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.
Approximately 300 additional participants will be enrolled per addendum.
The study will last approximately 91 weeks and include up to 26 visits in the main study.

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

195

Literatures (Medical) associated with Donanemab-AZBT

01 Feb 2026·Neural Regeneration Research

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

Article

Author: 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.

01 Jul 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

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

Review

Author: 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.

01 Jun 2025·JOURNAL OF NEUROLOGY

FDA vs. EMA: evaluating donanemab and the global debate on accelerated approvals

Letter

Author: Pokhrel, Prakriti ; Jindal, Aakriti ; Ahmed, Qadeer

506

News (Medical) associated with Donanemab-AZBT

22 May 2025

·www.biospace.com

Sanofi Buys Vigil for $470M Upfront, Reigniting a Battered Alzheimer’s Target

iStock, Naeblys The deal helps revitalize the TREM2 target after the high-pro of AbbVie and Alector’s candidate last year. Sanofi will acquire Vigil Neuroscience , adding an Alzheimer’s disease therapy for about $470 million upfront and starting a new chapter in a partnership the two companies began last year. The deal represents “a great outcome for Vigil and shareholders,” analysts said. It could also help to reenergize a TREM2 space that took a hit last fall with the failure of AbbVie and Alector’s candidate in the same disease. Sanofi will pay out $8 per share, representing a 250% premium on Vigil’s share price. Shareholders will also receive a contingent value right of $2 per share conditional on the first sale of Vigil’s TREM2 agonist VG-3927, which is aimed at treating neurodegenerative diseases like Alzheimer’s. With the CVR, the total consideration for the deal could reach $600 million. In an investor note following the sale, Stifel analysts said the high premium suggests there was a competitive process to buy out the neuroscience biotech. But $8 per share represents a fall from the $14 per share Vigil collected for its 2022 IPO. Still, it’s a positive given the challenging biotech markets and recent failure of a rival TREM2 med from AbbVie and Alector . “Even though $8 is below IPO price, it represents a nearly 250% premium (seemingly [a] competitive process?), while the broader market has changed, and the TREM2 story has become more nuanced,” Stifel wrote on Wednesday evening. Vigil CEO Ivana Magovčević-Liebisch said in the company’s statement that the deal will allow the Vigil team to tap into “Sanofi’s resources, broad platform and far-reaching network” to develop VG-3927. Sanofi’s Houman Ashrafian, head of R&D, said the deal fits neatly into the French pharma’s neurology focus. “TREM2 represents a compelling target at the intersection of immune dysregulation and neurodegeneration, particularly in people living with Alzheimer’s because they face devastating cognitive decline with limited treatment options,” he said. Sanofi is not, however, interested in Vigil’s lead program, the monoclonal antibody TREM2 agonist iluzanebart (VGL101) that had been in development for adult-onset leukoencephalopathy. The drug was originally licensed from Amgen and will return to that company prior to the closing of the Sanofi transaction. Vigil had been pursuing an accelerated approval for the asset but had not recently provided an update on the FDA discussions. The deal is expected to close in the third quarter of this year. No Credit for TREM2 The failure of AbbVie and Alector’s AL002 in November 2024 cast a shadow over the TREM2 space. The drug did not significantly slow clinical progression in patients with Alzheimer’s disease. The Phase II trial was unsuccessful on the main endpoint, improving symptoms of dementia, as well as other key secondary goals and functional effects. It also failed to significantly improve biomarkers like brain amyloid levels. There was also evidence of amyloid-related imaging abnormalities (ARIA), which can suggest brain swelling or bleeding. The side effect has plagued the rollout of newly approved Alzheimer’s medicines from Eisai and Biogen and Eli Lilly. “For public investors, the failure of ABBV/ALEC’s AL002 in Alzheimer’s disease significantly diminished enthusiasm for the target,” Stifel wrote. But Vigil’s drug is different, they said, even if the data are not yet available to definitively settle the matter. Stifel said VG-3927 seemed to have improved biochemistry over AL002 and a different mechanism of action, despite targeting the same protein. However, investors were still waiting for Phase II data to be sure. Of the Alector failure, Stifel said: “We can debate the readthrough of this to Vigil’s small molecule, but regardless it was going to make it hard for Vigil to get credit here from public market investors.” VG-3927 advanced out of Phase I earlier this year with data showing high brain penetration, a tolerable safety pro a 50% reduction in sTREM2, a biomarker that increases in concentration during the early symptomatic phases of Alzheimer’s. A Phase II study had been expected to get underway in the third quarter of this year. Vigil had already signaled a desire to partner out the VG-3927 program. Evidently, those talks turned into a whole company acquisition, Stifel noted. This is not Sanofi and Vigil’s first introduction. Sanofi provided $40 million in development capital to the biotech through a private placement in July 2024. At the time, Sanofi secured the right of first refusal for VG-3927. Sanofi’s Alzheimer’s play comes after Alzheimer’s peers Biogen and Eisai got Leqembi fully approved in 2023, followed a year later by Eli Lilly with Kisunla . Stifel suspects that Sanofi saw that success and spied an opportunity to build on the learnings from the amyloid space, which had undergone decades of failure before finally showing some clinical benefits. “For these reasons—and considering the strong scientific rationale behind TREM2—it’s not shocking that another company is enthusiastic to re-test the thesis in AD,” Stifel said.

Phase 2AcquisitionDrug Approval

21 May 2025

·www.prnewswire.com

Lilly's Kisunla (donanemab) receives marketing authorization in Australia for the treatment of early symptomatic Alzheimer's disease

The authorization in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers INDIANAPOLIS, May 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in adults who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Kisunla is the first amyloid-targeting therapy for people with Alzheimer's registered in Australia and the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. Kisunla can help remove the excessive buildup of amyloid plaques and help slow the cognitive and functional decline in patients with early symptomatic Alzheimer's disease. "It is exciting to see Kisunla's marketing authorization in Australia, marking it as the 13th regulatory authorization. In our TRAILBLAZER-ALZ 2 Phase 3 study, results showed that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease, which allowed them more time to do things that mattered most to them like remember information, make meals, manage finances, and maintain independence," said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company. "As our data showed, the earlier patients are identified, diagnosed, and treated with Kisunla, the greater their response to treatment." It's estimated that 600,000 Australians are currently living with Alzheimer's disease,1 with approximately 450,000 of these individuals in the early stages of the disease who could be assessed to determine eligibility for treatment with Kisunla.4 Alzheimer's disease is the third leading cause of death in Australia.1 The registration of Kisunla in Australia was based on the TRAILBLAZER-ALZ 2 Phase 3 and TRAILBLAZER-ALZ 6 clinical trial data. The TRAILBLAZER-ALZ 2 study demonstrated that Kisunla significantly slowed cognitive and functional decline — characterized by more significant memory and thinking deficits, with related impacts on daily functioning and requiring higher levels of caregiver support—by up to 35% compared to placebo at 18 months and reduced the risk of progressing to the next clinical stage of disease by 39% over the same period.3 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 are usually asymptomatic, although serious and life-threatening events can rarely occur.2 Because ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke, the product information in Australia includes a boxed warning that notes treatment to dissolve blood clots should be carefully considered by the patient's doctor. The titration schedule approved in Australia is based on TRAILBLAZER-ALZ 6, which demonstrated that the incidence of ARIA-E at 24 weeks was significantly lowered versus the original dosing schedule, while preserving Kisunla's ability to reduce amyloid plaque and plasma P-tau217.2 The modified titration schedule has been submitted for regulatory review in other countries. Donanemab is now approved in the United States, Japan, China, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico and Australia. About Kisunla In Australia, Kisunla is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer's disease in adult patients who are ApoE ε4 heterozygotes or non-carriers. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), and infusion-related reactions. Donanemab is a prescription medicine administered intravenously every four weeks. About TRAILBLAZER-ALZ 2 Study TRAILBLAZER-ALZ 2 (NCT04437511) was a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA). About TRAILBLAZER-ALZ 6 study and the TRAILBLAZER-ALZ program TRAILBLAZER-ALZ 6 (NCT05738486) was a Phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan. The primary endpoint results were published in Alzheimer's and Dementia. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, focused on reducing risk of progression to symptomatic AD in participants with preclinical Alzheimer's disease; and TRAILBLAZER-ALZ 5, a registration trial for early symptomatic Alzheimer's disease currently enrolling in China, Korea, Taiwan, and other geographies. 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: Headache Dizziness Nausea Difficulty walking Confusion Vision changes 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 treatment for people with early symptomatic Alzheimer's disease, the supply and commercialization of Kisunla, and future readouts, presentations, 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 Diagnosis to Dignity – A Vision for Alzheimer's Disease in Australia. Evohealth. October 2024. Wang, H., Nery, E. S. M., Ardayfio, P., Khanna, R., Svaldi, D. O., Gueorguieva, I., Shcherbinin, S., Andersen, S. W., Hauck, P. M., Engle, S. E., Brooks, D. A., Collins, E. C., Fox, N. C., Greenberg, S. M., Salloway, S., Mintun, M. A., & Sims, J. R. (2025). Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimer S & Dementia, 21(4). 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. Eli Lilly Australia. Data on file. 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

Phase 3Clinical ResultDrug Approval

20 May 2025

·www.fiercebiotech.com

SV Health’s latest pharma-backed dementia fund raises $269M to invest in new therapies

The latest fund drew in Big Pharma backers like El Lilly, Pfizer and Bristol Myers Squibb. \n A dementia-focused transatlantic venture capital initiative has secured $269 million in commitments for its second fund.The first Dementia Discovery Fund (DDF) was launched by VC firm SV Health Investors a decade ago with the goal of delivering new drug approaches for the disease-modifying treatment of dementia by 2025. With that timeline reached, SV Health has now created a second DDF. Some of the $269 million in commitments for the latest fund has already been invested into four companies. The May 20 release didn’t reveal the identity of these biotechs, only saying they align with DDF’s “investment strategy of building and backing highly innovative biotech companies developing life-changing therapies for patients worldwide, to generate attractive returns.”The ultimate goal of DDF-2 is to build a final portfolio of between 10 and 15 companies spread across the U.S., U.K. and Europe, according to the release. The previous fund, which had raised 250 million pounds ($333 million) by the time it closed in 2018, has contributed to over 50 different dementia-focused programs.The latest fund drew in Big Pharma backers like Eli Lilly and Pfizer—who were namechecked in the first DDF—along with Bristol Myers Squibb. Other previous cornerstone investors that returned were AARP, British Business Bank and Gates Frontier, which were joined by the Alzheimer’s Association. Recent years have seen Alzheimer’s drugs reach markets in the form of Lilly’s Kisunla and Eisai and Biogen’s Leqembi. However, these offerings have faced scepticism from regional regulators about their efficacy and potential side effects, as well as barriers to uptake in the U.S. due to healthcare infrastructure limitations and burdensome diagnostics.“Drug development for dementia is thankfully gaining momentum since the launch of DDF and the first disease-modifying Alzheimer\'s drugs have been approved—underscoring that success is possible but that we still have far to go,” SV Health partner Jonathan Behr said in this morning’s release.“With DDF-2, we have an exciting opportunity to make a real difference in the fight against dementia while delivering returns through investments in new treatments,” Behr added.

100 Deals associated with Donanemab-AZBT

External Link

KEGG	Wiki	ATC	Drug Bank
D11500	Donanemab-AZBT	-	-

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Psychotic Disorders	NDA/BLA	Canada	Eli Lilly Canada, Inc.	-
Neurocognitive Disorders	Phase 3	Argentina	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	Australia	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	Taiwan Province	Eli Lilly & Co.	10 Oct 2022
Cognitive Dysfunction	Phase 2	Canada	Eli Lilly & Co.	23 Nov 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TRAILBLAZER-ALZ and ALZ 2 (Pubmed \| JAMA Neurol)	Not Applicable	Alzheimer Disease APOE ε4 allele number \| amyloid levels	3,030	Donanemab	kdqcbhlxwj(otfbctmlxg) = gdbokckhyj axufioxbch (koiroaqdnl ) View more	Positive	01 May 2025
				Placebo	kdqcbhlxwj(otfbctmlxg) = dbsicjrbqt axufioxbch (koiroaqdnl ) View more
S23.004 (AAN2025)	Not Applicable	Amyloidosis amyloid plaques	3,961	Donanemab	nkzwaqjdkp(qvagzzlpsx) = ikyurxryjq ufprfnhmxg (zcdkmbpxny ) View more	-	07 Apr 2025
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)	nykfsqxcbl(eupgwurpzi) = zyrumllrjm isiragtkkp (qcjnecdsmd ) 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)	nykfsqxcbl(eupgwurpzi) = nymyeyawie isiragtkkp (qcjnecdsmd ) View more
NCT05567159 (CTgov)	Phase 1	-	42	Donanemab	foedqsasfo(gttrwmuhpb) = jnvbldrcms hnkbytnmwy (oigdydqtzz, 23) View more	-	04 Oct 2024
NCT05533411 (CTgov)	Phase 1	-	36	Placebo (Placebo)	kpdsywfgrf = zlsqnvhnhf zdkluaoogg (khjbadujhm, omngjnrtru - hmvjfekude) View more	-	04 Oct 2024
				Donanemab (700 mg Donanemab)	kpdsywfgrf = crkkwhktzi zdkluaoogg (khjbadujhm, ryjzyuaebo - hvdnwpkrpu) View more
NCT01837641 (CTgov)	Phase 1	Alzheimer Disease \| Cognitive Dysfunction \| Mild cognitive disorder	63	Placebo (Placebo IV)	qpmojjzyqy = mgdasbjxqf iutswhzbci (qcxhhsmboc, emkpdzxrts - csemxlvuqf) View more	-	04 Oct 2024
				LY3002813 (0.1 mg/kg / 0.3 mg/kg LY3002813 IV)	qpmojjzyqy = jmfatatykv iutswhzbci (qcxhhsmboc, cyrpbreugd - lznrjvvgji) View more
NCT04437511 (FDA_CDER) Manual	Phase 3	Alzheimer Disease	1,736	KISUNLA	danvazdxxq(vcgzsvdnlt): 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	dtzlguuxiv(gfcbjkxicz) = maiekokrxf lqzrunspzk (oukqjxkuvm )	Positive	09 Apr 2024
NCT05108922 (TRAILBLAZER-ALZ 4, CTgov)	Phase 3	Alzheimer Disease \| Mild cognitive disorder	148	Aducanumab (Aducanumab)	wzpevcrbgk = dxlnnzeghw pykdoxftkh (pdipmkwthi, rmraxsisdy - qtmecwdpzx) View more	-	02 Nov 2023
				Donanemab (Donanemab)	wzpevcrbgk = tkrcjhwqqx pykdoxftkh (pdipmkwthi, iegesajioy - gvxywqbwxs) View more
NCT04437511 (TRAILBLAZER-ALZ 2, Pubmed) Manual	Phase 3	Alzheimer Disease	1,736	donanemab	teydlklsvd(vojtlqdasq) = eqtxbelclx fccwymwliq (cggozbbrez, -7.01 to to 5.03) Met View more	Positive	17 Jul 2023
				placebo	teydlklsvd(vojtlqdasq) = fjwtbwopxd fccwymwliq (cggozbbrez, -10.23 to to 8.31) Met View more

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