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Verquvo (VERICIGUAT)
Verquvo works by stimulating the enzyme guanylate cyclase to increase levels of a molecule called cGMP, which helps to relax blood vessels and improve heart function.
At a glance
| Generic name | VERICIGUAT |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Soluble Guanylate Cyclase Stimulator [EPC] |
| Target | Guanylate cyclase soluble subunit beta-1 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Vericiguat is stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), second messenger that plays role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.
Approved indications
- Chronic heart failure
- Heart failure
Boxed warnings
- 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 )
Common side effects
- Hypotension
- Anemia
- reported
Key clinical trials
- Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) (PHASE2,PHASE3)
- An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure Under Real World Conditions
- An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in Real-world Setting
- Effect of Vericiguat on cardiAc Remodeling in Patients With Heart faiLure and Reduced Ejection fractioN (HFrEF): A Prospective sTudy usIng NOvel Echocardiographic Imaging Techniques (VALENTINO)
- A Study to Learn More About the Safety of the Drug Vericiguat in Japanese People With Chronic Heart Failure Who Will be Receiving Vericiguat Under Real-world Conditions
- Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial (PHASE1)
- Vericiguat and Reverse Remodeling Indices in Heart Failure (PHASE4)
- 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
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Verquvo CI brief — competitive landscape report
- Verquvo updates RSS · CI watch RSS
- Merck & Co. portfolio CI