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SR121463B

Phase 3

Congestive Heart Failure | Small molecule | Cardiovascular |Sanofi|Trials Updated: May 26, 2016

SR121463B development status

Highest phase Phase 3
Registered trials 7 across 1 sponsor since Dec 2005

SR121463B target and mechanism

ModalitySmall molecule

Also known as Satavaptan

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials8
Total Enrollment1,191

FDA Designations

No designations recorded

SR121463B clinical trials

SR121463B · 8 trials · 6 indications

Phase 3 4Phase 2 4
NCT00358878Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)Ascites
COMPLETED463 Analytics
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
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
AscitesUnlock trial 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

Composite endpoint of ascites worsening
at week 12
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
Time to repeat therapeutic paracentesis
12 weeks
Change in body weight
within 14 days
change in body weight, change in serum sodium
within 14 days
serum sodium concentration

Secondary Endpoints

Composite endpoint of ascites worsening
at week 24
Increase in ascites
at week 12
Serum sodium
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SatavaptanEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SatavaptanDRUGoral administration once daily
placeboDRUGoral administration once daily
SR121463BDRUG -
satavaptan (SR121463B)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Participants with cirrhosis of the liver * Participants with clinically evident ascites primarily managed by diet and/or diuretics * Stable treatment of ascites for at least the previous 2 weeks without paracentesis * Participants having undergone no more than one therapeutic ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileCroatiaDenmarkFranceHungaryIsraelItalyNetherlandsPolandPortugalRomaniaRussiaSpainSwedenUnited KingdomGermanyHong KongSwitzerlandGreeceSouth AfricaCzechiaTaiwan
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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.