Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vericiguat Oral Tablet
Vericiguat · 7 trials · 4 indications
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.
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 |
|---|---|---|
| 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 (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) |
| Placebo | PLACEBO_COMPARATOR | 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) 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) (1.25 mg) | DRUG | 1.25 mg BAY1021189 tablets |
| Vericiguat (BAY1021189) (5 mg) | DRUG | 5 mg BAY1021189 tablets |
| Placebo | DRUG | - |
| Vericiguat (BAY1021189) | DRUG | A : 2.5 mg vericiguat A\*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C\*: 10 mg vericiguat |
| 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: * Has an Left ventricle ejection fraction (LVEF) of \<45% assessed within 12 months before Visit 1 by local any imaging method, and no subsequent LVEF measurement \> 45%. The most recent measurement must be used to determine eligibility. * systolic blood pressure (SBP) ≥ 100 mmH...
Vericiguat is an investigational small molecule being studied for cardiovascular conditions including heart failure, coronary artery disease, and chronic heart failure with reduced ejection fraction, as well as post-COVID ME/CFS. It is in Phase 2 clinical development and is not yet approved by the FDA.
Vericiguat is being developed by Bayer AG, which trades under the ticker BAYRY. The drug is currently in Phase 2 clinical trials for multiple cardiovascular indications and post-COVID ME/CFS.
Vericiguat is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials are ongoing or completed across several indications including chronic heart failure with reduced ejection fraction and post-COVID ME/CFS.
Vericiguat has been studied in several clinical trials. NCT05697640 is an active Phase 2 trial in post-COVID ME/CFS. Completed trials include NCT06195930 in chronic heart failure with reduced ejection fraction, and Phase 1 trials NCT02617550 and NCT03504982 in coronary artery disease.
Yes, Vericiguat is also known as Vericiguat Oral Tablet. The drug is administered orally and is being developed by Bayer AG for cardiovascular conditions and post-COVID ME/CFS.