REGN5381
/ Regeneron
- LARVOL DELTA
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October 23, 2025
NATRIX-SBP: REGN5381 in Adult Participants With Uncontrolled Hypertension
(clinicaltrials.gov)
- P2 | N=34 | Terminated | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Feb 2026 ➔ Oct 2025 | Active, not recruiting ➔ Terminated; Sponsor decision
Trial completion date • Trial termination • Cardiovascular • Hypertension
October 18, 2025
Agonist Antibody to Natriuretic Peptide Receptor 1 for CKD
(KIDNEY WEEK 2025)
- "The addition of empagliflozin to REGN5381 plus enalapril further improved survival and reduced albuminuria. In the RKM model of CKD, REGN5381 reduced albuminuria, and improved kidney histopathology and cardiac ejection fraction, indicating that the benefits of REGN5381 are not limited to AS. Conclusion NPR1 agonism with REGN5381 benefited the kidney and heart in multiple CKD models, presenting a potential novel therapeutic strategy to treat CKD."
Chronic Kidney Disease • Fibrosis • Genetic Disorders • Immunology • Inflammation • Nephrology • Renal Disease
October 08, 2025
NATRIX-BNP: REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction
(clinicaltrials.gov)
- P2 | N=89 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=394 ➔ 89 | Trial completion date: Feb 2027 ➔ Dec 2025 | Trial primary completion date: Nov 2026 ➔ Sep 2025
Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure
October 06, 2025
Impact of REGN5381, a Monoclonal Antibody Agonist to Natriuretic Peptide Receptor 1, on Pulmonary Capillary Wedge Pressure in Patients With Heart Failure With Preserved Ejection Fraction
(AHA 2025)
- "Available on Sunday, November 09, 2025 at 03:36pm CDT."
Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure
October 06, 2025
Safety and Tolerability of REGN5381, a Monoclonal Antibody Agonist of NPR1 in Patients With Heart Failure With Reduced Ejection Fraction
(AHA 2025)
- "Available on Saturday, November 08, 2025 at 10:59am CDT."
Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure
September 20, 2025
NATRIX-SBP: REGN5381 in Adult Participants With Uncontrolled Hypertension
(clinicaltrials.gov)
- P2 | N=34 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=732 ➔ 34 | Trial completion date: Jul 2026 ➔ Feb 2026 | Trial primary completion date: May 2026 ➔ Dec 2025
Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Hypertension
September 16, 2025
NATRIX-BNP: REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction
(clinicaltrials.gov)
- P2 | N=394 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2026 ➔ Feb 2027 | Trial primary completion date: Jan 2026 ➔ Nov 2026
Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure
June 11, 2025
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
(clinicaltrials.gov)
- P2 | N=59 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed
Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
April 29, 2025
NATRIX-SBP: REGN5381 in Adult Participants With Uncontrolled Hypertension
(clinicaltrials.gov)
- P2 | N=732 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting
Enrollment open • Cardiovascular • Hypertension
February 21, 2025
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
(clinicaltrials.gov)
- P2 | N=59 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=122 ➔ 59
Enrollment change • Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
February 18, 2025
NATRIX-SBP: REGN5381 in Adult Participants With Uncontrolled Hypertension
(clinicaltrials.gov)
- P2 | N=732 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals
New P2 trial • Cardiovascular • Hypertension
September 12, 2024
Agonist antibody to guanylate cyclase receptor NPR1 regulates vascular tone.
(PubMed, Nature)
- "In healthy human volunteers, REGN5381 produced the expected haemodynamic effects, reflecting reductions in venous pressures, without obvious changes in diuresis and natriuresis. These data support the development of REGN5381 for long-lasting and selective lowering of venous pressures that drive symptomatology in patients with heart failure."
Journal • Cardiovascular • Congestive Heart Failure • Heart Failure
May 31, 2024
A Trial to Learn How REGN5381 Works and How Safe it is in Adults With Heart Failure With Reduced Ejection Fraction (HFrEF)
(clinicaltrials.gov)
- P2 | N=391 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jul 2026 ➔ Apr 2026 | Trial primary completion date: Apr 2026 ➔ Jan 2026
Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
April 18, 2024
A Trial to Learn How REGN5381 Works and How Safe it is in Adults With Heart Failure With Reduced Ejection Fraction (HFrEF)
(clinicaltrials.gov)
- P2 | N=391 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting
Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
April 15, 2024
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
(clinicaltrials.gov)
- P1 | N=93 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed
Trial completion
January 26, 2024
EFFECTS OF REGN5381, A NATRIURETIC PEPTIDE RECEPTOR 1 AGONIST ANTIBODY, IN HYPERTENSIVE MOUSE MODELS AND MILDLY HYPERTENSIVE BUT OTHERWISE HEALTHY ADULTS IN A PHASE 1 FIRST-IN-HUMAN STUDY
(ACC 2024)
- P1 | "Consistent with the preclinical data, a single-dose REGN5381 showed sustained hemodynamic effects up to day 4 with an acceptable safety profile in mildly hypertensive adults."
P1 data • Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Hypotension
March 04, 2024
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
(clinicaltrials.gov)
- P2 | N=122 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Aug 2025 ➔ Apr 2025 | Trial primary completion date: Aug 2025 ➔ Apr 2025
Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
February 16, 2024
A Trial to Learn How REGN5381 Works and How Safe it is in Adults With Heart Failure With Reduced Ejection Fraction (HFrEF)
(clinicaltrials.gov)
- P2 | N=391 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals
New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
January 08, 2024
Safety and Tolerability of Single Ascending Intravenous (IV) Doses of REGN5381 in Adult Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure
(clinicaltrials.gov)
- P2 | N=122 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Suspended ➔ Recruiting | Trial completion date: Dec 2023 ➔ Aug 2025 | Trial primary completion date: Dec 2023 ➔ Aug 2025
Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
December 11, 2023
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
(clinicaltrials.gov)
- P1 | N=93 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting
Enrollment closed
August 12, 2023
Safety Outcomes From a First-in-Human Study of a Novel Investigational Monoclonal Antibody, REGN5381, an Agonist to the Natriuretic Peptide Receptor 1
(AHA 2023)
- P1 | "A single dose of REGN5381 is generally well-tolerated and provides sustained hemodynamic effects."
Clinical • P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypotension • Pain
September 05, 2023
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
(clinicaltrials.gov)
- P1 | N=107 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Suspended ➔ Recruiting | Trial completion date: Jan 2024 ➔ Jul 2024 | Trial primary completion date: Jan 2024 ➔ Jul 2024
Enrollment open • Trial completion date • Trial primary completion date
June 05, 2023
Safety and Tolerability of Single Ascending Intravenous (IV) Doses of REGN5381 in Adult Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure
(clinicaltrials.gov)
- P2 | N=149 | Suspended | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Suspended
Trial suspension • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
May 06, 2023
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
(clinicaltrials.gov)
- P1 | N=107 | Suspended | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Oct 2023 ➔ Jan 2024 | Recruiting ➔ Suspended | Trial primary completion date: Oct 2023 ➔ Jan 2024
Trial completion date • Trial primary completion date • Trial suspension
December 21, 2022
Safety and Tolerability of Single Ascending Intravenous (IV) Doses of REGN5381 in Adult Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure
(clinicaltrials.gov)
- P2 | N=149 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=80 ➔ 149
Enrollment change • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB
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