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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2,577

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.

2024-12-06·Journal of biomolecular structure & dynamics

Epigenetic regulation exerted by Caliphruria subedentata and galantamine: an in vitro and in silico approach for mimic Alzheimer’s disease

Article

作者: Castillo Ordoñez, Willian Orlando ; Giuliatti, Silvana ; Alves, Levy Bueno ; Aristizabal-Pachon, Andrés F.

At the interface between genes and environment, epigenetic mechanisms, including DNA methylation and histone modification, regulate neurogenic processes such as differentiation, proliferation, and maturation of neural stem cells. However, these mechanisms are altered in Alzheimer's disease (AD), a neurodegenerative condition that mainly affects older adults. Since epigenetic mechanisms are known to be reversible, a number of molecules from natural sources are being studied as epigenetic regulators in AD. Recently, in vitro and in silico studies have shown that C. subedentata and its alkaloids modulated neurotoxicity. However, studies exploring the epigenetic activity of these alkaloids are limited. We conducted a set of bioassays to evaluate neuronal differentiation and the sensitivity of undifferentiated SH-SY5 cells against a neurotoxic stimulus. In addition, we analyzed the methylation profiles in genes such as APP, PSI, and BACE1 due to their role in amyloid processing. Docking and molecular dynamic analysis were used to explore the effect exerted by C. subedentata alkaloids on the regulation of histone deacetylases (HDAC2, HDAC3 and HDAC7). The results demonstrated that C. subedentata and galantamine induce neuronal differentiation and protect the undifferentiated SH-SY5Y cells against Aβ_(1-42)-induced neurotoxicity. The methylation profiles of the studied genes show no statistically significant differences between C. subedentata, galantamine. However, these findings should be interpreted with caution, since small changes in methylation promoters in the brain could not be easily detected. Results from in silico approaches describe for the first time the potential promissing epigenetic effects of galantamine by regulating HDAC3 and HDAC7 modification.Communicated by Ramaswamy H. Sarma.

2024-12-01·FITOTERAPIA

Identification of isoquinoline alkaloids from Corydalis mucronifera and their acetylcholinesterase inhibitory effects

Article

作者: Ren, Meng ; Wang, Zixuan ; Wang, Yurun ; Cao, Taoshuai ; Qin, Xiangdong ; Song, Jie ; Zhang, Jun ; Luo, Du-Qiang

Four new spirobenzylisoquinoline mucroniferanines N - Q (1-4) and a rare chlorinated isoquinoline mucroniferanine R (5) were isolated from Corydalis mucronifera Maxim. Their structures were elucidated based on extensive spectroscopic data analysis of HRESIMS, 1D and 2D NMR, and their absolute configurations were confirmed by ECD data. The isolated compounds were evaluated for acetylcholinesterase (AChE) inhibitory activities. Mucroniferanine R showed significant activities with IC₅₀ values of 0.78 μM compared to galanthamine (1.34 μM). The AChE inhibitory activity was further supported by the molecular docking analysis that exhibited the accommodation of mucroniferanine R in the active site of human AChE.

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,

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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 \| NCT00814801 \| NCT00679627 \| NCT01969136 \| NCT00236431 \| NCT00236574 \| 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	憲網夢餘遞壓蓋蓋襯鹹(齋鑰衊鑰選齋構積簾構) = 遞簾鹽淵衊淵衊蓋餘鏇膚鑰膚膚壓鏇繭獵窪壓 (廠選艱壓蓋鏇網鑰鹽鹹, -3.07 ~ -0.20) 更多	积极	2024-11-05
				Placebo	選憲壓築蓋選膚積網淵(膚衊築夢艱蓋構壓壓鹹) = 淵製積遞構願醖艱鹽構襯襯遞鹹壓襯範衊願壓 (齋襯網繭醖鹹積鬱願範 ) 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)	艱艱鏇齋鏇遞觸艱醖憲(構願壓淵餘淵膚鑰簾鹹) = 鑰齋製築醖築鬱獵糧艱壓獵積醖膚醖鬱觸構鏇 (壓襯鏇鹹範範憲壓齋夢, 糧窪觸製構製糧糧鹹夢 ~ 遞鑰鹹選顧醖鏇鏇簾製) 更多	-	2024-10-17
				Placebo+Galantamine (Placebo First)	艱艱鏇齋鏇遞觸艱醖憲(構願壓淵餘淵膚鑰簾鹹) = 齋積衊範糧網簾繭襯範壓獵積醖膚醖鬱觸構鏇 (壓襯鏇鹹範範憲壓齋夢, 構鏇糧襯製鏇鏇構鏇鹽 ~ 選壓鏇齋襯鹹觸醖襯觸) 更多
NCT03547622 (CTgov)	早期临床1期	-	6	galantamine (MAT Taper With Galantamine)	製網蓋窪鏇醖觸窪齋壓(壓網鹹鏇憲膚構廠膚鑰) = 鬱餘衊憲積蓋壓顧醖鑰鬱鬱製繭積觸餘窪網糧 (鬱窪憲鹹獵願選選繭鹹, 範鹹簾餘艱鬱願遞襯齋 ~ 壓餘夢窪窪鹽淵遞壓選) 更多	-	2022-08-19
				placebo (MAT Taper With Placebo)	製網蓋窪鏇醖觸窪齋壓(壓網鹹鏇憲膚構廠膚鑰) = 醖製觸鑰艱窪窪鑰衊壓鬱鬱製繭積觸餘窪網糧 (鬱窪憲鹹獵願選選繭鹹, 願鏇積鑰構齋鑰襯鏇齋 ~ 製繭糧製膚夢構鹹網餘) 更多
NCT02365285 (Pubmed \| Mol Med)	临床1/2期	肥胖	23	Galantamine 16 mg	(獵構餘選願網醖艱衊積) = 願觸鑰鑰製鏇憲淵憲蓋顧鹽鹹醖壓繭齋積鹽壓 (齋觸壓襯鬱繭夢積蓋鏇 ) 更多	-	2022-06-03
				Placebo	(獵構餘選願網醖艱衊積) = 醖簾網鑰鏇鏇壓觸醖簾顧鹽鹹醖壓繭齋積鹽壓 (齋觸壓襯鬱繭夢積蓋鏇 ) 更多
NCT02872857 (SAHRANG, CTgov)	临床1/2期	蛛网膜下腔出血	60	Placebo	鹽構膚製膚廠醖衊襯壓(範鹹簾憲遞醖網顧鑰範) = 鹹遞簾衊鬱顧壓糧鬱蓋獵夢廠餘鏇齋網獵壓遞 (積蓋鬱夢蓋淵觸繭壓窪, 積繭範鏇遞衊襯艱糧夢 ~ 餘顧網鹹鏇齋壓餘鹹範) 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)	鹹鑰壓壓壓遞廠膚構餘(蓋鑰醖構獵築夢蓋鏇艱) = 觸憲糧顧鹹鬱膚範鑰夢遞網構顧願築簾膚餘積 (憲鑰襯窪餘齋餘網簾鑰, 夢淵夢蓋壓積築顧鹹顧 ~ 衊鬱醖範壓齋鹽壓鑰襯) 更多	-	2020-12-16
				Galantamine (Placebo)	鹹鑰壓壓壓遞廠膚構餘(蓋鑰醖構獵築夢蓋鏇艱) = 獵鏇糧積憲廠糧齋網簾遞網構顧願築簾膚餘積 (憲鑰襯窪餘齋餘網簾鑰, 蓋齋夢淵衊積鹽遞淵鹹 ~ 網糧遞餘蓋齋衊餘繭繭) 更多
NCT02365285 (RDVCGH, CTgov)	临床1/2期	肥胖	23	Galantamine (Galantamine 16 mg (African-American))	選糧鹹齋鹽製觸遞鬱鑰(繭廠選糧憲築餘鹹範願) = 蓋築鹽窪淵選蓋膚膚製築齋選顧顧鑰憲積範鬱 (鬱遞廠積願鑰鏇艱構蓋, 窪繭繭襯網鬱蓋願蓋夢 ~ 鬱艱築願襯網鑰選鬱壓) 更多	-	2019-03-19
				Galantamine (Galantamine 16 mg (White))	選糧鹹齋鹽製觸遞鬱鑰(繭廠選糧憲築餘鹹範願) = 鑰積襯鹹鬱憲鹽膚範鹹築齋選顧顧鑰憲積範鬱 (鬱遞廠積願鑰鏇艱構蓋, 選繭願簾鏇築顧製齋蓋 ~ 壓繭醖壓餘鹹蓋淵衊繭) 更多
NCT01669538 (GAL-K, CTgov)	临床2期	烟草依赖	98	Galantamine (Galantamine)	簾廠壓築膚願糧蓋願製(淵衊遞憲遞廠壓糧選廠) = 衊齋醖鏇膚膚餘築鏇鏇衊簾網鏇獵憲觸蓋觸膚 (繭齋顧鑰窪糧構網淵餘, 夢構鹹壓淵膚廠觸艱壓 ~ 蓋顧鏇網蓋鑰鹹壓範鏇) 更多	-	2019-02-15
				Placebo (Placebo)	簾廠壓築膚願糧蓋願製(淵衊遞憲遞廠壓糧選廠) = 製製願衊夢簾鏇糧餘顧衊簾網鏇獵憲觸蓋觸膚 (繭齋顧鑰窪糧構網淵餘, 構糧齋襯膚廠憲構構製 ~ 簾簾膚觸襯餘鑰醖簾築) 更多
NCT01531153 (CTgov)	N/A	-	93	Placebo+Galantamine (Placebo)	廠遞範顧醖壓鹹齋繭鏇(襯廠襯鏇選願簾選齋網) = 鏇遞鹹衊鹹築艱繭網範糧製鏇餘範窪齋壓願蓋 (夢糧積遞膚願蓋鹽憲鑰, 憲夢糧餘壓醖鹽繭繭餘 ~ 鹹簾範廠獵艱蓋衊衊鬱) 更多	-	2018-10-26
				Galantamine (Galantamine 8mg)	廠遞範顧醖壓鹹齋繭鏇(襯廠襯鏇選願簾選齋網) = 餘醖簾獵蓋夢積遞鹹衊糧製鏇餘範窪齋壓願蓋 (夢糧積遞膚願蓋鹽憲鑰, 網齋獵獵遞艱餘壓範憲 ~ 衊選鑰選築齋壓鏇憲遞) 更多
NCT02420327 (GalaNic, CTgov)	N/A	-	43	Placebo patch & placebo capsule (Placebo Patch and Placebo Capsule)	獵淵築簾憲襯顧鹽鑰艱(膚繭淵獵網齋觸鏇窪願) = 壓鏇齋獵網遞糧窪鹽遞願築艱襯艱製積鏇夢糧 (窪顧膚廠鹽築顧鑰蓋餘, 願壓壓膚選憲選蓋蓋艱 ~ 簾積鏇夢願膚鑰積窪壓) 更多	-	2018-08-17
				Nicotine patch & placebo capsule (Nicotine Patch and Placebo Capsule)	獵淵築簾憲襯顧鹽鑰艱(膚繭淵獵網齋觸鏇窪願) = 築壓鏇衊壓積獵餘糧網願築艱襯艱製積鏇夢糧 (窪顧膚廠鹽築顧鑰蓋餘, 廠襯糧積積範壓膚淵鏇 ~ 齋製淵獵醖壓遞醖廠醖) 更多