Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Serelaxin (RLX030), RLX030, Recombinant human relaxin-2, Recombinant human relaxin (rhRlx)
Serelaxin · 10 trials · 10 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.
Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.
Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.
Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.
Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.
The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)
Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP). Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).
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
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
| 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. |
| Serelaxin | ACTIVE_COMPARATOR | IV infusion of serelaxin (RLX030) for 2 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 |
| Serelaxin 10 mcg/kg/Day | EXPERIMENTAL | Participants received 10 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. |
| Serelaxin 30 mcg/kg/Day | EXPERIMENTAL | Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. |
| Part A: Terlipressin acetate | EXPERIMENTAL | Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection. |
| Part A: Serelaxin (RLX030) | EXPERIMENTAL | Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition |
| Part B Serelaxin (RLX030) | EXPERIMENTAL | The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of Portal pressure gradient (PPG) data acquisition. |
| RLX030 | EXPERIMENTAL | RLX030 as intravenous infusion for 20 hours |
| 7.5 µg/kg/d | EXPERIMENTAL | Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A. |
| 25 µg/kg/d | EXPERIMENTAL | Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A. |
| 75 µg/kg/d | EXPERIMENTAL | Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B. |
| Group 1 Treatment with serelaxin | EXPERIMENTAL | Patients with severe renal impairment will receive a single 4 hour i.v. infusion of serelaxin |
| Group 2 Treatment with serelaxin | EXPERIMENTAL | Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment |
| Group 3 Treatment with serelaxin | EXPERIMENTAL | Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and treatment and PK will be done in dialysis-free interval |
| Group 4 Treatment with serelaxin | EXPERIMENTAL | Healthy volunteers will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment |
| Name | Type | Description |
|---|---|---|
| RLX030 | DRUG | 1 mg/mL solution in 6 mL vials |
| Placebo | DRUG | Matching placebo solution to serelaxin |
| Serelaxin | DRUG | Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution |
| 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. |
| Terlipressin acetate | DRUG | IV bolus injection |
| Serelaxin (RLX030) | DRUG | Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 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)...
Serelaxin is an investigational small molecule developed by Novartis AG (ticker NVS) that acts as an activator of the RXFP1 and RXFP2 receptors. It has been studied in Phase 2 clinical trials across cardiovascular and hepatic conditions, including acute heart failure, compensated cirrhosis and portal hypertension, and coronary artery disease.
Serelaxin has been evaluated in Phase 2 clinical development for acute heart failure. A completed Phase 2 study, NCT02002702, assessed its safety, tolerability, and pharmacokinetics in Japanese patients with acute heart failure. Serelaxin is investigational and has not been approved for any indication.
Serelaxin targets the RXFP1 and RXFP2 receptors and functions as an activator of these receptors. This mechanism has been explored in clinical studies of acute heart failure, coronary artery disease, and portal hypertension related to liver cirrhosis.
Serelaxin is being developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored Phase 1 and Phase 2 clinical trials of serelaxin across multiple indications, including acute heart failure, coronary artery disease, chronic renal failure, and liver cirrhosis with portal hypertension.
Serelaxin is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority for any indication. Completed studies include Phase 2 trials in acute heart failure, coronary artery disease, and portal hypertension, as well as a Phase 1 trial in severe renal impairment.
Serelaxin has been studied in completed clinical trials including NCT02669875 in liver cirrhosis and portal hypertension, NCT02002702 in Japanese acute heart failure patients, NCT01979614 in coronary artery disease, and NCT01875523 in severe renal impairment and end-stage renal disease. These trials were randomized, double-blind, and placebo-controlled where reported.
Yes, Serelaxin is also known as RLX030. Both names refer to the same investigational small molecule developed by Novartis AG for conditions including acute heart failure, compensated cirrhosis and portal hypertension, and coronary artery disease.