Recent Updates
Recently added Catalysts

mesalamine

Phase 1

Healthy | Small molecule | Other |Bausch Health Companies Inc.|Last Updated: Nov 18, 2019

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
UNCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00622375PK Study of Encapsulated Mesalamine Granules in Healthy VolunteersPHASE1 COMPLETED 24Feb 1, 2008May 1, 2008Nov 18, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
14 days
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
mesalamineDRUGencapsulated mesalamine granules
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The subject is Male, or female of Non-childbearing potentia.l * The subject is female of childbearing potential, who has a negative serum pregnancy test at screen and agrees to using appropriate birth control. * The subject is between the ages of 18 and 45 years. * The subject...

Countries:United States
Unlock Eligibility Criteria