Recent Updates
Recently added Catalysts

Lixivaptan

Phase 3

Euvolemic Hyponatremia | Small molecule | Other |Biogen Inc.|Last Updated: Jun 28, 2011

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment206
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00876798A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic HyponatremiaPHASE3 COMPLETED 206 — — Jun 1, 2009 -Jun 28, 201190 United States, Belgium +6
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.
6 months
Secondary Endpoints
If lixivaptan demonstrates improvement in serum sodium, % of subjects achieving normalized serum sodium, % of subjects requiring fluid restriction, prevention of worsening hyponatremia, and the change from baseline to complete TMT-B.
6 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLixivaptan
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
LixivaptanDRUGCapsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
PlaceboDRUGCapsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites90

Inclusion Criteria: 1. Written informed consent. 2. Men or women aged 18 or older. 3. Diagnosis of euvolemic hyponatremia (Na+ \< 135 mEq/L). 4. Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose). 5. In the Investigator's ju...

Countries:United StatesBelgiumCzechiaIndiaIsraelItalyMexicoPeru
Unlock Eligibility Criteria