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Research Report
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/30 | Phase 2 | Completed | Recognify Life Sciences |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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