Verquvo

(Vericiguat)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Verquvo is a small molecule that works as a Sgc Stimulator.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Verquvo is one of 286 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

285

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionRecruiting

Acute Myocardial InfarctionNot yet recruiting

Chest PainRecruiting

Myocardial InfarctionActive, not recruiting

Breast CancerActive, not recruiting

Heart FailureCompleted

Chronic Kidney DiseaseActive, not recruiting

CARNot yet recruiting

Heart Failure With Reduced Ejection Fraction (hfref)Not yet recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionApproved

Recruiting

Acute Myocardial InfarctionApproved

Not yet recruiting

Chest PainPreclinical

Recruiting

Myocardial InfarctionPreclinical

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Heart FailureApproved

Completed

Chronic Kidney DiseasePreclinical

Active, not recruiting

CARPhase 2

Not yet recruiting

Heart Failure With Reduced Ejection Fraction (hfref)Approved

Not yet recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Spravato

WWim Janssens

Preclinical

2 9

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Acute Myocardial Infarction

NCT06812546

Phase 2Active, not recruiting

COVID-19

NCT05697640

Active, not recruiting

Chronic Heart Failure

NCT07877831

Q1 2027

Post-ApprovalActive, not recruiting

Heart Failure

NCT05704478

Q3 2027

ApprovedNot yet recruiting

Heart Failure With Reduced Ejection Fraction (hfref)

NCT07697833

PreclinicalRecruiting

Chest Pain

NCT06239974

Clinical

Trials by Indication[1]

Heart Failure14 trials

An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan

Completed· Bayer logo

Bayer··NCT06697353·4,936 enrolled

An Observational Study, Called VERI-China, to Learn More About How Well Vericiguat Works and How Safe it is in Real-world Setting in People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in China

Completed· Bayer logo

Bayer··NCT05728502·2,400 enrolled

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

Completed· Bayer logo

Bayer·Phase 2·NCT01951638·477 enrolled

Show 11 more trials

A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction

Completed· Bayer logo

Bayer·Phase 2·NCT06195930·106 enrolled

A Study to Learn How Well the Drug Vericiguat Works and How Safe it is Under Real World Conditions in Indian Participants After Worsening of a Long-term Heart Condition in Which the Left Side of the Heart Does Not Pump Blood as Well as it Should (Chronic Heart Failure With Reduced Ejection Fraction)

Completed· Bayer logo

Bayer·Phase 4·NCT05658458·205 enrolled

A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT05093933·6,106 enrolled

A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02861534·5,050 enrolled

The CardioMEMS Vericiguat Heart Failure Trial

Not yet recruiting·FFinn Gustafsson·Phase 4·NCT06671990·17 enrolled

Impact of Vericiguat on Hemodynamics of Heart Failure

Active, not recruiting·UUniversity of Colorado, Denver·Phase 4·NCT05704478·30 enrolled

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

Completed· Bayer logo

Bayer·Phase 2·NCT01951625·456 enrolled

An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States

Completed· Bayer logo

Bayer··NCT06363110·1,400 enrolled

A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT05714085·342 enrolled

Metabolic Remodelling in Worsening Heart Failure Treated With Vericiguat: A Prospective Multi-Omics Study Integrating Cardiac Imaging and Endothelial Function

Not yet recruiting·UUniversity of Salerno··NCT07901270·30 enrolled

CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure

Recruiting·UUniversity of Alberta·Phase 2·NCT06601465·120 enrolled

Chronic Heart Failure With Reduced Ejection Fraction3 trials

Retrospective, Non-interventional Database Study for the Evaluation of Real-world Drug Use Patterns, Clinical Characteristics and Clinical Outcomes in Patients Initiated on Vericiguat in India

Completed· Bayer logo

Bayer··NCT06632483·604 enrolled

Real World Outcomes of Patients Treated With Vericiguat in German Routine Care

Completed· Bayer logo

Bayer··NCT06486844·500 enrolled

Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction

Recruiting· Bayer logo

Bayer··NCT06148935·1,350 enrolled

Coronary Artery Disease2 trials

Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients

Completed· Bayer logo

Bayer·Phase 1·NCT02617550·36 enrolled

Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients

Completed· Bayer logo

Bayer·Phase 1·NCT03255512·41 enrolled

Chronic Heart Failure2 trials

Association Between Vericiguat Treatment and Incident Atrial Fibrillation in Patients With Chronic Heart Failure: An Ambispective Cohort Study

Active, not recruiting·BBeijing Tsinghua Chang Gung Hospital··NCT07877831·918 enrolled

Vericiguat Drug Use Two-arm Investigation in Chronic Heart Failure

Recruiting· Bayer logo

Bayer··NCT05666518·1,400 enrolled

Heart Failure With Reduced Ejection Fraction (HFrEF)2 trials

Vericiguat's Effects on Reverse Remodeling Indices: Pathophysiologic Approach to Treatment of Heart Failure With Reduced Ejection Fraction

Recruiting·UUniversity Medical Centre Ljubljana·Approved·NCT07405944·70 enrolled

Comparing the Efficacy and Safety of Vericiguat With Standard Medical Treatment in Patients With Heart Failure and Reduced Ejection Fraction: Randomized, Placebo-controlled, Parallel-group, Double-blind Trial

Not yet recruiting·NNational Institute of Cardiovascular Diseases, Pakistan·Approved·NCT07697833·500 enrolled

21 more indications

Vascular Function1 trial

The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation

Completed·JJosef Stehlik·Phase 4·NCT05420012·26 enrolled

Pediatric1 trial

Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects

Completed· Bayer logo

Bayer·Phase 1·NCT03145038·30 enrolled

Outcome1 trial

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

Completed· Bayer logo

Bayer·Phase 2·NCT03547583·789 enrolled

Single Dose1 trial

A Study in Healthy Adult Male Participants to Learn the Way Vericiguat is Absorbed With and Without Food When Taken as a Single Dose in Liquid Form Suitable for Children Compared to a 10 Milligram (mg) Tablet That Releases the Active Substance Immediately

Completed· Bayer logo

Bayer·Phase 1·NCT05086952·36 enrolled

Myocardial Infarction1 trial

Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

Not yet recruiting·QQilu Hospital of Shandong University··NCT06717204·210 enrolled

TIA1 trial

Study to Evaluate the QT / QTc Interval Prolongation Potential of Vericiguat

Completed· Bayer logo

Bayer·Phase 1·NCT03504982·74 enrolled

Cardiac Failure1 trial

Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial

Recruiting·KKhawaja Danish Ali·Phase 1·NCT07444398·130 enrolled

Kidney Disease1 trial

A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Kidney Disease and in Age-, Weight- and Gender-matched Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT04722484·39 enrolled

CAR1 trial

VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway

Not yet recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT06320951·200 enrolled

COVID-191 trial

Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome

Active, not recruiting·—·Phase 2·NCT05697640·104 enrolled

Liver Disease1 trial

A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT04722562·27 enrolled

Acute Myocardial Infarction1 trial

Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction

Not yet recruiting·DDongying Zhang·Phase 4·NCT06812546·200 enrolled

Metabolic Syndrome1 trial

Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

Completed·JJohns Hopkins University·Phase 2·NCT05711719·45 enrolled

Chronic Kidney Disease1 trial

A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure

Recruiting·GGuangdong Provincial People's Hospital·N/A·NCT07047547·118 enrolled

Calcific Aortic Valve Disease1 trial

Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (VERIFICATION Study)

Recruiting·WWest China Hospital·Phase 2·NCT07715279·238 enrolled

Endothelial Dysfunction1 trial

The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery

Recruiting·VVanderbilt University Medical Center·Approved·NCT05812755·170 enrolled

Breast Cancer1 trial

A Randomized Controlled Trial of the Soluble Guanylate Cyclase Stimulator Vericiguat in Patients With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction (ELEVATE)

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05806138·21 enrolled

Vasospastic Angina1 trial

Vericiguat in Vasospastic Angina

Completed·AAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Phase 2·NCT06415227·57 enrolled

Heart Failure With Reduced Ejection Fraction1 trial

The Effect of Vericiguat on Exercise Hemodynamics and Exercise Tolerance in Patients With Heart Failure and Reduced Ejection Fraction: The EVERHETT-HF Prospective Observational Cohort Study

Completed·AArgyrios Ntalianis··NCT07697365·40 enrolled

Chest pain1 trial

Randomised Controlled Trial of Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)

Recruiting·TThe University of Hong Kong·Preclinical·NCT06239974·94 enrolled

HFrEF1 trial

Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial

Not yet recruiting·DDaejeon St. Mary's hospital·Approved·NCT07668739·100 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 19, 2021

VERQUVO

NDA NDA214377

Nov 21, 2022

VERQUVO

NDA NDA214377

May 10, 2023

VERQUVO

NDA NDA214377

Jan 21, 2026

VERQUVO

NDA NDA214377

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Vericiguat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vericiguat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Vericiguat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214377). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Verquvo. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Vericiguat. U.S. National Library of Medicine.
[7]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sgc Stimulator[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[5]

Patent Cliff

May 19, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9993476May 19, 2031

8921377May 19, 2031

11439642May 19, 2031

10736896May 19, 2031

8420656May 19, 2031

1 more patents

9604948Nov 26, 2032

Key Publications[6]

Vericiguat in Heart Failure With Reduced Ejection Fraction: VICTORIA Long-Term

JAMA CardiolDec 7, 2022DOI: 10.1001/jamacardio.2022.4284

Verquvo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Heart Failure14 trials

Chronic Heart Failure With Reduced Ejection Fraction3 trials

Coronary Artery Disease2 trials

Chronic Heart Failure2 trials

Heart Failure With Reduced Ejection Fraction (HFrEF)2 trials

Vascular Function1 trial

Pediatric1 trial

Outcome1 trial

Single Dose1 trial

Myocardial Infarction1 trial

TIA1 trial

Cardiac Failure1 trial

Kidney Disease1 trial

CAR1 trial

COVID-191 trial

Liver Disease1 trial

Acute Myocardial Infarction1 trial

Metabolic Syndrome1 trial

Chronic Kidney Disease1 trial

Calcific Aortic Valve Disease1 trial

Endothelial Dysfunction1 trial

Breast Cancer1 trial

Vasospastic Angina1 trial

Heart Failure With Reduced Ejection Fraction1 trial

Chest pain1 trial

HFrEF1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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