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.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Southern California

[+3]

NCT06566170

/ RecruitingNot Applicable

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.

Start Date07 Oct 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT05738486

/ Active, not recruitingPhase 3

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Start Date28 Feb 2023

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Donanemab-AZBT

100 Translational Medicine associated with Donanemab-AZBT

100 Patents (Medical) associated with Donanemab-AZBT

183

Literatures (Medical) associated with Donanemab-AZBT

01 Jul 2025·European Journal of Medicinal Chemistry

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

Article

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

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.

01 May 2025·The Journal of Prevention of Alzheimer's Disease

Donanemab: Appropriate use recommendations

Article

Author: Weiner, M ; Greenberg, S M ; Rabinovici, G D ; Atri, A ; Salloway, S ; Schindler, S E ; Apostolova, L G ; Aisen, P ; Hendrix, S B ; Selkoe, D J ; Cummings, J ; Petersen, R C

Donanemab (Kisunla®), an IgG1 monoclonal antibody targeting N-terminal pyroglutamate-modified forms of amyloid-β, is approved in the United States for treatment of early symptomatic Alzheimer's disease (AD). Appropriate Use Recommendations (AUR) were developed to guide the implementation of donanemab in real-world practice, prioritizing safety considerations and opportunity for effectiveness. The AUR were developed by the AD and Related Disorders Therapeutic Workgroup by consensus, integrating available data and expert opinion. Appropriate candidates for donanemab treatment include persons with mild cognitive impairment or mild dementia due to AD (Clinical Stages 3-4, MMSE 20-30) who have biomarker confirmation of AD pathology by PET or CSF. Tau PET is not required for eligibility. Apolipoprotein E (APOE) genotyping should be performed prior to treatment to inform an individual's risk of developing Amyloid-Related Imaging Abnormalities (ARIA). Pre-treatment MRI should be obtained no more than 12 months prior to treatment. Patients with findings of >4 cerebral microbleeds, cortical superficial siderosis or a major vascular contribution to cognitive impairment should be excluded from treatment. The decision to initiate therapy should be grounded in a shared decision-making process that emphasizes the patient's values and goals of care. Donanemab is administered as a monthly intravenous infusion. Surveillance MRIs to evaluate for ARIA should be performed prior to the 2nd, 3rd, 4th and 7th infusions, prior to the 12th dose in higher risk individuals, and at any time ARIA is suspected clinically. Clinicians may consider discontinuing treatment if amyloid clearance is demonstrated by amyloid PET, typically obtained 12-18 months after initiating treatment.

01 Apr 2025·The Journal of Prevention of Alzheimer's Disease

Patient eligibility for amyloid-targeting immunotherapies in Alzheimer's disease

Article

Author: Jessen, Frank ; Rosen, Jurij

BACKGROUNDAmyloid beta (Aβ) targeting immunotherapies have evolved as promising treatment options for patients with early symptomatic Alzheimer's disease (AD). Understanding how eligibilty criteria impact on the number of patients potentially qualifying for treatment is of high relevance for designing diagnostic workflows in clinical practice and for estimating required ressources and costs.OBJECTIVESWe aimed at estimating the number of potentially eligible patients for treatment with the Aβ targeting antibodies aducanumab, lecanemab and donanemab in a specialized center real-world sample by the applying the phase 3 clinical trial and the appropriate use recommendations (AUR) inclusion and exclusion criteria to the data set. The post-mortem report was used for defining amyloid positivity and the presence of AD pathology in this study.DESIGNRetrospective, descriptive study.SETTINGThe multicenter National Alzheimer's Coordinating Center-Uniform Data Set (NACC-UDS) and Neuropathology Data Set (NACCNP).PARTICIPANTSWe included all 3,343 participants of the NACC dataset with available post-mortem pathology reports.MEASUREMENTS/RESULTS887 participants were potential candidates for anti-Aβ immunotherapy as they presented with amnestic mild cognitive impairment or mild dementia and the clinical diagnosis of AD (amnestic AD syndrome). Applying the criterion of amyloid positivity (post mortem report) and the clinical trial inclusion and exclusion criteria to this sample resulted in 83 (9 %), 275 (31 %), and 172 (19 %) participants eligible for treatment with aducanumab, lecanemab, and donanemab, respectively. Applying the criteria of the AUR resulted in 242 (27 %) and 266 (30 %) participants eligible for treatment with aducanumab or lecanemab, respectively. The eligible participant groups for each antibody showed partial, but not full overlap. Co-pathologies were common.CONCLUSIONSThe number of eligible participants varies between the different antibodies and the selected groups only partly overlap, indicating partly different groups of eligible participants for each antibody. Since not all inclusion and exclusion criteria can be extracted from the NACC-UDS dataset, the real number of eligible patients will be smaller.

482

News (Medical) associated with Donanemab-AZBT

01 May 2025

·www.fiercepharma.com

After years of sales declines, 'a new Biogen' emerges as launches take flight: CEO

Biogen charted first-quarter sales growth thanks to the launches of Leqembi, Zurzuvae and Skyclarys. Burdened by competitive pressures for its stalwart multiple sclerosis franchise, Biogen has weathered years of sales declines. But in the first quarter, the company was able to see a glimpse of its hoped-for future with revenue growth thanks to three launches.Lately, Biogen's story can be summed up as a “a tale of two companies,” CEO Chris Viehbacher mused on a Thursday earnings call with analysts.There’s one company, a multiple sclerosis (MS)-centered drugmaker, with a portfolio that has been gradually declining, with its sales falling 11% during the first quarter. But now with 45% of Biogen's revenue coming from medicines outside of its MS franchise, “there’s a new Biogen emerging,” according to Viehbacher.The fresh start is hallmarked by Alzheimer’s disease med Leqembi, postpartum depression (PPD) treatment Zurzuvae and Friedreich’s ataxia therapy Skyclarys, all of which helped drive Biogen to a 6% revenue increase during the first quarter of 2025. Overall, the company generated $2.4 billion during the period. Eisai-partnered Leqembi is now into “serious product territory,” Viehbacher noted, growing a whopping 395% since last year’s first quarter—and 11% from the fourth quarter of last year—to $96 million in sales. The drug finally cinched a European approval in April after months of back-and-forth decisions by European officials, unlocking a key market with “an awful lot of eligible patients,” according to the CEO.It’s been a “challenging product to launch,” Viehbacher observed, but several recent advancements in administration—including an anticipated FDA decision for subcutaneous maintenance dosing—should help reduce the treatment burden.Currently, the Alzheimer’s antibody treatment market consists of Leqembi and Eli Lilly’s rival Kisunla (donanemab), which has faced many of the same launch barriers. Biogen accepts the competition, acknowledging that it will ultimately be “up to the physician and the patient” to determine which treatment to choose, Viehbacher explained.“I think the market ultimately gets split between us and donanemab,” the CEO said. “The most important thing for both Lilly and Biogen and Eisai is that we start to really expand this market.” As it stands, the companies are both only treating a “small fraction” of the patients who “desperately need treatment," the CEO said.Zurzuvae, meanwhile, has so far treated more than 10,000 women since its 2023 launch. Its sales were up 123% since last year’s first quarter to $28 million. Biogen managed to expand the number of physicians writing prescriptions by 20%, the company reported, in part by focusing on OB-GYNs as opposed to psychiatrists. The drug was the first oral medicine approved to specifically treat PPD. With Zurzuvae on the market, physicians are becoming “more proactive” about diagnosing the historically overlooked condition, Viehbacher commented. Elsewhere, Biogen is still underway with a geographic expansion for Skyclarys, having scored recent approvals in the U.K. and Brazil. With $124 million in first-quarter sales, the drug was the biggest revenue contributor out of its three new launches. Friedreich’s ataxia is a genetic disease with European origin, leaving the Biogen team to get “very creative” in finding new U.S. patients through family trees and social media, according to the CEO.So far, around 2,400 patients are on the treatment globally; some are still on early access programs rather than commercial therapy. No concern for tariffs For many of Biogen's peers, the threat of looming pharmaceutical tariffs and changing trade policies could overshadow their future prospects. But Biogen's diversified revenue base means that some 55% of its product revenue last year came from sales outside of the U.S., which is “pretty unusual in our business,” Viehbacher said. And given that about 75% of last year’s U.S. product revenue is tied to drugs that have manufacturing operations in the U.S., Massachusetts-based Biogen is “more of a U.S.-based company” and is “quite proud of that,” the CEO noted. The drugmaker does not expect its financial outlook, which estimates a revenue decline by a mid-single-digit percentage in 2025 due to falling MS sales, to be impacted by currently announced tariffs, “even if the exemption for pharmaceuticals were to be removed,” the company said. Elsewhere in the policy vein, Biogen and Viehbacher have “not really seen” any delays in its interactions with the FDA or any “adverse effects” from key leaders who have left the agency.

Drug ApprovalBiosimilar

01 May 2025

·www.biospace.com

Tariffs Keep Biogen Execs Busy in Q1 but Impacts Expected To Be Minimal

iStock, Anton Vierietin Announcing first-quarter results, Biogen CEO Chris Viehbacher admitted that tariffs are “a new topic for us,” but said he does not expect major impacts—at least for 2025. “In 35 years in this industry, I’ve never had to spend as much time as we as a team have on tariffs in the first quarter,” Biogen CEO Chris Viehbacher told investors on a Thursday morning earnings call. Announcing first quarter results, the chief executive addressed what’s been on every investor’s mind as the reporting period has worn on. “It’s a new topic for us,” he said, noting the complexity of navigating the impact of tariffs, which have been threatened against the pharmaceutical industry but not yet defined by the president. In an attempt to anticipate the potential impact of the import taxes, analysts have been using Biogen’s tax rate as a surrogate for determining the potential impact of President Donald Trump’s tariffs, Viehbacher said. But he asserted that the tax rate is not a useful proxy for Biogen, because 75% of its 2024 U.S. product sales were generated from products that are manufactured in the country. Biogen actually exports more than it imports, the CEO said. In contrast to its peers, Biogen brought in 55% of its overall 2024 revenue from countries outside the U.S., Viehbacher said. Many pharma companies have a mix of about 60–80% of revenue coming from the U.S. “We are more of a U.S.-based company, and always have been, and actually, we’re quite proud of that,” the chief executive said. “Biogen is a whole lot more diversified, and that’s really a function of the products that we have,” he added. So for now, Viehbacher said Biogen does not expect major impacts this year, even if all the tariffs announced on April 22 by the administration were to suddenly apply to the pharmaceutical industry. He credited the company’s supply chain team for building out an inventory of products, active pharmaceutical ingredients and materials. CFO Robin Kramer explained that Biogen’s current guidance of $14.50 to $15.50 considers current tariff impacts, including retaliatory taxes from China. But the guidance does not include what could come. The guidance also includes a $165 million upfront payment for a licensing deal with Stoke Therapeutics to develop an epilepsy antisense oligonucleotide. The deal could total $385 million. Deal Position Shifts Viehbacher has urged investors to be patient on future deals over the past few quarters, insisting there is no desperation among the business development team to execute. He admitted on Thursday, however, that things have shifted in the past four to six weeks. Companies with low valuations that had been holding out are struggling to get financing, making deal conversations easier to come by, the CEO said. This is particularly true for companies looking to sign licensing or partnership agreements right now. “Companies will be able to provide some of the funding as some of the venture capital and some of the other sources of funding dry up for other companies, and so there are opportunities in there,” Viehbacher said. “It still requires an awful lot of patience and discipline to work your way through and find companies that work together.” He continued: “Biogen, just because of our own biotech roots, is a company that knows how to do collaborations, and I think can be a trusted partner in this.” Biogen’s Eisai-partnered Alzheimer’s disease medicine Leqembi met analyst expectations for the quarter. Biogen overall reported revenue of $2.43 billion, which was above William Blair’s estimate of $2.3 billion. Leqembi contributed $96 million, including U.S. sales of $52 million, representing 10% growth. This is right on track with Jefferies’ expected U.S. sales of $51 million. Leqembi is now in a tough market race with Eli Lilly’s Kisunla (donanemab). Viehbacher brushed off concerns about a neck-and-neck battle, instead saying there’s plenty of unaddressed patient need for both medicines. “I think the market ultimately just gets split between us and donanemab. The most important thing for both Lilly, I think, and Biogen and Eisai, is that we start to really expand this market,” Viehbacher said. “When you consider the number of patients who desperately need treatment, we’re still only treating a small fraction, and I think that’s really got to be the focus of all the companies in this space . . . to really ensure that more patients benefit from these disease-modifying treatments.” Lilly, which also reported first quarter earnings Thursday morning, reported sales of $21 million for Kisunla. The drug is only approved in the U.S.

Drug ApprovalLicense out/inOligonucleotide

29 Apr 2025

·www.prnewswire.com

The ADDF's Diagnostics Accelerator (DxA) Advances AI-Enabled Digital Cognitive Assessment Tool MoCA Solo with Investment to Aid in Early Identification of Alzheimer's Disease

Standardized digital test will expand early diagnosis capabilities to more primary care physicians NEW YORK, April 29, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator (DxA) today announced a significant investment that will support clinical validation for the digital version of the Montreal Cognitive Assessment (MoCA), MoCA Solo, an automatically scored test for tablet devices utilizing AI-enabled avatars, requiring only minimal supervision. The original MoCA is a one-page 30-point pen-and-paper cognitive test that is administered in ten minutes and used worldwide by trained professionals. MoCA Solo does not require trained administration, and if successful, MoCA Solo could be more widely used as a scalable tool for assessing mild cognitive impairment (MCI), especially in primary care clinical settings. "Combining the MoCA Solo assessment with blood biomarkers has the potential to enable earlier detection of Alzheimer's disease by identifying individuals with MCI who are most likely to benefit from specialist care," said Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "A scalable, accessible, and standardized assessment that can be easily administered across a variety of clinical settings empowers primary care physicians to play a more prominent role in the front lines of diagnosing and treating Alzheimer's. As the Alzheimer's population continues to grow, exceeding the capacity of specialists, conducting assessments at the primary care level is a critical step towards getting patients and their families the support they need sooner." Given the success of recently approved Alzheimer's drugs, Leqembi and Kisunla, comprehensive diagnosis and evaluation require both biomarker testing and cognitive testing to provide a holistic assessment of a patient's Alzheimer's and disease progression. While blood-based biomarkers are most likely to become the gold standard for the early diagnosis and detection of Alzheimer's-related biology, the addition of digital standardized cognitive assessment will provide complementary information on a patient's cognitive state, helping to determine which individuals are in the earliest stages of the disease and would benefit from referral to specialist care. Development of and access to standardized assessment and diagnostic tools is a foundational goal of the ADDF's Diagnostics Accelerator. Pairing cognitive assessment with individual biomarkers paves the way for early diagnosis and helps inform combination therapies that will allow us to treat Alzheimer's via precision medicine. "As new Alzheimer's therapies come to market, it's more important than ever to have reliable, standardized, easy-to-deploy tools for early detection," said Niranjan Bose, Managing Director of Health and Life Sciences at Gates Ventures. "Digitizing the widely used MoCA test empowers primary care physicians to detect cognitive decline earlier and reduce bottlenecks with specialist referrals. When paired with blood biomarker testing, the information gives doctors a more complete picture of an individual's condition, enabling timely and targeted intervention." "This investment by the ADDF underscores their commitment to innovation in digital diagnostics and expanding access to accurate, efficient cognitive testing at a national scale," said Dr. Ziad Nasreddine, creator of the MoCA, and CEO of MoCA Cognition. "We are proud to partner with the ADDF to help address the growing challenge of Alzheimer's disease." The gold standard pen-and-paper MoCA, developed in 1996 and clinically validated in 2005, demonstrated 90% sensitivity and 87% specificity for detecting MCI. The assessment includes questions designed to assess short-term memory, visuospatial skills, executive function, language, attention, concentration, working memory, and orientation. Today, the MoCA is the most widely used cognitive assessment for early detection and has been translated into 200+ languages and dialects. It is regularly cited in scientific articles and is used by both specialists and primary care physicians. A 2023 global Delphi consensus of experts published in Alzheimer's & Dementia ranked the MoCA as the preferred tool for detecting MCI and early AD among 53 cognition scales considered (Ellison et al., 2023). A validated and automated digital version will reduce the need for human administrators and enable further adoption, especially within primary care. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: . About the Diagnostics Accelerator (DxA) The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers. SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Donanemab-AZBT

External Link

KEGG	Wiki	ATC	Drug Bank
D11500	Donanemab-AZBT	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	United Kingdom	Eli Lilly Nederland BV	23 Oct 2024
Dementia due to Alzheimer's disease (disorder)	United Kingdom	Eli Lilly & Co.	23 Oct 2024
Mild cognitive disorder	United Kingdom	Eli Lilly & Co.	23 Oct 2024
Mild cognitive disorder	United Kingdom	Eli Lilly Nederland BV	23 Oct 2024
Alzheimer Disease	United States	Eli Lilly & Co.	02 Jul 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psychotic Disorders	NDA/BLA	Canada	Eli Lilly Canada, Inc.	-
Neurocognitive Disorders	Phase 3	Taiwan Province	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	Argentina	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	Australia	Eli Lilly & Co.	10 Oct 2022
Mild cognitive disorder	Phase 3	United States	Eli Lilly & Co.	16 Nov 2021
Cognitive Dysfunction	Phase 2	Canada	Eli Lilly & Co.	23 Nov 2020
Alzheimer Disease	Phase 2	European Union	Eli Lilly Nederland BV	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


S23.004 (AAN2025)	Not Applicable	Amyloidosis amyloid plaques	3,961	Donanemab	xlivhfdsts(kbulkhzwkd) = jyhvujabka ebfkwaoaef (jeiyatqiib ) View more	-	07 Apr 2025
NCT03367403;NCT04437511 (TRAILBLAZER-ALZ and ALZ 2, Pubmed \| JAMA Neurol)	Not Applicable	Alzheimer Disease APOE ε4 allele number \| amyloid levels	3,030	Donanemab	lcydojjtsg(sxoytzhheb) = lcioadptac jvbzffhsss (kovvwgasdw ) View more	Positive	10 Mar 2025
				Placebo	lcydojjtsg(sxoytzhheb) = vyobmjcxam jvbzffhsss (kovvwgasdw ) View more
NCT05738486 (TRAILBLAZER-ALZ 6, Company_Website) Manual	Phase 3	Alzheimer Disease	843	received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen)	(plukodktin) = qmbruqdqib lzuorfkxwx (fktldsbwkl ) View more	Positive	29 Oct 2024
				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)	(plukodktin) = xnuaogssdk lzuorfkxwx (fktldsbwkl ) View more
NCT01837641 (CTgov)	Phase 1	Alzheimer Disease \| Cognitive Dysfunction	63	Placebo (Placebo IV)	moqnvgvkwh(hepbgqsbwv) = papwszxiry pucwqzbsdx (tisnxarqpw, tpanmltaqy - nylchjqlyz) View more	-	04 Oct 2024
				LY3002813 (0.1 mg/kg / 0.3 mg/kg LY3002813 IV)	moqnvgvkwh(hepbgqsbwv) = mlzmcgnrhe pucwqzbsdx (tisnxarqpw, mapnnkzccy - zlnlcejhcq) View more
NCT05567159 (CTgov)	Phase 1	-	42	Donanemab	gqauvjenqq(dtihcytutr) = nipyfkcdfc gquvhpojxa (mxznuobugh, tkaaytihpi - rluocbthlt) View more	-	04 Oct 2024
NCT05533411 (CTgov)	Phase 1	-	36	Placebo (Placebo)	(nheinkqgpu) = ohablrmnfg getkuyrlhi (mfytbaidrg, tkywtajmnp - jkoxfmwajd) View more	-	04 Oct 2024
				Donanemab (700 mg Donanemab)	(nheinkqgpu) = bhzrvtarfo getkuyrlhi (mfytbaidrg, siwheszsyn - tqvedmofkc) View more
NCT04437511 (FDA_CDER) Manual	Phase 3	Alzheimer Disease	1,736	KISUNLA	(qthmmzzayo): Difference = 2.92, P-Value = <0.0001 View more	Positive	02 Jul 2024
				Placebo
NCT04437511 \| NCT03367403 (TRAILBLAZER-ALZ \| TRAILBLAZER-ALZ2, AAN2024)	Phase 2/3	number of microhemorrhages \| cortical superficial siderosis \| mean arterial pressure ... View more	2,031	Donanemab	goxpylqfhz(zebexnjpax) = gvpqxwefvc slwnvcytgs (koekoryqea )	Positive	09 Apr 2024
NCT05108922 (TRAILBLAZER-ALZ 4, CTgov)	Phase 3	Alzheimer Disease \| Mild cognitive disorder	148	Aducanumab (Aducanumab)	nqacewmdvk(aprtnadhsx) = nwoeqledex kwuykcrgye (uvftqrzgmt, ppkybsqiph - jzpupwqhqm) View more	-	02 Nov 2023
				Donanemab (Donanemab)	nqacewmdvk(aprtnadhsx) = jeqkuzclsd kwuykcrgye (uvftqrzgmt, dfxmplodpj - rbsbjziljv) View more
NCT04437511 (TRAILBLAZER-ALZ 2, Pubmed) Manual	Phase 3	Alzheimer Disease	1,736	donanemab	(bwlnneihyw) = wuymxhayhf vrwtmeihrd (imkvhrgbuq, -7.01 to to 5.03) Met View more	Positive	17 Jul 2023
				placebo	(bwlnneihyw) = imyenptrak vrwtmeihrd (imkvhrgbuq, -10.23 to to 8.31) Met View more

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