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TAK-875

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Takeda Pharmaceutical Company Limited|Last Updated: Jan 27, 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
CONTROLLED
Total Trials3
Total Enrollment1,747
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01433419Open-label Study of TAK-875PHASE3 COMPLETED 333Jan 1, 2012Dec 1, 2012Mar 22, 201331 Japan
NCT01433406Long-term Study of TAK-875PHASE3 COMPLETED 1,222Oct 1, 2011Dec 1, 2013Jan 27, 201471 Japan
NCT01433393Double-blind Comparative Study of TAK-875PHASE3 COMPLETED 192 -Sep 1, 2012Nov 9, 201219 Japan
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Study Endpoints
Primary Endpoints
Adverse events
HbA1c
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Study Design & Arms
ModelPARALLEL
Treatment Arms
ArmTypeDescription
TAK-875 25 mgEXPERIMENTAL -
TAK-875 50 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TAK-875DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: 1. The participant is an outpatient. 2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: 1. The participant has any serious cardiac disease, serious cere...

Countries:Japan
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