Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RLX030 · 4 trials · 3 indications
The percentage of participants with an adjudicated CV death through day 180 was assessed.
The percentage of participants with WHF through day 5 was assessed.
A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient's antibody status is considered to be undetermined during the study if it is not defined as positive or negative.
Measurements will be made using a Swan-Ganz indwelling catheter
Measurements will be made using a Swan-Ganz indwelling catheter
Serial blood and urine collections over time for determination of PAH and its clearance respectively
Serial blood and urine collections over time for determination of IOTH and its clearance respectively
| Arm | Type | Description |
|---|---|---|
| Serelaxin (RLX030) | EXPERIMENTAL | Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours. |
| Placebo | PLACEBO_COMPARATOR | Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours. |
| RLX030 (serelaxin) | EXPERIMENTAL | Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 |
| RLX030 | EXPERIMENTAL | RLX030 as intravenous infusion for 20 hours |
| Name | Type | Description |
|---|---|---|
| RLX030 | DRUG | 1 mg/mL solution in 6 mL vials |
| Placebo | DRUG | Matching placebo solution to serelaxin |
| RLX030 (serelaxin) | DRUG | RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours. |
Key Inclusion Criteria: * Male or female 18 years of age, with body weight ≤160 kg * Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department)...
RLX030, also known as serelaxin, is an investigational small molecule being developed for cardiovascular conditions, specifically acute heart failure and chronic heart failure. It is administered intravenously and has been studied in clinical trials for its effects on hemodynamics and renal function in heart failure patients.
RLX030 is a recombinant form of the hormone relaxin-2. It works by binding to relaxin family peptide receptors, which leads to vasodilation, increased cardiac output, and improved renal perfusion. These effects are being investigated as potential treatments for acute and chronic heart failure.
RLX030 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational therapy and has not been approved by regulatory authorities.
RLX030 has completed Phase 3 clinical trials for acute heart failure. The most advanced study, NCT01870778, enrolled 6,600 participants and evaluated the efficacy, safety, and tolerability of serelaxin when added to standard therapy. The drug remains investigational and is not yet approved for any indication.
RLX030 has been studied in four completed clinical trials. These include NCT01543854 and NCT01546532, which examined hemodynamic effects in acute and chronic heart failure, NCT01870778, a large Phase 3 efficacy trial in acute heart failure, and NCT01982292, which assessed the safety of repeat doses in chronic heart failure.
Yes, RLX030 is also known as serelaxin. The drug is a recombinant form of the human hormone relaxin-2 and has been investigated under both names in clinical trials for heart failure. Novartis is the developer of this investigational therapy.