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SR121463B

Phase 3

Congestive Heart Failure | Small molecule | Cardiovascular |Sanofi|Last Updated: Jan 21, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

SR121463B · 3 trials · 3 indications

Phase 3 3
NCT00264914Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionInappropriate ADH Syndrome
COMPLETED57 Analytics
NCT00274326DILIPO (DILutIonal HyPOnatremia)Congestive Heart Failure
COMPLETED150 Analytics
NCT00264927Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionInappropriate ADH Syndrome
COMPLETED77 Analytics
PHASE3COMPLETED
Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Inappropriate ADH SyndromeUnlock trial analytics
PHASE3COMPLETED
DILIPO (DILutIonal HyPOnatremia)
Congestive Heart FailureUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Inappropriate ADH SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
EFFICACY:Serum Sodium
SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
PHARMACOKINETICS:Plasma SR121463B concentrations
Serum sodium

Secondary Endpoints

Serum sodium
Weight; EQ-5D and pharmaco-economic assessments
Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SR121463BDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male or female patients aged 18 years and higher. * SIADH (the diagnosis of SIADH is based on several criteria including true serum hypoosmolality, inappropriate urinary osmolality, clinical euvolemia, elevated urinary sodium excretion while on normal salt and water intake, an...

Countries:United StatesAustraliaBelgiumBrazilCanadaFranceGermanyHong KongHungaryRussiaSwitzerlandArgentinaChileDenmarkGreeceIsraelPolandPortugalRomaniaSouth AfricaSwedenCroatiaNetherlandsSpain
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Frequently asked questions about SR121463B

What is SR121463B used for?

SR121463B is an investigational small molecule being studied for the treatment of Inappropriate ADH Syndrome, a condition also known as Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), which causes hyponatremia, and for Congestive Heart Failure. It is being developed by Sanofi and is in Phase 3 clinical development.

Who makes SR121463B?

SR121463B is being developed by Sanofi, a global pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 3 clinical trials for Inappropriate ADH Syndrome and Congestive Heart Failure.

What phase is SR121463B in?

SR121463B is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. Three Phase 3 trials have been completed, with a total enrollment of 150 patients across studies.

What clinical trials is SR121463B in?

SR121463B has been studied in three completed Phase 3 trials. NCT00264914 and NCT00264927 evaluated the drug in patients with Inappropriate ADH Syndrome and hyponatremia, enrolling 57 and 77 patients respectively. NCT00274326, titled DILIPO, studied the drug in 150 patients with Congestive Heart Failure.

Is SR121463B the same as tolvaptan?

No, SR121463B is not the same as tolvaptan. SR121463B is a distinct investigational small molecule developed by Sanofi for Inappropriate ADH Syndrome and Congestive Heart Failure. It is currently in Phase 3 clinical development and has not been approved for any use.