Recent Updates
Recently added Catalysts

Crofelemer

Phase 3

HIV Enteropathy | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Aug 31, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01374490Safety and Tolerability of Crofelemer for HIV-Associated DiarrheaPHASE3 COMPLETED 250Jun 7, 2011Oct 31, 2012Aug 31, 202021 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
48 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CrofelemerEXPERIMENTAL -
Interventions
NameTypeDescription
CrofelemerDRUGCrofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male or female ≥ 18 years old * History of HIV-1 infection * On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening *...

Countries:United States
Unlock Eligibility Criteria