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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Drug Development.

Dulmalika Navodya Herath Manchanayake1, Hashan S M Jayarathne1, Marianna Sadagurski1

  • 1Wayne State University, Detroit, MI, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
PubMed
Summary

Canagliflozin, a diabetes drug, shows promise in treating Alzheimer's disease (AD) by reducing brain pathology and improving cognition in male mice. This sodium-glucose cotransporter 2 inhibitor (SGLT2i) may offer new therapeutic avenues for neurodegenerative diseases.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Aging Research

Background:

  • Aging is a major risk factor for Alzheimer's disease (AD), with limited treatment options.
  • Canagliflozin (Cana), a sodium-glucose cotransporter 2 inhibitor (SGLT2i), previously extended lifespan in male mice and showed neuroprotective effects.
  • Cana demonstrated improved insulin response, reduced neuroinflammation, and enhanced behavior in aged male mice.

Purpose of the Study:

  • To investigate the potential of Canagliflozin (Cana) in mitigating AD-related pathologies.
  • To assess the effects of Cana on cognitive function, neuroinflammation, and amyloid-beta (Aβ) burden in a mouse model of AD.

Main Methods:

  • Utilized the 5XFAD mouse model of AD.
  • Administered Cana-containing diet from 3 months of age.

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  • Conducted metabolic, behavioral, and histological analyses at 6-7 months of age to evaluate Aβ burden, neuroinflammation, and hippocampal function.

    • Main Results:

    • Cana improved glucose tolerance in both male and female 5XFAD mice.
    • Male 5XFAD mice showed enhanced cognitive performance and spatial memory.
    • Cana significantly reduced hippocampal Aβ plaque burden and neuroinflammation in male mice.

    Conclusions:

    • Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have a novel role in alleviating AD pathologies.
    • SGLT2i show promise for repurposing in the treatment of neurodegenerative diseases.
    • Findings highlight Cana's potential therapeutic benefits for AD, particularly in males.