MedPath

Vericiguat

Generic Name
Vericiguat
Brand Names
Verquvo
Drug Type
Small Molecule
Chemical Formula
C19H16F2N8O2
CAS Number
1350653-20-1
Unique Ingredient Identifier
LV66ADM269

Overview

Vericiguat is a direct stimulator of soluble guanylate cyclase (sGC) used in the management of systolic heart failure to reduce mortality and hospitalizations. A key component of the NO-sGC-cGMP signaling pathway that helps to regulate the cardiovascular system, sGC enzymes are intracellular enzymes found in vascular smooth muscle cells (amongst other cell types) that catalyze the synthesis of cyclic guanosine monophosphate (cGMP) in response to activation by nitric oxide (NO). Cyclic GMP acts as a second messenger, activating a number of downstream signaling cascades that elicit a broad variety of effects, and these diverse cellular effects have implicated deficiencies in its production (primarily due to insufficient NO bioavailability) in the pathogenesis of various cardiovascular diseases. As a direct stimulator of sGC, vericiguat mitigates the need for a functional NO-sGC-cGMP axis and thereby helps to prevent the myocardial and vascular dysfunction associated with decreased sGC activity in heart failure. Vericiguat was approved by the FDA in January 2021 - developed by Merck under the brand name Verquvo - for use in certain patients with systolic heart failure. Although not the first sGC stimulator to be granted FDA approval (riociguat was approved in 2013 for use in pulmonary hypertension), vericiguat is unique amongst its peers in that modifications to its structure have dramatically decreased its susceptibility to oxidative metabolism, resulting in a relatively long half-life and allowing for once-daily dosing.

Background

Vericiguat is a direct stimulator of soluble guanylate cyclase (sGC) used in the management of systolic heart failure to reduce mortality and hospitalizations. A key component of the NO-sGC-cGMP signaling pathway that helps to regulate the cardiovascular system, sGC enzymes are intracellular enzymes found in vascular smooth muscle cells (amongst other cell types) that catalyze the synthesis of cyclic guanosine monophosphate (cGMP) in response to activation by nitric oxide (NO). Cyclic GMP acts as a second messenger, activating a number of downstream signaling cascades that elicit a broad variety of effects, and these diverse cellular effects have implicated deficiencies in its production (primarily due to insufficient NO bioavailability) in the pathogenesis of various cardiovascular diseases. As a direct stimulator of sGC, vericiguat mitigates the need for a functional NO-sGC-cGMP axis and thereby helps to prevent the myocardial and vascular dysfunction associated with decreased sGC activity in heart failure. Vericiguat was approved by the FDA in January 2021 - developed by Merck under the brand name Verquvo - for use in certain patients with systolic heart failure. Although not the first sGC stimulator to be granted FDA approval (riociguat was approved in 2013 for use in pulmonary hypertension), vericiguat is unique amongst its peers in that modifications to its structure have dramatically decreased its susceptibility to oxidative metabolism, resulting in a relatively long half-life and allowing for once-daily dosing.

Indication

适用于近期心力衰竭失代偿经静脉治疗后病情稳定的射血分数降低(射血分数<45%)的症状性慢性心力衰竭成人患者,以降低发生心力衰竭住院或需要急诊静脉利尿剂治疗的风险。

Associated Conditions

  • Cardiovascular Mortality
  • Heart Failure Hospitalization

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/02
Not Applicable
Recruiting
2025/02/06
Phase 4
Not yet recruiting
Dongying Zhang
2024/12/04
N/A
Not yet recruiting
2024/11/20
N/A
Active, not recruiting
2024/11/04
Phase 4
Not yet recruiting
Finn Gustafsson
2024/10/09
N/A
Not yet recruiting
2024/09/19
Phase 2
Not yet recruiting
2024/07/05
N/A
Recruiting
2024/05/24
Phase 3
Recruiting
2024/05/16
Phase 2
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Merck Sharp & Dohme LLC
0006-5030
ORAL
10 mg in 1 1
10/26/2023
Merck Sharp & Dohme LLC
0006-5029
ORAL
5 mg in 1 1
10/26/2023
Merck Sharp & Dohme LLC
0006-5028
ORAL
2.5 mg in 1 1
10/26/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
7/16/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
VERQUVO FILM-COATED TABLET 5MG
SIN16342P
TABLET, FILM COATED
5mg
10/1/2021
VERQUVO FILM-COATED TABLET 2.5MG
SIN16343P
TABLET, FILM COATED
2.5mg
10/1/2021
VERQUVO FILM-COATED TABLET 10MG
SIN16340P
TABLET, FILM COATED
10mg
10/1/2021

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Vericiguat Tablets
国药准字HJ20220052
化学药品
片剂
5/18/2022
Vericiguat Tablets
国药准字HJ20220050
化学药品
片剂
5/18/2022
Vericiguat Tablets
国药准字HJ20220051
化学药品
片剂
5/18/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

© Copyright 2025. All Rights Reserved by MedPath