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REGN5381 · 2 trials · 2 indications
| 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 |
| REGN5381 | EXPERIMENTAL | Single dose REGN5381 administered via IV infusion |
| Placebo | OTHER | Placebo matching single dose REGN 5381 administered via IV infusion |
| Name | Type | Description |
|---|---|---|
| REGN5381 | DRUG | Single dose administered via IV infusion |
| Matching Placebo | DRUG | Single dose administered via IV infusion |
| Placebo | OTHER | Placebo matching single dose REGN 5381 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 an investigational small molecule being studied for heart failure. It has been evaluated in a Phase 1 trial in healthy adults and a Phase 2 trial in heart failure participants with elevated pulmonary capillary wedge pressure. It is not approved and remains in clinical development.
REGN5381 is an NPR1 agonist, meaning it activates the natriuretic peptide receptor 1. This mechanism is being studied for its potential effects in heart failure. The drug is designed to act on this receptor, though its full clinical effects are still under investigation.
REGN5381 is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. Regeneron is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.
REGN5381 has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study assessed safety, tolerability, and pharmacokinetics in healthy adults, while the Phase 2 study evaluated the drug in heart failure participants. It remains investigational and is not FDA approved.
REGN5381 has been studied in two completed trials. NCT04506645 was a Phase 1 study in healthy adults in Belgium, enrolling 90 participants. NCT05353166 was a Phase 2 study in heart failure participants with elevated pulmonary capillary wedge pressure in Moldova, enrolling 59 participants.
Yes, REGN5381 is described as an NPR1 agonist, meaning it targets the natriuretic peptide receptor 1. This mechanism is central to its investigational use in heart failure. The drug is being developed by Regeneron Pharmaceuticals under the name REGN5381.