Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Serelaxin · 5 trials · 7 indications
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.
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 | ACTIVE_COMPARATOR | IV infusion of serelaxin (RLX030) for 2 hours |
| Placebo | PLACEBO_COMPARATOR | IV infusion of placebo (20mM sodium acetate pH5) matched to serelaxin for 2 hours |
| 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. |
| 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 |
|---|---|---|
| Serelaxin | DRUG | Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution |
| Placebo | DRUG | Placebo solution (20mM sodium acetate pH5) diluted in 5% v/v glucose solution |
Inclusion Criteria: 1. Male or female adult subjects over 18 years of age 2. Able to provide written informed consent and able to understand and willing to comply with the requirements of the study 3. Clinical imaging-diagnosed or biopsy-proven liver cirrhosis of any aetiology 4. Evidence of portal...
Serelaxin is an investigational small molecule being studied for cardiovascular and other conditions, including acute heart failure, coronary artery disease, induced labor, chronic renal failure, and liver cirrhosis. It is developed by Novartis AG and is currently in Phase 2 clinical development.
Serelaxin is a recombinant form of the human relaxin-2 hormone. It works by binding to the relaxin family peptide receptor 1 (RXFP1), which mediates its effects on vasodilation and organ protection. This mechanism is being studied for potential benefits in conditions like acute heart failure.
Serelaxin is developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Serelaxin is in Phase 2 clinical development. It has completed several Phase 1 and Phase 2 trials, but it is not yet approved by regulatory authorities. The drug remains investigational, and further studies are needed to establish its safety and efficacy.
Serelaxin has been studied in several completed trials, including NCT00259103 for induced labor, NCT01875523 for renal impairment, NCT01979614 for coronary artery disease, and NCT02002702 for acute heart failure. These trials have evaluated the drug's pharmacokinetics, safety, and vascular effects.
Serelaxin is a recombinant form of human relaxin-2, a naturally occurring hormone. While it is related to relaxin, Serelaxin is a specific pharmaceutical compound developed by Novartis for therapeutic use. It is not identical to endogenous relaxin but mimics its biological activity.