Advanced International Journal for Research

E-ISSN: 3048-7641   •   Impact Factor: 9.11

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Volume 7 Issue 4
July-August 2026

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Endosomal Escape Mechanisms of Non-viral Gene Delivery Vectors: from Molecular Insights to Clinical Translation

Author(s) Mr. Shouvik Mondal, Ms. Sukun Kumari
Country India
Abstract Gene therapy represents a revolutionary approach to treating genetic and acquired diseases, yet the clinical implementation of non-viral gene delivery systems remains significantly constrained by poor endosomal escape following cellular uptake. This review provides a comprehensive analysis of endosomal escape mechanisms employed by the three principal classes of non-viral gene delivery vectors: lipid-based vectors, polymer-based vectors, and peptide-based vectors. For lipid-based vectors, the molecular mechanism of endosomal escape involves ionizable lipid protonation-induced membrane fusion and bilayer-to-hexagonal phase transitions, alongside design principles including cholesterol analogue utilisation and PEG-lipid engineering to improve endosomal escape efficiency. For polymer-based vectors, the proton sponge hypothesis and emerging alternative strategies, such as pKa-tunable biodegradable polymers, enhance intracellular delivery efficiency. For peptide-based vectors, pH-dependent fusogenic mechanisms and hybridisation strategies improve cytoplasmic entry. Clinical progress includes the landmark approval of patisiran (Onpattro) and the remarkable success of lipid nanoparticle-mRNA vaccines, alongside persistent challenges in the field. By reviewing the working mechanisms and clinical development of non-viral gene delivery vectors, this study provides insight into the rational design of next-generation non-viral vectors for effective gene delivery.
Keywords Clinical Translation, Endosomal Escape, Gene Therapy, Lipid Nanoparticles, Non-Viral Vectors
Field Chemistry > Pharmacy
Published In Volume 7, Issue 4, July-August 2026
Published On 2026-08-01
DOI https://doi.org/10.63363/aijfr.2026.v07i04.7110
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E-ISSN 3048-7641
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