THERAPY DOSSIER · th-f6f409edc9b0

Recombinant human relaxin-2 (hRLX2)

Hormone · ACTIVATOR of relaxin receptors RXFP1 and RXFP2. Peptide, recombinant human relaxin-2. EMA and FDA rejected marketing authorisation.

Not approved Suggest a correction

Evidence & regulatory context

Mechanism: ACTIVATOR of relaxin receptors RXFP1 and RXFP2. Peptide, recombinant human relaxin-2. EMA and FDA rejected marketing authorisation.
Target: CHEMBL1293316 (relaxin receptor 1); CHEMBL1628482 (relaxin receptor 2)
Injury models: Radiation
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL2108358 ↗
ChEMBL max phase: 3 / 4 (development scale, not regulatory approval)
Synonyms: Serelaxin; Recombinant human relaxin; Human relaxin 2 (relaxin H2); RLX-030; RLX030
Note: Not recorded

Clinical trials 10

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT01870778 ↗PHASE3completed

Phase III Study to Evaluate Efficacy, Safety and Tolerability of Serelaxin Added to Standard Therapy in Acute Heart Failure Patients (RELAX-AHF-2)

Acute Heart Failure

Enrolment: 6600 · Results not recorded

NCT02064868 ↗PHASE3terminated

Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure Patients

Acute Heart Failure

Enrolment: 2666 · Results not recorded

NCT02007720 ↗PHASE3terminated

Phase III Study to Evaluate Efficacy, Safety and Tolerability of Serelaxin Added to Standard Therapy in Acute Heart Failure Patients

Acute Heart Failure

Enrolment: 876 · Results not recorded

NCT01982292 ↗PHASE2completed

Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

Chronic Heart Failure

Enrolment: 321 · Results not recorded

NCT01543854 ↗PHASE2completed

Study to Evaluate the Hemodynamic Responses to Intravenous RLX030 Infusion in Subjects With Acute Heart Failure

Acute Heart Failure

Enrolment: 71 · Results not recorded

NCT01640964 ↗PHASE2completed

Exploratory Study to Investigate the Haemodynamic Effects of Serelaxin (RLX030) in Patients With Compensated Cirrhosis and Portal Hypertension

Compensated Cirrhosis and Portal Hypertension

Enrolment: 47 · Results not recorded

NCT02625922 ↗PHASE2terminated

Phase II Study to Assess the Effect of Serelaxin Versus Placebo on hs-cTnI Release in Patients With Chronic Heart Failure After Exercise

Chronic Heart Failure

Enrolment: 26 · Results not recorded

NCT02151383 ↗PHASE2terminated

Dose Escalation Study of Safety, Tolerability and Pharmacokinetics of RLX030 in Paediatric Patients Hospitalized With Acute Heart Failure

Acute Heart Failure

Enrolment: 12 · Results not recorded

NCT00406575 ↗PHASE2terminated

Phase II Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

Congestive Heart Failure

Enrolment: 11 · Results not recorded

NCT01875523 ↗PHASE1completed

Study to Assess the Pharmacokinetics of Serelaxin in Patients With Severe Renal Impairment or End-Stage Renal Disease on Hemodialysis

Renal Failure, Chronic · End-Stage Renal Disease

Enrolment: 36 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 29806709 ↗2018Reported benefit

Relaxin-2 therapy reverses radiation-induced fibrosis and restores bladder function in mice.

MouseRadiationC57Bl/6Femalen = n = 4 per group for cystometry and plasma measurements; n =…Continuous subcutaneous infusion via ALZET osmotic pump (model 1002) implanted at the lower mid-back50 to 400 micrograms per kg per day, with 400 micrograms pe…Started 7 weeks after irradiation

Model: Selective bladder irradiation at 10 Gy via laparotomy, producing chronic radiation cystitis with fibrosis, reduced compliance and contractility and overflow incontinence within 6 weeks

hRLX2 reversed radiation-induced bladder fibrosis, reduced collagen content, improved bladder wall architecture and increased bladder compliance, detrusor Cav1.2 expression and detrusor contractility. At 400 micrograms per kg per day the voiding pattern normalised with larger voided volumes and com…

Extraction: extract · Supplied extraction confidence: 0.85. Machine-extracted fields require source verification.

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