Approval Probability
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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 being developed for the treatment of heart failure. It has been studied in patients with chronic heart failure with reduced ejection fraction and in patients with chronic heart failure with preserved ejection fraction.
Neladenoson bialanate is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY.
Neladenoson bialanate is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed.
Neladenoson bialanate has been studied in two completed Phase 2 trials. NCT02992288 enrolled 427 patients with chronic heart failure with reduced ejection fraction, and NCT03098979 enrolled 305 patients with chronic heart failure with preserved ejection fraction. Both trials were randomized, double-blind, and placebo-controlled.
Neladenoson bialanate is also known as BAY 1021189. This alternative name may be used in scientific literature and clinical trial registries.