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XXB750

Phase 1

Heart Failure With Reduced Ejection Fraction (HFrEF) | Small molecule | Cardiovascular |Novartis AG|Trials Updated: Sep 30, 2025

XXB750 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Apr 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

XXB750 clinical trials

XXB750 · 1 trial · 2 indications

Phase 1 1
NCT05328752Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)Heart Failure With Reduced Ejection Fraction (HFrEF)
COMPLETED27 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
Heart Failure With Reduced Ejection Fraction (HFrEF)Unlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events, which may include abnormal vital signs, safety lab tests, or ECG parameters that induce clinical signs or symptoms, are considered clinically significant or require therapy
91 days (Cohort 1), 146 days (Cohort 2)

To evaluate the safety and tolerability of XXB750 in adult participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).

Secondary Endpoints

Pharmacokinetics parameters Tmax
91 days (Cohort 1), 146 days (Cohort 2)
Pharmacokinetics parameters Cmax
91 days (Cohort 1), 146 days (Cohort 2)
Pharmacokinetics parameters AUClast for Cohort 1
91 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XXB750 Cohort 1EXPERIMENTALXXB750, single dose
Placebo Cohort 1PLACEBO_COMPARATORPlacebo, single dose
XXB750 Cohort 2EXPERIMENTALXXB750, multiple doses
Placebo Cohort 2PLACEBO_COMPARATORPlacebo, multiple doses

Interventions

NameTypeDescription
XXB750DRUGXXB750
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * NYHA functional class II-III * LVEF ≤ 50% documented at screening * Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive * Treatment with a stable dose of a beta blocker. * Cohort 1: Treatmen...

Countries:United StatesNetherlands
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Frequently asked questions about XXB750

What is XXB750?

XXB750 is an investigational small molecule developed by Novartis AG for heart failure with reduced ejection fraction, or HFrEF. It has been studied in a single Phase 1 clinical trial in participants with reduced or mildly reduced ejection fraction. It is not an approved therapy and remains in clinical development.

What is XXB750 used for in HFrEF?

XXB750 is being developed for heart failure with reduced ejection fraction, a condition in which the heart muscle does not pump blood efficiently. The Phase 1 study also enrolled participants with mildly reduced ejection fraction, or HFmrEF. The drug is investigational and has no approved indication.

Who makes XXB750?

XXB750 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the Phase 1 study of the compound in heart failure participants. No other developer or partnership for XXB750 has been announced.

What phase is XXB750 in?

XXB750 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was randomized, double-blind, and placebo-controlled, enrolling 27 participants. XXB750 is investigational and has not been approved by the FDA.

What clinical trials is XXB750 in?

XXB750 has been evaluated in one completed Phase 1 trial, NCT05328752, titled a safety and tolerability study in heart failure participants with reduced or mildly reduced ejection fraction. It enrolled 27 adults across the United States and the Netherlands. The trial was randomized, double-blind, and placebo-controlled, and it has completed.