Drug intelligence / Profile preview

Onivyde

Development stage
Approved
Lead developer
Ipsen
Modality
Small Molecules, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

Onivyde (irinotecan liposome) is a liposomal nanoparticle formulation of the topoisomerase I inhibitor irinotecan, developed by Ipsen. The drug encapsulates irinotecan within a lipid bilayer vesicle, which significantly extends its circulation time and enhances its accumulation within tumor tissues compared to unencapsulated irinotecan. Once at the tumor site, irinotecan is converted into its active metabolite, SN-38, which stabilizes the cleavable complex between DNA and topoisomerase I, leading to double-strand DNA breaks and apoptosis. Onivyde was first approved for the second-line treatment of metastatic pancreatic adenocarcinoma in combination with 5-fluorouracil and leucovorin. In February 2024, it received FDA approval for first-line treatment of metastatic pancreatic adenocarcinoma as part of the NALIRIFOX regimen, which includes oxaliplatin, fluorouracil, and leucovorin.

Brand names
Onivyde
Other names
irinotecan liposomeliposomal irinotecanirinotecan liposome injection
02

Targets

TOP1 (DNA Topoisomerase I)

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