Overview
Osoresnontrine is under investigation in clinical trial NCT02281773 (A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Report on Osoresnontrine (BI-409306): An Investigational PDE9A Inhibitor
Executive Summary
Osoresnontrine, identified by the developmental code BI-409306, is an orally bioavailable, small molecule compound developed by Boehringer Ingelheim as a potent and selective inhibitor of the enzyme phosphodiesterase 9A (PDE9A).[1] The therapeutic rationale for its development was predicated on a well-defined neurobiological hypothesis: the inhibition of PDE9A, an enzyme highly expressed in cognition-relevant brain regions, would lead to an elevation of intracellular cyclic guanosine monophosphate (cGMP) levels. This biochemical change was expected to enhance N-methyl-D-aspartate (NMDA) receptor-dependent signaling pathways, which are fundamental to synaptic plasticity, learning, and memory.[1] Consequently, Osoresnontrine was advanced into clinical trials as a potential symptomatic treatment for the cognitive impairments associated with Alzheimer's disease and schizophrenia, two conditions with significant unmet medical needs.
Preclinical investigations provided a robust foundation for this hypothesis, with rodent models demonstrating that Osoresnontrine successfully crossed the blood-brain barrier, engaged its target to increase brain cGMP levels, enhanced long-term potentiation (a cellular correlate of memory), and improved performance in cognitive tasks.[1] Crucially, this mechanism was confirmed in human subjects, where the drug produced a dose-dependent increase in cGMP in the cerebrospinal fluid (CSF), providing clear evidence of target engagement within the central nervous system.[6]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/10/26 | Phase 1 | Completed | |||
2019/05/01 | Phase 1 | Completed | |||
2018/04/23 | Phase 1 | Completed | |||
2017/11/22 | Phase 2 | Terminated | |||
2017/07/26 | Phase 2 | Terminated | |||
2017/06/20 | Phase 1 | Completed | |||
2017/05/12 | Phase 1 | Completed | |||
2015/12/21 | Phase 1 | Completed | |||
2015/05/08 | Phase 1 | Completed | |||
2015/01/14 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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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
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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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
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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