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YM087

Phase 3

Hyponatremia | Small molecule | Other |Cumberland Pharmaceuticals Inc.|Last Updated: May 2, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment167
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00380575Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic HyponatremiaPHASE3 COMPLETED 84 — — Aug 1, 2000Feb 1, 2003May 2, 201447 United States, Canada +2
NCT00492037Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic HyponatremiaPHASE3 COMPLETED 83 — — Jan 1, 2000Feb 1, 2002May 2, 201429 Belgium, Finland +7
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Study Endpoints
Primary Endpoints
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
Change in serum sodium from Baseline Safety of each dosing regimen
Beginning through end of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
YM087DRUG -
YM087 oralDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Serum sodium levels 115 to \< 130mEq/L * Euvolemic or Hypervolemic hyponatremia Exclusion Criteria: * Clinical evidence of volume depletion or dehydration * Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency * Uncontrolled brady-or tachyarrhythmias re...

Countries:United StatesCanadaIsraelSouth AfricaBelgiumFinlandFranceGermanyItalyNetherlandsPolandSpainUnited Kingdom
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