Iclepertin

DRUG7 trials

Sponsors

Boehringer Ingelheim

Conditions

HealthyHepatic InsufficiencySchizophrenia

Phase 1

A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

CompletedNCT05613777

Boehringer IngelheimHealthy

Start: 2022-11-24End: 2023-10-04Updated: 2026-05-06

A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems

CompletedNCT05731895

Boehringer IngelheimHepatic Insufficiency

Start: 2023-03-08End: 2023-12-11Updated: 2026-04-24

A Study in Healthy People to Test Whether Iclepertin Has an Effect on Cardiac Safety

CompletedNCT06070597

Boehringer IngelheimHealthy

Start: 2024-01-25End: 2024-06-05Updated: 2024-07-09

Phase 3

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

CompletedNCT04846868

Boehringer IngelheimSchizophrenia

Start: 2021-09-08End: 2024-10-01Updated: 2025-11-05

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

CompletedNCT04846881

Boehringer IngelheimSchizophrenia

Start: 2021-08-24End: 2024-11-17Updated: 2025-12-12

CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia

CompletedNCT04860830

Boehringer IngelheimSchizophrenia

Start: 2021-08-09End: 2024-11-20Updated: 2026-02-06

A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study

TerminatedNCT05211947

Boehringer IngelheimSchizophrenia

Start: 2022-03-21End: 2025-03-18Updated: 2026-04-08

Related Papers

The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies

Drugs in R&D2026-03-28

Efficacy and safety of iclepertin for cognitive impairment associated with schizophrenia (CONNEX programme): results from three phase 3 randomised controlled trials.

2025-12-011 citations

The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females.

2025-09-04

Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia.

2024-12-141 citations

CONNEX, a Phase III Randomized Trial Program Assessing Efficacy and Safety of Iclepertin in Schizophrenia: Recruitment and Baseline Characteristics

BJPsych Open2024-06-01

The Phase III CONNEX programme assessing the efficacy and safety of iclepertin in patients with schizophrenia: Trial design and recruitment update

European Psychiatry2024-04-011 citations

Preliminary data from the CONNEX-X extension trial examining the long-term safety of iclepertin in patients with schizophrenia who completed Phase III CONNEX trials

European Psychiatry2024-04-01

Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program

CNS Spectrums2023-04-012 citations