Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RLX030 (serelaxin), serelaxin*, *International Nonproprietary Name, Recombinant human relaxin-2
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 is being developed for the treatment of acute heart failure and chronic heart failure. It has been studied both as a treatment added to standard therapy in acute heart failure and as repeat intravenous dosing in chronic heart failure. It remains an investigational therapy rather than an approved product.
RLX030 is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trial program evaluating the drug in heart failure, including the large Phase 3 study in acute heart failure and the Phase 2 studies in chronic heart failure.
RLX030 has reached Phase 3 clinical development. The Phase 3 study NCT01870778 evaluated its efficacy, safety and tolerability when added to standard therapy in acute heart failure and enrolled 6,600 participants. Additional Phase 2 studies have also been completed in acute and chronic heart failure.
RLX030 has been studied in completed trials including NCT01870778, a Phase 3 trial of serelaxin added to standard therapy in acute heart failure, and NCT01982292, a Phase 2 trial of repeat intravenous doses in chronic heart failure. Phase 2 trials NCT01546532 and NCT01543854 examined hemodynamic and renal effects.
Yes, RLX030 is also known as serelaxin. The two names refer to the same investigational drug, and the clinical trial records use both, with some studies listed under RLX030 and others under serelaxin, including the Phase 3 acute heart failure trial NCT01870778.