ArticleDrug design, development and therapy2019
Effect of hepatic and renal impairment on the pharmacokinetics of olanzapine and samidorphan given in combination as a bilayer tablet.
Article in Drug design, development and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021Pooled it
- Samidorphan sadness: does the addition of samidorphan to olanzapine have prodepressive effects?International clinical psychopharmacology · 2026Article
- Beyond antipsychotic efficacy and toward an individualized therapeutic strategy: analysis of the systemic, metabolic, and inflammatory effects of olanzapine, haloperidol, and their combination in schizophrenic patients.Frontiers in pharmacology · 2026Article
- Analysis of Current Industry Practices for Informing Dosing Recommendation for Patients With Renal Impairment.Clinical and translational science · 2026Review
- Acute inflammation induced by the Escherichia coli lipopolysaccharide considerably increases the systemic and brain exposure of olanzapine after oral administration in mice.The international journal of neuropsychopharmacology · 2025Article
- New Agents in the Treatment of Psychiatric Disorders: What Innovations and in What Areas of Psychopathology?Pharmaceuticals (Basel, Switzerland) · 2025Review
- Olanzapine Pharmacokinetics: A Clinical Review of Current Insights and Remaining Questions.Pharmacogenomics and personalized medicine · 2023Review
- Combination Olanzapine and Samidorphan for the Management of Schizophrenia and Bipolar 1 Disorder in Adults: A Narrative Review.Health psychology research · 2022Review
- Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia.Journal of clinical pharmacology · 2021Article
- Using physiologically-based pharmacokinetic modeling for predicting the effects of hepatic impairment on the pharmacokinetics of olanzapine and samidorphan given as a combination tablet.CPT: pharmacometrics & systems pharmacology · 2021Article
- Effects of 5-HTClinical and translational science · 2021Article
- Olanzapine/Samidorphan: First Approval.Drugs · 2021Review
- An Evidence-Based Review of OLZ/SAM for Treatment of Adults with Schizophrenia or Bipolar I Disorder.Neuropsychiatric disease and treatment · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA combination of olanzapine and samidorphan (OLZ/SAM) is in development to provide the established antipsychotic efficacy of olanzapine while mitigating olanzapine-induced weight gain.
methodsTwo multicenter, open-label, parallel-cohort studies were performed to evaluate the effect of moderate hepatic impairment (Child-Pugh score 7-9 [class B]; study 1) and severe renal impairment (estimated glomerular filtration rate: 15-29 mL/min/1.73 m
resultsThere was a 1.67-fold increase in area under the plasma concentration-time curve from time 0 to infinity (AUC
conclusionOLZ/SAM 5/10 mg was generally well tolerated under the conditions of the studies, with a safety profile consistent with that observed in other clinical studies of OLZ/SAM.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.