Drug intelligence / Profile preview

HLX99

Development stage
Unknown
Lead developer
Henlius
Modality
Small Molecules
01

Overview

HLX99 is an innovative small molecule coupled chemical drug developed by Henlius for the treatment of neurodegenerative diseases, specifically amyotrophic lateral sclerosis (ALS) and Parkinson's disease. The compound exhibits multiple pharmacological activities, including the regulation of gut microbiota, modulation of the immune system, and inhibition of oxidative stress. Mechanistically, it is designed to recondition the gut microbiota to a healthy state, potentially mitigating neurodegeneration via the gut-brain axis. In February 2025, the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for HLX99, allowing for clinical evaluation in ALS.

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