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satavaptan

Phase 3

Ascites | Small molecule | Gastrointestinal |Sanofi|Trials Updated: May 26, 2016

satavaptan development status

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

satavaptan target and mechanism

Molecular targetAVPR2
Target classAntagonist
ModalitySmall molecule

Also known as satavaptan (SR121463B), SR121463B

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials8
Total Enrollment1,191

FDA Designations

No designations recorded

satavaptan clinical trials

satavaptan · 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 satavaptan

What is satavaptan used for?

Satavaptan is an investigational small molecule developed for ascites, including cirrhotic ascites, and for the syndrome of inappropriate antidiuretic hormone secretion (SIADH). It has been studied in patients with ascites due to liver cirrhosis, both with and without low sodium levels, and in the prevention of ascites.

What does satavaptan target?

Satavaptan targets AVPR2, the vasopressin V2 receptor. It acts as an antagonist at this receptor, meaning it blocks the receptor's activity. This mechanism is relevant to conditions involving fluid retention and low sodium levels, such as ascites and SIADH.

Who is developing satavaptan?

Satavaptan is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical trials evaluating satavaptan in patients with ascites and related conditions.

What phase is satavaptan in?

Satavaptan has been studied in Phase 3 clinical development. A Phase 3 trial, the CATS study, has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is satavaptan in?

Satavaptan has been evaluated in four completed clinical trials. These include the Phase 3 CATS trial (NCT00358878) in cirrhotic ascites, and three Phase 2 dose-ranging studies: NCT00501722 in hyponatraemic patients, NCT00501566 in normonatraemic patients, and NCT00501384 for the prevention of ascites.

Is satavaptan the same as SR121463B?

Yes, satavaptan is also known as SR121463B. SR121463B is an alternative identifier for the same investigational drug developed by Sanofi.