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Iclepertin

Alternative Names: Iclepertin, bi-425809, bi425809, bi 425809
Latest Update: 2025-04-04
Latest Update Note: Clinical Trial Update

Product Description

BI 425809, a novel glycine transporter-1 (GlyT1) inhibitor, forms a key component of Boehringer Ingelheim’s Mental Health research program. (Sourced from: https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheims-investigational-treatment-cognitive-impairment-associated)

Mechanisms of Action: GlyT1 Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Breakthrough Therapy - Schizophrenia *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Iclepertin

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Active Clinical Trial Count: 19

Highest Development Phases

Phase 3: Schizophrenia

Phase 1: Healthy Volunteers|Hepatic Insufficiency|Kidney Diseases|Liver Failure

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
jRCT2061220034

P3

Recruiting

Schizophrenia

2025-08-31

2020-003745-11

P3

Active, not recruiting

Schizophrenia

2025-04-25

1346-0014

P3

Completed

Schizophrenia

2025-01-15

CONNEX-3

P3

Completed

Schizophrenia

2024-10-28

Recent News Events

Date

Type

Title

01/16/2025

News Article

 Boehringer provides update on iclepertin Phase III program in schizophrenia

05/06/2024

PubMed

 Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments.

04/23/2024

PubMed

 Beyond dopamine: Novel strategies for schizophrenia treatment.

03/11/2024

News Article

 Boehringer Ingelheim and Sosei Heptares join forces to develop first-in-class treatments targeting all symptoms of schizophrenia

11/01/2023

PubMed

 Stable isotope synthesis of glycine transporter 1 inhibitor Iclepertin (BI 425809) and its major metabolites.

08/05/2021

News Article

 Schizophrenia Drug Pipeline Market Research Report 2021 - ResearchAndMarkets.com

05/24/2021

News Article

 Boehringer Ingelheim's Investigational Treatment for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation

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