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
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VERQUVO vericiguat 5 mg film-coated tablet blister pack | 339994 | Medicine | A | 11/15/2021 | |
VERQUVO vericiguat 2.5 mg film-coated tablet blister pack | 339992 | Medicine | A | 11/15/2021 | |
VERQUVO vericiguat 10 mg film-coated tablet blister pack | 339993 | Medicine | A | 11/15/2021 |