Inidascamine (RL-007/FSV7-007): A Comprehensive Report on its Development for Cognitive Impairment Associated with Schizophrenia

1. Executive Summary

Inidascamine, also known by its developmental codes RL-007 and FSV7-007, is an orally administered, investigational neuromodulator currently in advanced clinical development for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS).[1] CIAS represents a significant unmet medical need, as there are currently no FDA-approved treatments for this debilitating aspect of schizophrenia.[3] Developed by Recognify Life Sciences, a subsidiary of atai Life Sciences, Inidascamine is distinguished by its multi-target mechanism of action, putatively modulating cholinergic, NMDA, and GABA-B receptor systems to enhance synaptic plasticity and cognition.[1]

The compound has a history of investigation, including earlier phase studies under the code FSV7-007, with over 500 unique subjects dosed, where pro-cognitive signals were observed.[2] This foundation has led to a focused development program for CIAS. A Phase 2a proof-of-mechanism study in CIAS patients demonstrated a clinically meaningful pro-cognitive profile and target engagement via qEEG biomarkers, alongside good tolerability.[7]