Drug intelligence / Profile preview

NALIRIFOX (Ipsen)

Development stage
Unknown
Lead developer
Ipsen
Modality
Nanoparticles → Drug Delivery Systems, Small Molecules
Administration
Intravenous
01

Overview

NALIRIFOX is a combination chemotherapy regimen consisting of liposomal irinotecan, oxaliplatin, 5-fluorouracil (5-FU), and leucovorin. It is primarily utilized as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and is under investigation for locally advanced pancreatic cancer (LAPC). The regimen exerts its therapeutic effect through multiple mechanisms: irinotecan (in a liposomal formulation) inhibits DNA topoisomerase I, oxaliplatin acts as a platinum-based DNA alkylating agent, and 5-fluorouracil is an antimetabolite that inhibits thymidylate synthase, with leucovorin serving to enhance its binding. In the pivotal Phase III NAPOLI-3 trial, NALIRIFOX demonstrated superior overall survival and progression-free survival compared to the gemcitabine plus nab-paclitaxel (GnP) regimen, leading to its FDA approval in early 2024.

Other names
liposomal irinotecan + oxaliplatin + fluorouracil + leucovorin
02

Targets

dsDNA (Double-stranded DNA)TOP1 (DNA Topoisomerase I)DNATS (Thymidylate synthase)

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