Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1237592 · 1 trial · 1 indication
PVR = 80\* (PAP - PCWP) / CO (dyn·sec·cm-5) * PAP = pulmonary arterial pressure * PCWP = pulmonary capillary wedge pressure * CO = cardiac output
PVR = 80\* (PAP - PCWP) / CO (dyn·sec·cm-5)
| Arm | Type | Description |
|---|---|---|
| Untreated patients (Part A and Part B) | EXPERIMENTAL | Part A: Untreated PAH and CTEPH patients will be enrolled to test 5 ascending doses of BAY1237592 with 4 patients per dose group up to a maximum dose of 4000 µg. Part B: The highest safe, well tolerated and effective dose of Part A will be tested in further untreated patients. |
| Monotherapy (Part B) | EXPERIMENTAL | The highest safe, well tolerated and effective dose chosen from Part A will be tested in pre-treated patients with any kind of monotherapy for PAH/CTEPH. |
| Combined therapy (Part B) | EXPERIMENTAL | The highest safe, well tolerated and effective dose from Part A will be tested in pre-treated patients with any kind of double combination treatment for PAH/CTEPH. |
| Name | Type | Description |
|---|---|---|
| BAY1237592 | DRUG | Oral inhalation with dry powder inhaler, single dose. |
Main Inclusion Criteria: * Patients with PAH or CTEPH undergoing medically indicated routine invasive diagnostics * Men and women aged 18 to 80 years Part A: \- Untreated patients: Therapy-naïve patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids...
BAY1237592 is an investigational small molecule being developed for pulmonary hypertension, specifically for two disease groups: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). It is administered by inhalation and is currently in Phase 1 clinical development.
BAY1237592 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is in Phase 1 clinical development for pulmonary hypertension.
BAY1237592 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
BAY1237592 has one completed Phase 1 clinical trial, identified as NCT03754660. This study tested the safety, tolerability, and effects of inhaled BAY1237592 in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The trial enrolled 38 participants across Austria, Czechia, Germany, and Poland.
BAY1237592 is administered by inhalation. The completed Phase 1 trial (NCT03754660) tested the safety and tolerability of the inhaled formulation in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH).