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2025 Alzheimer’s Drug Pipeline Shows Growth and Diversity

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2025 Alzheimers Drug Pipeline Shows Growth and Diversity

New data shows 182 trials testing 138 drugs for Alzheimer’s, with diverse targets, repurposed agents, and growing use of biomarkers across all phases.

A newly published review of the 2025 Alzheimer’s disease (AD) drug development pipeline shows promising progress, with a record number of trials and a broadening array of therapeutic targets. Led by Professor Jeffrey Cummings and colleagues, the annual review tracks global clinical trials registered on ClinicalTrials.gov, offering a comprehensive snapshot of current drug development efforts in AD.

Key Findings from the 2025 Pipeline:

  • 138 drugs are being tested across 182 clinical trials, with increases in all phases compared to 2024.
  • 74% of drugs in the pipeline are disease-targeted therapies (DTTs), aiming to slow or halt disease progression.
  • 33% of the drugs are repurposed, originally developed for other conditions and now being tested for Alzheimer’s.
  • 15 disease processes are targeted, ranging from amyloid and tau to inflammation and synaptic function.
  • Biomarkers play a central role: over half of trials use them as inclusion criteria, and 27% use biomarkers as primary outcomes.

This year’s report notes a marked increase in early-stage (Phase 1) activity, nearly doubling since 2024. Researchers are particularly focused on diversifying the mechanisms of action, with several trials addressing emerging targets like the gut-brain axis and circadian rhythm disruptions.

Repurposing and Innovation Drive Progress

Repurposing continues to be a cost-effective strategy, with 43% of DTT small molecules and 53% of neuropsychiatric symptom (NPS) treatments using previously approved drugs. Trials also include combinations designed to maximise efficacy or reduce side effects, such as pairing dextromethorphan with metabolism inhibitors to enhance CNS penetration.

In addition to traditional agents targeting amyloid and tau, the pipeline includes innovative biologics, small molecules, and combination therapies tackling neuroinflammation, bioenergetics, and vascular dysfunction. Plasma-based biomarkers like p-tau217 are gaining prominence for screening and monitoring treatment response.

Global Participation and Recruitment Challenges

With over 50,000 participants required to populate the trials, recruitment remains a significant challenge. North America and the rest of the world contribute equally in terms of trial sites, though most locations host only one trial. Expanding and consolidating global recruitment sites could improve efficiency and representation.

Looking Ahead

Twelve drugs are expected to complete Phase 3 trials in 2025, including candidates such as semaglutide, simufilam, and combinations like xanomeline plus trospium. Outcomes from these studies will shape the next phase of clinical development and regulatory review.

Overall, the 2025 AD drug development pipeline reflects cautious optimism. While challenges persist, particularly around recruitment and trial duration, the growing number of trials, diversity of targets, and increasing reliance on biomarkers highlight a dynamic and maturing research environment.

The full paper, Alzheimer’s disease drug development pipeline: 2025, is open access and available via Alzheimer’s & Dementia: Translational Research & Clinical Interventions.


A D Transl Res Clin Interv - 2025 - Cummings - Alzheimer s disease drug development pipeline 2025

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