Trial reportEuropean journal of clinical pharmacology2021
Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat: results from six phase I studies in healthy subjects.
Trial report in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 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
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.
- Analysis of research trends and development prospects of soluble guanylate cyclase stimulators/activators: using bibliometric methods.Frontiers in pharmacology · 2025Pooled it
- Safety, pharmacokinetic, and pharmacodynamic characteristics of SK-08, a soluble guanylate cyclase activator, after oral administration in healthy participants: a randomized phase 1 trial.BMC nephrology · 2026Trial
- Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials.Naunyn-Schmiedeberg's archives of pharmacology · 2024Trial
- First-in-human trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of zagociguat (CY6463), a CNS-penetrant soluble guanylyl cyclase stimulator.Clinical and translational science · 2023Trial
- Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023Trial
- Evaluation of the Influence of Sildenafil on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vericiguat in Healthy Adults.Clinical pharmacokinetics · 2023Trial
- Vericiguat in Combination with Short-Acting Nitroglycerin in Patients With Chronic Coronary Syndromes: The Randomized, Phase Ib, VENICE Study.Clinical pharmacology and therapeutics · 2022Trial
- Vericiguat in combination with isosorbide mononitrate in patients with chronic coronary syndromes: The randomized, phase Ib, VISOR study.Clinical and translational science · 2022Trial
- Vericiguat: A New Horizon for Heart Failure Treatment.Reviews in cardiovascular medicine · 2026Review
- Food-drug interactions of novel drugs used in cardiologic and diabetic patients - a PRISMA scoping review.Frontiers in pharmacology · 2026Review
- The Role of Vericiguat in Heart Failure Therapy: From Clinical Trials to Clinical Practice.Reviews in cardiovascular medicine · 2025Review
- Vericiguat: A Promising Drug for the Treatment of Heart Failure.Current cardiology reviews · 2025Review
- Evaluating haemodynamic changes: vericiguat in patients with heart failure with reduced ejection fraction.ESC heart failure · 2024Article
- Fluid Restriction for Patients with Heart Failure: Current Evidence and Future Perspectives.Journal of personalized medicine · 2024Review
- Towards the Fifth Pillar for the Treatment of Heart Failure with Reduced Ejection Fraction: Vericiguat in Older and Complex Patients.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024Review
- Clinical Pharmacokinetic and Pharmacodynamic Profile of Vericiguat.Clinical pharmacokinetics · 2024Review
- Applied physiologically-based pharmacokinetic modeling to assess uridine diphosphate-glucuronosyltransferase-mediated drug-drug interactions for Vericiguat.CPT: pharmacometrics & systems pharmacology · 2024Article
- Vericiguat suppresses ventricular tachyarrhythmias inducibility in a rabbit myocardial infarction model.PloS one · 2024Article
- Safety, tolerability, pharmacokinetics, and pharmacodynamics of a soluble guanylate cyclase stimulator, HEC95468, in healthy volunteers: a randomized, double-blinded, placebo-controlled phase 1 trial.Frontiers in pharmacology · 2024Article
- An Investigation of Pharmacokinetic Interaction of Vericiguat with Apigenin based on a Newly Developed Ultra-performance Liquid Chromatography-tandem Mass Spectrometry Assay.Current medicinal chemistry · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo characterize the safety, pharmacodynamics, and pharmacokinetics (PK) of vericiguat in healthy males.
methodsSix phase I studies were conducted in European, Chinese, and Japanese males. Subjects received oral vericiguat as a single dose (0.5-15.0 mg solution [for first-in-human study] or 1.25-10.0 mg immediate release [IR tablets]) or multiple doses (1.25-10.0 mg IR tablets once daily [QD] or 5.0 mg IR tablets twice daily for 7 consecutive days). Bioavailability and food effects on vericiguat PK (IR tablets) were also studied in European subjects.
resultsOverall, 255 of 265 randomized subjects completed their respective studies. There were no deaths or serious adverse events. Vericiguat was generally well tolerated at doses ≤ 10.0 mg. In the first-in-human study, the most frequent drug-related adverse events were headache and postural dizziness (experienced by five subjects each [7.2%]). Three of four subjects who received vericiguat 15.0 mg (oral solution, fasted) experienced orthostatic reactions. Vericiguat (≤ 10.0 mg, IR tablets) was rapidly absorbed (median time to reach maximum plasma concentration ≤ 2.5 h [fasted]) with a mean half-life of about 22.0 h (range 17.9-27.0 h for single and multiple doses). No evidence for deviation from dose proportionality or unexpected accumulation was observed. Administration of vericiguat 5.0 mg IR tablets with food increased bioavailability by 19% (estimated ratio 119% [90% confidence interval]: 108; 131]), reduced PK variability, and prolonged vericiguat absorption relative to the fasted state.
conclusionIn general, vericiguat was well tolerated. These results supported further clinical evaluation of vericiguat QD in patients with heart failure. REGISTRY NUMBERS: EudraCT: 2011-001627-21; EudraCT: 2012-000953-30.
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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.