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nanoliposomal irinotecan (PharmaEngine, Inc.)
- Development stage
- Unknown
- Lead developer
- PharmaEngine
- Modality
- Small Molecules, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Administration
- Intravenous
01
Overview
Nanoliposomal irinotecan (Onivyde, PEP02) is a liposome-encapsulated formulation of the topoisomerase I inhibitor irinotecan. Developed by PharmaEngine and later licensed to Ipsen and Servier, this nanotherapeutic is designed to enhance the delivery of irinotecan and its active metabolite, SN-38, to tumor tissues while reducing systemic toxicity. The liposomal carrier protects the drug from premature metabolism and promotes accumulation in the tumor microenvironment via the enhanced permeability and retention (EPR) effect. Once inside the tumor, the irinotecan is released and converted to SN-38, which binds to the topoisomerase I-DNA complex, preventing DNA religation and causing lethal double-strand breaks. It is FDA-approved for the treatment of metastatic pancreatic adenocarcinoma and is being investigated in Phase 1 trials for various refractory solid tumors, including in combination with agents like TAS-102.
- Brand names
- Onivyde
- Other names
- nal-IRIliposomal irinotecanirinotecan liposome injectionirinotecan sucrosofate liposome injection
02
Targets
DNATOP1 (DNA Topoisomerase I)
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