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2026-01-15

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2025-12-01

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.

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100 项与多奈单抗相关的专利（医药）

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242

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.

2025-11-01·JPAD-Journal of Prevention of Alzheimers Disease

Early Alzheimer’s disease (mild cognitive impairment or mild dementia): Prevalence, diagnostics, treatment options, and guidelines in Asia, Australasia, and Pacific nations countries

Review

作者: Shea, Yat Fung ; Park, Kee Hyung ; Tan, Lolita Stephanie ; Prusty, Vinay ; Hsu, Jung-Lung ; Panegyres, Peter K ; Eom, Young In ; Huang, Yao Hsien

Early diagnosis of mild cognitive impairment (MCI) and Alzheimer's disease (AD) with mild dementia is becoming increasingly important to enable patients to receive appropriate treatment with available amyloid-targeting therapies. Reviews of AD prevalence and diagnostic and treatment patterns typically focus on global or western populations, but the situation in Asia, Australasia, and Pacific Nations (AAPN) countries is less clear. We performed a narrative review of literature for AD in several AAPN countries, focusing on patients with MCI or mild dementia who may benefit from early treatment. Published information regarding AD incidence and prevalence and current practice in AAPN countries is limited and the nature of available information differs between countries. However, AAPN countries include some of the most rapidly aging populations and show the associated increasing trend of all-cause dementia prevalence observed globally. Although lecanemab and donanemab are now approved for AD with MCI and mild dementia in several AAPN countries, the most appropriate diagnostic pathway for patients with MCI and early AD is not established. Even though the AAPN region includes countries with routine access to advanced technologies, concerns have already been raised about the ability of healthcare systems in Australia, New Zealand, and Korea to respond to approvals of new AD therapies, including the need to ensure availability of biomarker testing and dementia specialists to allow patients to receive the early diagnosis required to enable appropriate treatment. Guidelines and national policies also need updating to differentiate between dementia subtypes and include amyloid-targeting therapies for eligible patients with early AD.

2025-11-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Mapping the evolving landscape of lecanemab research in Alzheimer's Disease: A bibliometric analysis

Article

作者: Xu, Dingwen ; Shen, Jiaxing ; Ma, Ruijia ; Zhao, Xu ; Yang, Zhe

BACKGROUND:

Lecanemab, a monoclonal antibody that targets amyloid-beta aggregates, has emerged as a promising therapeutic for Alzheimer's disease (AD). AD is a progressive neurodegenerative disorder characterized by cognitive decline and amyloid pathology. Research on the use of lecanemab in treating AD has increased; however, no relevant bibliometric analyses have been conducted. To address this gap, this study employed bibliometric methods to search for the relevant literature and analyze research trends investigating AD and lecanemab.

METHODS:

We performed a literature search of the Web of Science core database for studies investigating AD and lecanemab, published from database inception up to April 3rd, 2025. After rigorous screening, Excel, VOSviewer, and CiteSpace were used to perform a bibliometric analysis of publications, citations, and collaboration networks among countries, institutions, and authors, along with cluster and burst analyses of keywords. Coremine was used for text mining entries significantly related to AD and lecanemab.

RESULTS:

The number of studies published on AD and lecanemab has increased annually. The countries with the highest publication output were the United States, the United Kingdom, and China. The leading institutions that produced the most articles were Eisai Inc. (Bunkyo City, Tokyo, Japan), Uppsala University (Uppsala, Sweden), and Harvard Medical School (Boston, MA, USA). The top three authors were Lars Lannfelt, Shobha Dhadda, and Michio Kanekiyo. The most prolific journals included The Journal of Alzheimer's Disease, Alzheimer's and Dementia, and Ageing Research Reviews. The most cited article was "Lecanemab in Early Alzheimer's Disease," by Van Dyck et al., published in The New England Journal of Medicine in 2023, which has accrued 172 citations. The 10 most frequently occurring keywords were Alzheimer's disease, lecanemab, dementia, aducanumab, amyloid-beta, immunotherapy, tau, a-beta, mouse model, and donanemab. Text mining revealed that drugs, anatomical structures, chemical molecules, genes, diseases, and procedures were significantly associated with both AD and lecanemab.

CONCLUSION:

The bibliometric and text mining analysis revealed trends in research investigating the correlation between lecanemab and AD. It analyzed the cooperation among countries, regions, and authors, highlighting recent research hotspots. These data offer objective insights for scientific research and clinical practice on lecanemab and AD. These findings provide a roadmap for prioritizing clinical trials, optimizing drug development strategies, and addressing knowledge gaps in amyloid-targeted therapies.

1,146

项与多奈单抗相关的新闻（医药）

2025-10-07

·FierceBiotech

Lilly calls for \'urgent improvements\' in Europe to boost diagnostic testing for Alzheimer\'s

Eli Lilly says Alzheimer\'s disease experts are warning the disease “remains critically underdiagnosed\" across Europe. \n Eli Lilly is calling on European countries to make “urgent improvements” to their Alzheimer’s disease diagnostic testing practices just weeks after nabbing a new approval on the continent for its Alzheimer\'s therapy Kisunla.The Indianapolis Big Pharma has teamed up with leading Alzheimer\'s experts at this year\'s Alzheimer Europe Conference to call for “urgent improvements to diagnostic pathways to ensure people in Europe can benefit from new therapeutic innovation.”Lilly points to a recent survey, published in the Journal of Alzheimer’s Disease, that found 70% of clinicians believe biomarker tests, which can find evidence of Alzheimer\'s or dementia, are “important or extremely important.\" Still, such tests remain \"underutilized,\" according to Lilly\'s Oct. 7 release.The survey questioned clinicians who treat patients with mild cognitive impairment (MCI) and Alzheimer\'s in France, Germany, Italy, Spain, the U.K., Japan and the U.S. The team found that across these countries, fewer than 1 in 5 patients (15.2%) received biomarker testing to confirm the specific pathology, with those in Germany and the U.K. the least likely to receive these tests, according to the journal.As a result, experts warn Alzheimer\'s and dementia “remain critically underdiagnosed,” Lilly said in the release, which has the effect of \"denying patients the opportunity to access treatment and care options.\"Lilly markets Kisunla, which works as an amyloid-plaque-targeting therapy and has an FDA approval for early symptomatic Alzheimer\'s, which includes the MCI or the mild dementia stages of the disease.The drug was approved by the FDA last year and received a final European sign-off just last month.To qualify for the drugs, patients must have a confirmed amyloid pathology, which can be done via several routes including a PET scan, a blood test or an MRI.Lilly also markets Amyvid, which works as an injectable prescription imaging agent to find high level of plaques. These are a buildup of a protein called amyloid beta in the brain that, if found, can be ultimately used by patients or their doctors to help prescribe Alzheimer\'s meds such as Kisunla. More diagnoses of Alzheimer\'s also mean potentially more uptake for medicines. Rival drug Leqembi, marketed by Biogen and Eisai, was also approved in the EU earlier this year.“Emerging therapies that target the pathology of Alzheimer\'s disease offer hope to slow progression and delay the need for care services,” said Stéphane Epelbaum, M.D., Ph.D., associate vice president for international medical affairs at Eli Lilly, in a statement.“But this possibility hinges on early detection, as approximately one-third of individuals in early symptomatic stages of the disease will progress to more advanced clinical stages within one year. Timely and accurate diagnosis is essential to ensure patients can access the next generation of Alzheimer\'s disease care.”

$Lilly calls for \'urgent improvements\' in Europe to boost diagnostic testing for Alzheimer\'s$

上市批准

2025-10-01

·Firstwordpharma

Irish startup launches with plan to use 'shuttles' to get RNAi into brain

Dublin-based biotech Aerska emerged from stealth on Wednesday with $21 million in seed financing to develop RNAi medicines for neurological disorders. The startup is betting that its antibody-oligo conjugate platform can overcome the delivery bottleneck that has long stymied genetic medicines in the central nervous system (CNS).The round was co-led by Age1, Backed VC and Speedinvest, with participation from BlueYard Capital, Lingotto, Norrsken VC, Kerna, PsyMed, Saras and Ada Ventures."GalNAc [N-acetylgalactosamine] proved what RNAi can do when delivered to a specific tissue and we're now on the cusp of a similar leap forward in CNS medicine," said Stuart Milstein, Aerska's co-founder and head of platform strategy, who helped pioneer brain delivery efforts at Alnylam Pharmaceuticals. "The velocity and ambition of this team is electric," he added.The company's platform is designed to pair RNAi molecules with brain-shuttle antibodies, allowing them to cross the blood-brain barrier (BBB) and provide durable gene knockdown inside neurons. "By integrating brain shuttles with RNA therapeutics, we aim to enable precise, durable gene silencing in the CNS," said CEO and co-founder Jack O'Meara, who previously led RNA liver disease specialist Ochre Bio.Aerska's initial programmes focus on genetic forms of Alzheimer's and Parkinson's disease, with the company making targeted investments in data science capabilities to advance its precision strategy.Pharma's appetite for BBB technologies has been growing. Roche is expected to launch a pair of Phase III studies — TRONTIER 1 and TRONTIER 2 — later this month in early symptomatic Alzheimer's disease after its Brainshuttle technology showed it could overcome some of the dosing and safety problems faced by anti–beta-amyloid antibodies (see – Spotlight On: Roche's trontinemab looks safer than Leqembi, Kisunla – with an asterisk).Meanwhile, GSK signed a deal in April potentially worth over £2.1 billion ($2.8 billion) giving it access to ABL Bio's BBB shuttle technology to develop therapeutic modalities for neurodegenerative diseases.

临床3期

2025-09-30

·BiG生物创新社

礼来的时代已然开启

作者｜momo 专利悬崖、政策摇摆、竞争白热化……医药圈的“水逆期”好像看不到头。但就在这一片混沌中，一条最强主线已杀出重围，到2030年，礼来将强势碾压所有对手，登顶全球药企营收榜！凭什么？就凭它用GLP-1撕开市场，用口服SERD巩固战线，再用神经科学布局未来。EvaluatePharma在《World Preview 2025》报告中预测，礼来营收将达到昔日巨头辉瑞、诺华的两倍之多，增速更是一骑绝尘，让对手望尘莫及。 01 瞄准10亿美元大药 9月25日，礼来宣布其口服雌激素受体拮抗剂Inluriyo（imlunestrant）获FDA批准，用于治疗ER阳性、HER2阴性、携带ESR1突变的晚期或转移性乳腺癌成人患者。这是全球第二款获批的口服选择性雌激素受体降解剂（SERD）药物，对标SERD领域的王牌药物年销售额超过10亿美元的氟维司群。作为第一代SERD药物，氟维司群由阿斯利康开发，于2002年获批上市。其通过阻断雌激素受体信号传导同时诱导受体降解发挥作用，能够从根本上切断乳腺癌细胞的生长信号。然而，氟维司群存在生物利用度低、患者依从性差、联合用药便利性不足等显著缺陷，为口服SERD药物的发展创造了机会。研究发现，大约30%-40%的晚期乳腺癌患者存在ESR1突变，在接受过CDK4/6抑制剂治疗的患者中，这一比例高达40%。这种突变会导致雌激素受体过度活跃，驱动癌症生长，并常常引起对传统内分泌治疗的耐药。礼来Inluriyo聚焦于ESR1突变亚群，采用每日一次的口服给药方式，极大地提高了用药的便利性。在III期EMBER-3试验中，与标准内分泌治疗相比，Inluriyo将疾病进展或死亡风险降低了38%。在携带ESR1突变的患者中，与氟维司群或依西美坦相比，Inluriyo相较于氟维司群或依西美坦显著改善了无进展生存期 (PFS)，中位PFS为5.5个月 vs 3.8个月。图1.Inluriyo III期EMBER-3试验临床数据值得注意的是，礼来意图将Inluriyo的治疗应用从晚期向前线设置扩展。目前，Inluriyo正在进行的III期EMBER-4试验计划在全球招募约8000名患者，评估Inluriyo用于ER阳性、HER2阴性早期乳腺癌辅助治疗的效果,潜在市场空间巨大。图2.全球III期及上市SERD结构随着礼来Inluriyo的加入，口服SERD赛道的竞争格局日益清晰。目前，全球已有四款口服SERD药物顺利完成III期研究，除了已上市的艾拉司群，Inluriyo还面临着来自罗氏的Giredestrant和来自阿斯利康的Camizestrant等在研口服SERD候选药物的潜在竞争。未来，礼来还需要交出足够亮眼的成绩来证明Inluriyo的差异化优势。 02 GLP-1最大赢家 2025年全球医药市场最具看点的竞争莫过于GLP-1类药物领域的“药王”之争。2025年上半年，诺和诺德的司美格鲁肽以166.32亿美元销售额暂时领跑，但礼来的替尔泊肽以121.3%的惊人增速紧追不舍，斩获147.34亿美元销售额。更具里程碑意义的是，在第二季度，替尔泊肽单季销售额（85.80亿美元）已成功反超司美格鲁肽（80.34亿美元）。2025年全球“药王”宝座极有可能易主。替尔泊肽的崛起速度令人惊叹，作为GLP-1/GIP双受体激动剂，替尔泊肽在降糖和减重方面展现出优于单靶点药物的疗效。礼来通过精准的市场策略，将替尔泊肽以降糖版Mounjaro和减重版Zepbound两个品牌推向市场。2025年H1，Mounjaro同比增长85%至90.41亿美元，Zepbound更是大卖56.93亿美元，增速高达223%。礼来在市场份额上也已取得领先，2025年Q1，礼来GLP-1产品在美国市场的处方量占比达到53.3%，超过诺和诺德的46.1%。到上半年结束时，这一差距进一步扩大至57.0%对42.5%，显示出强劲的市场渗透力。礼来还积极拓展适应症范围，Zepbound可能在2025年底解锁射血分数保留型心力衰竭（HFpEF）第三项适应症，这将为其业绩增长提供新的增量。据EvaluatePharma预测，到2030年替尔泊肽的全球销售额将达到617亿美元，这一数字将是现任“药王”帕博利珠单抗2024年销售额（295亿美元）的两倍多（图3）。图3.替尔泊肽2030预测全球销售额另外，在替尔泊肽之后，礼来正在打造新的增长引擎，口服GLP-1药物Orforglipron。与需要注射的替尔泊肽不同，Orforglipron是一种每日一次的口服小分子GLP-1受体激动剂，ACHIEVE-3 III期临床研究结果显示，Orforglipron在降糖和减重方面均表现出色。第52周时，接受12 mg、36 mg Orforglipron治疗患者的A1C水平分别平均降低1.9 %与2.2 %；而接受7 mg与14 mg活性对照药物患者的A1C则分别降低1.1%与1.4%（图4）。图4.ACHIEVE-3 III期临床研究结果在体重管理方面，接受12 mg、36 mg Orforglipron治疗患者的平均体重下降分别为14.6磅（6.7%）与19.7磅（9.2%）；而接受7 mg与14 mg活性对照药物患者的体重则分别下降7.9磅（3.7%）与11.0磅（5.3%）（图4）。在最高剂量组比较中，Orforglipron组患者的体重下降幅度相对高出73.6%。此外，Orforglipron还在非高密度脂蛋白胆固醇、收缩压与甘油三酯等关键心血管危险因素上带来具有临床意义的改善。礼来已于2025年8月公布了orforglipron的关键性III期临床（ATTAIN-1）数据，每日口服一次36毫克该药物可以让体重减轻12.4%。其计划在2025年底前向美国、英国、欧盟和日本等国递交Orforglipron的上市申请。 EvaluatePharma预测，orforglipron 2030年销售额预计将达到127亿美元。随着2025年下半年替尔泊肽增势延续，它极有可能从司美格鲁肽手中接过“药王”权杖。而Orforglipron作为便利性更强的口服制剂，将成为礼来巩固市场领导地位的关键棋子，礼来在这场竞赛中的霸主地位已经很明显了。 03 加码布局CNS赛道血脑屏障（BBB）曾是将绝大多数中枢神经系统药物拒之门外的天堑，如今正成为MNC攻坚的下一个前沿。 BBB是CNS疾病药物研发面临的主要生理障碍，它由脑毛细血管壁与神经胶质细胞构成，仅允许特定类型分子通过，阻止绝大多数小分子和大分子药物进入大脑（图5）。图5.大多数药物无法渗透血脑屏障 2025年4月，礼来与Sangamo Therapeutics达成14亿美元合作，获得的STAC-BBB技术是一种高效穿透血脑屏障的腺相关病毒（AAV）衣壳，该衣壳在非人灵长类动物模型中表现出强力穿越血脑屏障能力和神经元转导效果。根据Sangamo数据，与传统AAV9衣壳相比，STAC-BBB驱动转基因在CNS神经元中表达的能力提高了700倍。这意味着，研究人员可以开发静脉注射的基因组药物，治疗以往难以触及的CNS系统疾病。此外，礼来获得的许可是全球独家的，涵盖一个初始疾病靶点，并有权增加最多四个神经系统疾病靶点。这种灵活性使礼来能够针对多种CNS疾病开发基因疗法。然而，这只是礼来在神经科学领域布局的冰山一角。 2024年，礼来心血管代谢板块贡献了295.21亿美元收入，占总营收的66%，而神经科学板块仅占3%，业绩主要依赖偏头痛药物Galcanezumab。然而，面对激烈的市场竞争，Galcanezumab增长乏力，神经科学板块亟需新产品接棒。因此，礼来正在积极构建新的增长曲线，一方面依托内部研发，已获批的Donanemab及在研药物Remternetug有望接棒增长；另一方面，礼来也积极通过收购与合作，持续拓展其在神经科学领域的产品管线。 2020年12月，礼来以10.4亿美元收购Prevail，获得其针对帕金森病和戈谢病的GBA1基因疗法PR001； 2022年10月，以约6.1亿美元收购Akouos，加码用于额颞叶痴呆症的听力基因疗法AK-OTOF； 2024年3月，参与蛋白降解公司TRIMTECH Therapeutics的种子轮融资，该公司专注于靶向致病蛋白聚集，开发神经退行性疾病及炎症性疾病疗法； 2024年6月，礼来以超过6亿美元引进QurAlis公司的渐冻症反义寡核苷酸药物QRL-204； 2024年9月，礼来中国宣布成立独立的神经科学事业部，进一步彰显公司对该领域的重视； 2025年1月，与Alchemab合作，利用其抗体平台开发多达五种治疗肌萎缩侧索硬化症的抗体； 2025年5月，与韩国Rznomics达成13亿美元合作，共同开发用于感音神经性听力损失的RNA编辑疗法。结语在GLP-1赛道，礼来凭借替尔泊肽的惊人增速与市场渗透力，正试图从诺和诺德手中夺过“药王”权杖；在肿瘤领域，口服SERD药物Inluriyo的成功获批，进一步凸显了其在乳腺癌领域的差异化实力；而在被视为“未来战场”的神经科学领域，礼来通过收购、合作与自主研发，为中长期增长开辟新的可能性。 2025，礼来的时代依然开启。参考资料 [1]https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1 [2]https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head [3]https://www.chemicalbook.com/ProductIndex.aspx [4]https://app.evaluate.com/ux/WebReport/Welcome2.aspx [5]https://www.fusfoundation.org/the-technology/mechanisms-of-action/blood-brain-barrier-opening/ 共建Biomedical创新生态圈！如何加入BiG会员？

临床3期

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 & Co.	2024-10-23
阿尔茨海默病引起的痴呆症	英国	Eli Lilly Nederland BV	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

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
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	中国	Eli Lilly & Co.	2022-10-10
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
神经认知障碍	临床3期	英国	Eli Lilly & Co.	2022-10-10
认知功能障碍	临床2期	美国	Eli Lilly & Co.	2020-11-23

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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


NCT04437511 (TRAILBLAZER-ALZ 2, PRNewswire) 人工标引	临床3期	阿尔茨海默症	-	Kisunla	艱齋構鏇醖蓋顧積蓋艱(膚構襯選觸範蓋壓餘蓋): Difference = -0.6 更多	积极	2025-07-30
				Neuroimaging Initiative (untreated external cohort)
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	膚獵鑰鏇積蓋鏇鹽獵獵(獵鏇醖觸築製遞網築醖) = 蓋襯選蓋製醖糧夢淵鹹壓築願繭窪製願範觸積 (糧窪積糧鑰獵鏇鏇淵繭 ) 更多	积极	2025-05-01
				Placebo	膚獵鑰鏇積蓋鏇鹽獵獵(獵鏇醖觸築製遞網築醖) = 餘壓蓋積蓋網膚醖願膚壓築願繭窪製願範觸積 (糧窪積糧鑰獵鏇鏇淵繭 ) 更多
NCT05108922 (TRAILBLAZER-ALZ 4, Pubmed \| Alzheimers Dement)	临床3期	阿尔茨海默症 amyloid plaque clearance	148	Donanemab	觸製築膚餘餘鑰簾鹹淵(餘獵構艱淵鹹構襯獵積) = 積醖鹽齋壓積蓋獵簾憲膚觸鹽積積鏇艱齋鏇淵 (遞餘鏇夢鏇襯製顧簾簾 ) 更多	积极	2025-05-01
				Aducanumab	觸製築膚餘餘鑰簾鹹淵(餘獵構艱淵鹹構襯獵積) = 膚艱獵憲製鹽齋獵醖壓膚觸鹽積積鏇艱齋鏇淵 (遞餘鏇夢鏇襯製顧簾簾 ) 更多
NCT05738486 (TRAILBLAZER-ALZ 6, Company_Website 1 \| Company_Website 2) 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) thereafterdonanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen)	鏇獵網獵製製遞築衊鬱(鏇構選積醖鬱艱製繭醖) = 選壓選鏇繭襯壓顧夢齋襯廠構鑰鑰齋範選憲淵 (範製糧積鹹繭積簾醖繭 ) 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,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)	鏇獵網獵製製遞築衊鬱(鏇構選積醖鬱艱製繭醖) = 膚選窪鑰觸獵夢齋鹹積襯廠構鑰鑰齋範選憲淵 (範製糧積鹹繭積簾醖繭 ) 更多
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)	糧構窪窪遞鹽鑰築鹹選 = 窪夢衊齋醖襯鏇繭膚齋築蓋簾廠構壓獵鏇蓋遞 (觸觸積顧觸衊淵積壓構, 餘築衊憲築願觸夢淵獵 ~ 鬱憲遞簾鹹夢淵鑰範繭) 更多	-	2024-10-04
				LY3002813 (0.1 mg/kg / 0.3 mg/kg LY3002813 IV)	糧構窪窪遞鹽鑰築鹹選 = 選網顧衊簾繭鑰遞顧窪築蓋簾廠構壓獵鏇蓋遞 (觸觸積顧觸衊淵積壓構, 壓鬱夢壓製築壓積餘蓋 ~ 衊願蓋襯憲簾願膚製襯) 更多
NCT05533411 (CTgov)	临床1期	-	36	Placebo (Placebo)	淵憲網襯艱窪齋網夢膚 = 夢願積憲願淵淵繭憲艱糧窪醖簾淵餘醖顧鹽餘 (壓齋獵廠鬱獵網廠製鑰, 築壓齋顧糧醖壓壓鹽醖 ~ 鑰餘齋簾齋構憲窪糧齋) 更多	-	2024-10-04
				Donanemab (700 mg Donanemab)	淵憲網襯艱窪齋網夢膚 = 繭夢淵製繭鏇鏇鹽衊鑰糧窪醖簾淵餘醖顧鹽餘 (壓齋獵廠鬱獵網廠製鑰, 衊淵製築觸鏇廠醖淵夢 ~ 鑰顧遞憲窪齋觸鏇齋構) 更多
NCT05567159 (CTgov)	临床1期	-	42	Donanemab	襯蓋衊鏇廠餘觸範簾壓(鹽鹹衊夢襯鏇顧蓋鏇廠) = 遞夢齋顧繭襯選蓋鑰壓衊範繭觸鹹糧鑰醖蓋艱 (繭衊願繭壓壓襯醖繭窪, 23) 更多	-	2024-10-04
NCT04437511 (FDA_CDER) 人工标引	临床3期	阿尔茨海默症	1,736	KISUNLA	糧獵獵獵餘鏇簾鹹鹽鹽(壓願衊膚艱構遞製廠遞): 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	願積襯艱遞鑰憲餘膚齋(顧憲範繭製襯襯蓋夢鹽) = 蓋夢願網鏇製選範襯蓋夢憲鹽範繭鑰壓鏇蓋積 (餘繭築鏇鹹獵觸襯構蓋 )	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)	製壓憲醖簾蓋鹽顧製繭 = 獵憲鑰範鏇鹹淵蓋製網壓壓鑰鹹糧積憲繭壓壓 (糧鹹壓鏇網鏇願艱簾鏇, 選夢築衊蓋願憲鹹襯齋 ~ 醖蓋鑰窪築衊艱齋築鹹) 更多	-	2023-11-02
				Donanemab (Donanemab)	製壓憲醖簾蓋鹽顧製繭 = 糧壓製膚糧衊鹽鬱醖築壓壓鑰鹹糧積憲繭壓壓 (糧鹹壓鏇網鏇願艱簾鏇, 蓋選醖壓窪鹹繭醖構獵 ~ 膚餘鏇醖膚顧夢網築夢) 更多