A COMPREHENSIVE REVIEW OF KISUNLA(DONANEMAB-AZBT): CHEMISTRY, MECHANISM OF ACTION, PHARMACOKINETICS, THERAPEUTIC EFFICACY AND ADVERSE EFFECTS


Ganeshkumar Vishwanath Kulaye
Lokmangal College of Pharmacy, Wadala, Solapur, Maharashtra, India, 413222
Abstract
Donanemab, a monoclonal antibody targeting amyloid-beta (Aβ) plaque, has shown promising results in Alzheimer’s disease (AD) by significantly reducing amyloid burden and potentially slowing cognitive decline. A dose-escalation study confirmed its efficacy in amyloid clearance with a manageable safety profile (1. Lowe et al., 2021). Pharmacokinetic modeling demonstrated a strong exposure-response relationship, linking higher drug levels to greater amyloid reduction (2. Gueorguieva et al., 2023a). The TRAILBLAZER-ALZ study further highlighted rapid amyloid clearance, with many patients achieving amyloid-negative status within a year (3. Shcherbinin et al., 2021). Population-level analyses confirmed predictable drug behavior and manageable risks, primarily related to infusion reactions and amyloid-related imaging abnormalities (ARIA) (4. Gueorguieva et al., 2023b). Comparative reviews positioned donanemab among leading anti-amyloid therapies, emphasizing its strong amyloid-targeting mechanism (5. Cummings et al., 2023). Mechanistically, donanemab selectively binds to pyroglutamate-modified Aβ, triggering microglial clearance (6. DrugBank, 2023). Common side effects include ARIA and infusion-related reactions (7. RxList, 2023), while its pharmacokinetics indicate a controlled distribution and elimination pathway (8. RxReasoner, 2023). Regulatory guidelines provide structured dosing protocols for safe administration (9. DailyMed, 2023), and metabolism studies confirm proteolytic degradation with minimal renal or hepatic involvement (10. Eli Lilly, 2023). These findings establish donanemab as a potential disease-modifying therapy, warranting further research to optimize long-term efficacy and safety.
Keywords: Donanemab, Amyloid Plaque Reduction, Alzheimer’s disease Treatment, Anti-Amyloid Immunotherapy, Amyloid-Related Imaging Abnormalities (ARIA)
Journal Name :
EPRA International Journal of Research & Development (IJRD)

VIEW PDF
Published on : 2025-02-24

Vol : 10
Issue : 2
Month : February
Year : 2025
Copyright © 2025 EPRA JOURNALS. All rights reserved
Developed by Peace Soft