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Also known as Neladenoson bialanate (BAY1067197)
Neladenoson bialanate · 2 trials · 1 indication
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
| Arm | Type | Description |
|---|---|---|
| Neladenoson bialanate (BAY1067197) (5 mg) | EXPERIMENTAL | Chronic heart failure with preserved ejection fraction |
| Neladenoson bialanate (BAY1067197) (10 mg) | EXPERIMENTAL | Chronic heart failure with preserved ejection fraction |
| Neladenoson bialanate (BAY1067197) (20 mg) | EXPERIMENTAL | Chronic heart failure with preserved ejection fraction |
| Neladenoson bialanate (BAY1067197) (30 mg) | EXPERIMENTAL | Chronic heart failure with preserved ejection fraction |
| Neladenoson bialanate (BAY1067197) (40 mg) | EXPERIMENTAL | Chronic heart failure with preserved ejection fraction |
| Placebo | PLACEBO_COMPARATOR | Chronic heart failure with preserved ejection fraction |
| Name | Type | Description |
|---|---|---|
| Neladenoson bialanate (BAY1067197) | DRUG | 5 mg orally once daily for 20 weeks |
| Placebo | DRUG | Orally once daily for 20 weeks |
Inclusion Criteria: * Men or women aged 45 years and older * Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP Exclusion Criteria: * Acute decompensated heart failure within the past 4 weeks * ...
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Neladenoson bialanate is an investigational small molecule developed by Bayer AG for chronic heart failure. It is a Phase 2 clinical candidate that has been studied in two completed trials enrolling 732 patients total, including patients with heart failure with preserved ejection fraction and heart failure with reduced ejection fraction.
Neladenoson bialanate was studied as a treatment for chronic heart failure in two Phase 2 trials. One trial enrolled 305 patients with heart failure with preserved ejection fraction, and the other enrolled 427 patients with heart failure with reduced ejection fraction. Both studies are completed, and the drug remains investigational.
Neladenoson bialanate is developed by Bayer AG, which trades under the ticker BAYRY. Bayer sponsored both Phase 2 heart failure trials of the compound.
Neladenoson bialanate is in Phase 2 development. Two Phase 2 trials in chronic heart failure have been completed, and no trials are currently active. It is an investigational drug and has not been approved by the FDA for any indication.
Neladenoson bialanate has been evaluated in two completed Phase 2 trials: NCT03098979, which studied it over 20 weeks in 305 patients with chronic heart failure with preserved ejection fraction, and NCT02992288, which studied it over 20 weeks in 427 patients with chronic heart failure with reduced ejection fraction. Both were randomized, double-blind, and placebo-controlled.
Yes. Neladenoson bialanate is also known as BAY1067197, the Bayer compound code used during its development. Both names refer to the same investigational small molecule studied in Phase 2 trials for chronic heart failure.