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Review
. 2025 Jun 3;11(2):e70098.
doi: 10.1002/trc2.70098. eCollection 2025 Apr-Jun.

Alzheimer's disease drug development pipeline: 2025

Jeffrey L Cummings  1   2 , Yadi Zhou  3 , Garam Lee  1   2 , Kate Zhong  1   2 , Jorge Fonseca  4 , Amanda M Leisgang-Osse  1   2 , Feixiong Cheng  3   5   6   7
Affiliations
Review

Alzheimer's disease drug development pipeline: 2025

Jeffrey L Cummings et al. Alzheimers Dement (N Y). .

Abstract

Clinical trials for Alzheimer's disease (AD) must be registered on clinicaltrials.gov. The registry presents a variety of types of information related to the planned clinical trial. We assess clinicaltrials.gov to document and compare aspects of drug development across the AD pipeline. Currently, there are 138 drugs being assessed in 182 clinical trials in the AD pipeline. Biological disease-targeted therapies (DTTs) comprise 30% of the pipeline; small molecule DTTs account for 43% of the pipeline; drugs addressing cognitive enhancement account for 14% of the pipeline; and drugs aiming to ameliorate neuropsychiatric symptoms in participants with AD contribute 11% of the pipeline. Biomarkers are among the primary outcomes of 27% of active trials. Repurposed agents represent 33% of the pipeline agents. The pipeline has more trials and more drugs compared to the 2024 pipeline.

Highlights: The 2025 Alzheimer's disease drug development pipeline hosts 182 trials and 138 novel drugs.The 2025 Alzheimer's disease drug development pipeline is diverse, with agents that address 15 basic disease processes.The 2025 Alzheimer's disease drug development pipeline has more trials and more drugs than the 2024 pipeline.Biomarkers play an important role in current trials to determine trial eligibility and as outcomes of trials.Repurposed agents comprise approximately one-third of the agents and trials in the 2025 Alzheimer's disease drug development pipeline.

Keywords: Alzheimer's disease; Common Alzheimer's Disease Research Ontology (CADRO); Phase 1; Phase 2; Phase 3; amyloid; biomarkers; clinical trials; drug development; inflammation; pharmaceutical companies; repurposed drugs; synaptic function; tau.

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Conflict of interest statement

J.L.C. has provided consultation to Acadia, Acumen, ALZpath, Annovis, Aprinoia, Artery, Axsome, Biogen, Biohaven, BioXcel, Bristol‐Myers Squib, Cervomed, Eisai, Fosun, GAP Foundation, Green Valley, IGC, Janssen, Kinoxis, Lighthouse, Lilly, Lundbeck, LSP/eqt, Mangrove Therapeutics, Merck, MoCA Cognition, New Amsterdam, Novo Nordisk, NSC Therapeutics, Optoceutics, Otsuka, Oxford Brain Diagnostics, Praxis, Prothena, ReMYND, Roche, Scottish Brain Sciences, Signant Health, Simcere, sinaptica, T‐Neuro, TrueBinding, and Vaxxinity pharmaceutical, assessment, and investment companies. G.L. is a full‐time employee of Eisai Co., Ltd. K.Z. is CEO of CNS Innovations. Y.Z., J.F., A. L.‐O., and F.C. declare no competing interests. Author disclosures are available in the Supporting Information.

Figures

FIGURE 1
FIGURE 1
Agents in clinical trials for treatment of Alzheimer's disease on the Index Date of January 1, 2025, as recorded on clinicaltrials.gov. The inner ring shows Phase 3 agents; the middle ring includes Phase 2 agents; the outer ring presents Phase 1 therapies. Agents in green areas are biologics; those in purple areas are disease modifying small molecules; agents in orange areas are symptomatic agents addressing cognitive enhancement; and those in the blue sections of the figure target behavioral and neuropsychiatric symptoms. The shape of the icon denotes the population of the trial; the color of the icon denotes the CADRO‐based class of the agent ((C)J. Cummings; M. de la Fleur, PhD, Illustrator). CADRO, Common Alzheimer's Disease Research Ontology.
FIGURE 2
FIGURE 2
Alzheimer‐related processes as categorized by the Common Alzheimer's Disease Research Ontology (CADRO) for agents in each phase of the Alzheimer's drug development pipeline (J. Cummings; M. de la Flor, PhD, Illustrator).
FIGURE 3
FIGURE 3
Mechanisms of action of agents in Phase 3 Alzheimer clinical trials as classified using four categories of therapeutic purpose (left) or the Common Alzheimer's Disease Research Ontology (CADRO) approach (right) ((C) figure J Cummings; M de la Flor, PhD, Illustrator).
FIGURE 4
FIGURE 4
Mechanisms of action of agents in Phase 2 Alzheimer clinical trials as classified using 4 categories of therapeutic purpose (left) or the Common Alzheimer's Disease Research Ontology (CADRO) approach (right)((C) figure: J. Cummings; M. de la Flor, PhD, Illustrator).
See this image and copyright information in PMC

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