Serelaxin

Also known as: RLX030

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 36 of 235 publications on PubMed
Registered clinical trials 17 0 active
Adverse event reports 53 52 classified as serious
  • Serelaxin is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 235 publications mentioning it, including 36 randomized controlled trials and 31 animal-only studies.
  • ClinicalTrials.gov lists 17 registered studies testing it (0 active).
  • FDA's adverse event system (FAERS) holds 53 reports mentioning it; 52 classified as serious. Reports do not prove causation.

Research topics

  • Heart Failure 87
  • Acute Disease 51
  • Cardiovascular Agents 26
  • Fibrosis 25
  • Kidney 18
  • Vasodilator Agents 18
  • Receptors, G-Protein-Coupled 14
  • Receptors, Peptide 14
  • Cardiovascular Diseases 12
  • Prognosis 12

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 235
  • Human (MeSH) 162
  • Animal only 31
  • Clinical trials 39
  • Randomized controlled trials 36
  • Systematic reviews & meta-analyses 4
  • Case reports 1
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
17
Active
0
With posted results
10

Conditions studied

  • Acute Heart Failure 5
  • Chronic Heart Failure 2
  • Liver Cirrhosis 1
  • Hypertension, Portal 1
  • Coronary Artery Disease 1
  • Acute Heart Failure (AHF) 1
  • Renal Failure, Chronic 1
  • End-Stage Renal Disease 1
  • Pre-eclampsia 1
  • Compensated Cirrhosis and Portal Hypertension 1
  • Chronic Heart Failure (CHF) 1
  • Hepatic Impairment 1
Study Status Phase Start
Serelaxin To Lower Portal Pressure
NCT02669875 University of Edinburgh
Completed Phase 2 October 18, 2017
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
NCT02625922 Novartis Pharmaceuticals Results posted
Terminated Phase 2 February 5, 2016
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
NCT02151383 Novartis Pharmaceuticals Results posted
Terminated Phase 2 September 5, 2014
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
NCT01982292 Novartis Pharmaceuticals Results posted
Completed Phase 2 May 2014
Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF
NCT02007720 Novartis Pharmaceuticals Results posted
Terminated Phase 3 March 12, 2014
Study of the Vascular Effects of Serelaxin
NCT01979614 Novartis Pharmaceuticals Results posted
Completed Phase 2 February 3, 2014
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
NCT02064868 Novartis Pharmaceuticals Results posted
Terminated Phase 3 January 31, 2014
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
NCT02002702 Novartis Pharmaceuticals Results posted
Completed Phase 2 Jan 2014
Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
NCT01870778 Novartis Pharmaceuticals Results posted
Completed Phase 3 October 2, 2013
PK of Serelaxin in Severe Renal Impairment and ESRD
NCT01875523 Novartis Pharmaceuticals
Completed Phase 1 Aug 2013
Show 7 more studies
Study Status Phase Start
Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
NCT01566630 Novartis Pharmaceuticals Results posted
Terminated Phase 2 May 2013
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
NCT01640964 Novartis Pharmaceuticals Results posted
Completed Phase 2 Apr 2013
Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
NCT01543854 Novartis Pharmaceuticals
Completed Phase 2 Mar 2012
Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)
NCT01546532 Novartis Pharmaceuticals
Completed Phase 2 Feb 2012
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
NCT01433458 Novartis Pharmaceuticals
Completed Phase 1 Jul 2011
Recombinant Human Relaxin for the Treatment of Decompensated CHF
NCT00406575 Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Terminated Phase 2 Nov 2006
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
NCT00259103 Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Completed Phase 2 Nov 2005

All 17 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
53
Serious
52
With death outcome
7

Most reported reactions

  • Acute kidney injury 7
  • Cardiac failure 7
  • Hypotension 7
  • Angioedema 6
  • Gastrooesophageal reflux disease 6
  • Renal failure 6
  • Chronic kidney disease 5
  • Dehydration 5
  • Sinus node dysfunction 5
  • Anaemia 4
  • Bradycardia 3
  • Renal impairment 3

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.