Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pecavaptan (BAY1753011)
Pecavaptan · 1 trial · 2 indications
Dose-normalized AUC (AUC/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Dose-normalized Cmax (Cmax/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Dose-normalized AUCu (AUCu/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Dose-normalized Cmax,u (Cmax,u/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
| Arm | Type | Description |
|---|---|---|
| Healthy | EXPERIMENTAL | Age-, weight- and gender- matched control group of healthy volunteers received a single oral dose of 30 mg BAY1753011 tablet. |
| Mild renal impairment | EXPERIMENTAL | Subjects with mild renal impairment received a single oral dose of 30 mg BAY1753011 tablet. |
| Moderate renal impairment | EXPERIMENTAL | Subjects with moderate renal impairment received a single oral dose of 30 mg BAY1753011 tablet. |
| Severe renal impairment | EXPERIMENTAL | Subjects with severe renal impairment received a single oral dose of 15 mg BAY1753011 tablet. |
| Name | Type | Description |
|---|---|---|
| Pecavaptan (BAY1753011) | DRUG | 30 mg, immediate release tablet, single dose, oral |
Inclusion Criteria: * Male or female White participants (women without childbearing potential) * Aged from ≥18 years * body mass index above or equal 18.5 kg/m2 and below or equal 36 kg/m2 at the first screening visit * Participants with renal impairment: with an eGFR \<90 mL/min/1.73 m\^2 determin...
Pecavaptan is an investigational small molecule developed by Bayer AG for congestive heart failure. It is a Phase 1 clinical candidate and has not been approved by the FDA. It belongs to the cardiovascular therapeutic area and is being studied for its effects in patients with heart failure and reduced kidney function.
Pecavaptan is being studied for congestive heart failure, a condition in which the heart cannot pump enough blood. The clinical program has also included participants with renal impairment alongside heart failure. It remains investigational and is not approved for any indication.
Pecavaptan targets AVPR2 and AVPR1A, which are vasopressin receptors. It acts as an antagonist at these receptors, meaning it blocks vasopressin signaling. This mechanism is relevant to fluid regulation and cardiovascular function in congestive heart failure.
Pecavaptan is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program for this investigational cardiovascular small molecule.
Pecavaptan is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program has completed one trial, and there are currently no active trials listed.
Pecavaptan has been studied in one completed Phase 1 trial, NCT05599997. This trial enrolled 32 participants in Germany and evaluated how BAY1753011 moves through the body, its safety, and its effects in participants with reduced kidney function compared to those with normal kidney function.
Yes, Pecavaptan is also known as BAY1753011. Both names refer to the same investigational small molecule developed by Bayer AG for congestive heart failure. The clinical trial NCT05599997 uses the BAY1753011 designation.