多奈单抗(Donanemab-AZBT) - 药物靶点：pGlu3Aβ_在研适应症：阿尔茨海默病引起的痴呆症，轻度认知障碍，阿尔茨海默症_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Donanemab、Donanemab (USAN)、N3pG-AB-monoclonal-antibody-Eli-Lilly

+ [12]

靶点

pGlu3Aβ

作用方式

抑制剂

作用机制

焦谷氨酸 (3pE) 修饰型β-淀粉样蛋白抑制剂

治疗领域

神经系统疾病其他疾病

在研适应症

阿尔茨海默病引起的痴呆症轻度认知障碍阿尔茨海默症+ [3]

非在研适应症-

原研机构

Eli Lilly & Co.

在研机构

Eli Lilly & Co.Eli Lilly Australia Pty Ltd.Eli Lilly Nederland BV

+ [2]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2024-07-02),

阿尔茨海默症

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、突破性疗法 (中国)、优先审评 (中国)

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结构/序列

Sequence Code 190619L

来源: *****

Sequence Code 190621H

来源: *****

关联

16

项与多奈单抗相关的临床试验

NCT06996730

/ Not yet recruiting临床2/3期IIT

A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Amyloid PET scans will be conducted at screening, 9, and 18 months in Part 1. Participants who are at or below 11 CL at screening or reach complete amyloid plaque clearance as measured by florbetapir F18 PET (defined as ≤11 CL) at 9 months will initiate Part 2. Participants who are ≤11 CL at screening may delay their entry into Part 2 for up to 6 months at the discretion of the Investigator. All remaining participants will start Part 2 after completing 18 months (76 weeks) in Part 1 independent of amyloid results. Non-carriers will receive placebo in both Parts 1 and 2.
In Part 2, study participants who are mutation carriers will be randomized 1:1:1:1 in a full factorial design to receive either RG6289 + placebo-donanemab (RG6289 alone group), donanemab + placebo-RG6289 (donanemab alone group), the combination of RG6289 and donanemab (combination group), or placebo-RG6289 and placebo-donanemab (placebo group). All non-carriers will be assigned to the placebo group. CDR-GS at the end of Part 1 and the amyloid level using the last completed amyloid PET scan in Part 1 will be used for stratification. All study participants will participate in a double-dummy design for the duration of Part 2 receiving both an intravenous (IV) infusion at the required interval for the donanemab or matching placebo as well as a daily oral treatment of RG6289 or matching placebo.
An exploratory outcome of Part 1 is a comparison of the amyloid clearance between this ADAD cohort and historical controls using propensity score matching. The primary outcome in Part 2 is change from the start of Part 2 through the end of Part 2 in brain amyloid load in PSEN1 E280A mutation carriers as measured by amyloid PET imaging. Other endpoints will include fluid and imaging biomarkers and measures of cognition and functioning. The maximum study duration for any individual participant will be 3 years, not including the screening or follow-up periods

开始日期2025-12-01

申办/合作机构

Banner Health

[+2]

NCT06911944

/ Not yet recruiting临床4期IIT

A Randomized, Double-Blind, Placebo-Controlled, Phase 4 Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Donanemab in Adults With Down Syndrome

The goal of this clinical trial is to learn if donanemab can reduce levels of amyloid in the brain, and if donanemab is safe and well-tolerated in participants with Down syndrome.
The main questions it aims to answer are: Does donanemab reduce amyloid in the brain? Is donanemab safe and well-tolerated in people with Down syndrome? Researchers will compare donanemab to a placebo (a look-alike substance that contains no drug) to see if donanemab works to reduce levels of amyloid in the brain.
Participants in the study will be 35-50 years old and will be in the study for 12 months. Participants will then stay in the study for an additional 12 months in an long-term extension where all participants will receive donanemab. Participants who had a reduction in amyloid (measured by amyloid brain scan) by the end of the first 12 months will receive placebo for the long-term extension, while participants who did not have an amyloid reduction will receive study donanemab for the long-term extension. Everyone (participants and study staff) will remain blinded to treatment for the duration of the study.
Participants will:
* Have intravenous (IV) infusions of donanemab (or placebo) every 4 weeks
* Visit the clinic once every other month for checkups and tests. These tests will include brain scans (magnetic resonance imaging [MRI] and positron emission tomography [PET] ), blood draws and memory tests.
* Have a study partner who who can provide information about the participant and can join participant for some of the study visits.

开始日期2025-06-01

申办/合作机构

University of Southern California

[+3]

NCT06566170

/ RecruitingN/A

Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)

The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.

开始日期2024-10-07

申办/合作机构

Eli Lilly & Co.

100 项与多奈单抗相关的临床结果

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100 项与多奈单抗相关的转化医学

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100 项与多奈单抗相关的专利（医药）

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205

项与多奈单抗相关的文献（医药）

2026-02-01·Neural Regeneration Research

Recent advances in immunotherapy targeting amyloid-beta and tauopathies in Alzheimer’s disease

Article

作者: Guo, Wanshu ; Sha, Sha ; Ren, Lina ; Qu, Le ; Li, Ying ; Cao, Yunpeng ; Wang, Yan ; Xing, Xiaona

Alzheimer’s disease, a devastating neurodegenerative disorder, is characterized by progressive cognitive decline, primarily due to amyloid-beta protein deposition and tau protein phosphorylation. Effectively reducing the cytotoxicity of amyloid-beta42 aggregates and tau oligomers may help slow the progression of Alzheimer’s disease. Conventional drugs, such as donepezil, can only alleviate symptoms and are not able to prevent the underlying pathological processes or cognitive decline. Currently, active and passive immunotherapies targeting amyloid-beta and tau have shown some efficacy in mice with asymptomatic Alzheimer’s disease and other transgenic animal models, attracting considerable attention. However, the clinical application of these immunotherapies demonstrated only limited efficacy before the discovery of lecanemab and donanemab. This review first discusses the advancements in the pathogenesis of Alzheimer’s disease and active and passive immunotherapies targeting amyloid-beta and tau proteins. Furthermore, it reviews the advantages and disadvantages of various immunotherapies and considers their future prospects. Although some antibodies have shown promise in patients with mild Alzheimer’s disease, substantial clinical data are still lacking to validate their effectiveness in individuals with moderate Alzheimer’s disease.

2025-09-01·Value in Health Regional Issues

Evaluating the Cost-Effectiveness of Pharmacological Therapy in Alzheimer Disease in Brazil

Article

作者: Moriguti, Julio Cesar ; Price, Price Udo ; Pereira, Leonardo Regis Leira ; Heggie, Robert

OBJECTIVES:

Alzheimer disease (AD) is a worsening neurodegenerative disorder and the leading cause of dementia, accounting for 60% to 70% of cases. It contributes significantly to disability, caregiver reliance, and is the eighth leading cause of death. AD is one of the most expensive diseases to treat, creating an economic burden for the healthcare system and families of patients. Dementia care costs in Brazil are projected to reach $49.2 billion by 2030, $63.5 billion by 2040, and $77.3 billion by 2050. This study evaluated the cost-effectiveness of acetylcholinesterase inhibitors (standard of care [SoC]) in slowing disease progression compared with no pharmacological therapy (best supportive care [BSC]), lecanemab, and donanemab in mild AD patients.

METHODS:

We developed a decision-analytic model to simulate AD progression, using cost and health utility data specific to Brazil, supplemented with data from the literature when necessary. The model covers a 20-year horizon from both the Brazilian national healthcare system and societal perspectives. Costs and quality-adjusted life years (QALYs) were discounted at 3.5% per year to reflect their present value. Costs in local currencies were converted to US dollars (US$) and inflation-adjusted to 2024 values.

RESULTS:

In the base-case analysis from the healthcare perspective, SoC was more clinically effective than BSC with a cost per QALY of $5211. For lecanemab versus SoC, the cost per QALY gained was $2 098 225, whereas donanemab versus lecanemab was $1 460 400.

CONCLUSIONS:

The SoC is a cost-effective pharmacological intervention for AD, offering the lowest cost per QALY gains over a 20-year period.

2025-07-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

New drugs approved by the NMPA in 2024: Synthesis and clinical applications

Review

作者: Yuan, Lin ; Gong, Zheng ; Zhao, Xinxin ; Yuan, Ye ; Geng, Jin ; Li, Mengqi

In 2024, the National Medical Products Administration (NMPA) approved 46 Class 1 or 1.1 innovative drugs, including 7 imported drugs and 39 domestically developed drugs, marking a new record in China's pharmaceutical innovation. These approvals encompassed 23 chemical drugs, 20 biological products, and 3 traditional Chinese medicines or natural products, demonstrating continuous growth in innovative drug development. Compared to 16 approvals in 2020 and the surge in 2021, when approvals equaled the total of the previous four years, the trend of increased approvals has resumed since 2024. Therapeutically, oncology drugs remained the dominant category in 2024, comprising 50 % (23/46) of approvals. Gastrointestinal and metabolic drugs, accounting for 13.04 % (6/46), surpassed other categories to rank second, followed by neurological drugs (8.7 %, 4/46). Anti-infectives, miscellaneous drugs, and traditional Chinese medicines each contributed three approvals (7.5 % each). Regulatory advancements played a significant role, with 18 drugs (39.13 %) approved via priority reviews, emergency reviews, or conditional approvals. This group included 9 chemical drugs and 9 biological products, with notable breakthrough therapies such as taletrectinib, lutetium monoclonal antibodies, and donanemab receiving special recognition. The 2024 data reflect China's growing capabilities in drug innovation and its commitment to addressing critical medical needs through accelerated regulatory pathways.

1,052

项与多奈单抗相关的新闻（医药）

2025-06-18

·BioSpace

More Than a One Trick Pony, Lilly Feeds Success Back Into Biotech

iStock, Michael Vi On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs. Eli Lilly is on something of a tear, aiming to prove with Tuesday’s $1.3 billion acquisition of Verve Therapeutics that it’s more than just a cardio-metabolic and neuroscience company. The Indianapolis-based pharma is most famous for its obesity and type 2 diabetes drugs, Zepbound and Mounjaro, and Alzheimer’s medicine Kisunla. But in addition to these two areas, along with oncology and immunology, Lilly also has an unofficial fifth focus, Julie Gilmore, vice president and global head of Lilly Gateway Labs and Catalyze360 Portfolio Management, told BioSpace at BIO2025 on Tuesday. That bonus focus is platforms and genetic medicine, which “can span all four of those core therapeutic areas,” Gilmore explained. In the case of this week’s Verve purchase, Lilly is gaining gene therapies that target cardiovascular disease. “This is the whole intent of what we’re doing, finding exciting science,” said Gilmore, who runs Lilly’s incubator program. “[Verve is] a great example.” One might think that Lilly should be content with its current portfolio. The company’s $45 billion in 2024 revenue was good enough for 9 th place among its top 20 pharma peers, and a 32% bump over the $34.1 billion for 2023. Lilly overtook its closest obesity competitor, Novo Nordisk, whose $42.1 billion was good for 11 th place. Julie Gilmore, vice president and global head of Lilly Gateway Labs and Catalyze360 Portfolio Management But Lilly isn’t resting on its laurels with Zepbound and Kisunla, or even relying only on its current key therapeutic areas. In fact, Gilmore said, only about 50% of its incubator companies are focused on these spaces. “At least half of our companies are doing things outside of our core strategy,” she said. “So they may be pursuing different therapeutic areas, different targets, different disease states, different modalities.” This is with an eye toward possibly branching out in the future, she added. “What is the greatest emerging science and what can we do to be a part of that and learn?” One emerging therapeutic area Lilly has already identified through the incubators is healthspan and longevity, which Gilmore said is “kind of adjacent” to the company’s current internal efforts. She questioned, however, whether it’s a space on its own. “I don’t know that we see that, but we do see it playing out in each of our areas of interest, and maybe even beyond our core therapeutic areas,” she said. “It’s something we’re definitely keeping an eye on.” She added that there are lots of new companies forming around longevity science. One of these companies, the aptly named Life Biosciences, was also at BIO2025. Chief Scientific Officer Sharon Rosenzweig-Lipson wouldn’t wager a guess as to the million-dollar question: How long could human beings actually live? But she did tell BioSpace , “We’re focused on reversing and treating age-related diseases, with hopefully a side effect of longevity. And then we’ll see.” Back at Lilly, Gilmore said incubator companies are selected based on “cutting edge science” and the potential for a symbiotic relationship. “Does Lilly have something we can offer them, do we have history, expertise, capabilities that we could apply to help them move forward?” In the current marketplace, Gilmore said she has “such admiration for those out there, fighting the good fight right now, because it’s not easy. . . . We’re stepping in to say, okay, where can a company like Lilly help while you’re fundraising?” Gilmore has been at Lilly for most of her career, and one thing she is proud of is how the company is leveraging its success and learnings in the obesity space to support biotech. “It’s not just going back into our own portfolio. We’re actually trying to use that success to support others. And that’s been a lot of fun, kind of a proud moment to be able to do that.”

并购

2025-06-12

·EINPresswire

Interim report: Nuravax's Alzheimer’s vaccine AV-1959R found safe, immunogenic in all healthy volunteers.

Nuravax’s Alzheimer’s vaccine AV-1959R is safe, triggered strong immune responses in all Phase 1 trial participants, showing promise for disease prevention. IRVINE, CA, UNITED STATES, June 12, 2025 / EINPresswire.com / -- Nuravax Inc. , a biotechnology company specializing in active immunotherapy for neurodegenerative disorders, received promising preliminary clinical data from its placebo-controlled, double-blind Phase 1 trial of AV-1959R . The amyloid-beta (Aβ) adjuvanted vaccine is based on its universal MultiTEP platform technology, licensed from the non-profit Institute for Molecular Medicine (IMM). No serious adverse events (SAEs) have been reported, and MRI scans show no signs of ARIA-E (edema) or ARIA-H (microhemorrhages) in all vaccinated and placebo people. “Initial results on immunogenicity are highly encouraging, with very strong antibody responses meeting our expectations based on the study's active-to-placebo allocation, said Roman Kniazev, CEO of Nuravax. “Achieving a 100% responder rate and an excellent safety profile so far in this Phase 1 trial is a significant milestone. This safe and immunogenic vaccine has full potential in Phase 2 to demonstrate its ability to prevent the onset of Alzheimer’s disease in vaccinated cognitively unimpaired individuals who are at risk for the disease.” This initial human data from a MultiTEP ® -based AV-1959R vaccine highlights the platform’s strong potential, which also supports other Nuravax’s preventive vaccine candidates for neurodegenerative disorders currently under development. The MultiTEP technology, licensed from IMM, is designed to activate non-harmful T helper cell responses that trigger humoral immunity and stimulate the production of antibodies. These antibodies help reduce or prevent the accumulation of aggregated Aβ, which initiates Alzheimer's disease pathophysiology. “Preclinical results and clinical data with monoclonal antibodies, Leqembi ® , Kisunla™ suggest that a safe and immunogenic Aβ vaccine may inhibit the accumulation of pathological amyloid, potentially delaying the onset of Alzheimer’s in cognitively unimpaired individuals at risk of disease,” said Dr. Michael Agadjanyan, VP of IMM. "These early findings suggest that after the completion of Nuravax’s Phase 1 trial, this AV-1959R vaccine would be a prime candidate for primary and secondary preventive therapy for individuals at risk of Alzheimer’s.” These encouraging early results also reflect the impact of a carefully developed manufacturing strategy that preserves the antigen’s structure. This process is critical for inducing high-titer, target-specific, and functional antibodies, an essential factor in achieving effective immune engagement in the context of Alzheimer’s disease prevention. About Nuravax Nuravax Inc. is a clinical-stage biotech company developing and advancing immunotherapeutic vaccines for neurodegenerative diseases, including Alzheimer's, Parkinson's, TBI, and CTE. Focused on early intervention, Nuravax aims to alter disease progression before irreversible damage occurs. In addition to AV-1959R, the company’s portfolio of Alzheimer’s prevention vaccines includes AV-1980R and Duvax. About IMM The Institute for Molecular Medicine (IMM) is a non-profit research organization dedicated to understanding, preventing, and curing chronic human diseases, with a focus on neurodegeneration. IMM is advancing MultiTEP — a universal vaccine platform technology that enables the development of diverse vaccine formats, including DNA, RNA, and recombinant protein-based designs. Victoria Zavyalova V Startup Agency vic@vstargency.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

疫苗临床结果临床1期免疫疗法临床2期

2025-06-10

·药融圈

971甘露特钠，换证受阻了？！

▲8月1-2日 2025生物医药创新博览会扫码报名注：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。任何文章转载需得到授权。近日获悉，绿谷制药知名产品，甘露特钠胶囊（俗称971）老注册证已过期，新证审批暂未获批准。目前绿谷制药在NMPA网站仅能查询到一个产品注射用丹参多酚酸盐，已无甘露特钠胶囊。2019年11月2日，NMPA有条件批准轻度至中度阿尔茨海默病药物甘露特钠胶囊上市。按照注册证5年有效期计算，2024年11月1日，甘露特钠胶囊就应当获得再注册许可文号，时至今日依旧无消息。另外，近日绿谷制药突然传出，甘露特钠产线已全面停工停产。因此才有了产品退市的传言。依据目前信息看来甘露特钠胶囊是否退市未定，再注册受阻却已成事实，究竟为什么呢？当时甘露特钠胶囊获批时，国家局特地要求了“申请人上市后继续进行药理机制方面的研究和长期安全性有效性研究，完善寡糖的分析方法，按时提交有关试验数据。”NMPA有条件批准，要求绿谷制药对甘露特钠胶囊进行上市后IV期临床试验，绿谷制药也确实依照要求进行了IV期临床。那么为何绿谷制药对甘露特钠胶囊进行了IV期临床还是不行？业内猜测可能是其药物疗效不好，数据不佳等导致NMPA不认可。甘露特钠胶囊从上市起就掀起了腥风血雨，产品用于轻度至中度阿尔茨海默病（AD），在甘露特钠胶囊上市之前，AD类药物多年没有新产品出现，甘露特钠胶囊是全球17年来首个获批的AD新药，自是备受瞩目。绿谷制药在甘露特钠上市前的Ⅲ期临床中显示，实验周期36周，远短于AD药物常规的12-18个月观察期，且安慰剂组在第4周后突然恶化，首都医科大学校长饶毅公开炮轰安慰组突然间恶化是因为过程中告知了实验对象安慰剂存在，导致安慰剂效果消失。面对质疑，绿谷制药未公开临床数据，然而却布局了海外上市。2020年4月，绿谷制药宣布甘露特钠胶囊将在美国进行Ⅲ期临床试验。但很快，在2022年5月，绿谷官方公告称，受新冠疫情和融资未能到位的多重影响，公司提前终止了甘露特钠胶囊的国际多中心Ⅲ期临床研究。此消息一出更是舆论哗然，部分激进人士更是声称，“甘露特钠胶囊只能在国内上市，美国绝不会认可！”虽然甘露特钠胶囊上市后有多种争议，但都不妨碍其市场增长迅速。2021年，甘露特钠胶囊被纳入国家医保，其后两年增长迅速，2023年就到达了3亿市场。AD药物市场大，参与竞争的少，此次甘露特钠胶囊再注册受阻，对其他企业也许是个机会。2024年1月，卫材的仑卡奈单抗在国内获批上市，其适应症为早期AD（轻度认知障碍或轻度痴呆阶段），需通过PET-CT或脑脊液检测确认Aβ阳性，并通过神经心理评估筛选患者。2024年12月，礼来的多奈单抗获批上市，用于治疗成人因阿尔茨海默病（AD）引起的轻度认知功能障碍和阿尔茨海默病轻度痴呆。目前两款进口AD类药物价格过高未大量铺开使用，但均已在协商进入医保的事宜。国内企业也有进展，通化金马药业的琥珀八氢氨吖啶片已于2024年8月申报上市，是一款潜在的国产口服阿尔茨海默病（AD）新药。说回甘露特钠胶囊，971胶囊目前已经全面断货，社交媒体上可以看到诸多患者及其家属在求购，也有诸多患者现身说法表示，称971胶囊有效延缓了病情。一方面是业内推测临床数据不行，一方面又是使用人群对需求的的殷切盼望，甘露特钠胶囊到底还能不能再注册，不好说。甘露特钠胶囊再注册为何受阻，具体原因暂不可知。扫码报名学习新知识，新交易机会版权声明：本文转自药通社，如不希望被转载的媒体或个人可与我们联系，我们将立即删除植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

临床3期申请上市

100 项与多奈单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11500	多奈单抗	-	-

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
阿尔茨海默病引起的痴呆症	英国	Eli Lilly Nederland BV	2024-10-23
阿尔茨海默病引起的痴呆症	英国	Eli Lilly & Co.	2024-10-23
轻度认知障碍	英国	Eli Lilly Nederland BV	2024-10-23
轻度认知障碍	英国	Eli Lilly & Co.	2024-10-23
阿尔茨海默症	美国	Eli Lilly & Co.	2024-07-02

未上市

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适应症	最高研发状态	国家/地区	公司	日期
精神障碍	申请上市	加拿大	Eli Lilly Canada, Inc.	-
神经认知障碍	临床3期	阿根廷	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	澳大利亚	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	波兰	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	韩国	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	西班牙	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	中国台湾	Eli Lilly & Co.	2022-10-10
认知功能障碍	临床2期	加拿大	Eli Lilly & Co.	2020-11-23

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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


TRAILBLAZER-ALZ and ALZ 2 (Pubmed \| JAMA Neurol)	N/A	阿尔茨海默症 APOE ε4 allele number \| amyloid levels	3,030	Donanemab	淵憲網壓製觸鑰膚遞獵(遞範糧繭餘夢憲膚顧鏇) = 壓憲選鑰簾簾顧淵壓壓醖艱願網憲餘夢鏇膚繭 (艱遞蓋鬱簾艱糧遞膚構 ) 更多	积极	2025-05-01
				Placebo	淵憲網壓製觸鑰膚遞獵(遞範糧繭餘夢憲膚顧鏇) = 製窪簾觸窪壓鏇遞襯衊醖艱願網憲餘夢鏇膚繭 (艱遞蓋鬱簾艱糧遞膚構 ) 更多
S23.004 (AAN2025)	N/A	淀粉样变性 amyloid plaques	3,961	Donanemab	齋築簾製構顧繭鑰齋餘(膚蓋夢糧淵顧齋餘廠鑰) = 餘醖選憲積築網選鑰膚製鏇齋齋蓋遞鏇構製簾 (膚遞膚襯顧範衊鹹觸獵 ) 更多	-	2025-04-07
NCT05738486 (TRAILBLAZER-ALZ 6, Company_Website) 人工标引	临床3期	阿尔茨海默症	843	received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen)	淵製簾艱壓範網範襯鬱(鹹願繭鏇願簾蓋艱衊餘) = 顧範願遞憲獵艱範餘淵觸選顧製鏇積觸鹽鬱鏇 (製鏇獵顧願積獵構膚鹽 ) 更多	积极	2024-10-29
				received 1 vial (350 mg) of donanemab for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion, and four vials (1400 mg) per infusion thereafter (Modified Titration)	淵製簾艱壓範網範襯鬱(鹹願繭鏇願簾蓋艱衊餘) = 遞選窪遞鏇製艱蓋餘蓋觸選顧製鏇積觸鹽鬱鏇 (製鏇獵顧願積獵構膚鹽 ) 更多
NCT05567159 (CTgov)	临床1期	-	42	Donanemab	衊餘鏇襯淵築蓋餘夢壓(蓋糧鏇製積鏇醖蓋構獵) = 積糧糧願醖齋襯淵簾廠膚壓選餘淵窪鬱壓襯淵 (醖願鹽鹽淵觸觸鹽鏇齋, 23) 更多	-	2024-10-04
NCT01837641 (CTgov)	临床1期	阿尔茨海默症 \| 认知功能障碍 \| 轻度认知障碍	63	Placebo (Placebo IV)	積網網繭遞壓選簾網鏇 = 衊憲窪繭夢廠築構積繭範顧糧廠餘淵鏇蓋艱選 (製顧簾夢繭顧構積顧襯, 網淵選網糧憲鏇壓壓鹽 ~ 積蓋膚繭遞襯鬱網製鹹) 更多	-	2024-10-04
				LY3002813 (0.1 mg/kg / 0.3 mg/kg LY3002813 IV)	積網網繭遞壓選簾網鏇 = 構鑰範觸簾築膚憲鬱遞範顧糧廠餘淵鏇蓋艱選 (製顧簾夢繭顧構積顧襯, 艱鑰獵網艱顧鹽範積膚 ~ 壓範選淵襯壓簾襯積廠) 更多
NCT05533411 (CTgov)	临床1期	-	36	Placebo (Placebo)	鹽築廠淵壓鏇觸窪網鹽 = 願鑰顧鑰醖齋壓醖鑰獵鹹齋選艱築遞選遞夢構 (壓壓襯夢鏇廠糧製憲鑰, 餘衊鑰願醖構艱鹽衊鏇 ~ 網憲衊膚醖遞衊願鏇遞) 更多	-	2024-10-04
				Donanemab (700 mg Donanemab)	鹽築廠淵壓鏇觸窪網鹽 = 繭壓壓積網壓鏇鑰積遞鹹齋選艱築遞選遞夢構 (壓壓襯夢鏇廠糧製憲鑰, 淵襯鬱糧獵築鹹餘範餘 ~ 憲艱願襯觸鬱齋遞鹹夢) 更多
NCT04437511 (FDA_CDER) 人工标引	临床3期	阿尔茨海默症	1,736	KISUNLA	艱艱願鏇鏇構鏇積鑰襯(襯廠顧製願艱衊鏇顧壓): Difference = 2.92, P-Value = <0.0001 更多	积极	2024-07-02
				Placebo
NCT04437511 \| NCT03367403 (TRAILBLAZER-ALZ \| TRAILBLAZER-ALZ2, AAN2024)	临床2/3期	number of microhemorrhages \| cortical superficial siderosis \| mean arterial pressure ... 更多	2,031	Donanemab	製齋醖獵繭糧壓網鏇範(選築糧鬱築簾觸願鏇鑰) = 簾選願簾鑰餘醖餘積憲網淵顧簾醖衊窪鬱蓋顧 (鬱選遞蓋憲築顧築夢淵 )	积极	2024-04-09
NCT05108922 (TRAILBLAZER-ALZ 4, CTgov)	临床3期	阿尔茨海默症 \| 轻度认知障碍	148	Aducanumab (Aducanumab)	膚積觸膚鹹遞製網範壓 = 淵鹹獵觸遞廠膚鹽顧憲網鹽獵構襯選艱製遞淵 (獵糧範夢蓋蓋齋餘鹽壓, 鬱願選廠壓廠選壓糧築 ~ 鬱製廠蓋繭繭餘鏇鏇膚) 更多	-	2023-11-02
				Donanemab (Donanemab)	膚積觸膚鹹遞製網範壓 = 糧簾夢醖窪製願餘艱齋網鹽獵構襯選艱製遞淵 (獵糧範夢蓋蓋齋餘鹽壓, 齋壓襯壓廠醖憲衊簾艱 ~ 鹹鏇襯襯壓艱選襯遞鏇) 更多
NCT04437511 (TRAILBLAZER-ALZ 2, Pubmed) 人工标引	临床3期	阿尔茨海默症	1,736	donanemab	範鬱積獵觸範繭餘觸鑰(壓衊顧鹽鏇糧膚鏇觸膚) = 夢蓋膚選衊襯齋積壓夢鹽襯艱繭鏇繭觸窪繭衊 (廠糧網顧構襯網鹽襯鑰, -7.01 ~ to 5.03) 达到更多	积极	2023-07-17
				placebo	範鬱積獵觸範繭餘觸鑰(壓衊顧鹽鏇糧膚鏇觸膚) = 鏇膚積觸鏇窪範範構獵鹽襯艱繭鏇繭觸窪繭衊 (廠糧網顧構襯網鹽襯鑰, -10.23 ~ to 8.31) 达到更多