VERQUVO (vericiguat)
Verquvo helps patients with symptomatic chronic heart failure who have an ejection fraction of less than 45%. It is used for adults who have recently experienced a heart failure hospitalization or required outpatient IV diuretics. This medication helps reduce the risk of cardiovascular death and future hospitalizations related to heart failure.
How VERQUVO Works
Vericiguat is a direct stimulator of soluble guanylate cyclase (sGC), an enzyme in the nitric oxide (NO) signaling pathway. It works by directly stimulating sGC independently of NO and by acting synergistically with endogenous NO to increase intracellular cGMP levels. This augmentation of cGMP promotes smooth muscle relaxation and vasodilation, while also playing a role in regulating cardiac contractility and remodeling, addressing the impaired NO-sGC-cGMP signaling pathway characteristic of heart failure.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-01-19
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
VERQUVO Approval History
What VERQUVO Treats
1 indicationsVERQUVO is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heart Failure
VERQUVO Boxed Warning
EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full pr...
WARNING: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Do not administer VERQUVO to a pregnant female because it may cause fetal harm. ( 4 , 5.1 , 8.1 ) Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. ( 2.2 , 5.1 , 8.3 )
VERQUVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VERQUVO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07405944 VERI-PATH | 0120-5/2025-2711-3 | Ph 4 | recruiting | Vericiguat and Reverse Remodeling Indices in Heart Failure |
| NCT05711719 results posted | IRB00310207 | Ph 2 | completed | Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction |
| NCT05093933 VICTOR results posted | 1242-035 MK-1242-035, 2022-500881-80-00 | Ph 3 | completed | A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035) |
| NCT05704478 | 22-2321 | Ph 4 | active not recruiting | Impact of Vericiguat on Hemodynamics of Heart Failure |
| NCT05420012 results posted | IRB_00152530 | Ph 4 | completed | The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation |
| NCT05806138 | 23-050 | Ph 2 | active not recruiting | A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction |
| NCT06601465 CONVERGE-HF | CONVERGE-HF-2023-6 | Ph 2 | recruiting | COgnitioN With VERiciGuat Evaluation in Heart Failure |
| NCT05812755 SOLSTICE | 222089 R01HL164909 | Ph 4 | recruiting | SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery |
| NCT06415227 ViVA | EU CT 2022-502998-42-00 | Ph 2 | not yet recruiting | The Impact of Vericiguat on Microvascular Function in Patients with Documented Vasospastic Angina Pectoris |
| NCT06812546 VIC-MI | VIC-MI 82300372; 82270406, CSTB2024NSCQ-LZX0144 | Ph 4 | not yet recruiting | Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction |
| NCT06671990 ARETHA | 2024-514111-10-00 | Ph 4 | not yet recruiting | The CardioMEMS Vericiguat Heart Failure Trial |
| NCT02861534 VICTORIA results posted | 1242-001 2016-000671-25, MK-1242-001 | Ph 3 | completed | A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VERQUVO FDA Label Details
Indications & Usage
FDA Label (PDF)VERQUVO is indicated for the treatment of Heart Failure.
WARNING: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO ...
VERQUVO Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VERQUVO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 54 active patents
Trial Analysis
- • 12 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment