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Also known as baloncibart
REGN7544 · 2 trials · 2 indications
Only for Cohort B
| Arm | Type | Description |
|---|---|---|
| REGN7544 | EXPERIMENTAL | - |
| Placebo (PB) | PLACEBO_COMPARATOR | - |
| Low Dose | EXPERIMENTAL | Randomized 1:1:1 |
| High Dose | EXPERIMENTAL | Randomized 1:1:1 |
| Matching Placebo | PLACEBO_COMPARATOR | Randomized 1:1:1 |
| Name | Type | Description |
|---|---|---|
| REGN7544 | DRUG | Administered per the protocol |
| PB | DRUG | Administered per the protocol |
| Placebo | DRUG | SC administration |
Key Inclusion Criteria: 1. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period 2. Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Art...
REGN7544 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. for cardiovascular conditions. It is being studied in adults for Postural Orthostatic Tachycardia Syndrome (POTS) and sepsis-induced hypotension. REGN7544 is in Phase 2 clinical development and has not been approved by the FDA.
REGN7544 is being studied as a treatment for Postural Orthostatic Tachycardia Syndrome (POTS) in adults. A Phase 2 trial evaluated it in patients with POTS in the United States and Canada. REGN7544 remains investigational and is not approved for POTS or any other indication.
REGN7544 targets natriuretic peptide receptor 1, also known as NPR1. NPR1 is a protein receptor, and REGN7544 is described as an NPR1 antagonist. By acting on this receptor, the small molecule is designed to modulate natriuretic peptide signaling in cardiovascular and hemodynamic conditions.
REGN7544 is developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical trials studying REGN7544 in Postural Orthostatic Tachycardia Syndrome and sepsis-induced hypotension.
REGN7544 is in Phase 2 clinical development. It is an investigational small molecule and has not been approved by the FDA. Regeneron has completed Phase 2 trials in sepsis-induced hypotension and in Postural Orthostatic Tachycardia Syndrome, and no active trials are currently listed.
REGN7544 has been studied in two completed Phase 2 trials. NCT06608901 evaluated REGN7544 in adults with sepsis-induced hypotension across the United States and France, enrolling 76 patients. NCT06593600 studied an NPR1 antagonist in adults with Postural Orthostatic Tachycardia Syndrome in the United States and Canada, enrolling 82 patients.