XXB750 / Novartis - LARVOL DELTA

Natriuretic Peptide Receptor-1 Agonist for Resistant Hypertension: A Randomized Phase 2 Trial. (PubMed, J Am Coll Cardiol) - P2 | "XXB750, an NPR-1 agonist, had a neutral effect on 24-hour ambulatory SBP in patients with resistant hypertension, despite showing a robust dose-response relationship for engagement of the target of pharmacologic action as indicated by increases in cyclic guanosine monophosphate levels. (An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients; NCT05562934)."

Clinical • Journal • P2 data • Cardiovascular • Hypertension • Hypotension

The Npr1 Agonist Xxb750 In Heart Failure (ACC 2026) - "Abstract is embargoed at this time."

Late-breaking abstract • Cardiovascular • Congestive Heart Failure • Heart Failure

Blood Pressure Lowering Effects of a Novel Long-Acting NPR1 Agonist, XXB750, in Healthy Participants: A Randomized, First-in-Human Clinical Study. (PubMed, Circulation) - No abstract available

Journal • P1 data

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure (clinicaltrials.gov) - P2 | N=136 | Terminated | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2025 ➔ Nov 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2025 ➔ Nov 2024; Sponsor Decision

Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Congestive Heart Failure • Heart Failure

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. (clinicaltrials.gov) - P2 | N=194 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure (clinicaltrials.gov) - P2 | N=136 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=720 ➔ 136

Enrollment change • Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

A randomised, double-blind, placebo-controlled study to investigate the safety and tolerability of XXB750 in heart failure patients with reduced or mildly reduced ejection fraction (ESC 2024) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants (clinicaltrials.gov) - P1 | N=77 | Completed | Sponsor: Novartis Pharmaceuticals

New P1 trial

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. (clinicaltrials.gov) - P2 | N=191 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF) (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Feb 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure (clinicaltrials.gov) - P2 | N=720 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure (clinicaltrials.gov) - P2 | N=720 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF) (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure (clinicaltrials.gov) - P2 | N=720 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Blood Pressure Lowering Effects of a Novel and Long-Acting Natriuretic Peptide Receptor 1 Agonist in Healthy Participants: A First-in-Human Clinical Study (AHA 2023) - "We reported for the first time that a novel long acting NPR1 agonist, XXB750, significantly increases plasma cGMP and reduces BP in a dose-dependent manner in humans. XXB750 has the potential for future development as a novel therapy for cardiovascular diseases."

Clinical • P1 data • Cardiovascular

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2023 ➔ Apr 2024 | Trial primary completion date: Aug 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2024 ➔ Aug 2023 | Trial primary completion date: Jun 2024 ➔ Aug 2023

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2023 ➔ Jun 2024 | Trial primary completion date: Sep 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2023 ➔ Sep 2023 | Trial primary completion date: Jun 2023 ➔ Sep 2023

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial primary completion date: Feb 2023 ➔ Feb 2024

Enrollment open • Trial primary completion date • Cardiovascular • Hypertension

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Cardiovascular • Hypertension

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: May 2022 ➔ Jun 2023

Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | N=18 ➔ 27 | Trial completion date: Oct 2022 ➔ Apr 2023 | Trial primary completion date: Oct 2022 ➔ May 2022

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure