Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN5381 · 1 trial · 1 indication
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as those adverse events with either initial onset after study drug dose or that represented an exacerbation of a pre-existing condition after the study drug dose.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Randomized 1:1; limited to participants with heart failure with reduced ejection fraction (HFrEF) not taking sacubitril/valsartan |
| Group B | EXPERIMENTAL | Randomized 1:1; limited to participants with HFrEF taking sacubitril/valsartan |
| Group C | EXPERIMENTAL | Randomized 1:1; limited to participants with heart failure with preserved ejection fraction (HFpEF) not taking sacubitril/valsartan |
| Name | Type | Description |
|---|---|---|
| REGN5381 | DRUG | Single dose administered via IV infusion |
| Matching Placebo | DRUG | Single dose administered via IV infusion |
Key Inclusion Criteria: 1. Body mass index (BMI) between 18 and 35 kg/m\^2, inclusive, rounded to the nearest whole number 2. Ambulatory participants with New York Heart Association (NYHA) class II/III heart failure and at least 1 sign and/or symptom of congestion (eg, dyspnea on exertion, worsenin...
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REGN5381 is being developed for the treatment of heart failure. It is an investigational small molecule studied in adult participants with heart failure and elevated pulmonary capillary wedge pressure. Regeneron Pharmaceuticals is evaluating it in a Phase 2 clinical program, so it is not yet an approved therapy for any indication.
REGN5381 targets NPR1, also known as the natriuretic peptide receptor 1. NPR1 is a protein target, and REGN5381 is a small molecule designed to act on it. This receptor is part of the natriuretic peptide signaling pathway relevant to cardiovascular function and fluid and pressure regulation in heart failure.
Regeneron Pharmaceuticals, Inc. is developing REGN5381. The company trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor behind the clinical program evaluating this small molecule in heart failure, including the Phase 2 study conducted in adult participants with elevated pulmonary capillary wedge pressure.
REGN5381 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial in heart failure has been completed, and no active trials of REGN5381 are currently listed in the development program.
REGN5381 has been studied in the Phase 2 trial NCT05353166, titled REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure. The trial enrolled 59 participants, was randomized, double blind, and controlled, and included adults aged 18 years and older of all sexes. It was conducted in Moldova and is completed.