Drug intelligence / Profile preview

SNE-101

Development stage
Phase 1
Lead developer
SNE Bio
Modality
Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

SNE-101 is an **exosome-based therapeutic** developed for the treatment of **acute ischemic stroke**. It marks the first clinical entry of exosome therapy in Korea. The therapeutic uses exosomes, which are vesicles secreted by stem cells, harnessing their regenerative and reparative properties as a safer and potentially more efficacious alternative to live stem cell transplantation. SNE-101 is produced using a three-dimensional stem cell culture system to yield higher concentrations of active exosomal components and improved production efficiency. The therapy is manufactured under GMP-compliant processes, ensuring critical quality standards and batch consistency for clinical application. Clinical approval was granted in April 2025 for a phase 1b trial to evaluate its safety, tolerability, and preliminary efficacy in acute ischemic stroke, with intravenous administration as the delivery route[7][9].

Brand names
SNE-101SNE101SNE 101
Other names
SNE-101SNE101SNE 101

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