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Rifaximin SSD IR

Phase 1

Dementia Alzheimer Type | Small molecule | Neurology |Bausch + Lomb Corporation|Last Updated: Apr 3, 2026

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
Double-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06718686Rifaximin SSD in Dementia TrialPHASE1 RECRUITING 20Dec 30, 2024Dec 30, 2027Apr 3, 20261 United States
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Study Endpoints
Primary Endpoints
Change in stool and serum short-chain fatty acid levels
10 weeks

Change in SCFA in stool and serum in rifaximin SSD phase vs placebo phase

Change in bile acids in stool and serum
10 weeks

Change in bile acids in stool and serum in rifaximin SSD phase vs placebo phase

Secondary Endpoints
Systemic inflammatory change
10 weeks
Stool microbiome composition
10 weeks
Change in dementia biomarkers
10 weeks
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Study Design & Arms
AllocationNA
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPatients will be given placebo and actual drug sequentially with the order hidden
Rifaximin SSD 40mg IR BIDEXPERIMENTALPatients will be given placebo and actual drug sequentially with the order hidden
Interventions
NameTypeDescription
Rifaximin SSD 40 mg IR tabletDRUGDrug therapy vs placebo
PlaceboDRUGPlacebo drug
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Probable Alzheimer's Disease (AD) or Vascular Dementia (VaD) mild or moderate based on Clinical Dementia Rating Scale. * Males and Females Age ≥ 65 years * Community living with availability of caregiver to accompany participant to study visits and to participate in the study....

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06718686studyFirstPostDate: changed