Cited by 4,792Nanoparticle-Based Drug DeliveryUltrasound and Hyperthermia ApplicationsRNA Interference and Gene Delivery

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Doxil® — The first FDA-approved nano-drug: Lessons learned

Barenholz, Yechezkel (Chezy)·2012·Journal of Controlled Release

DOI 10.1016/j.jconrel.2012.03.020

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Abstract

Doxil®, the first FDA-approved nano-drug (1995), is based on three unrelated principles: (i) prolonged drug circulation time and avoidance of the RES due to the use of PEGylated nano-liposomes; (ii) high and stable remote loading of doxorubicin driven by a transmembrane ammonium sulfate gradient, which also allows for drug release at the tumor; and (iii) having the liposome lipid bilayer in a "liquid ordered" phase composed of the high-T(m) (53 °C) phosphatidylcholine, and cholesterol. Due to the EPR effect, Doxil is "passively targeted" to tumors and its doxorubicin is released and becomes available to tumor cells by as yet unknown means. This review summarizes historical and scientific perspectives of Doxil development and lessons learned from its development and 20 years of its use. It demonstrates the obligatory need for applying an understanding of the cross talk between physicochemical, nano-technological, and biological principles. However, in spite of the large reward, ~2 years after Doxil-related patents expired, there is still no FDA-approved generic "Doxil" available.

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Authors: Barenholz, Y. (.
Affiliations: Hebrew University of Jerusalem (IL)
Corresponding author: Barenholz, Yechezkel (Chezy)
ORCID: Barenholz, Yechezkel (Chezy)
Venue: Journal of Controlled Release
Publisher: Elsevier BV
Published: 2012-06
Volume: 160
Issue: 2
Pages: 117-134
ISSN: 0168-3659 (ISSN-L)
DOI: 10.1016/j.jconrel.2012.03.020
OpenAlex: W1989230986
Cited by: 4,792
References: 140
Citations by year: 2026: 415 · 2025: 541 · 2024: 462 · 2023: 405 · 2022: 444 · 2021: 441 · 2020: 436 · 2019: 303 · 2018: 324 · 2017: 284 · 2016: 243 · 2015: 188 · 2014: 174 · 2013: 106 · 2012: 23
FWCI: 8.16
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Controlled Release (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
Physical Sciences › Engineering › Biomedical Engineering › Ultrasound and Hyperthermia Applications
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
Keywords: pegylated liposomal doxorubicin, PEGylated liposomes, nanotherapeutics, doxorubicin, enhanced permeability and retention effect, passive tumor targeting, liposome circulation time, remote loading, phosphatidylcholine, cholesterol, drug release, generic drug availability
MeSH terms: Antibiotics, Antineoplastic, Chemistry, Pharmaceutical, Delayed-Action Preparations, Doxorubicin, Drug Carriers, Drug Compounding, Humans, Liposomes, Solubility, United States, United States Food and Drug Administration, Drug Design, Drug Approval, Nanoparticles

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