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MD-0727

Phase 2

Hypercholesterolemia | Small molecule | Metabolic |Ironwood Pharmaceuticals, Inc.|Last Updated: Oct 1, 2007

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00404001Study of Oral MD-0727 Administered to Patients With Primary HypercholesterolemiaPHASE2 COMPLETED 150Nov 1, 2006Jul 1, 2007Oct 1, 200720 United States
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Study Endpoints
Primary Endpoints
Low density lipoprotein cholesterol (LDL-C)
Secondary Endpoints
Total cholesterol
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MD-0727DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Patient is male or non-pregnant, non-breastfeeding female, at least 18 years of age * Patient must agree to use contraception and/or birth control if sexually active * Patient may not be on lipid-lowering therapies at least 6 weeks prior to study and must have a fasting LDL-C ...

Countries:United States
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