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IW-9179

Phase 2

Diabetic Gastroparesis | Small molecule | Other |Ironwood Pharmaceuticals, Inc.|Last Updated: Dec 5, 2016

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02289846Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)PHASE2 COMPLETED 90Oct 1, 2014Dec 1, 2015Dec 5, 201622 United States
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Study Endpoints
Primary Endpoints
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo BIDPLACEBO_COMPARATORPlacebo once in the morning and once in the evening.
IW-9179 QD AM + Placebo QD PMEXPERIMENTALIW-9179 once in the morning and placebo once in the evening.
Placebo QD AM + IW-9179 QD PMEXPERIMENTALPlacebo once in the morning and IW-9179 once in the evening.
IW-9179 BIDEXPERIMENTALIW-9179 once in the morning and once in the evening
Interventions
NameTypeDescription
IW-9179DRUG -
Matching PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit. * Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus. * Patient has a diagnosis of DGP with no history or evidence of mechanical o...

Countries:United States
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