baloncibart (REGN7544) / Regeneron - LARVOL DELTA

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS) (clinicaltrials.gov) - P2 | N=82 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular

ESTELLA: A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension (clinicaltrials.gov) - P2 | N=76 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Hypotension • Infectious Disease • Septic Shock

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS) (clinicaltrials.gov) - P2 | N=82 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular

The Impact of an Investigational, First-in-class Natriuretic Peptide Receptor 1-blocking Monoclonal Antibody, REGN7544, in a Preclinical Model of Sepsis-induced Hypotension (ATS 2026) - No abstract available

Preclinical • Hypotension • Infectious Disease • Septic Shock

ESTELLA: A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2026 ➔ Apr 2026 | Trial primary completion date: Jul 2026 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Hypotension • Infectious Disease • Septic Shock

The Impact of an Investigational First-In-Class Fully Human Natriuretic Peptide Receptor 1-Blocking Monoclonal Antibody REGN7544 on Systolic Blood Pressure and Hypovolemic and Hypotensive Disorders in Mice (AHA 2025) - "These data demonstrated that the high-affinity NPR1-blocking antibody REGN7544 increased SBP in normotensive and hypotensive NPR1hu/hu mice and normotensive monkeys, possibly via inhibited vasorelaxation and altered blood volume. REGN7544 has potential to be a selective and long-acting treatment for hypervolemic and hypotensive disorders, including postural orthostatic tachycardia syndrome and sepsis-induced hypotension."

Preclinical • Cardiovascular • Hypotension • Infectious Disease • Septic Shock

A First-In-Human Phase 1 Study of the Safety, Tolerability, and Pharmacodynamics of REGN7544, a Novel Natriuretic Peptide Receptor 1–Blocking Monoclonal Antibody (AHA 2025) - P1 | "REGN7544 was generally well-tolerated at doses up to 1000 mg IV and 600 mg SC. REGN7544 durably increased BP to a plateau (5–10 mmHg), with body weight and biomarker results suggesting increased plasma volume. These data support the development of REGN7544 for conditions characterized by hypovolemia and/or hypotension, such as postural orthostatic tachycardia syndrome and sepsis-associated hypotension."

Clinical • First-in-human • P1 data • PK/PD data • Cardiovascular • Hypotension • Infectious Disease • Septic Shock • NPPB

PRECLINICAL DATA OF REGN7544: A FIRST-IN-CLASS, FULLY HUMAN NATRIURETIC PEPTIDE RECEPTOR 1-BLOCKING MONOCLONAL ANTIBODY FOR HYPOVOLEMIC AND HYPOTENSIVE DISORDERS - Kishor Devalaraja-Narashimha (ACC 2025) - "REGN7544 is a high-affinity NPR1-blocking antibody that increases SBP in NPR1hu/hu mice and monkeys, potentially through altered blood volume and/or vasoconstriction. It may serve as a long-acting treatment for hypervolemic and hypotensive disorders, such as postural orthostatic tachycardia syndrome and sepsis‑induced hypotension."

Preclinical • Cardiovascular • Hypotension • Infectious Disease • Septic Shock

A FIRST-IN-HUMAN PHASE I STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REGN7544, A NOVEL NATRIURETIC PEPTIDE RECEPTOR 1-BLOCKING MONOCLONAL ANTIBODY - Ethan Marin (ACC 2025) - P1 | "REGN7544 was generally well-tolerated at doses up to 1000 mg IV and 600 mg SC. REGN7544 durably increased BP to a moderate degree (5-10 mm Hg), with laboratory evidence suggesting increased plasma volume. These data support development of REGN7544 for conditions characterized by hypovolemia and/or hypotension, such as postural orthostatic tachycardia syndrome and sepsis-associated hypotension."

Clinical • P1 data • PK/PD data • Cardiovascular • Hypotension • Infectious Disease • Septic Shock • NPPB

A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Hypotension • Infectious Disease • Septic Shock

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS) (clinicaltrials.gov) - P2 | N=81 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular

A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Hypotension • Infectious Disease • Septic Shock

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS) (clinicaltrials.gov) - P2 | N=81 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Cardiovascular

A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion