按有关生物等效性试验的规定，选择ヤンセンファーマ株式会社持证的氢溴酸加兰他敏口腔崩解片（商品名：Reminyl®，规格：8mg）为参比制剂，对北京星昊医药股份有限公司生产并提供的受试制剂氢溴酸加兰他敏口崩片（规格：8mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。

开始日期2024-07-09

申办/合作机构

北京星昊医药股份有限公司

NCT03454646 / Not yet recruiting临床4期IIT

Comparison of Therapeutic Strategies With Cholinesterase Inhibitors: Stop or Still (SOS) Trial

Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild to moderate Alzheimer's disease (AD) in spite of enormous research efforts. However, these drugs presented as "symptomatic treatment" of AD are considered as having only a weak effect on the course of AD. The reimbursement of these drugs is regularly challenged due to the lack of evidence for the impact of these drugs on milestones stages of AD evolution (survival without severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major consequences in public health (hospitalization and institutionalization). The great majority of previous randomized controlled trials conducted with CI have had a too short duration and the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK, independently of the pharmaceutical industry, showed that the true effect of CI might be more to avoid or to delay the cognitive or functional decline in AD than to improve patients; the institutionalisation (2) was also delayed. However, this trial was conducted in patients with moderate to severe AD, and the interest of the drugs at the mild to moderate stage remains questionable.
The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.

开始日期2024-06-01

申办/合作机构-

ChiCTR2400081930 / Recruiting临床4期IIT

A real-world study of the safety and efficacy of galanthamine hydrobromide in the treatment of cognitive impairment

开始日期2024-03-15

申办/合作机构-

100 项与氢溴酸加兰他敏相关的临床结果

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100 项与氢溴酸加兰他敏相关的转化医学

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100 项与氢溴酸加兰他敏相关的专利（医药）

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2,586

项与氢溴酸加兰他敏相关的文献（医药）

2025-03-01·TALANTA

Sensitive and eco-friendly voltammetric detection of galantamine using a screen-printed sensor with a functional boron-doped diamond electrode

Article

作者: Gawor, Andrzej ; Bulska, Ewa ; Dubenska, Liliya ; Panas, Krystyna ; Vojs, Marian ; Marton, Marian ; Matvieiev, Oleksandr ; Dushna, Olha

The presented study focused on developing and optimizing a modern electroanalytical platform for the direct quantitative determination of galantamine. This work used different voltammetric methods to use a screen-printed sensor with a working boron-doped diamond electrode (SP/BDDE). Beneficial analytical performance for detecting galantamine was achieved in a Britton-Robinson buffer with pH 3.0. The oxidation peaks at 0.92 V and 1.20 V were followed for electrochemical quantification of galantamine. High-resolution mass spectrometry was used for the first time to analyze the products of preparative electrolysis, and a mechanism for the electrochemical oxidation of galantamine was proposed, which describes the demethylation of galantamine and the further oxidation of the hydroxyl group to a ketone group in the galantamine molecule. Coupled with the optimized parameters of differential pulse voltammetry and square-wave voltammetry on the SP/BDDE detected galantamine in two linear ranges (the first range was from 1.22 μM to 10 μM; the second range was from 10 μM to 200 μM), providing the limit of detection and limit of quantification on a micromolar level (0.50 μM and 1.48 μM, respectively). Amperometry and chronoamperometry were employed to develop a rapid detection method for galantamine. In this approach, galantamine can be detected at a level of 1.08 μM (amperometry at the second peak). The selectivity of the optimized amperometric methods was found to be excellent in the presence of ten times higher concentrations of certain interferences. The practical applicability of the SP/BDDE for detecting galantamine was demonstrated through the analysis of pharmaceutical products and human urine samples. The proposed procedure fully complies with the latest requirements of green analytical chemistry.

2025-01-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Purification, characterization, and inhibition studies of a new acetylcholinesterase obtained from the neotropical brown stink bug Euschistus heros

Article

作者: Dos Reis, Vitor Eduardo Narciso ; Cardoso, Carmen Lucia ; Dinamarco, Taisa Magnani

We purified acetylcholinesterase from adult Euschistus heros stink bugs (AChEeh) a pest that damages economically important crops by affinity chromatography. An AChEeh inhibitor was bound to the resin, which provided selectivity for the enzyme and yielded 6.82 % of pure AChEeh. We found that the enzyme has specific activity of 115.82 ± 1.67 U.mg^-1, fold purification of 44.27, molecular weight of approximately 180 kDa on SDS-PAGE and 358.11 ± 13.84 kDa on size exclusion chromatography under native conditions, and optimal activity at 25 °C and pH = 8.0. On the basis of circular dichroism, AChEeh has α-helical structure with negative minimum at 208 nm and a positive peak at 193 nm. AChEeh Km and Vmax for acetylthiocholine hydrolysis are 24.33 ±0.33 μM and 50. ± 3. U.mg^-1, respectively. We used two inhibitors to evaluate AChEeh specificity: galantamine, a standard AChE inhibitor, and carbofuran, a pesticide, and obtained IC₅₀ of 102.0 ± 14.8 and 104.8 ± 10.71 nM and Ki of 7.00 ± 2.13 and 8.50 ± 2.88 nM, respectively. The purified AChEeh could be used to screen selective inhibitors in future screening assays.

2025-01-01·Journal of experimental botany

Navigating Amaryllidaceae alkaloids: bridging gaps and charting biosynthetic territories

Review

作者: Liyanage, Nuwan Sameera ; Desgagné-Penix, Isabel ; Gonçalves dos Santos, Karen Cristine ; Mérindol, Natacha ; Awwad, Fatima ; Jayawardena, Thilina U

Abstract:

Amaryllidaceae alkaloid (AA) biosynthesis has garnered significant attention in recent years, particularly with the commercialization of galanthamine as a treatment for the symptoms of Alzheimer’s disease. A significant amount of research work over the last eight decades has focused on the understanding of AA biosynthesis, starting from early radiolabelling studies to recent multi-omics analysis with modern biotechnological advancements. Those studies enabled the identification of hundreds of metabolites, the characterization of biochemical pathways, and an understanding of the environmental stimuli and of the molecular regulation of these pharmaceutically and agriculturally important metabolites. Despite numerous studies, there remain significant gaps in understanding the biosynthesis of AAs in Amaryllidaceae plants. As such, further research is needed to fully elucidate the metabolic pathways and facilitate their production. This review aims to provide a comprehensive summary of the current state of knowledge on AA biosynthesis, from elicitation of expression of transcription factors in the cell nucleus to alkaloid transport in the apoplast, and to highlight the challenges that need to be overcome for further advancement.

项与氢溴酸加兰他敏相关的新闻（医药）

2024-12-05

·摩熵医药

2亿+重磅抗AD药，步长制药拿下！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 12月5日，据山东步长制药发布公告，称其全资子公司保定天浩制药提交的4类仿制药盐酸多奈哌齐片获批上市，截至目前，公司在盐酸多奈哌齐片项目上投入的研发费用约为714.50万元。截图来源：企业公告 AD新药上市匮乏，多奈哌齐超10家药企仿制盐酸多奈哌齐片由卫材(Eisai)研发，于1996年在美国上市。随后，在1999年10月8日获日本PMDA批准上市，由卫材在美国和日本上市销售，商主要用于轻度或中度阿尔茨海默病（AD）症状痴呆症状的治疗。作为第二批国家集采品种，重庆植恩药业和浙江华海药业两家企业成功中选，其中选价格的大幅下降促使国内众多药企纷纷加入仿制行列，导致产品价格持续走低。近年来，受这一趋势影响，盐酸多奈哌齐片在全国院内市场的销售额在近两年内有所缩减。据摩熵医药数据库显示，2023年该药物在全国院内市场的销售额超2亿元。截图来源：摩熵医药（原药融云）全国医院销售数据库近30年来，仅少数AD新药获批上市，如他克林（1993年）、多奈哌齐（1996年）、利斯的明（2000年）、加兰他敏（2001年）、美金刚（2003年）及美金刚多奈哌齐复方制剂（2014年）等。在仿制药领域，盐酸多奈哌齐片已有13家国内药企获生产批文，其中12家通过一致性评价，包括保定天浩制药、江苏豪森药业、石药集团欧意药业等。山东步长制药的盐酸多奈哌齐片获批，进一步丰富了国内抗AD药物市场。截图来源：摩熵医药（原药融云）过评药品汇总数据库多奈哌齐国内5中剂型获批上市，片剂领跑院内市场目前国内已上市的多奈哌齐剂型有片剂、胶囊、分散片、口崩片以及滴丸5种，涉及山东罗欣药业、山东新时代药业等企业。在2023年的全国院内市场中，多奈哌齐片剂以高达96.37%的市场份额占据领先地位，紧随其后的是口崩片，其市场份额为1.69%。截图来源：摩熵医药（原药融云）全国医院销售数据库在仿制药布局方面，盐酸多奈哌齐片仅山东新时代药业一家药企提交了4类仿制申请。2024年至今，山东步长制药（含子公司）有磷酸西格列汀片、孟鲁司特钠咀嚼片、左乙拉西坦缓释片、盐酸达泊西汀片等11个品种获批并过评。小结步长制药成功拿下盐酸多奈哌齐片这一重磅抗AD药，不仅丰富了公司的产品线，也为阿尔茨海默病患者提供了更多治疗选择。同时，公司在其他药品领域的研发和生产也取得了显著成果，展示了其强大的研发实力和市场竞争力。未来，步长制药将继续致力于药品研发和创新，为患者提供更多优质、高效的药品。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准一致性评价医药出海

2024-11-29

·贝壳社

阿尔茨海默病从病理机制到创新药物的探索之路

药渡/踏雪阿尔茨海默病（AD）是全球医药界面临的一大挑战，也是最常见的痴呆症类型。其病因极为复杂，涉及衰老、遗传和环境等多种因素的共同作用。科学界提出了多种病理机制假说，包括胆碱能功能失调、淀粉样蛋白积累、tau蛋白异常、炎症反应、氧化应激、金属离子失衡、谷氨酸兴奋毒性、微生物-肠-脑轴紊乱以及异常自噬等。然而，这些病理因素之间的相互作用仍未完全解明，导致AD的主要诱因依然是个谜。尽管过去几十年里科学家们进行了大量药物开发的尝试，但由于疗效不足或副作用较多，大多数药物都未能成功。以往获批的治疗药物大多只能暂时缓解症状，且常伴随副作用。最近FDA批准了三种新药——aducanumab、lecanemab和donanemab，它们显示出清除Aβ斑块并减缓认知衰退的潜力，但其长期疗效和安全性仍需进一步验证。随着研究的深入，尤其是在免疫治疗领域的突破，AD治疗正从传统的单一靶点策略逐渐向小分子治疗模式转变。新一代AD小分子药物通过多种机制，如选择性靶向、双靶点、变构调节、共价结合、PROTACs技术以及蛋白-蛋白相互作用（PPI）调控，来优化药物特性、安全性和疗效。这种多维度的创新正在加速AD药物的开发进程，并减少相关挑战，为患者带来新的希望。 01 AD的发病机制阿尔茨海默病（AD）的发病机制至今仍未完全明确，是一个复杂且充满谜团的领域。 Aβ的积累是AD的一个标志性病理特征，它源于淀粉样前体蛋白（APP）的逐步裂解，而APP的加工受到许多因素的调控。同时，Aβ的积累与载脂蛋白E（APOE）密切相关，特别是APOEε4等位基因，它是AD最强的遗传风险因素之一。此外，tau蛋白作为神经原纤维缠结（NFTs）的主要成分，与AD的临床症状密切相关。除了关键的β淀粉样蛋白（Aβ）和tau蛋白外，乙酰胆碱缺乏、神经炎症、氧化应激、金属离子失衡、谷氨酸失调、胰岛素抵抗、肠道微生物群异常、胆固醇稳态破坏、线粒体功能障碍和自噬异常等多种因素也可能在其中扮演重要角色（图1）。图1. AD发病机制示意图这些病理机制并非独立存在，而是彼此交互，构成了AD发展的复杂网络。理解这些复杂的相互作用，不仅有助于揭示AD的根本原因，也为开发更有效的治疗方法提供了重要线索。 02 信号通路与AD发病机制的关联神经炎症信号通路 AD中的多种病理因素，如Aβ、促炎细胞因子和氧化应激，可激活小胶质细胞，启动下游信号通路，如MAPK、NF-κB和PI3K/Akt。这些通路的激活进一步促进小胶质细胞的活化和炎症介质的产生，加剧神经毒性。溶酶体功能障碍溶酶体在维持细胞内环境稳定中起着关键作用，其功能障碍与AD的发展密切相关。AD中溶酶体酸化缺陷可能削弱Aβ的清除，导致细胞外Aβ斑块的积累。胆固醇代谢异常胆固醇在AD中也扮演着重要角色。胆固醇的合成、运输、代谢和清除失衡可能通过介导Aβ、tau、炎症等病理变化促进AD的进展。线粒体功能障碍线粒体是细胞能量的主要来源，其功能障碍在AD中表现为能量代谢缺陷、氧化应激增加、钙离子失衡和线粒体动力学异常等，可导致神经元功能障碍甚至凋亡。钙信号通路钙信号在AD中也受到干扰。细胞内钙浓度的升高和钙信号通路的异常可影响内质网、线粒体和溶酶体等细胞器的功能，导致神经退行性疾病的发生。胰岛素信号通路胰岛素信号通路与AD密切相关。在AD大脑中，胰岛素信号通路受损，导致糖原合成酶激酶-3（GSK-3）活性增加，tau蛋白磷酸化和Aβ产生增加。神经营养信号通路失调神经营养因子在AD中减少，导致神经元的生存、生长和分化受到影响，突触可塑性和神经元信号功能减弱。血脑屏障功能障碍血脑屏障的破坏与AD的发展密切相关。血脑屏障的完整性受损、运输功能改变、脑血流量减少和神经炎症等都可能导致AD的病理变化。 03 AD的诊断标志物：寻找疾病的线索影像学标志物磁共振成像（MRI）和正电子发射断层扫描（PET）等分子成像技术可用于检测AD 患者的脑部结构和功能变化。结构MRI可评估海马和内嗅皮层萎缩；18FDG-PET可检测后扣带回和颞顶叶的葡萄糖代谢降低；PET成像可显示Aβ和tau沉积。然而，这些方法在诊断AD时存在局限性，不能准确区分AD与其他具有相似病理的神经退行性疾病。脑脊液标志物脑脊液中的Aβ42、磷酸化tau（P-tau）和总tau（T-tau）等是AD的重要标志物。P- tau181浓度是区分AD与非AD痴呆的最准确指标。虽然amyloid和tau PET以及脑脊液标志物可特异性指示AD相关病理，但它们之间并不完全等同。研究表明，amyloid PET与脑脊液结果高度负相关，而脑脊液P-tau 与tau PET结果不一致。血液标志物血液标志物为AD的诊断提供了一种经济、方便、微创且高度可及的选择。许多脑脊液标志物（如Aβ、P-tau、NfL、GFAP）在血液中也有应用，随着高灵敏度分析平台和检测技术的进步，血液标志物的诊断精度和可靠性不断提高。 04 传统AD药物的探索之路传统的阿尔茨海默病（AD）治疗药物主要包括乙酰胆碱酯酶抑制剂（AChEIs）和N-甲基-D-天冬氨酸（NMDA）受体拮抗剂（图2）。图2. FDA/中国批准的AD治疗药物 AChEIs家族中，最早被批准用于AD治疗的药物是他克林。该药物通过抑制乙酰胆碱酯酶的活性，增加乙酰胆碱的浓度和作用时间，进而提升患者的认知和行为能力。然而，由于他克林的肝毒性问题，它虽在1993年获批，但最终在2013年被市场撤回。尽管如此，他克林在多靶点配体研究中仍具备潜力。在AChEIs中，后续开发的多奈哌齐、利凡斯的明和加兰他敏被称为第二代药物。这些药物不仅在选择性方面更为优越，副作用更少，且药代动力学特性更好，因而成为AD治疗的一线药物。美金刚是NMDA受体拮抗剂中唯一被FDA批准用于中度至重度AD治疗的药物。美金刚通过调节谷氨酸传递和多巴胺受体的活性，在一定程度上改善了患者的认知功能、日常生活能力和行为表现。此外，美金刚与多奈哌齐的固定剂量组合药物Namzaric，为中度至重度AD患者提供了另一种治疗选择。尽管这些药物在调节神经递质方面表现出色，但它们无法改变疾病的进程，这为新药的设计提供了重要参考。近年来，研究者们提出了“疾病修饰治疗”的概念，旨在通过干预AD的基本生物机制，阻止疾病进展，并为患者提供持久的治疗益处。2019年，中国有条件批准了一种从海藻中提取的寡糖盐GV-971作为AD的治疗药物。GV-971的作用机制被认为是通过抑制肠道菌群失调引发的神经炎症，并破坏Aβ纤维的形成来抵抗AD。研究显示，GV-971能够依赖性别改变肠道微生物群的组成和丰度，调节微生物代谢和外周炎症，从而减少神经炎症和淀粉样病变。目前，GV-971的两个四期临床试验正在进行中，预计将持续到2025年。在AD治疗领域，单克隆抗体如Aducanumab、Lecanemab和Donanemab也取得了一定进展。这些抗体主要针对Aβ蛋白，显示出不同的疗效和副作用。Aducanumab在2021年获得FDA加速批准，虽然备受争议，但其清除Aβ斑块和减缓认知衰退的能力不容忽视。随后，Lecanemab在2023年获得批准，Donanemab也于2024年获批。然而，这些药物的使用也伴随着显著的影像学异常风险和高昂的治疗费用。此外，新兴药物Brexpiprazole也显示出对AD症状的缓解效果。Brexpiprazole原本用于治疗抑郁症和精神分裂症，通过作用于5-羟色胺、多巴胺和去甲肾上腺素受体，能够有效减轻AD患者的焦虑症状。随着研究的深入，这些新药为AD的治疗提供了多样化的靶点选择，并为阻止或逆转AD的进展带来了新的希望。 05 突破传统：下一代AD治疗的潜在药物传统AD药物的疗效有限，而且在临床试验中失败率较高，主要原因在于疗效不足或副作用过大。这些问题促使新一代AD药物的开发标准不断提高，目标是为患者提供多样化且精准的治疗方案，能够根据个人的独特病理过程量身定制。随着对疾病机制的深入理解和药物开发技术的进步，创新性AD药物的开发正逐步成为现实（表1）。表1. 下一代的AD治疗药物选择性抑制剂随着对病理蛋白质生理功能的理解加深，选择性抑制剂的开发取得了显著进展。这些抑制剂能够特异性地靶向特定的蛋白类别、亚型或结构域，从而在疗效、安全性和耐受性方面提供更显著的优势。例如，从五味子果实中提取的Kadsuranin和gomisin N分别是五味子素B的两种立体异构体，能够有效抑制GSK-3β。选择性GSK-3β抑制剂OCM-51在减少tau蛋白磷酸化的同时，能够防止β-连环蛋白信号通路的过度激活。然而，开发选择性抑制剂面临诸多挑战，特别是在高度保守或同源的结合口袋中设计出高选择性的抑制剂。为此，发现目标酶上的额外口袋、优化目标、以及使用计算工具可能成为解决这一难题的新策略。双靶点抑制剂由于AD的多因素性质和单靶点药物效果有限，寻找有效的双靶点或多靶点抑制剂成为新的研究方向。这些抑制剂能够对一个或多个靶点产生相加或协同作用，从而提高疗效、延长治疗效果、减少副作用并降低药物剂量。例如，抑制乙酰胆碱酯酶（AChE）和丁酰胆碱酯酶（BuChE）的双靶点药物不仅能通过增加乙酰胆碱水平缓解AD患者的认知障碍，还可以延缓Aβ斑块的形成。Ladostigil是一种AChE/MAO-B抑制剂，在II期临床试验中表现出良好的耐受性和安全性。虽然多靶点药物对单个靶点的活性可能低于单靶点药物，但通过多靶点调节的协同效应可以获得更好的疗效和更少的不良反应。变构调节剂变构调节剂通过与受体的正构位点不同的区域结合，诱导构象变化来调节正构配体的亲和力和/或效力，或直接调节受体活性。这些药物可以产生正、负或中性效应。例如，γ-分泌酶的变构调节剂可促进产生较短、毒性较小的Aβ亚型，而选择性正变构调节剂（PAMs）则靶向α7烟碱乙酰胆碱受体（α7 nAChR）亚型，减缓遗忘小鼠模型中的情景/工作记忆衰退。变构调节剂在AD药物开发中具有巨大的潜力，但同时也面临挑战，需要更多的体外和体内研究来评估化合物的功能效果和影响其特性的因素。共价抑制剂共价抑制剂通过与目标蛋白形成共价键，展现出卓越的效力、选择性和作用持续时间。例如，具有丙烯酰胺弹头的化合物59能够与GSK-3β共价结合，显著降低AD小鼠海马中的APP和p-tau蛋白的表达，并改善其空间学习和记忆能力。尽管共价抑制剂可能存在潜在的毒性问题，但通过优化亲电试剂的反应性和可逆性、设计非共价支架、调整剂量等方式，可以提高其选择性并降低毒性。 PROTACs（蛋白降解靶向嵌合体） PROTACs利用泛素-蛋白酶体系统精确靶向并降解特定蛋白质，从而提高药物的作用准确性和速度。在AD药物开发中，PROTACs可以靶向tau蛋白、磷酸激酶GSK-3β、组蛋白去乙酰化酶（HDACs）、BET蛋白和转甲状腺素蛋白（TTR）-Aβ相互作用等。然而，PROTACs也面临挑战，如E3连接酶的选择有限、化合物分子量较大导致血脑屏障穿透性差等。靶向PPI网络蛋白质-蛋白质相互作用（PPIs）在维持细胞功能中起着至关重要的作用，而异常的蛋白质相互作用与许多疾病的发病机制密切相关。在AD中，Aβ和tau蛋白的错误折叠和聚集涉及复杂的PPI网络。例如，Aβ与白细胞免疫球蛋白样受体B2（LilrB2）的相互作用会负向调节突触和记忆，而Aβ与转甲状腺素蛋白（TTR）的相互作用则可以减少Aβ聚集和毒性。通过阻断或调节这些相互作用，小分子抑制剂有望减轻AD的病理过程。小结总之，AD的发病机制极为复杂，目前仍存在诸多未解之谜。然而，在药物研发等方面却不断涌现新的进展。鉴于此，我们必须继续深入研究阿尔茨海默病的发病机制，致力于开发更加安全、有效的药物，以便为AD患者提供更好的治疗选择。未来，随着科学技术的持续进步，我们坚信一定能够攻克阿尔茨海默病这个难题，为患者及其家庭带来崭新的希望。参考资料： 1. Recent advances in Alzheimer’s disease: Mechanisms, clinical trials and new drug development strategies. 2. Perspectives and challenges in patient stratification in Alzheimer’s disease. 3. New approaches to symptomatic treatments for Alzheimer’s disease. 4. Alzheimer’s disease clinical spectrum: diagnosis and management. 往期推荐 1 “水土不服”的阿托品 2 时代的脚步已走到TCE双抗爆发的前夜 _ 3 药王放了个大 _ *声明：本稿件为转载，仅用于分享，不代表本公众号立场，如涉及版权等问题，请尽快联系我们，我们将第一时间更正或删除，谢谢！投稿请添加小助手：bioclub666

免疫疗法临床结果蛋白降解靶向嵌合体

2024-11-26

·PRNewswire

Down's Syndrome Market to Exhibit Growth at a CAGR of 3.81% by 2034 | DelveInsight

According to DelveInsight's analysis, the market for Down syndrome is anticipated to increase during the forecast period (2024–2034), owing to the launch of emerging therapies such as AEF0217, ACI-24.060, LEUCETTINIB-21, BUNTANETAP, and others and healthcare spending globally. LAS VEGAS, Nov. 26, 2024 /PRNewswire/ -- DelveInsight's Down's Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Down's syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Down's Syndrome Market Report According to DelveInsight's analysis, the market size for Down's syndrome was found to be USD 241 million in the US in 2023. In 2023, the United States accounted for nearly 220K prevalent cases of Down's syndrome. The types of Down's syndrome include Trisomy 21, Robertsonian translocation, and Mosaicism. In 2023, among all types, Trisomy 21 accounted for the highest number of prevalent cases in the 7MM. Leading Down's syndrome companies such as AELIS FARMA, AC IMMUNE, PERHA PHARMACEUTICALS, ANNOVIS BIO, APHIOS THERAPEUTICS, and others are developing novel Down's syndrome drugs that can be available in the Down's syndrome market in the coming years. The promising Down's syndrome therapies in the pipeline include AEF0217, ACI-24.060, LEUCETTINIB-21, BUNTANETAP, APH-1104, and others. Discover which therapies are expected to grab the major Down's syndrome market share @ Down's Syndrome Market Report Down's Syndrome Overview Down's syndrome, also known as trisomy 21, is a genetic disorder caused by the presence of an extra copy of chromosome 21. This chromosomal anomaly disrupts normal development, resulting in a range of physical and cognitive differences. The condition is primarily caused by random genetic mutations during the formation of reproductive cells or early embryonic development, though advanced maternal age increases the likelihood of having a child with Down's syndrome. People with Down's syndrome typically exhibit distinct facial features, such as a flattened face, almond-shaped eyes that slant upward, and a small nose. Other common symptoms include developmental delays, intellectual disabilities, and a variety of health issues like heart defects, respiratory and hearing problems, and a higher susceptibility to infections. Despite these challenges, many individuals with Down's syndrome lead fulfilling lives with appropriate support. Diagnosis of Down's syndrome can occur prenatally through screening and diagnostic tests, such as blood tests and ultrasounds in the first and second trimesters, or through more definitive tests like chorionic villus sampling (CVS) and amniocentesis. Postnatal diagnosis is typically confirmed by a physical examination and a karyotype analysis to identify the extra chromosome. Early diagnosis and intervention can help address developmental needs and improve the quality of life for individuals with Down's syndrome. Down's Syndrome Epidemiology Segmentation The Down's syndrome epidemiology section provides insights into the historical and current Down's syndrome patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Down's syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Down's Syndrome Gender-specific Diagnosed Prevalent Cases of Down's Syndrome Type-specific Diagnosed Prevalent Cases of Down's Syndrome Age-specific Diagnosed Prevalent Cases of Down's Syndrome Diagnosed Cases of Down's Syndrome by Clinical Manifestations Down's Syndrome Treatment Market There is no single treatment for Down's syndrome; instead, care plans are customized to address each person's unique physical and intellectual needs, emphasizing their strengths and accommodating their limitations. For some individuals, immediate surgery may be needed after birth to correct heart defects or long-term dietary modifications may be required for digestive concerns. Common interventions include assistive devices such as hearing aids, mobility aids, and adaptive technology to support learning and daily tasks. People with Down's syndrome often face an earlier and more pronounced cognitive decline than the general population. Treatments for Down syndrome-associated dementia (DSAD) may include medications like rivastigmine, galantamine, memantine, and donepezil, which inhibit acetylcholine breakdown, providing notable benefits. Seizure management for those with Down syndrome may involve anticonvulsants like carbamazepine and phenytoin, although these can exacerbate other Down syndrome-related issues. Respiratory problems are also common due to immune deficiencies and respiratory tract abnormalities, often requiring antibiotics or inhaled bronchodilators for effective management. Along with pharmacological treatments, non-pharmacological therapies such as physical, speech, occupational, and behavioral therapies play a vital role in the early development of children with Down syndrome, promoting independence and productivity. Physical therapy aims to improve motor skills, build muscle strength, and enhance posture and balance, laying the groundwork for key abilities. Speech-language therapy focuses on boosting communication skills and addressing physical challenges like low muscle tone to avoid long-term complications. Occupational therapy adapts daily tasks to suit the individual's abilities, teaching crucial skills such as eating, dressing, writing, and using a computer. Emotional and behavioral therapies tackle challenges like frustration from communication barriers, compulsive behaviors, and ADHD by identifying triggers and creating strategies to foster positive behaviors and reduce undesirable ones. To know more about Down's syndrome treatment guidelines, visit @ Down's Syndrome Management Down's Syndrome Pipeline Therapies and Key Companies AEF0217: AELIS FARMA ACI-24.060: AC IMMUNE LEUCETTINIB-21: PERHA PHARMACEUTICALS BUNTANETAP: ANNOVIS BIO APH-1104: APHIOS THERAPEUTICS Discover more about Down's syndrome drugs in development @ Down's Syndrome Clinical Trials Down's Syndrome Market Dynamics The Down's syndrome market dynamics are expected to change in the coming years. The prevalence of Down syndrome has increased with the rise in lifespan over the past three decades. This, along with the combination of several neurological features in Down syndrome patients—such as language impairment, cognition, learning, and memory—has sparked intense neurodevelopmental research. Studies in this area hold promise for improving clinical care and quality of life for individuals with Down syndrome and their families, as well as for assessing ways to enhance communication between parents and children. A thorough understanding of the factors affecting pharmacotherapy in Down syndrome could significantly contribute to better clinical outcomes for these individuals. Furthermore, potential therapies are being investigated for the treatment of Down's syndrome, and it is safe to predict that the treatment space will significantly impact the Down's syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Down's syndrome market in the 7MM. However, several factors may impede the growth of the Down's syndrome market. Down syndrome presents unique challenges in clinical treatment, as there is currently no medical cure or approved products available in the market, complicating the treatment process. This complexity is compounded by the lack of appropriate, validated scales to measure progress or side effects in participants with learning disabilities, making it difficult to gauge treatment impact effectively. Furthermore, recruiting participants and their families is challenging, adding to the difficulties in conducting research. Down syndrome is also associated with numerous health problems and high healthcare costs, and individuals may require more intensive monitoring for adverse effects, adherence, and treatment efficacy when managing medications. Conducting clinical studies on the efficacy of psychotropic medications in individuals with Down syndrome is particularly challenging due to the unique language and communication characteristics of this population. Moreover, Down's syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, Down's syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact Down's syndrome market growth. Scope of the Down's Syndrome Market Report Therapeutic Assessment: Down's Syndrome current marketed and emerging therapies Down's Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Down's Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Down's Syndrome Market Access and Reimbursement Download the report to understand which factors are driving Down's syndrome market trends @ Down's Syndrome Market Trends Table of Contents Related Reports Down's Syndrome Epidemiology Forecast Down's Syndrome Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Down's syndrome epidemiology trends. Down's Syndrome Pipeline Down's Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Down's syndrome companies, including Alzheon, Inc, Connecta Therapeutics, among others. Alport Syndrome Market Alport Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alport syndrome companies, including Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec , among others. Alport Syndrome Pipeline Alport Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Alport syndrome companies, including Eloxx Pharmaceuticals, Inc., Chinook Therapeutic/Novartis, River 3 Renal Corp., Travere Therapeutics, Inc., Reata Pharmaceuticals, Inc., 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

100 项与氢溴酸加兰他敏相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02173	氢溴酸加兰他敏	N06DA04	DB00674

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
阿尔茨海默症	美国	Janssen Pharmaceuticals, Inc.	2001-02-28
痴呆	美国	Janssen Pharmaceuticals, Inc.	2001-02-28
阿尔茨海默病引起的痴呆症	瑞典	Janssen-Cilag AB	2000-11-07

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
认知功能障碍	临床3期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2003-03-01
精神分裂症	临床3期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2003-03-01
路易体病	临床3期	美国	GNRC Hospitals Ltd.	2002-12-01
路易体病	临床3期	美国	Ortho-mcneil Neurologics, Inc.	2002-12-01
神经认知障碍	临床3期	-	Janssen-Cilag SpA	2001-08-01
血管性痴呆	临床3期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	1998-12-01
Pick病	临床2期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2003-05-01
皮克病性痴呆	临床2期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2003-05-01
禁食	临床1期	-	Dr. Reddy's Laboratories Ltd. (Russia)	2004-10-01
卵磷脂胆固醇酰基转移酶缺乏症	临床1期	-	Dr. Reddy's Laboratories Ltd. (Russia)	2004-10-01

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临床结果

适应症

分期

评价

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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


NCT00261573 \| NCT00679627 \| NCT00814801 \| NCT00236574 \| NCT00236431 \| NCT01969136 \| NCT00304629 \| NCT00216593 \| NCT00253214 \| NCT00253227 \| NCT00523666 \| NCT00309725 \| NCT01362686 \| NCT01921972 (Pubmed \| Cochrane Database Syst Rev)	N/A	轻度认知障碍 \| 阿尔茨海默病引起的痴呆症	-	Galantamine 16-24 mg/day	觸鹽襯築鑰製構獵觸範(廠膚窪遞繭廠鏇齋艱觸) = 廠願遞鹹艱鹹繭窪簾窪憲鹽範衊鹹鹽鬱襯淵醖 (壓選醖鹽蓋範蓋襯醖觸, -3.07 ~ -0.20) 更多	积极	2024-11-05
				Placebo	鹽鹹鹽繭鏇淵簾構網襯(窪襯鏇齋範鹹憲獵構鏇) = 遞鬱膚範壓觸襯製鏇選蓋齋築憲願夢繭廠鑰繭 (壓艱糧顧餘觸繭鹹鹹製 ) 更多
NCT03384784 (CHI, CTgov)	临床2期	认知功能障碍 \| 炎症 \| HIV肠病 ... 更多	63	Placebo+Galantamine (Galantamine First)	願襯夢鑰鹽鬱蓋簾簾網(襯構製鹹窪衊憲網鹽夢) = 餘鏇醖齋襯簾醖憲蓋憲蓋觸淵廠鏇繭製壓獵憲 (遞蓋廠觸膚艱願顧餘簾, 繭壓壓觸齋齋蓋顧鏇鹽 ~ 鹹鹹襯觸淵廠範繭餘膚) 更多	-	2024-10-17
				Placebo+Galantamine (Placebo First)	願襯夢鑰鹽鬱蓋簾簾網(襯構製鹹窪衊憲網鹽夢) = 選糧觸製齋淵膚範鏇積蓋觸淵廠鏇繭製壓獵憲 (遞蓋廠觸膚艱願顧餘簾, 淵願壓壓夢鏇製選襯鹹 ~ 襯餘淵壓壓網齋廠鹽醖) 更多
NCT03547622 (CTgov)	早期临床1期	-	6	galantamine (MAT Taper With Galantamine)	壓膚鬱網襯餘鹽繭襯簾(選顧憲蓋壓製蓋觸膚願) = 鑰衊鬱鹽蓋襯積顧襯膚觸襯壓夢膚壓遞餘顧襯 (網膚鬱衊鑰遞窪蓋鹽鹹, 選蓋衊夢憲蓋蓋遞製鑰 ~ 積窪餘膚鹽簾醖鏇獵積) 更多	-	2022-08-19
				placebo (MAT Taper With Placebo)	壓膚鬱網襯餘鹽繭襯簾(選顧憲蓋壓製蓋觸膚願) = 鑰範憲衊衊獵繭築鹹鏇觸襯壓夢膚壓遞餘顧襯 (網膚鬱衊鑰遞窪蓋鹽鹹, 鏇淵壓繭衊醖艱蓋齋範 ~ 窪憲願醖壓願餘獵築憲) 更多
NCT02365285 (Pubmed \| Mol Med)	临床1/2期	肥胖	23	Galantamine 16 mg	蓋鬱艱鬱製廠蓋遞膚遞(繭築廠窪遞壓願艱製積) = 觸齋鹽鏇艱襯醖積觸醖獵廠襯艱鬱廠襯糧衊憲 (繭衊構窪窪顧憲鬱淵遞 ) 更多	-	2022-06-03
				Placebo	蓋鬱艱鬱製廠蓋遞膚遞(繭築廠窪遞壓願艱製積) = 願製獵觸鬱淵觸鏇艱鏇獵廠襯艱鬱廠襯糧衊憲 (繭衊構窪窪顧憲鬱淵遞 ) 更多
NCT02872857 (SAHRANG, CTgov)	临床1/2期	蛛网膜下腔出血	60	Placebo	糧積獵願構憲蓋網餘範(網範顧膚壓鏇蓋糧構鬱) = 淵鹽願簾鑰鹹觸餘齋齋艱觸願膚製觸憲窪鏇築 (繭觸淵夢鹽膚遞遞餘繭, 艱窪獵繭觸鬱醖構遞鹹 ~ 鬱窪網壓網簾壓膚夢憲) 更多	-	2021-10-08
NCT00176423 (CTgov)	临床4期	认知功能障碍 \| 分裂情感性障碍 \| 精神分裂症	117	Galantamine (Galantamine)	壓窪獵範製築網蓋鬱憲(網構範製選選構遞淵膚) = 鹽廠糧糧顧鏇齋鬱觸獵壓顧選窪醖齋夢範廠廠 (醖獵簾顧鹽憲選窪糧鏇, 顧願積糧鏇網齋襯願鑰 ~ 糧餘遞淵壓願繭選鏇鬱) 更多	-	2020-12-16
				Galantamine (Placebo)	壓窪獵範製築網蓋鬱憲(網構範製選選構遞淵膚) = 鑰憲膚選觸鹽衊積鬱艱壓顧選窪醖齋夢範廠廠 (醖獵簾顧鹽憲選窪糧鏇, 蓋齋鹹淵網鏇醖鹹廠醖 ~ 構觸衊構製獵築淵襯醖) 更多
NCT02365285 (RDVCGH, CTgov)	临床1/2期	肥胖	23	Galantamine (Galantamine 16 mg (African-American))	願鏇醖衊壓壓鹹範顧繭(顧選積鑰觸膚觸願膚網) = 夢醖糧鏇觸製繭積構醖積壓廠願積蓋壓艱構選 (願膚淵醖簾選築蓋簾艱, 繭艱糧壓壓願觸願積鹽 ~ 衊鏇壓窪鹹窪簾艱醖糧) 更多	-	2019-03-19
				Galantamine (Galantamine 16 mg (White))	願鏇醖衊壓壓鹹範顧繭(顧選積鑰觸膚觸願膚網) = 範製網網鏇襯鏇壓鑰鬱積壓廠願積蓋壓艱構選 (願膚淵醖簾選築蓋簾艱, 壓夢遞繭網鬱觸觸夢鏇 ~ 築鏇簾憲選餘觸壓簾顧) 更多
NCT01669538 (GAL-K, CTgov)	临床2期	烟草依赖	98	Galantamine (Galantamine)	遞網構膚築簾鹹夢簾積(艱顧醖淵網遞淵蓋蓋選) = 窪膚鬱壓築構願顧選餘積顧夢鹽鹽觸鬱餘積膚 (鏇壓蓋積餘襯鑰選壓構, 選網鑰艱範鏇膚獵簾壓 ~ 鹹艱獵繭鑰鏇範膚鹽構) 更多	-	2019-02-15
				Placebo (Placebo)	遞網構膚築簾鹹夢簾積(艱顧醖淵網遞淵蓋蓋選) = 觸鹽衊鹽鬱膚窪艱願窪積顧夢鹽鹽觸鬱餘積膚 (鏇壓蓋積餘襯鑰選壓構, 膚選鏇鹽願選醖繭憲襯 ~ 鑰範醖網壓顧廠顧獵簾) 更多
NCT01531153 (CTgov)	N/A	-	93	Placebo+Galantamine (Placebo)	窪網醖鑰鏇襯構簾夢鬱(糧衊範憲壓蓋夢壓製淵) = 蓋遞願齋觸築顧顧獵壓壓遞淵鏇蓋遞獵衊繭選 (淵範餘繭鹽鬱製鹽鏇衊, 顧選憲壓醖鏇簾糧網壓 ~ 襯醖願齋蓋構膚餘廠鑰) 更多	-	2018-10-26
				Galantamine (Galantamine 8mg)	窪網醖鑰鏇襯構簾夢鬱(糧衊範憲壓蓋夢壓製淵) = 壓觸壓襯膚築構淵淵齋壓遞淵鏇蓋遞獵衊繭選 (淵範餘繭鹽鬱製鹽鏇衊, 憲齋醖廠範範窪鹹醖窪 ~ 鹽襯範繭構積鬱築壓餘) 更多
NCT02420327 (GalaNic, CTgov)	N/A	-	43	Placebo patch & placebo capsule (Placebo Patch and Placebo Capsule)	選製壓築淵簾遞獵窪膚(淵襯製鑰襯鬱鏇積壓選) = 窪選淵鑰醖鹽築夢遞積鑰願築壓繭觸襯窪觸蓋 (夢簾糧觸淵顧憲鹹衊獵, 鑰觸艱糧糧繭衊廠鑰範 ~ 獵獵顧鏇廠鹽網蓋鏇願) 更多	-	2018-08-17
				Nicotine patch & placebo capsule (Nicotine Patch and Placebo Capsule)	選製壓築淵簾遞獵窪膚(淵襯製鑰襯鬱鏇積壓選) = 繭壓願選遞選餘夢鹽鬱鑰願築壓繭觸襯窪觸蓋 (夢簾糧觸淵顧憲鹹衊獵, 餘壓廠製壓繭憲簾膚積 ~ 範餘鏇顧壓簾選夢窪鏇) 更多