰剂对照试验结果的支持，这些试验共同表明，给药后10分钟内患者心率降低40%至90%，而安慰剂组为0%至11%。不良事件在Rapiblyk治疗患者中比在安慰剂中更常见。Rapiblyk旨在用于急诊和重症监护科，以及手术和重症监护环境，它不适用于治疗慢性心律失常。 2 Imkeldi 研发企业：Shorla Oncology 适应症：几种形式的白血病和其他癌症 FDA批准了Shorla Oncology的Imkeldi，是FDA批准的第一个用于某些白血病的伊马替尼口服液体制剂。用于治疗某些类型的慢性粒细胞白血病和急性淋巴细胞白血病，以及其他癌症，如骨髓增生异常/骨髓增生性疾病、侵袭性系统性肥大细胞增多症和隆起性皮肤纤维肉瘤。 Imkeldi中的活性成分伊马替尼是一种酪氨酸激酶抑制剂，通过阻断BCR-ABL蛋白起作用，进而防止癌细胞不受控制地生长并触发其死亡。它最初于2001年获得批准，由诺华以Gleevec品牌作为片剂销售。与固体制剂相比，Imkeldi的液体制剂提供了更好的剂量准确性，对于吞咽药片困难或需要使用特定剂量的患者，Imkeldi可以提供便捷替代方案。 3 Attruby 研发企业：BridgeBio 适应症：转甲状腺素蛋白淀粉样变性心肌病 FDA批准了Attruby，用于治疗患有转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）的成年人，以减少心血管死亡和心血管相关的住院治疗。Attruby是第一个也是唯一一个药物标签上标明转甲状腺素蛋白（TTR）接近完全稳定（≥90％）的药物。 Attruby的批准得到了III期ATTRibute-CM的积极结果的支持，其中转甲状腺素蛋白稳定剂显著减少了死亡和心血管相关住院事件，并改善了生活质量。 4 仿制药艾塞那肽研发企业：Amneal Pharmaceuticals 适应症：2型糖尿病 FDA批准Amneal Pharmaceuticals的艾塞那肽（阿斯利康Byetta的仿制药），利润丰厚且竞争激烈的GLP-1领域迎来了一个新仿制药。与Byetta一样，Amneal的仿制药适用于改善2型糖尿病患者的血糖控制。仿制药艾塞那肽将提供1.2mL和2.4mL预装笔。同样，这种仿制药与Byetta具有相同的不良反应，包括恶心、呕吐、头晕、腹泻和低血糖，以及其他常见的副作用。 Amneal的艾塞那肽是“首批在美国获得批准的GLP-1注射剂仿制药之一，首席商务官AndyBoyer在一份声明中说，到2031年，GLP-1市场预计将达到557亿美元左右。目前，该领域由礼来和诺和诺德主导，它们分别销售tirzepatide和semaglutide，有效地垄断了GLP-1药物的糖尿病和肥胖市场。 5 Ziihera 研发企业：Jazz & Zymeworks 适应症：HER2阳性胆道癌 JAZZ宣布FDA加速批准Ziihera®（zanidatamab-hrii）用于治疗无法切除或转移性HER2阳性（IHC3+）胆道癌（BTC）的成人患者。 Ziihera是一种双特异性抗体，靶向HER2受体上的两个不重叠位点。这种独特的结合谱为Ziihera提供了多种作用机制，包括HER2信号传导的双重阻断和癌细胞表面HER2蛋白的去除。双特异性抗体还可以增强免疫系统的抗癌活性。加速批准得到了IIb期HERIZON-BTC-01研究数据的支持，该研究报告称，接受Ziihera治疗的患者确认客观缓解率为41.3%，治疗缓解持续时间中位为12.9个月。安全性方面，中期试验发现Ziihera耐受性良好，只有两名患者因毒性而停止治疗。验证性、全球性、随机性3期试验HERIZON-BTC-302（NCT06282575）正在进行中，该试验正在评估zanidatamab与标准疗法联合治疗与单独使用标准治疗在HER2阳性BTC患者一线治疗中的疗效。Ziihera的继续获批可能取决于此次验证性试验中临床益处的验证和描述。 Zanidatamab还在针对其他多种肿瘤类型进行研究，包括针对胃食管腺癌（GEA）和转移性乳腺癌（mBC）的3期试验。 6 Bimzelx 研发企业：UCB 适应症：中度至重度化脓性汗腺炎 Bimzelx是一种人源化IgG1单克隆抗体，旨在靶向IL-17A和IL-17F细胞因子，它们在免疫和炎症级联反应中起关键作用。2023年10月，FDA批准Bimzelx用于患有中度至重度斑块状银屑病的成年患者，并于2024年9月将其标签扩大到包括银屑病关节炎、强直性脊柱炎和中轴型脊柱关节炎。11月批准用于中度至重度化脓性汗腺炎治疗。此次批准得到了两项III期研究——BEHEARDI和BEHEARDII的数据的支持。这些试验的结果表明，与安慰剂相比，接受Bimzelx治疗的患者在16周时化脓性汗腺炎的体征和症状至少改善了50%，并且这种治疗反应在48周的随访中得以维持。此外，Bimzelx还在几个关键的次要研究终点中有临床意义的改善。 Bimzelx是第一个也是迄今为止唯一一个获批准的选择性阻断IL-17A和IL-17A的疗法。 7 Revuforj（revumenib）研发企业：Syndax Pharmaceuticals 适应症：赖氨酸甲基转移酶2A基因易位的复发或难治性急性白血病 FDA批准Revuforj用于携带赖氨酸甲基转移酶2A（KMT2A）基因易位突变的成人或儿童患者，使其成为市场上第一个用于治疗复发或难治性急性白血病的menin抑制剂。 KMT2A基因重排（KMT2Ar）可能会导致侵袭性急性白血病，其预后极差且复发率高。据估计，超过95%的KMT2Ar急性白血病患者携带KMT2A易位，超过一半的KMT2Ar急性白血病患者在接受传统一线治疗后会复发，其中位总生存期（OS）不到一年。在接受三线或后续治疗时，仅5%的患者可达到完全缓解，其中位OS不足三个月。 Revuforj的批准得到了I/II期AUGMENT-101研究中104名患者数据的支持，其中21%接受治疗的患者达到完全缓解或部分血液学恢复。这种类型的治疗反应的中位持续时间为6.4个月。 Syndax预计将于本月在美国推出110毫克和160毫克的Revuforj片剂。同时，可用于年轻患者或体重低于40公斤的患者的25毫克剂量将于明年第一季度末或第二季度初上市。 8 Danziten尼洛替尼研发企业：Azurity Pharmaceuticals 适应症：新诊断的费城染色体阳性慢性粒细胞白血病 FDA批准了第一种也是唯一一种不限制进餐时间的尼洛替尼片Danziten。尼洛替尼是一种口服BCR-ABL激酶抑制剂，通过阻止癌细胞的生长和增殖起作用，进而诱导其死亡。Tasigna是诺华公司的尼洛替尼片，在国内名为达希纳，该药物于2010年被批准用于治疗新诊断的慢性期成年患者。该药物的处方信息规定患者在治疗前2小时和治疗后1小时内应禁食。因为Tasigna的生物利用度在与食物一起服用时会飙升，并可能导致心脏副作用。服用Tasigna的患者在服药前通常需要严格禁食，以避免这些毒性。作为一种解决方法，Azurity重新设计了尼洛替尼Danziten，其生物利用度比Tasigna更高，可以减少剂量并消除进餐时间限制的要求。 9 Aucatzyl 研发企业：Autolus Therapeutics 适应症：B细胞急性淋巴细胞白血病在FDA批准用于治疗成人复发或难治性B细胞急性淋巴细胞白血病（ALL）后，Aucatzyl加入了FDA批准的CAR-T疗法名单。 II期FELIX研究的数据支持Aucatzyl获批，该研究显示总体完全缓解率为63%，其中包括51%的患者达到完全缓解。Aucatzyl的优势在于安全性，细胞因子释放综合征和3级毒性的发生率较低，并且没有4级或5级不良事件。 Aucatzyl是第一个在没有风险评估缓解策略计划要求的情况下，获得批准的CAR-T疗法。Aucatzyl安全性将使其成为成人ALL患者的首选治疗选择。 10 Emrosi 研发企业：Journey Medical 适应症：酒渣鼻的炎性病变 FDA批准治疗酒渣鼻炎症病变的口服药物Emrosi。此次批准得到了两项III期试验的支持，其中治疗达到所有主要和次要终点。Emrosi在两项试验中都显示出优于当前标准护理治疗（Oracea40毫克胶囊）和安慰剂。Emrosi有可能成为治疗该病症的同类最佳口服药物。参考资料： https://www.biospace.com/biospace-fda-decision-tracker 声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

上市批准临床3期

2024-12-05

·微信

博瑞医药启动BGM0504 vs 司美格鲁肽降糖III期研究

12月4日，美国临床试验收录网站clinicaltrials显示，博瑞医药启动了BGM0504对比司美格鲁肽治疗2型糖尿病的III期临床试验。这是第三个在III期研究中挑战司美格鲁肽的国产GLP-1药物，前两个为恒瑞医药HRS9531和信达生物IBI362。该研究是一项随机、开放标签临床试验，拟纳入537例BMI≥23kg/m2且7.5%≤HbA1c≤11.0%的2型糖尿病患者，旨在评估BGM0504（5mg或10mg，每周1次）或司美格鲁肽（1mg，每周1次）作为二甲双胍和/或磺脲类降糖药物的附加治疗在这类患者中的疗效和安全性。研究的主要终点为第32周患者的HbA1c（糖化血红蛋白）相对于基线的变化。 BGM0504是博瑞医药自主研发的GLP-1R/GIPR激动剂，于2023年1月进入临床开发阶段（定义为启动I期临床）。目前，BGM0504已完成一项降糖II期研究和一项减重II期研究，相关结果也已公布。在降糖II期研究中，初诊或初治2型糖尿病患者接受每周1次的BGM0504治疗后，5/10/15mg剂量组患者的HbA1c水平均显著降低。具体展开来看，治疗第4周时，5/10/15mg BGM0504组和司美格鲁肽组患者的HbA1c水平较基线平均降幅（扣除安慰剂）分别为-1.32%、-1.48%、-2.16%和-1.03%。治疗第12周时，5/10/15mg BGM0504组和司美格鲁肽组患者的HbA1c水平较基线平均降幅（扣除安慰剂）分别为-1.99%、-2.21%、-2.76%和-1.71%；控糖达标率（给药治疗后HbA1c<7.0%的患者比例）分别为76.9%、81.8%、91.7%和75%，其中中高剂量组中分别有27.3%和50%的受试者达到了糖化正常水平（HbA1c<5.7%），远高于司美格鲁肽组（12.5%）。 BGM0504在其它指标上亦有显著优势，详见：博瑞医药BGM0504 II期降糖头对头数据公布，优于司美格鲁肽和替尔泊肽历史数据。在减重II期研究中，不伴2型糖尿病的超重或肥胖受试者接受每周1次的BGM0504治疗后，5/10/15mg剂量组患者的体重均显著减轻。具体展开来看，治疗第4周时，5/10/15mg BGM0504组受试者的体重较基线平均降幅（扣除安慰剂）分别为-5.20%、-7.00%和-9.50%；治疗第12周时，5/10/15mg BGM0504组受试者的体重较基线平均降幅（扣除安慰剂）分别为-8.40%、-12.00%和-13.80%；治疗第24周时，5/10/15mg BGM0504组受试者的体重较基线平均降幅（扣除安慰剂）分别为-10.80%、-16.20%和-18.50%。 BGM0504在其它指标上亦有显著优势，详见：24周减重18.5%！博瑞医药GLP-1R/GIPR激动剂减重II期研究成功。推荐阅读 GLP-1R/GIPR再添两款III期产品，恒瑞、博瑞、翰森三家争霸国产GLP-1跑出黑马全球药企的GLP-1梦优化配方，实现每日1次给药！辉瑞继续推进口服GLP-1开发一年两次！艾塞那肽植入剂初显减重实力，GLP-1赛道竞争转向剂型战？国产首个！恒瑞小分子GLP-1进入III期，挑战达格列净礼来GLP-1新药布局：再添三靶点激动剂诺和诺德终止开发每月1次GLP-1/GIP双受体激动剂 1个月减重6.1%！罗氏口服GLP-1 I期研究结果积极 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。精彩预告线上直播 ↑点击扫码，直达直播间↑

临床2期临床结果临床3期临床1期

2024-12-04

·Business Wire

Vivani Medical to Present at the Innovation in Obesity Therapeutics Summit West Coast

ALAMEDA, Calif.--( BUSINESS WIRE )--Vivani Medical, Inc. (NASDAQ: VANI ) (the “Company” or “Vivani”), an innovative biopharmaceutical company developing miniaturized, ultra long-acting drug implants, announced today that CEO Adam Mendelsohn, Ph.D., will present and participate in a panel discussion at the Innovation in Obesity Therapeutics Summit West Coast, taking place in San Diego, California, from December 10-12, 2024. Event details are as follows: Panel Discussion: The Obesity Race on the Manufacturing Floor – Exploring Supply Challenges with Innovations in Discovery Panel Date: Wednesday, December 11, 2024 Panel Time: 2:40 pm, Pacific Time Dr. Mendelsohn will be joined by Feng Liu, Executive Director at Regor Therapeutics, and David Bearss, co-founder and Chairman at Biolexis Therapeutics, in a panel discussion of supply chain challenges for GLP-1 drugs and the innovative solutions that are being explored to address these issues. Presentation: Advancing Chronic Disease Management with Ultra Long-Acting Miniature Subdermal Implants of GLP-1 Presentation Date: Wednesday, December 11, 2024 Presentation Time: 4:20pm, Pacific Time In this session, Dr. Mendelsohn will provide an overview of Vivani’s emerging portfolio of miniature, drug implant candidates designed to revolutionize the treatment of chronic diseases by leveraging the company’s proprietary NanoPortal™ implant technology. The Company’s lead program, NPM-119, is a six-month GLP-1 (exenatide) implant in development for chronic weight management. Clinical data from LIBERATE-1, the first-in-human, study in obese and overweight individuals, is expected in 2025. These ultra long-acting implants are designed for once or twice-yearly dosing and directly address main [major] challenges to optimal treatment, including poor medication adherence and potentially poor patient tolerability. More information about Innovation in Obesity Therapeutics Summit West Coast can be found at https://innovation-obesity-summit.com/ . About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani’s lead program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani’s emerging pipeline also includes the NPM-139 (semaglutide implant) which is also under development for chronic weight management in obese and overweight individuals. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company’s type 2 diabetes development program utilizing a six-month, subdermal exenatide implant. Both the NPM-115 and NPM-119 programs utilize exenatide-based products with a higher-dose associated with the NPM-115 program for chronic weight management in obese or overweight patients. These NanoPortal™ implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the initiation of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for NPM-115, NPM-139, or Vivani’s plans with respect to Cortigent and its proposed initial public offering, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani’s products, including NPM-115 and NPM-119; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities, including Vivani’s ability to commence clinical development of NPM-119; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical trials and the results therefrom; Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business; market conditions and the ability of Cortigent to complete its initial public offering. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission filed on March 26, 2024, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.

100 项与艾塞那肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04121	艾塞那肽	A10BJ01	DB01276

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
2型糖尿病	美国	AstraZeneca AB	2005-04-28

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
假性脑肿瘤	临床3期	美国	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	澳大利亚	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	德国	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	以色列	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	新西兰	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	英国	Invex Therapeutics Ltd.	2022-11-18
1型糖尿病	临床3期	荷兰	AstraZeneca PLC	2017-02-21
肥胖	临床3期	美国	AstraZeneca PLC	2016-03-22
多囊卵巢综合征	临床3期	美国	AstraZeneca PLC	2016-03-22
心脏衰竭	临床3期	法国	AstraZeneca PLC	2015-05-01

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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


NCT01107717 (EDICT, CTgov)	临床4期	2型糖尿病	318	exenatide+pioglitazone+metformin (Triple Therapy)	繭構鬱蓋鏇鹹醖築願淵(網構齋積遞廠鹽鹽襯夢) = 簾蓋觸範製艱廠鬱範網構願襯膚憲鹹築夢糧鬱 (憲艱餘範繭鹽夢膚範鏇, 遞衊衊鏇網夢積餘遞遞 ~ 獵鏇選範鑰築淵鬱遞選) 更多	-	2024-09-05
				glargine+metformin+glyburide (Conventional Therapy)	繭構鬱蓋鏇鹹醖築願淵(網構齋積遞廠鹽鹽襯夢) = 鑰築餘獵觸齋鏇夢艱鹽構願襯膚憲鹹築夢糧鬱 (憲艱餘範繭鹽夢膚範鏇, 鹽顧餘積齋積繭遞積膚 ~ 繭製築醖憲廠選築醖鹹) 更多
NCT03029351 (1981, CTgov)	临床4期	肾脏疾病 \| 2型糖尿病 \| 蛋白尿	15	Exenatide Extended Release for Inj Susp 2 MG (Exenatide Extended Release)	壓鹽廠鑰獵齋願觸網簾(鬱廠觸鹹糧餘醖鹽鬱鑰) = 範鹹廠獵範鬱簾糧鹹簾糧餘壓簾遞糧製鏇範顧 (願構糧獵齋艱鑰網齋網, 鏇範網觸遞築顧願築鑰 ~ 鹹範選遞製繭鏇觸遞壓) 更多	-	2024-04-16
				Placebo (Placebo)	壓鹽廠鑰獵齋願觸網簾(鬱廠觸鹹糧餘醖鹽鬱鑰) = 醖窪選繭餘構鹽鏇糧積糧餘壓簾遞糧製鏇範顧 (願構糧獵齋艱鑰網齋網, 淵窪獵網積獵窪築艱構 ~ 築簾夢遞廠窪鏇鏇構艱) 更多
NCT02962492 (CTgov)	N/A	1型糖尿病	70	Placebo (Placebo Arm:)	範獵獵顧膚膚願繭顧襯(膚鹽糧壓鬱齋壓憲鏇鏇) = 窪醖襯蓋繭廠壓網網鹹觸顧構鏇衊築淵積襯膚 (窪鏇淵衊遞鹹鏇積鹽淵, 窪遞獵網網鹹選遞範遞 ~ 積餘製構構構襯蓋構鏇) 更多	-	2024-02-29
				Dapagliflozin (Dapagliflozin Arm:)	範獵獵顧膚膚願繭顧襯(膚鹽糧壓鬱齋壓憲鏇鏇) = 醖鹽廠艱膚簾製範鬱簾觸顧構鏇衊築淵積襯膚 (窪鏇淵衊遞鹹鏇積鹽淵, 選簾醖鏇艱膚膚觸膚廠 ~ 鑰夢遞廠願夢鹽鑰鏇獵) 更多
NCT01524705 (FLAT-SUGAR, CTgov)	临床4期	2型糖尿病	102	Insulin Glargine+Exenatide+Metformin	繭衊廠鏇衊鑰遞願膚構(醖憲憲艱築艱獵淵製觸) = 製鏇範積餘艱鏇製憲壓餘糧獵齋壓糧淵願襯夢 (夢鹹願衊鹽憲鏇齋淵壓, 醖壓醖觸憲衊壓鏇鬱廠 ~ 蓋鹽選鹽顧網積廠艱憲) 更多	-	2023-12-29
NCT02621489 (Rebuild Study, Pubmed \| Cardiovasc Diabetol)	临床4期	2型糖尿病 GLP-1R	38	Exenatide + standard treatment	簾鏇襯製鹹遞繭願膚夢(遞餘齋鑰齋餘憲範淵繭) = 蓋製鏇齋觸遞遞齋餘範餘願鹽鬱膚餘餘艱鑰淵 (積鏇蓋觸餘遞醖憲夢膚 )	不佳	2023-12-08
				Standard treatment alone	簾鏇襯製鹹遞繭願膚夢(遞餘齋鑰齋餘憲範淵繭) = 構窪範觸製鏇積齋齋醖餘願鹽鬱膚餘餘艱鑰淵 (積鏇蓋觸餘遞醖憲夢膚 )
NCT04307797 (EASD2023)	临床4期	2型糖尿病	8	Saline	(築壓糧選齋醖構餘膚齋) = There were no adverse events 鑰膚鑰簾獵鑰獵製壓觸 (醖顧獵醖憲鏇夢壓鏇醖 ) 更多	不佳	2023-10-04
				Glucagon
NCT02621489 (Rebuild study, EASD2023)	临床4期	2型糖尿病 HbA1c	38	Exenatide	夢醖淵遞網遞鑰鬱觸艱(範觸糧艱廠製築積醖壓) = 鏇壓製選蓋構觸築糧艱願餘廠網製憲憲醖窪醖 (觸憲膚鑰憲壓糧選窪襯 ) 更多	不佳	2023-10-04
				Standard treatment	夢醖淵遞網遞鑰鬱觸艱(範觸糧艱廠製築積醖壓) = 繭醖醖壓觸廠構鹽簾鹽願餘廠網製憲憲醖窪醖 (觸憲膚鑰憲壓糧選窪襯 ) 更多
ACTRN12619000497101 (ACTRN, EASD2023)	临床2期	2型糖尿病	32	Exenatide once-weekly (QW)	選鹹艱顧製鏇衊構築蓋(觸壓廠窪繭衊憲窪鏇獵) = 觸觸衊蓋艱顧鬱簾網憲夢襯壓構蓋鹽淵鏇艱夢 (淵廠觸鹽繭蓋願選膚窪, 1.7)	积极	2023-10-04
				Placebo	選鹹艱顧製鏇衊構築蓋(觸壓廠窪繭衊憲窪鏇獵) = 鬱窪襯製衊選膚蓋艱夢夢襯壓構蓋鹽淵鏇艱夢 (淵廠觸鹽繭蓋願選膚窪, 2.1)
Rebuild study (ESC2023)	N/A	非胰岛素依赖型糖尿病2	38	Bydureon	醖網齋憲膚餘觸遞蓋襯(憲夢鏇獵夢鹽淵獵構積) = 鑰憲窪願窪觸窪襯廠夢簾遞選衊遞鏇糧製製願 (鹽膚鏇醖廠窪窪鑰願範 ) 更多	-	2023-08-25
				Standard treatment	醖網齋憲膚餘觸遞蓋襯(憲夢鏇獵夢鹽淵獵構積) = 鏇鬱積壓範夢範齋憲遞簾遞選衊遞鏇糧製製願 (鹽膚鏇醖廠窪窪鑰願範 ) 更多
NCT03331289 (CTgov)	临床4期	2型糖尿病	107	Placebo (Placebo)	鏇鏇觸積遞鏇糧範窪鏇(簾膚鑰窪遞夢範獵夢憲) = 餘淵膚糧鏇餘窪繭壓憲選憲鹽蓋餘憲醖窪鹽壓 (廠廠餘鹽艱遞積憲築醖, 餘顧範鬱築齋鑰廠範網 ~ 繭鹽鹽淵鏇夢構鑰齋網) 更多	-	2023-07-24
				Exenatide (Exenatide)	鏇鏇觸積遞鏇糧範窪鏇(簾膚鑰窪遞夢範獵夢憲) = 窪鹹積網鑰遞淵衊製糧選憲鹽蓋餘憲醖窪鹽壓 (廠廠餘鹽艱遞積憲築醖, 鹽醖鑰襯糧襯廠獵鑰製 ~ 願製壓網鹹範淵壓築壓) 更多