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XXB750 · 2 trials · 3 indications
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).
To evaluate the safety and tolerability of single ascending SC doses of XXB750 in healthy participants. Adverse events may include abnormal vital signs, safety laboratory tests, physical exam tests and ECG parameters that include clinical signs or symptoms, are considered clinically significant or require therapy.
| Arm | Type | Description |
|---|---|---|
| XXB750 Cohort 1 | EXPERIMENTAL | XXB750, single dose |
| Placebo Cohort 1 | PLACEBO_COMPARATOR | Placebo, single dose |
| XXB750 Cohort 2 | EXPERIMENTAL | XXB750, multiple doses |
| Placebo Cohort 2 | PLACEBO_COMPARATOR | Placebo, multiple doses |
| XXB750 s.c 1 mg | EXPERIMENTAL | Single SC dose of XXB750 1 mg |
| XXB750 s.c 3 mg | EXPERIMENTAL | Single SC dose of XXB750 3 mg |
| XXB750 s.c 10 mg | EXPERIMENTAL | Single SC dose of XXB750 10 mg |
| XXB750 s.c 30 mg | EXPERIMENTAL | Single SC dose of XXB750 30 mg |
| XXB750 s.c 60 mg | EXPERIMENTAL | Single SC dose of XXB750 60 mg |
| XXB750 s.c 120 mg | EXPERIMENTAL | Single SC dose of XXB750 120 mg |
| XXB750 s.c 240 mg | EXPERIMENTAL | Single SC dose of XXB750 240 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo to XXB750 |
| XXB750 s.c 240 mg Japanese cohort | EXPERIMENTAL | Single SC dose of XXB750 240 mg in the Japanese cohort |
| Placebo for Japanese cohort | PLACEBO_COMPARATOR | Placebo to XXB750 in the Japanese cohort |
| XXB750 s.c 450 mg (HBP) | EXPERIMENTAL | Single SC dose of XXB750 450 mg (High Blood Pressure Cohort) |
| XXB750 s.c 600 mg (HBP) | EXPERIMENTAL | Single SC dose of XXB750 600 mg (High Blood Pressure Cohort) |
| Placebo to High Blood Pressure cohort | PLACEBO_COMPARATOR | Placebo to XXB750 in High Blood Pressure cohorts |
| Name | Type | Description |
|---|---|---|
| XXB750 | DRUG | XXB750 |
| Placebo | DRUG | Placebo |
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...
XXB750 is an investigational small molecule being studied for heart failure with reduced ejection fraction (HFrEF) and heart failure with mildly reduced ejection fraction (HFmrEF). It has also been evaluated in healthy participants to assess safety, tolerability, and pharmacokinetics. The drug is in Phase 1 clinical development.
XXB750 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and tolerability in heart failure patients and healthy volunteers.
XXB750 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in heart failure participants with reduced or mildly reduced ejection fraction and another in healthy participants. The drug is investigational and has not been approved by regulatory authorities.
XXB750 has been studied in two completed Phase 1 trials. NCT05328752 evaluated safety and tolerability in 27 participants with heart failure with reduced or mildly reduced ejection fraction in the United States and Netherlands. NCT06558097 assessed safety, tolerability, and pharmacokinetics in 77 healthy participants in the United States.
XXB750 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. Completed trials have focused on safety, tolerability, and pharmacokinetics in heart failure patients and healthy volunteers. Further clinical studies would be needed to support any regulatory approval.