Approval Probability
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Label indication VERQUVO ® is 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% [see Clinical Studies (14) ] . FDA label
Also known as Vericiguat Oral Tablet, Vericiguat (BAY1021189)
Vericiguat · 9 trials · 8 indications
Change in log-transformed aortic valve calcium score from baseline, measured by non-contrast electrocardiographic-gated cardiac CT (Agatston method). Higher scores mean worse outcome.
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 1 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 2 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week ten is considered clinically meaningful.
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure.
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Left atrial volume was measured by echocardiography.
Area under the concentration vs. time curve from zero to infinity after single dose administration
AUC unbound
Maximum observed drug concentration in measured matrix after single dose administration
Cmax unbound
| Arm | Type | Description |
|---|---|---|
| Vericiguat | ACTIVE_COMPARATOR | Vericiguat orally once daily. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets orally once daily |
| Overall study | EXPERIMENTAL | At Visit 1 participants will receive 1x 5 mg Vericiguat (BAY1021189) tablet daily (on top of standard of care) for at least 14 days to max 18 days (+4 days time window allowed) |
| Vericiguat Oral Tablet | ACTIVE_COMPARATOR | Tested IMP: Vericiguat (film-coated tablet). Authorization status: Not authorised in this targeted therapeutic indication; Vericiguat is authorized for the dosages that will be administered in this trial for another indication. The tablets used in this trial are no trade product, but a special trial product produced and provided by the marketing authorization holder Bayer. Administration: Once daily (oral). Planned dosage: Three different dosages starting with 2.5 mg for two weeks, followed by 5 mg for two weeks and 10 mg for six weeks. The general IMP titration regimen was investigated and proven to be safe (max. dosages 10 mg/day) in patients with heart failure and reduced ejection fraction (Armstrong et al., 2020). |
| Placebo Oral Tablet | PLACEBO_COMPARATOR | Comparator IMP: Placebo (film-coated tablet). Authorization status: Not authorised. The tablets used in this trial are no trade product, but a special trial product produced and provided by the marketing authorization holder Bayer. Administration: Once daily (oral). Planned dosage: Three different dosages starting with 2.5 mg for two weeks, followed by 5 mg for two weeks and 10 mg for six weeks to have identical conditions to verum. |
| Vericiguat up to 10 mg | EXPERIMENTAL | Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6. |
| Vericiguat up to 15 mg | EXPERIMENTAL | Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6. |
| Vericiguat (BAY1021189) (10 mg) | EXPERIMENTAL | 2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks |
| Vericiguat (BAY1021189) (5 mg) | EXPERIMENTAL | 2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration) |
| Vericiguat (BAY1021189) (2.5 mg) | EXPERIMENTAL | 2.5 mg orally once daily for 12 weeks (with sham titrations) |
| Vericiguat (BAY1021189) (1.25 mg) | EXPERIMENTAL | 1.25 mg orally once daily for 12 weeks (with sham titrations) |
| Vericiguat (BAY1021189)(10 mg) | EXPERIMENTAL | 2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks |
| Treatment 1 | EXPERIMENTAL | Treatment sequences: A\*-B-C-D |
| Treatment 2 | EXPERIMENTAL | Treatment sequences: D-A-B-C\* |
| Vericiguat + Nitroglycerin | EXPERIMENTAL | Co-administration of vericiguat and nitroglycerin |
| Placebo + Nitroglycerin | PLACEBO_COMPARATOR | Aministration of matching placebo and nitroglycerin. |
| Child Pugh A | EXPERIMENTAL | Participants with mild hepatic impairment |
| Child Pugh B | EXPERIMENTAL | Participants with moderate hepatic impairment |
| Healthy participants | EXPERIMENTAL | Participants with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Vericiguat (BAY1021189) | DRUG | Vericiguat 2.5 mg orally once daily, titrated every 2 weeks (2.5 mg → 5 mg → 10 mg) to a target maintenance dose of 10 mg once daily. Total treatment duration: 24 months |
| Placebo | DRUG | Matching placebo tablets orally once daily, with a dose-titration schedule synchronized to the vericiguat arm to maintain blinding. Placebo tablets are identical to vericiguat tablets (2.5 mg, 5 mg, and 10 mg dose strengths) in size, shape, color, and texture. The same SBP-based dose-adjustment rules are applied. Total treatment duration: 24 months. |
| Vericiguat (BAY1021189) 5 mg | DRUG | 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) |
| Vericiguat Oral Tablet | DRUG | The treatment period includes ten weeks of daily vericiguat or placebo intake (depending on randomization) and a 30-day follow-up period (no vericiguat/placebo intake). |
| Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets | DRUG | Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6. |
| Vericiguat (BAY1021189) (1.25 mg) | DRUG | 1.25 mg BAY1021189 tablets |
| Vericiguat (BAY1021189) (5 mg) | DRUG | 5 mg BAY1021189 tablets |
| Moxifloxacin | DRUG | D: 400 mg moxifloxacin |
| Nitroglycerin | DRUG | 0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat \[trough\] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat \[peak\] or placebo) on day 13, day 27 and day 41 |
Inclusion Criteria: 1. The participant agrees to enter this clinical trial and consents to long-term follow-up; 2. 35 ≤ age \< 80 years; 3. Echocardiographically confirmed mild-to-moderate (peak aortic jet velocity ≥ 2.5 m/s and \< 4.0 m/s, aortic valve area \> 1.0 cm², and mean aortic valve pressu...
Vericiguat is being studied for several cardiovascular and related conditions, including chronic heart failure with reduced ejection fraction, chronic heart failure with preserved ejection fraction, calcific aortic valve disease, coronary artery disease, and Post-COVID ME/CFS. It is an investigational small molecule developed by Bayer AG and is currently in Phase 2 clinical development.
Vericiguat targets the soluble guanylate cyclase subunits GUCY1A1, GUCY1A2, and GUCY1B1. It acts as an activator of these targets. This mechanism is being investigated in cardiovascular conditions such as heart failure and calcific aortic valve disease.
Vericiguat is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating Vericiguat in heart failure, calcific aortic valve disease, and Post-COVID ME/CFS.
Vericiguat is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for the indications currently being studied. The Phase 2 trials are evaluating its safety and effects in conditions such as chronic heart failure with reduced ejection fraction and Post-COVID ME/CFS.
Vericiguat has been studied in several clinical trials, including NCT07715279 in calcific aortic valve disease, NCT06195930 in chronic heart failure with reduced ejection fraction, NCT05697640 in Post-COVID ME/CFS, and NCT04722562 in participants with liver disease and healthy volunteers. These trials include Phase 1 and Phase 2 studies.
Yes, Vericiguat is also known as BAY1021189. Other alternative names include Vericiguat Oral Tablet and Vericiguat (BAY1021189) in 1.25 mg, 2.5 mg, 5 mg, and 10 mg immediate-release tablet forms. These names refer to the same investigational small molecule developed by Bayer AG.