Clinical Trials
Numerous clinical trials evaluate vericiguat across Phase 1 through Phase 4 for indications including chronic heart failure with reduced ejection fraction, metabolic syndrome, coronary microvascular dysfunction, and calcific aortic valve disease. Spearheaded by pharmaceutical sponsors alongside academic medical centers, these initiatives encompass pivotal Phase 3 outcome studies evaluating long-term therapeutic efficacy. Spanning completed, active, recruiting, and uninitiated protocols, these programs continuously examine the drug's safety, pharmacokinetic profile, and real-world treatment titration.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05714085 | RECRUITING | Heart Failure; Left Ventricular Systolic Dysfunction |
Merck Sharp & Dohme LLC |
2023-05-31 | PHASE2; PHASE3 |
| NCT07715279 | NOT_YET_RECRUITING | Calcific Aortic Valve Disease; AORTIC VALVE DISEASES; Aortic Valve Stenosis |
West China Hospital |
2026-08-20 | PHASE2 |
| NCT07594509 | NOT_YET_RECRUITING | Cardio Vascular Disease; Cardiopulmonary Bypass |
Nanjing Medical University |
2026-05-31 | |
| NCT05806138 | ACTIVE_NOT_RECRUITING | Breast Cancer; Cardiac Dysfunction |
Memorial Sloan Kettering Cancer Center |
2023-07-17 | PHASE2 |
| NCT06601465 | RECRUITING | Heart Failure; Cognitive Impairment |
University of Alberta |
2025-06-03 | PHASE2 |
| NCT05812755 | RECRUITING | Endothelial Dysfunction; Vascular Diseases; Kidney Injury; Brain Disease; Vascular Inflammation |
Vanderbilt University Medical Center |
2023-05-19 | PHASE4 |
| NCT07668739 | NOT_YET_RECRUITING | HFrEF; Tricuspid Regurgitation (TR) |
Daejeon St. Mary's hospital |
2026-07-01 | PHASE4 |
| NCT06320951 | NOT_YET_RECRUITING | Cardiovascular Diseases; Insulin Sensitivity/Resistance; Metabolic Disease; Metabolism; Energy Expenditure; Obesity |
University of Alabama at Birmingham |
2026-12-01 | PHASE2 |
| NCT06239974 | RECRUITING | Chest Pain |
The University of Hong Kong |
2024-09-01 | |
| NCT07405944 | RECRUITING | Heart Failure With Reduced Ejection Fraction (HFrEF); Chronic Heart Failure |
University Medical Centre Ljubljana |
2025-11-01 | PHASE4 |
| NCT07697833 | NOT_YET_RECRUITING | Heart Failure With Reduced Ejection Fraction (HFrEF) |
National Institute of Cardiovascular Diseases, Pakistan |
2026-07-15 | PHASE4 |
| NCT06415227 | COMPLETED | Vasospastic Angina |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2025-02-10 | PHASE2 |
| NCT06812546 | NOT_YET_RECRUITING | Heart Failure; Acute Myocardial Infarction (AMI); Acute Heart Failure (AHF) |
Dongying Zhang |
2025-04-01 | PHASE4 |
| NCT07047547 | RECRUITING | Hemodialysis Complication; Heart Failure |
Guangdong Provincial People's Hospital |
2025-06-01 | |
| NCT05697640 | ACTIVE_NOT_RECRUITING | Post-COVID ME/CFS |
Charite University, Berlin, Germany |
2023-06-22 | PHASE2 |
| NCT07444398 | RECRUITING | Decompensated Heart Failure |
Khawaja Danish Ali |
2026-01-01 | PHASE1 |
| NCT05704478 | ACTIVE_NOT_RECRUITING | Heart Failure |
University of Colorado, Denver |
2024-01-01 | PHASE4 |
| NCT05711719 | COMPLETED | Metabolic Syndrome; Coronary Microvascular Dysfunction |
Johns Hopkins University |
2023-06-16 | PHASE2 |
| NCT06671990 | NOT_YET_RECRUITING | Heart Failure; Pulmonary Arterial Hypertension |
Finn Gustafsson |
2024-12-01 | PHASE4 |
| NCT05093933 | COMPLETED | Chronic Heart Failure With Reduced Ejection Fraction |
Merck Sharp & Dohme LLC |
2021-11-02 | PHASE3 |
| NCT05420012 | COMPLETED | Heart Failure; Heart Failure With Reduced Ejection Fraction (HFrEF) |
Josef Stehlik |
2023-05-01 | PHASE4 |
| NCT06474208 | COMPLETED | Heart Failure |
Bayer |
2024-07-01 | PHASE1 |
| NCT05658458 | COMPLETED | Chronic Heart Failure With Reduced Ejection Fraction; Worsening Heart Failure |
Bayer |
2022-12-16 | PHASE4 |
| NCT06195930 | COMPLETED | Chronic Heart Failure With Reduced Ejection Fraction |
Bayer |
2024-04-18 | PHASE2 |
| NCT06363110 | Active not recruiting | Chronic Heart Failure With Reduced Ejection Fraction |
Bayer |
2024-04-10 | -- |
| NCT06148935 | Recruiting | Chronic Heart Failure With Reduced Ejection Fraction |
Bayer |
2023-11-30 | -- |
| NCT05974189 | Active not recruiting | Chronic Heart Failure With Reduced Ejection Fraction |
Bayer |
2023-07-11 | -- |
| NCT05711719 | Recruiting | Metabolic Syndrome|Coronary Microvascular Dysfunction |
Johns Hopkins University|Merck Sharp & Dohme LLC |
2023-06-16 | Phase 2 |
| NCT05086952 | COMPLETED | Heart Failure; Children |
Bayer |
2021-10-12 | PHASE1 |
| NCT03547583 | COMPLETED | Chronic Heart Failure With Preserved Ejection Fraction |
Bayer |
2018-06-15 | PHASE2 |
| NCT02861534 | COMPLETED | Heart Failure; Chronic Heart Failure With Reduced Ejection Fraction |
Merck Sharp & Dohme LLC |
2016-09-20 | PHASE3 |
| NCT03504982 | COMPLETED | Coronary Artery Disease |
Bayer |
2018-05-17 | PHASE1 |
| NCT03255512 | COMPLETED | Coronary Artery Disease |
Bayer |
2017-08-17 | PHASE1 |
| NCT03145038 | COMPLETED | Pharmacokinetics |
Bayer |
2017-05-16 | PHASE1 |
| NCT02617550 | COMPLETED | Coronary Artery Disease |
Bayer |
2015-11-18 | PHASE1 |
| NCT01951638 | COMPLETED | Heart Failure |
Bayer |
2013-11-06 | PHASE2 |
| NCT01951625 | COMPLETED | Heart Failure |
Bayer |
2013-11-29 | PHASE2 |
| NCT04722484 | COMPLETED | Heart Failure |
Bayer |
2014-06-12 | PHASE1 |
| NCT04722562 | COMPLETED | Heart Failure |
Bayer |
2014-07-16 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-28)
Check the
Vericiguat
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.