Recent Updates
Recently added Catalysts

SR121463B

Phase 3

Inappropriate ADH Syndrome | Small molecule | Other |Sanofi|Last Updated: Jan 21, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment134
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264914Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionPHASE3 COMPLETED 57Jul 1, 2005Aug 1, 2007Jan 21, 200911 United States, Australia +9
NCT00264927Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionPHASE3 COMPLETED 77May 1, 2004Sep 1, 2007Dec 10, 200811 United States, Belgium +9
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
Serum sodium
Secondary Endpoints
Serum sodium
Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SR121463BDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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 KongHungaryRussiaSwitzerlandCroatiaNetherlandsPortugalSpain
Unlock Eligibility Criteria