Drug intelligence / Profile preview

GAL-475

Development stage
Phase 1
Lead developer
Neurim Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

GAL-475 is an investigational small molecule therapeutic developed by Neurim Pharmaceuticals for the treatment of sleep apnea syndromes. As a first-in-class agent, it has undergone Phase I clinical evaluation in a randomized, double-blind, placebo-controlled, single ascending dose trial (NCT04115306) to assess its safety, tolerability, and pharmacokinetics in healthy male volunteers and male patients with sleep apnea. While the specific molecular target has not been officially disclosed by Neurim, the compound is part of a program focused on novel mechanisms for respiratory stability during sleep, potentially involving the modulation of galanin receptors. The drug is designed for oral administration and represents a novel approach to treating sleep-disordered breathing by targeting CNS-related pathways involved in respiratory control.

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