Recent Updates
Recently added Catalysts

LX1033

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Lexicon Pharmaceuticals, Inc.|Last Updated: Mar 23, 2015

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_CONTROLLED
Total Trials1
Total Enrollment373
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01494233A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel SyndromePHASE2 COMPLETED 373Feb 1, 2012 -Mar 23, 201581 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change from baseline in stool consistency
4 weeks
Secondary Endpoints
Change from baseline in plasma 5-HIAA levels
4 weeks
Change from baseline in worst abdominal pain in past 24 hours
4 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low doseEXPERIMENTAL500 mg LX1033 two times daily
Mid doseEXPERIMENTAL500 mg LX1033 three times daily
High doseEXPERIMENTAL1000 mg LX1033 two times daily
PlaceboPLACEBO_COMPARATORMatching placebo dosing
Interventions
NameTypeDescription
250 mg LX1033 tabletsDRUG250 mg LX1033 tablets administered orally
Placebo tabletDRUGMatching placebo tablet administered orally
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites81

Inclusion Criteria: * Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis * Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale) * Weekly average of wor...

Countries:United States
Unlock Eligibility Criteria