Trial reportHypertension research : official journal of the Japanese Society of Hypertension2023
Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers.
Trial report in Hypertension research : official journal of the Japanese Society of Hypertension, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05500820 (A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CIN-107 Following Multiple Oral Doses in Healthy Subjects), which is not on this map. Cited by 42 papers, 6 of them syntheses 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.
A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CIN-107 Following Multiple Oral Doses in Healthy Subjects
Who cites it
42 citing papers in PubMed, 6 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Baxdrostat in Resistant and Uncontrolled Hypertension: A Systematic Review and Meta-Analysis.Cardiovascular drugs and therapy · 2026Pooled it
- Efficacy and Safety of Baxdrostat for Hypertension: A Systematic Review and Meta-Analysis of Three Phase 2/3 Randomized Controlled Trials.Clinical cardiology · 2026Pooled it
- Aldosterone Synthase Inhibitors for Resistant Hypertension: Pharmacological Insights - A Systematic Review.Drugs · 2025Pooled it
- Efficacy and Safety of Aldosterone Synthase Inhibitors in Hypertension: A Systematic Review and Meta-Analysis.Endocrinology, diabetes & metabolism · 2025Pooled it
- Blood Pressure-Lowering Effects of Aldosterone Synthase Inhibitors-A Systematic Review.Basic & clinical pharmacology & toxicology · 2025Pooled it
- Systematic Review Article: New Drug Strategies for Treating Resistant Hypertension-the Importance of a Mechanistic, Personalized Approach.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2024Pooled it
- No Evidence of QTc Interval Prolongation With Baxdrostat Treatment: Concentration-QTc Modeling Assessment.Pharmacology research & perspectives · 2025Trial
- Phase 1 studies of the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 690517 (vicadrostat), a novel aldosterone synthase inhibitor, in healthy male volunteers.Naunyn-Schmiedeberg's archives of pharmacology · 2025Trial
- Results From a Randomized, Open-Label, Crossover Study Evaluating the Effect of the Aldosterone Synthase Inhibitor Baxdrostat on the Pharmacokinetics of Metformin in Healthy Human Subjects.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023 · on this mapTrial
- Baxdrostat: First Approval.Drugs · 2026Review
- Baxdrostat (BaxfendyMedicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents · 2026Article
- Aldosterone Synthase Inhibitors: Emerging Therapeutic Strategies in Resistant Hypertension.Life (Basel, Switzerland) · 2026Review
- Aldosterone synthase inhibitors: a new option for antihypertensive, cardio-renal protection.Hypertension research : official journal of the Japanese Society of Hypertension · 2026Review
- Baxdrostat versus osilodrostat: steroid biosynthesis in human adrenocortical cells.Endocrine connections · 2026Article
- Combined Aldosterone Synthase and SGLT2 Inhibition: A Recipe for Success in CKD with Uncontrolled Blood Pressure?Current hypertension reports · 2026Review
- Emerging Medical Therapies for Primary Aldosteronism.Hypertension (Dallas, Tex. : 1979) · 2026Review
- Review
- Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial.Journal of the American Society of Nephrology : JASN · 2026Article
- Risk of Hypertension and Chronic Kidney Disease Following Aldosterone Dysregulation.American journal of hypertension · 2026Article
- Comparing Efficacy and Safety of Different Aldosterone Synthase Inhibitors for Hypertension: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.Clinical Medicine Insights. Cardiology · 2026Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Baxdrostat is a selective inhibitor of aldosterone synthase designed for the treatment of disorders associated with elevated aldosterone. This study evaluated the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of baxdrostat in healthy volunteers. Subjects were randomized to receive oral baxdrostat (0.5, 1.5, 2.5, or 5.0 mg) or placebo once daily for 10 days and were placed on either a low-salt or normal-salt diet for the duration of the study. Blood samples were collected before and after dosing on days 1 and 10 to characterize pharmacokinetics and pharmacodynamics. Safety was assessed by adverse events, physical examinations, electrocardiograms, orthostatic vital signs, and clinical laboratory evaluations. Fifty-four subjects completed the study. There were no deaths or serious adverse events, and all treatment-emergent adverse events in subjects receiving baxdrostat were mild in severity. Plasma levels of baxdrostat increased proportionally with ascending doses, with peak concentrations observed within 4 h after dosing and a mean half-life of 26 to 31 h. A dose-dependent reduction of plasma aldosterone occurred with baxdrostat doses ≥1.5 mg, regardless of diet. Decreases in plasma aldosterone were sustained, with levels reduced by approximately 51 to 73% on day 10. Baxdrostat had no meaningful impact on plasma cortisol levels and resulted in mild dose-dependent decreases in plasma sodium levels and increases in potassium levels. Baxdrostat was safe and well tolerated with a half-life that supports once-daily dosing. The dose-dependent reduction in plasma aldosterone and lack of effect on cortisol demonstrate the selective blockade of aldosterone synthase.
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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.