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Relaxin

Phase 2

Heart Failure, Congestive | Small molecule | Cardiovascular |Novartis AG|Trials Updated: Oct 30, 2012

Relaxin development status

Highest phase Phase 2
Registered trials 4 across 3 sponsors since Nov 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,179

FDA Designations

No designations recorded

Relaxin clinical trials

Relaxin · 2 trials · 1 indication

Phase 2 2
NCT00520806Efficacy and Safety of Relaxin for the Treatment of Acute Heart FailureHeart Failure, Congestive
COMPLETED1,161 Analytics
NCT00259116A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart FailureHeart Failure, Congestive
COMPLETED18 Analytics
PHASE2COMPLETED
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
Heart Failure, CongestiveUnlock trial analytics
PHASE2COMPLETED
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Heart Failure, CongestiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Relief of dyspnea in acute heart failure
Up to day 5
Cardiac hemodynamics including PCWP, CO/CI, SVR

Secondary Endpoints

Days alive and out of hospital
Up to day 60
CV death or rehospitalization due to heart failure or renal failure
Up to day 60
Safety and tolerability
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR48 hour iv infusion of placebo
RelaxinEXPERIMENTAL48 hour iv infusion of relaxin at 30 ug/kg/day

Interventions

NameTypeDescription
RelaxinDRUGIntravenous infusion for 48 h at 30 ug/kg/day
PlaceboDRUGIntravenous infusion for 48 h
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Hospitalized for acute heart failure * Dyspnea at rest or with minimal exertion * Pulmonary congestion * Able to provide informed consent * Systolic blood pressure \> 125 mmHg * Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2 Exclusion Criteria: * Use of ot...

Countries:United StatesIsraelGermany
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Frequently asked questions about Relaxin

What is Relaxin used for?

Relaxin is being studied for the treatment of congestive heart failure. It has been evaluated in Phase 2 clinical trials for acute heart failure and compensated heart failure. It is an investigational therapy and is not approved for any indication.

Who is developing Relaxin?

Relaxin is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS. Novartis is the sponsor of the clinical trials evaluating Relaxin in heart failure.

What phase is Relaxin in?

Relaxin is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are currently recruiting. The program has enrolled a total of 1,179 participants across both studies.

What clinical trials is Relaxin in?

Relaxin has been tested in two completed Phase 2 trials: NCT00520806, which enrolled 1,161 patients with acute heart failure in the United States and Israel, and NCT00259116, a pilot study of recombinant human Relaxin in 18 patients with compensated congestive heart failure in Germany.

Is Relaxin FDA approved?

No, Relaxin is not approved by the FDA. It remains an investigational drug in clinical development, with both Phase 2 trials completed. Approval would require successful completion of later-stage trials.