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.

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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.

2025-08-01·Neurology-Clinical Practice

Management of Patients With Mild Cognitive Impairment in the Era of Anti-Amyloid Therapy

Article

作者: Smith, Eric E. ; Switzer, Aaron R. ; Ganesh, Aravind ; McLeod, Graham A. ; Zea Vera, Alonso Gonzalo ; Bartolini, Luca

Background and Objectives:

The aim of this study was to explore practice patterns in managing mild cognitive impairment (MCI). The investigation and management of MCI is considered important because it offers the opportunity to potentially stave off conversion to dementia. However, there are few data on current practices/approaches in this area, especially worldwide; such data can help identify potential disparities and anticipate adoption of new therapies.

Methods:

We performed a worldwide electronic survey of neurology practitioners through the Practice Current section of Neurology® Clinical Practice with clinical and practice-related questions in November 2019-August 2021 and repeated it in May-October 2023 after the FDA's approval of aducanumab and lecanemab but before the approval of donanemab. Clinical questions addressed access to and utilization of diagnostic investigations, pharmacologic and nonpharmacologic management of MCI, and (in 2023) attitudes toward novel anti-amyloid agents. Responses were compared using the Fisher exact test and multivariable logistic regression adjusted for region, regional income, year of survey response, years in practice, and number of cognitive patients seen annually.

Results:

We received 1,257 responses from 95 countries, including 237 cognitive subspecialists and 464 respondents from low-/middle-income countries. On multivariable analysis, cognitive subspecialists were more likely than other practitioners to investigate MCI with a lumbar puncture (aOR 1.90, 95% CI 1.32-2.73), luorodeoxyglucose-PET (FDG-PET) (aOR 1.45, 95% CI 1.00-2.10) and to offer pharmacotherapy if investigations suggested neurodegeneration (aOR 1.92, 95% CI 1.29-2.85). Regionally, respondents from Europe, Latin America, and Asia were more likely than those from the United States/Canada to order FDG-PET (e.g., Europe: aOR 2.38, 95% CI 1.29-4.39) and amyloid PET (Europe: aOR 3.30, 95% CI 1.85-5.87), controlling for reported access to these tests. Pharmacologic and nonpharmacologic approaches were comparable between cognitive subspecialists and other respondents. Despite concerns about safety (77.1% expressed being somewhat or very concerned), attitudes toward prescribing new anti-amyloid agents were similar among all respondents, reflecting a generally favorable attitude (e.g., 62% would prescribe anti-amyloid therapy if it was available).

Discussion:

Our results highlight practice differences among cognitive subspecialists and other practitioners worldwide in the management of MCI. Attitudes toward anti-amyloid therapy indicate cautious optimism, with concerns about side effects but a general interest to prescribe.

1,083

项与多奈单抗相关的新闻（医药）

2025-07-25

·EndPoints

CHMP backs Lilly’s Alzheimer’s drug in certain patients, Gilead’s twice-yearly HIV prevention shot, among others

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) landed on a number of high-profile decisions this week, including changing course on Eli Lilly’s Alzheimer’s drug in certain patients and recommending Gilead’s twice-yearly HIV preventive approach. Overall, CHMP said Friday that it is endorsing the authorization of 13 new medicines. It also said that the European Commission should reject three drugs, including Sarepta’s troubled Duchenne drug Elevidys , which Roche is licensed to distribute in Europe. Lilly’s Alzheimer’s drug Kisunla initially received a negative opinion in March. At the time, CHMP noted the benefits of the drug did not outweigh the risks of patients developing bleedings and swellings of the brain called amyloid-related imaging abnormalities (ARIA), which can be fatal. Kisunla was approved in the US in July 2024. CHMP has now reversed its previously negative opinion on Kisunla after reviewing Lilly’s new dosing plan, which includes starting off with a lower dose and additional measures to reduce the risk of ARIAs. Regulators have been wary of approving drugs with risks of ARIAs, such as Eisai and Biogen’s Alzheimer’s drug Leqembi, which was also initially rejected by the EMA last July. Since then, Leqembi was approved by the EC in April this year, becoming the first of its kind to be approved in Europe. It secured FDA approval in January. CHMP also endorsed Gilead’s twice-yearly injectable lenacapavir to prevent HIV. Lenacapavir is currently approved in Europe as a treatment for adults with multidrug-resistant HIV-1 infection, and not as a preventive measure. In a landmark move, lenacapavir was approved as PrEP in the US last month under the brand name Yeztugo. The same preventive product would have a different name in the EU : Yeytuo. Elsewhere, the European regulators also gave a positive opinion for Pfizer and BioNTech’s LP.8.1-adapted monovalent Covid-19 vaccine for individuals aged six months and older. This comes after the EMA’s Emergency Task Force recommended in May that Covid-19 vaccines need to be updated to target the LP.8.1 strain. Pfizer and BioNTech have already started manufacturing their LP.8.1-adapted Covid-19 vaccine. As soon as the EC gives its approval, the companies will be ready to ship the vaccine, they said in a Friday release . CHMP also recommended the approval of the following products: The EU regulators suggested recommending the following label expansions: CHMP recommended rejecting TETEC Tissue Engineering Technologies’ autologous cartilage-derived articular chondrocytes called Jelrix, as well as Prilenia Therapeutics’ Huntington’s disease drug Nurzigma.

上市批准疫苗

2025-07-25

·PRNewswire

Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease

The opinion will now be referred to the European Commission for final regulatory decision on donanemab INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers. The European Commission is expected to make a regulatory decision on donanemab in the coming months. "This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across Europe," said Patrik Jonsson, executive vice president and president of Lilly International. "Donanemab has the potential to make a meaningful difference for people living with early symptomatic Alzheimer's disease, and Lilly remains committed to advancing the science through ongoing clinical trials and programs." Alzheimer's disease currently affects as many as 6.9 million people in Europe, with this figure expected to almost double by 2050 as aging populations continue to increase.1-2 Approximately one-third of individuals with mild cognitive impairment or mild dementia due to Alzheimer's disease progress to the next clinical stage of disease in one year.3 The positive opinion was primarily based on clinical trial data from the TRAILBLAZER-ALZ 2 clinical trial demonstrating that donanemab significantly slowed cognitive and functional decline and reduced the risk of progressing to the next clinical stage of disease, as well as the TRAILBLAZER-ALZ 6 clinical trial which evaluated a modified titration dosing schedule.4 In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the dosing schedule used in TRAILBLAZER-ALZ 2 at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the ApoE4 gene may be at higher risk of developing Alzheimer's disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers. About Kisunla Donanemab, a monthly infusion, is currently marketed as Kisunla in the United States and other countries, including Japan, China, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore*, Taiwan, Brazil, Mexico and Australia. In the United States, Japan, China and many other countries, donanemab is approved for patients regardless of ApoE4 status. Donanemab is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.5-8 U.S. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla™ (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease. Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures. Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk. Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion. Other common side effects Headache Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or . Before you receive Kisunla, tell your healthcare provider: About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby. How to receive Kisunla Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes. Learn more For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com. This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you. DN CON BS APP Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a potential treatment for people with early symptomatic Alzheimer's disease, and regulatory approval and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer's & Dementia. 2023;19:658-670. . Alzheimer Europe. Prevalence of dementia in Europe. Available at: . Potashman M, Buessing M, Levitchi Benea M, et al. Estimating progression rates across the spectrum of Alzheimer's disease for amyloid-positive individuals using national Alzheimer's coordinating center data. Neurol Ther. 2021;10(2):941-953. doi:10.1007/s40120-021-00272-1 Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239. Boustani M, Doty EG, Garrison LP Jr, et al. Assessing the Cost-effectiveness of a Hypothetical Disease-modifying Therapy With Limited Duration for the Treatment of Early Symptomatic Alzheimer Disease. Clin Ther. 2022;44(11):1449-1462. doi:10.1016/j.clinthera.2022.09.008. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239. Ross EL, Weinberg MS, Arnold SE. Cost-effectiveness of Aducanumab and Donanemab for Early Alzheimer Disease in the US. JAMA Neurol. 2022;79(5):478-487. doi:10.1001/jamaneurol.2022.0315. Mattke S, Ozawa T and Hanson M. Implications of Treatment Duration and Intensity on the Value of Alzheimer's Treatments. Clinical Trials on Alzheimer's Disease. Oct. 24-27, 2023. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床结果临床3期

2025-07-25

·Firstwordpharma

EU backing for Lilly's Alzheimer's therapy, Gilead's twice-yearly HIV preventative

Eli Lilly succeeded in convincing EU regulators that Kisunla (donanemab) should be approved for the treatment of early Alzheimer's disease, but only in certain patients and when a new dosing regimen is used to reduce the risk of amyloid-related imaging abnormalities (ARIA). The decision from the Committee for Medicinal Products for Human Use (CHMP) comes after the company requested a re-examination of a negative opinion handed down in March."This positive opinion marks a significant milestone in our efforts to bring [Kisunla] to eligible patients across Europe," remarked Patrik Jonsson, president of Lilly International. The anti-amyloid antibody was approved in the US just over a year ago, with a modified dosing schedule given the okay earlier this month. It is this dosing regimen — which involves using lower doses of Kisunla to start with — as well as additional measures to manage the risk of ARIA, that prompted the CHMP to overturn its initial decision. However, despite originally seeking approval in all patients with early Alzheimer's disease, the panel's positive decision is for people who do not have a copy of the ApoE4 gene or those who have only one copy of the gene: these populations are at a lower risk of ARIA and serious cases of ARIA.Twice-yearly HIV preventativeOther positive opinions from the European Medicines Agency's CHMP issued on Friday include for Gilead Sciences' Yeytuo (lenacapavir) for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The long-acting HIV-1 capsid inhibitor, approved in the US last month under the name Yeztugo, can be dosed just twice a year.Doctors are eager to get their hands on Gilead's new offering, with a recent FirstWord poll showing that nearly 90% foresee its twice-yearly dosing bringing at least moderate improvements to patient adherence and satisfaction. For more, see Physician Views Results: Doctors say 'yes' to Yeztugo's twice-yearly promise in HIV PrEP.The CHMP also recommended approval of IntraBio's Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick Type C (NPC) disease in adults and children from 6 years of age weighing at least 20 kg. If authorised, the modified amino acid (N-acetyl-L-leucine) will be available as 1 g granules for oral suspension.

上市批准临床研究

100 项与多奈单抗相关的药物交易

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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

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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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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	構壓繭餘鹹網糧窪餘網(蓋鏇襯網鑰鏇遞築構窪) = 憲衊鹽蓋壓糧壓壓觸襯鹹衊築淵製醖鏇淵獵蓋 (選鏇鏇製願網範簾築淵 ) 更多	积极	2025-05-01
				Placebo	構壓繭餘鹹網糧窪餘網(蓋鏇襯網鑰鏇遞築構窪) = 膚蓋鹽醖範繭鹽鏇膚衊鹹衊築淵製醖鏇淵獵蓋 (選鏇鏇製願網範簾築淵 ) 更多
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)	獵艱淵齋淵鑰積獵鹹襯(繭繭蓋製膚衊獵構膚製) = 醖壓蓋鑰憲遞糧憲鏇衊衊觸淵鹹積鑰獵憲顧窪 (壓糧壓窪醖鬱鹽願範齋 ) 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)	獵艱淵齋淵鑰積獵鹹襯(繭繭蓋製膚衊獵構膚製) = 艱艱襯糧鹽繭艱觸獵膚衊觸淵鹹積鑰獵憲顧窪 (壓糧壓窪醖鬱鹽願範齋 ) 更多
NCT05533411 (CTgov)	临床1期	-	36	Placebo (Placebo)	範觸網獵憲遞範選廠構 = 艱願壓製鹽蓋衊築糧鏇艱鬱憲遞糧膚糧鏇製淵 (糧鹹窪壓鹽築構淵繭鏇, 鬱醖築範夢膚廠鹽蓋艱 ~ 艱窪艱襯襯築襯鏇糧鏇) 更多	-	2024-10-04
				Donanemab (700 mg Donanemab)	範觸網獵憲遞範選廠構 = 鏇餘鬱願鏇鹽艱憲艱範艱鬱憲遞糧膚糧鏇製淵 (糧鹹窪壓鹽築構淵繭鏇, 範選網繭觸糧餘齋糧襯 ~ 製憲夢範鬱夢遞選鹽顧) 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)	鑰糧蓋鹽鏇範網鏇膚艱 = 糧顧顧壓願鑰壓遞範築醖鑰鑰蓋簾遞觸簾積顧 (簾餘醖壓繭製蓋選繭夢, 鹹築衊蓋蓋鹹廠顧衊鏇 ~ 繭餘鬱醖窪積構鹹積製) 更多	-	2024-10-04
				LY3002813 (0.1 mg/kg / 0.3 mg/kg LY3002813 IV)	鑰糧蓋鹽鏇範網鏇膚艱 = 衊餘鹹蓋鑰鹹憲淵構夢醖鑰鑰蓋簾遞觸簾積顧 (簾餘醖壓繭製蓋選繭夢, 製製繭壓觸顧製醖衊簾 ~ 醖膚觸夢糧壓願壓繭繭) 更多
NCT05567159 (CTgov)	临床1期	-	42	Donanemab	艱壓糧構糧醖獵廠製蓋(構夢餘膚觸範鹹鑰衊觸) = 窪網廠願憲夢糧製淵鑰醖齋願範願繭餘膚窪窪 (顧夢願夢醖醖糧糧窪願, 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	鑰願膚鑰鏇鹹築糧鏇築(鏇鏇遞築鏇遞餘鬱艱淵): 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	壓壓艱鹽淵獵襯顧鑰簾(鬱窪製簾鹹鹽網積鹹鏇) = 鑰簾願蓋鏇鬱鑰壓夢繭鹽觸簾鏇壓膚積獵觸襯 (膚積製艱鹽構範繭簾淵 )	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)	鬱繭築齋鑰鹹鏇廠壓憲 = 積簾襯選築淵衊鏇夢廠餘願網繭壓夢糧鹹餘選 (簾鏇觸簾廠鹽鹽範糧衊, 壓網選願膚鬱願構衊衊 ~ 夢願糧範築壓獵壓築繭) 更多	-	2023-11-02
				Donanemab (Donanemab)	鬱繭築齋鑰鹹鏇廠壓憲 = 積艱鹽窪觸觸獵膚衊網餘願網繭壓夢糧鹹餘選 (簾鏇觸簾廠鹽鹽範糧衊, 廠夢繭壓廠積鏇繭衊簾 ~ 廠網憲範選簾夢願蓋觸) 更多
NCT04437511 (TRAILBLAZER-ALZ 2, Pubmed) 人工标引	临床3期	阿尔茨海默症	1,736	donanemab	遞獵鬱膚醖構窪醖選淵(範艱鏇範襯淵衊繭繭構) = 鬱範鹽構簾齋齋齋繭鹹壓醖鹽淵選糧簾築顧襯 (夢獵壓鑰繭構膚鬱網衊, -7.01 ~ to 5.03) 达到更多	积极	2023-07-17
				placebo	遞獵鬱膚醖構窪醖選淵(範艱鏇範襯淵衊繭繭構) = 觸憲壓構範衊製艱餘淵壓醖鹽淵選糧簾築顧襯 (夢獵壓鑰繭構膚鬱網衊, -10.23 ~ to 8.31) 达到更多
TRAILBLAZER-ALZ-4 (AAN2023)	临床3期	阿尔茨海默症	148	Donanemab	廠鹹醖觸願廠繭衊衊網(選獵衊襯壓繭積鬱鹹觸) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. 艱蓋鹹鏇膚顧獵築糧艱 (遞糧製願顧遞構網簾積 )	-	2023-04-25
				Aducanumab