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In the VICTORIA trial, VERQUVO demonstrated an adverse event profile similar to placebo

VERQUVO is well tolerated by patients following a HF hospitalization or use of outpatient IV diuretics

The adverse drug reactions occurring more commonly with VERQUVO than placebo and in ≥5% of patients treated with VERQUVO in VICTORIA

Adverse Drug Reactions for VERQUVO (N=2,519) vs Placebo (N=2,515): Hypotension - 16% VERQUVO, 15% Placebo; Anemia - 10% VERQUVO, 7% Placebo

7.0% of patients taking VERQUVO discontinued due to AEs1

AEs = adverse events.

Percentage of Patients Taking VERQUVO and a Placebo Discontinued Due to Adverse Events: 6.3% Placebo; 7.0% VERQUVO

Treatment initiation with VERQUVO 5 mg once daily in VELOCITY was similarly tolerated as treatment initiation of 2.5 mg once daily in the VICTORIA study.

aBackground therapy included beta blocker, ACE inhibitor, ARB, MRA, ARNI, and/or SGLT2 inhibitor.

Study designs

VICTORIA was a Phase 3, randomized, parallel-group, placebo-controlled, double-blind, event-driven, multicenter trial comparing VERQUVO to placebo when added to background HF therapy in 5,050 adult patients with NYHA class II-IV chronic HF and LVEF <45% following a worsening HF event (defined as HF hospitalization within 6 months before randomization or use of outpatient IV diuretics for HF within 3 months before randomization). Patients were treated up to the target maintenance dose of VERQUVO 10 mg once daily or matching placebo. The primary endpoint was a composite of time to first event of CV death or HF hospitalization.1

VELOCITY was a Phase 2b, 2-week, open-label, single-arm, multinational prospective trial evaluated the safety and tolerability of VERQUVO 5 mg once daily as a starting dose. The trial enrolled 106 adult patients aged ≥18 years with chronic heart failure and a left ventricular ejection fraction <45%, New York Heart Association class II–IV symptoms, and systolic blood pressure ≥100mmHg at screening and Visit 1. Study participants with or without worsening heart failure on background guideline-directed medical therapy for heart failure underwent screening for eligibility. Eligible patients returned 2 weeks later for Visit 1. At this Visit 1, VERQUVO 5 mg daily was initiated and continued for 2 weeks as tolerated until the final visit (Visit 2). The primary endpoint was to assess the tolerability of a 5 mg VERQUVO starting dose, defined as completing the 2-week course with no more than a 1-day interruption and without moderate-to-severe symptomatic hypotension.2

Definitions:

ACE = angiotensin-converting enzyme; AEs = adverse events; ARB = angiotensin II receptor blocker; ARNI = combination of an angiotensin receptor and neprilysin inhibitor; CV = cardiovascular; HF = heart failure; IV = intravenous; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; NYHA = New York Heart Association; SGLT2 = sodium glucose co-transporter 2; VICTORIA = Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.

Reference:

  1. Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883-1893.
  2. Greene SJ, Corda S, McMullan CJ, et al, on behalf of the VELOCITY investigators. Safety and tolerability of a 5 mg starting dose of vericiguat among patients with heart failure: The VELOCITY study. Eur J Heart Fail. 2025(27):2837-2840. https://doi.org/10.1002/ejhf.3699

Indication

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Selected Safety Information

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.

  • VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
  • VERQUVO is contraindicated in pregnancy.
  • Embryo-Fetal Toxicity: Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.
  • There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
  • In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency ≥5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).
  • Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended due to the potential for hypotension.
  • There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

 

Before prescribing VERQUVO, please read the accompanying Prescribing Information including the Boxed Warning about embryo-fetal toxicity. The Medication Guide also is available.

Indication
Selected Safety Information

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Selected Safety Information

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.

  • VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
  • VERQUVO is contraindicated in pregnancy.
  • Embryo-Fetal Toxicity: Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.
  • There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
  • In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency ≥5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).
  • Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended due to the potential for hypotension.
  • There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

 

Before prescribing VERQUVO, please read the accompanying Prescribing Information including the Boxed Warning about embryo-fetal toxicity. The Medication Guide also is available.