Relaxin-2
Evidence: DEvidence: BGrade D — Applies to native/endogenous Relaxin-2 evidence considered separately from the manufactured Serelaxin clinical-development programme -- see Related Programme Evidence..
Grade B — Serelaxin (recombinant human Relaxin-2) clinical-development programme.
Serelaxin is a manufactured recombinant form of human Relaxin-2 with the same mature hormone sequence/structure. Its clinical programme includes controlled hemodynamic studies and two major acute-heart-failure programmes. RELAX-AHF generated symptom and exploratory outcome signals, but the larger 6,545-patient RELAX-AHF-2 trial did not reduce cardiovascular death or worsening heart failure. EMA refused marketing authorization for Reasanz after concluding efficacy had not been sufficiently demonstrated. These product-specific data are kept separate from the native Relaxin-2 page's Grade D evidence assessment.
Cardiovascular / Vascular
Evidence Snapshot
What this grade covers
Applies to native/endogenous Relaxin-2 evidence considered separately from the manufactured Serelaxin clinical-development programme -- see Related Programme Evidence.
Regulatory Context
Native Relaxin-2 is an endogenous hormone and is not itself an FDA- or EMA-approved drug product. A recombinant form, Serelaxin, was refused marketing authorization by the European Medicines Agency (Reasanz) after the agency concluded efficacy had not been sufficiently demonstrated -- this is a product/indication-specific regulatory decision and does not mean native Relaxin-2 is banned, prohibited, or unsafe.
Research Takeaway
Relaxin-2 (Human Relaxin H2) is a distinct human relaxin-family hormone and must not be merged with Relaxin-1, Relaxin-3, non-human relaxins, or RXFP-targeting drugs.
Evidence boundary: Serelaxin is the recombinant human Relaxin-2 product programme and must be labeled as such rather than treated as an unrestricted alias for every Relaxin-2 preparation.
See all 6 evidence claims →Quick Summary
Relaxin-2 is the native human H2 relaxin hormone. The much larger intervention evidence base belongs to Serelaxin, a sequence-equivalent recombinant Relaxin-2 product. Serelaxin showed early hemodynamic and symptom signals, but the pivotal RELAX-AHF-2 trial was neutral for cardiovascular death and worsening heart failure, and EMA refused Reasanz marketing authorization. The Serelaxin programme is therefore graded separately rather than silently upgrading native Relaxin-2.
Mechanism & Research Overview
Relaxin-2 is the native human H2 relaxin hormone. The much larger intervention evidence base belongs to Serelaxin, a sequence-equivalent recombinant Relaxin-2 product. Serelaxin showed early hemodynamic and symptom signals, but the pivotal RELAX-AHF-2 trial was neutral for cardiovascular death and worsening heart failure, and EMA refused Reasanz marketing authorization. The Serelaxin programme is therefore graded separately rather than silently upgrading native Relaxin-2.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Relaxin-2 (Human Relaxin H2) is a distinct human relaxin-family hormone and must not be merged with Relaxin-1, Relaxin-3, non-human relaxins, or RXFP-targeting drugs.
Does not establish
Evidence boundary: Serelaxin is the recombinant human Relaxin-2 product programme and must be labeled as such rather than treated as an unrestricted alias for every Relaxin-2 preparation.
Sources: Reasanz (serelaxin) -- EMA refusal of marketing authorisation
Supported
Serelaxin is recombinant human Relaxin-2 and is sequence/structure equivalent to mature naturally occurring human Relaxin-H2.
Does not establish
Evidence boundary: Sequence identity does not erase manufacturing, formulation, clinical-programme, or regulatory distinctions.
Sources: Reasanz (serelaxin) -- EMA refusal of marketing authorisation
Supported
Serelaxin was tested in large randomized acute-heart-failure trials; early RELAX-AHF results included symptom and exploratory outcome signals, but the 6,545-patient RELAX-AHF-2 trial did not reduce cardiovascular mortality or worsening heart failure.
Does not establish
Evidence boundary: This is Serelaxin product-programme evidence and must not be rewritten as established therapeutic efficacy of arbitrary native Relaxin-2 preparations.
Sources: Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial; Effects of Serelaxin in Patients with Acute Heart Failure
Supported
Serelaxin has controlled human hemodynamic and renal-pharmacology evidence in heart-failure populations.
Does not establish
Evidence boundary: Surrogate hemodynamic/renal changes do not override the neutral pivotal outcome trial.
Sources: A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure; Renal hemodynamic effects of serelaxin in patients with chronic heart failure; Effects of Serelaxin in Patients with Acute Heart Failure
Supported
The European Medicines Agency refused marketing authorization for Reasanz (serelaxin) for acute heart failure after concluding that efficacy had not been sufficiently demonstrated.
Does not establish
Evidence boundary: This is a product- and indication-specific regulatory decision and is not a declaration that endogenous Relaxin-2 is banned, unsafe, or globally prohibited.
Sources: Reasanz (serelaxin) -- EMA refusal of marketing authorisation
Supported
The much larger Serelaxin clinical evidence body is intentionally graded separately from native Relaxin-2 evidence.
Does not establish
Evidence boundary: Native peptide remains Grade D because sequence-identical recombinant-product trials are not being used to silently upgrade arbitrary native Relaxin-2 preparations.
Sources: Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial; Effects of Serelaxin in Patients with Acute Heart Failure; Reasanz (serelaxin) -- EMA refusal of marketing authorisation
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Serelaxin is vasoactive; blood-pressure reduction/hypotension is a relevant human safety consideration.Safety Consideration
Early promising signals were not confirmed for pivotal RELAX-AHF-2 cardiovascular-death/worsening-HF endpoints.Safety Consideration
EMA refusal is product/indication specific and must not be exaggerated into molecule-wide safety/prohibition claim.Safety Consideration
Long-term safety and therapeutic efficacy of arbitrary native Relaxin-2 preparations are not established by Serelaxin trials.
Research Areas Being Studied
Research areas discussed on this page reflect the Cardiovascular / Vascular category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Effects of Serelaxin in Patients with Acute Heart Failure (2019):
- A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure (2014):
- Renal hemodynamic effects of serelaxin in patients with chronic heart failure (2014):
- Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial (2013):
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Effects of Serelaxin in Patients with Acute Heart Failure | 2019 | 6,545 acute-heart-failure patients; multicenter randomized double-blind placebo-controlled event-driven | 48-hour Serelaxin infusion did not reduce 180-day cardiovascular death or worsening heart failure compared with placebo. | ||
| A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure | 2014 | Acute heart failure; randomized double-blind placebo-controlled multicentre | Assessed acute Serelaxin hemodynamic effects in AHF. | ||
| Renal hemodynamic effects of serelaxin in patients with chronic heart failure | 2014 | Chronic heart failure; placebo-controlled | Serelaxin increased renal plasma flow and altered filtration fraction without improving GFR. | ||
| Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial | 2013 | 1,161 acute-heart-failure patients; randomized placebo-controlled | RELAX-AHF tested Serelaxin in acute heart failure and reported improvement on one prespecified dyspnea assessment plus exploratory clinical signals. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Reasanz (serelaxin) -- EMA refusal of marketing authorisation | 2014 | EMA CHMP refused marketing authorization for Reasanz after concluding efficacy had not been sufficiently demonstrated; EMA explicitly describes Serelaxin as recombinant Relaxin-2. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-08-25.
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