Cited by 33Nanoparticle-Based Drug DeliveryBarrier Structure and Function StudiesExtracellular vesicles in disease

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Clinical translation of nanomedicines for brain diseases: Current challenges and future directions

Wang, Guoying, Wang, Ningyang, Xia, Xue, Ismail, Muhammad, Shi, Bingyang·2026·Journal of Controlled Release

DOI 10.1016/j.jconrel.2025.114426

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Abstract

Since the approval of Doxorubicin Liposomal (Doxil®) by the U.S. Food and Drug Administration (FDA) in 1995, the field of nanomedicine has undergone substantial growth, transforming the landscape of drug delivery. Nanomedicine offers innovative approaches to enhance the pharmacokinetics and pharmacodynamics of conventional therapeutic agents. Notably, nanomedicine facilitates targeted and multifunctional drug delivery as well as enabling at-site controlled drug release, improving therapeutic precision and minimizing off-target effects. To date, over 50 nanomedicines have received regulatory approval for the treatment of various diseases, with more than 100 currently undergoing clinical trials. However, despite these great advancements, the application of nanomedicines in treating brain diseases remains limited. The blood-brain barrier (BBB) hurdle and the intricate complexity of the central nervous system (CNS) significantly hinder the development of brain-targeted nanotherapeutics. In this review, we will summarize the current challenges encountered in developing nanomedicines for brain diseases and explore potential strategies to overcome these barriers, aiming to accelerate their translation into clinical practice.

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“The majority of clinical trials, in addition to being in early phases, are primarily focused on brain tumors, since NDs like AD express multiple and often interrelated pathogenic pathways hindering the discovery of universal therapeutic targets [127].”
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Authors: Wang, G., Wang, N., Xia, X., Ismail, M., & Shi, B.
Affiliations: Macquarie University (AU)
Henan University (CN)
University of Technology Sydney (AU)
Corresponding author: Ismail, Muhammad
Shi, Bingyang
ORCID: Wang, Guoying
Ismail, Muhammad
Venue: Journal of Controlled Release
Publisher: Elsevier BV
Published: 2026-01
Volume: 389
Pages: 114426
ISSN: 0168-3659 (ISSN-L)
DOI: 10.1016/j.jconrel.2025.114426
OpenAlex: W4416416234
Cited by: 33
References: 409
Citations by year: 2026: 33
FWCI: 1.92
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
Locations: Journal of Controlled Release (publishedVersion)
PubMed (publishedVersion)
Funders: Cancer Institute NSW (2022/ECF1449)
Topics: Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
Life Sciences › Neuroscience › Neurology › Barrier Structure and Function Studies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Extracellular vesicles in disease
Keywords: nanomedicine, brain disorders, blood-brain barrier, brain drug delivery, nanotherapeutics, clinical translation, central nervous system, controlled drug release, targeted drug delivery
MeSH terms: Animals, Blood-Brain Barrier, Brain Diseases, Humans, Drug Delivery Systems, Nanomedicine, Nanoparticles

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Clinical translation of nanomedicines for brain diseases: Current challenges and future directions

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