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Osoresnontrine

Generic Name
Osoresnontrine
Drug Type
Small Molecule
Chemical Formula
C16H17N5O2
CAS Number
1189767-28-9
Unique Ingredient Identifier
O9OC34WOAY

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

Published: Sep 24, 2025

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]

Continue reading the full research report

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

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Effective Date
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

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Status
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No TGA approvals found for this drug.

Health Canada Drug Approvals

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Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Prescription Type
Status
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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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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