Drugs / Vericiguat
Vericiguat
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed symptomatic heart failure 2 milestones | |||||
| Filed | China (NMPA) | — | symptomatic heart failure | 2020-08-28 | “Vericiguat has been submitted for marketing authorization in Japan and China as well as multiple other countries worldwide.” bayer.com ↗ “Bayer today announced the submission of the regulatory application seeking the approval of vericiguat in China.” bayer.com ↗ |
| Filed | US (FDA) | — | symptomatic heart failure | 2020-07-16 | “the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat” bayer.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | VERQUVO | — | 2026-01-21 | fda.gov ↗ |
| Approved | EU (EMA) | Verquvo | — | 2021-07-16 | europa.eu ↗ |
| Approved | US (FDA) | VERQUVO | — | 2021-01-19 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | — | — | “Vericiguat has been submitted for marketing authorization in Japan and China as well as multiple other countries worldwide.” bayer.com ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials · 1 met primary | ||||||
| Phase 1 | NCT07444398 | Jan → Mar 2026 overdue | symptomatic heart failure | Khawaja Danish Ali | Recruiting | No outcome recorded |
| Phase 1 | NCT06474208 | Jul → Sep 2024 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05086952 | Oct → Dec 2021 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03504982 | May → Nov 2018 | coronary artery disorder | Bayer | Completed | Met primary |
| Phase 1 | NCT03255512 | Aug 2017 → Feb 2018 | coronary artery disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03145038 | May → Aug 2017 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02617550 | Nov 2015 → May 2016 | coronary artery disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04722562 | Jul 2014 → Jan 2015 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04722484 | Jun 2014 → Jan 2015 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 29 trials · 3 missed | ||||||
| Phase 2 | NCT06320951 | Dec 2026 → Apr 2028 expected | cardiovascular disorder, metabolic disease, obesity disorder | University of Alabama at Birmingham | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06601465 | Jun 2025 → Jul 2026 overdue | cognitive disorder, heart failure | University of Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT06415227 | Apr 2025 → Jun 2026 | Prinzmetal angina | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 2 | NCT06195930 | Apr → Jul 2024 | congestive heart failure | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT05806138 | Jul 2023 → Jul 2028 expected | breast cancer, heart failure | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05711719 | Jun 2023 → Nov 2025 | coronary microvascular disorder, metabolic syndrome X | Johns Hopkins University | Completed | Mixed |
| Phase 2 | NCT03547583 | Jun 2018 → Oct 2019 | diastolic heart failure | Bayer | Completed | Missed primary |
| Phase 2 | NCT01951625 | Nov 2013 → May 2015 | heart failure | Bayer | Completed | Missed primary |
| Phase 2 | NCT01951638 | Nov 2013 → Aug 2015 | heart failure | Bayer | Completed | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05714085 | May 2023 → Apr 2032 expected | systolic heart failure | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05093933 | Nov 2021 → Nov 2024 | symptomatic heart failure | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT02861534 | Sep 2016 → Jun 2019 | congestive heart failure | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT07697833 | Jul 2026 → May 2027 expected | systolic heart failure | National Institute of Cardiovascular Diseases, Pakistan | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07668739 | Jul 2026 → May 2028 expected | symptomatic heart failure, tricuspid valve insufficiency | Daejeon St. Mary's hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07405944 | Nov 2025 → Jul 2027 expected | systolic heart failure | University Medical Centre Ljubljana | Recruiting | No outcome recorded |
| Phase 4 | NCT06812546 | Apr 2025 → Jun 2026 overdue | acute myocardial infarction, heart failure | Dongying Zhang | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06671990 | Dec 2024 overdue | heart failure, pulmonary arterial hypertension | Finn Gustafsson | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05420012 | May 2023 → Oct 2024 | systolic heart failure | Josef Stehlik | Completed | No outcome recorded |
| Phase 4 | NCT05658458 | Dec 2022 → Sep 2024 | symptomatic heart failure | Bayer | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07594509 | May 2026 → Dec 2028 expected | cardiovascular disorder | Nanjing Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07047547 | Jun 2025 → Jun 2026 overdue | heart failure | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| — | NCT06239974 | Sep 2024 → Aug 2027 expected | intermediate coronary syndrome | The University of Hong Kong | Recruiting | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT07715279 Comparator | Sep 2026 → Oct 2029 expected | aortic valve calcification, aortic valve stenosis | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05697640 Comparator | Jun 2023 → Apr 2026 overdue | myalgic encephalomeyelitis/chronic fatigue syndrome | Charite University, Berlin, Germany | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05704478 Comparator | Jan 2024 → Mar 2026 overdue | heart failure | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05812755 Comparator | May 2023 → Dec 2026 expected | acute kidney injury, brain disorder, vasculitis | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| — | NCT07678021 Background | Aug 2026 → Dec 2029 expected | coronary artery disorder | China National Center for Cardiovascular Diseases | Not yet recruiting | No outcome recorded |
| — | NCT07335900 Background | Dec 2025 → Dec 2026 expected | aortic valve stenosis | RenJi Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-08-30 | Merck Sharp & Dohme LLC | Results Merck Provides New Results for VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction merck.com ↗
Results from the Phase 3 VICTOR trial and a pooled analysis of the VICTOR and VICTORIA trials were presented today at the ESC Congress 2025 and simultaneously published in The Lancet |
| 2025-08-30 | Bayer | Results Data from Phase III VICTOR clinical trial of vericiguat presented at ESC Congress 2025 bayer.com ↗
Vericiguat when added to guideline-directed medical therapy (GDMT) did not reduce the risk of the primary composite endpoint of heart failure hospitalization or cardiovascular death compared to placebo plus GDMT. |
| 2022-05-19 | Bayer | Regulatory Verquvo™ (vericiguat) approved in China to treat patients with chronic heart failure and reduced ejection fraction bayer.com ↗
Bayer announced today that China’s National Medical Products Administration (NMPA) has approved vericiguat under the brand name Verquvo™. |
| 2021-07-21 | Merck Sharp & Dohme LLC | Regulatory VERQUVO® (vericiguat) Approved in the European Union merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat). |
| 2021-07-21 | Bayer | Regulatory Bayer’s new symptomatic chronic heart failure treatment Verquvo™ (vericiguat) approved in EU bayer.com ↗
The European Commission has granted marketing authorization in the European Union (EU) for vericiguat under the brand name Verquvo™. |
| 2021-06-23 | Bayer | Regulatory Vericiguat approved in Japan to treat patients with chronic heart failure bayer.com ↗
Bayer announced today that the Ministry of Health, Labour, and Welfare (MHLW) in Japan has approved soluble guanylate cyclase (sGC) stimulator vericiguat under the brand name Verquvo™. |
| 2021-05-21 | Bayer | Regulatory Positive CHMP opinion for Bayer’s new symptomatic chronic heart failure treatment vericiguat bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended vericiguat, a soluble guanylate cyclase (sGC) stimulator, for marketing authorization in the European Union. |
| 2021-01-20 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA Approval of VERQUVO® (vericiguat) merck.com ↗ |
| 2021-01-20 | Bayer | Regulatory U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved soluble guanylate cyclase (sGC) stimulator vericiguat under the brand name Verquvo®. |
| 2020-08-28 | Bayer | Regulatory Bayer submits vericiguat for marketing authorization in China for the treatment of chronic heart failure bayer.com ↗
Bayer today announced the submission of the regulatory application seeking the approval of vericiguat in China. |
| 2020-07-16 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat merck.com ↗ |
| 2020-07-16 | Bayer | Regulatory U.S. FDA grants priority review to New Drug Application for vericiguat to treat chronic heart failure bayer.com ↗ |
| 2020-06-05 | Bayer | Regulatory Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure bayer.com ↗
Bayer today announced the submission of two regulatory applications seeking the approval of vericiguat in the EU and Japan. |
| 2020-03-28 | Merck Sharp & Dohme LLC | Results 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 merck.com ↗ |
| 2020-03-28 | Bayer | Results Vericiguat significantly reduced the risk of the composite primary endpoint of cardiovascular death or heart failure hospitalization bayer.com ↗
Bayer announced today detailed results from the Phase III VICTORIA study, which demonstrate superiority in the composite primary efficacy endpoint of investigational vericiguat versus placebo. |
| 2019-11-18 | Merck Sharp & Dohme LLC | Results Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure merck.com ↗
Vericiguat reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies. |
| 2019-11-18 | Bayer | Results Phase III VICTORIA study with vericiguat in patients with worsening chronic heart failure meets primary endpoint bayer.com ↗
The findings demonstrate superiority of vericiguat in prolonging the time to first occurrence of the composite endpoint of cardiovascular death or heart failure hospitalization. |
All press releases naming this drug 23 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vericiguat | “Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid...” NCT07678021 ↗36“Oral suspension of Vericiguat (BAY1021189) in single dose (SD).” NCT06474208 ↗ “specific populations): vericiguat” NCT07335900 ↗ |
| Known as | BAY1021189 | “Vericiguat (BAY1021189) will be taken as 5 mg tablet 1x daily over at least 14 days up to 18 days (+ 4 days time window allowed)” NCT06195930 ↗12“Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization” NCT03547583 ↗ “the once-daily oral sGC stimulator vericiguat (BAY 1021189) over 12 weeks compared with placebo” PMID 25056511 ↗ Jul 2014 “Oral suspension of Vericiguat (BAY1021189) in single dose (SD).” NCT06474208 ↗ “Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed” NCT03145038 ↗ “Vericiguat (BAY1021189) - Intervention A” NCT05086952 ↗ “Drug: Vericiguat (BAY1021189) (1.25 mg)” NCT01951625 ↗ “Vericiguat (Verquvo, BAY1021189)” NCT05658458 ↗ “Drug: Vericiguat (BAY1021189)” NCT03255512 ↗ “Vericiguat (BAY1021189)” NCT02617550 ↗ “Vericiguat (BAY1021189)” NCT03504982 ↗ |
| Known as | MK-1242 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4066936 ↗ |
| Known as | Verquvo | “Vericiguat (Verquvo, BAY1021189) - Intervention D” NCT05086952 ↗1“Vericiguat (Verquvo, BAY1021189)” NCT05658458 ↗ |
| Action | Activate | “vericiguat, a soluble guanylate cyclase stimulator” PMID 26547357 ↗ Dec 2015 |
| Modality | Other / unclassified | “Vericiguat is a soluble guanylate cyclase (sGC) stimulator” NCT06415227 ↗ |
| Route | Oral | “the once-daily oral sGC stimulator vericiguat (BAY 1021189) over 12 weeks compared with placebo” PMID 25056511 ↗ Jul 2014 |