Verquvo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 25, 2021.

FDA Approved: Yes (First approved January 19, 2021)
Brand name: Verquvo
Generic name: vericiguat
Dosage form: Tablets
Company: Merck
Treatment for: Heart Failure with Reduced Ejection Fraction

Verquvo (vericiguat) is a soluble guanylate cyclase (sGC) stimulator indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Verquvo is the first soluble guanylate cyclase stimulator approved to treat heart failure.
Verquvo tablets are taken orally once daily with food.
The Verquvo product label carries a boxed warning that indicates that Verquvo may cause fetal harm, and should not be administered to pregnant females. Common adverse reactions include hypotension and anemia.

Development timeline for Verquvo

Date	Article
Jan 20, 2021	Approval FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction
Jul 16, 2020	FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat
Mar 28, 2020	Investigational Drug Vericiguat Significantly Reduced the Risk of the Composite Endpoint of Heart Failure Hospitalization or Cardiovascular Death, Compared to Placebo, When Given in Combination with Available Heart Failure Therapies
Nov 18, 2019	Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Verquvo FDA Approval History

Development timeline for Verquvo

See also

Further information