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Drug intelligence / Profile preview
Onivyde is a liposomal nanoparticle formulation of irinotecan, a topoisomerase I inhibitor. Originally developed by Merrimack Pharmaceuticals and later acquired by Ipsen, the drug consists of irinotecan encapsulated within pegylated liposomes. This lipid nanoparticle delivery system is designed to protect the active ingredient from premature metabolism, prolong its circulation time, and enhance its accumulation in tumor tissues through the enhanced permeability and retention (EPR) effect. Once at the tumor site, the liposomes release irinotecan, which is then converted by carboxylesterase enzymes into its active metabolite, SN-38. SN-38 binds to and stabilizes the DNA-topoisomerase I complex, preventing the religation of single-strand DNA breaks and leading to lethal double-strand DNA damage during replication. Onivyde is FDA-approved for the treatment of metastatic pancreatic adenocarcinoma, both as a second-line therapy following gemcitabine-based treatment and as a first-line therapy in combination with oxaliplatin, fluorouracil, and leucovorin (the NALIRIFOX regimen).
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