Drugs / Vericiguat
Vericiguat
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT03547583 | Jun 2018 → Oct 2019 | diastolic heart failure | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01951625 | Nov 2013 → May 2015 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01951638 | Nov 2013 → Aug 2015 | heart failure | Bayer | Completed | No outcome recorded |
| 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 | ||||||
| Phase 3 | NCT05093933 | Nov 2021 → Nov 2024 | symptomatic heart failure | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02861534 | Sep 2016 → Jun 2019 | congestive heart failure | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT07715279 Comparator | Aug 2026 → Oct 2029 expected | aortic valve calcification, aortic valve stenosis | West China Hospital | Not yet 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 42 trials | ||||||
| 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 |
| Phase not applicable2 trials | ||||||
| — | 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 |
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)” NCT03504982 ↗ “Vericiguat (BAY1021189)” NCT04722562 ↗ “Vericiguat (BAY1021189)” NCT04722484 ↗ “Vericiguat (BAY1021189)” NCT02617550 ↗ |
| 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 |