ReviewJournal of clinical pharmacology2026
The Effect of Iclepertin on Hematological Parameters: An Overview of Nonclinical Studies and Clinical Trials in Healthy Volunteers and Patients with Cognitive Impairment Associated with Schizophrenia.
Review in Journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Pharmacokinetic/pharmacodynamic analysis to characterize the effect of long-term GlyT1 inhibitor iclepertin exposure on hemoglobin levels.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
There are currently no approved pharmacotherapies to treat cognitive impairment associated with schizophrenia (CIAS). Iclepertin (BI 425809) is a selective glycine transporter-1 (GlyT1) inhibitor that was investigated for the treatment of CIAS. As hemoglobin reduction is considered a class effect of GlyT1 inhibitors, nonclinical studies and clinical trials were assessed to determine if this effect applied to iclepertin. Nonclinical studies of iclepertin-treated rodents demonstrated a reversible reduction in hemoglobin versus vehicle-control animals. Pooled Phase I data from healthy volunteers (N = 391) showed no clinically relevant changes in hemoglobin. Analysis of Phase II, 12-week, randomized-controlled trials in patients with CIAS (N = 709) receiving placebo or iclepertin 2, 5, 10, or 25 mg demonstrated a small hemoglobin decrease in the 10-mg group and, in the 25-mg group, a dose- and pharmacokinetic-dependent, mild hemoglobin decrease that recovered slightly at post-treatment follow-up (Week 16). Pooled data from the Phase III CONNEX trial program, which included three 26-week, randomized-controlled trials (N = 1835), and one 52-week open-label extension (N = 1356) in patients with CIAS, showed that iclepertin was well-tolerated. In placebo-treated patients, hemoglobin concentration was stable, with small fluctuations over 26 weeks. In iclepertin-treated patients, hemoglobin concentration dropped within the first 18 weeks (mean change vs baseline, -2.4 g/L) and remained stable until the end of treatment (≤78 weeks). As the primary and secondary CIAS efficacy endpoints were not met, the CONNEX trial program was terminated. Findings from these nonclinical studies and clinical trials suggest reversible mean hemoglobin reductions were of limited significance and iclepertin was well-tolerated with a consistent safety profile.
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Registered trials
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