Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
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 |
|---|---|---|---|---|---|
2023/01/17 | Phase 2 | Recruiting | Recognify Life Sciences | ||
2021/03/30 | Phase 2 | Completed | Recognify Life Sciences |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.