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mesalamine

Phase 3FDA approved

Undisclosed | Small molecule | Other |Bausch Health Companies Inc.|Trials Updated: Nov 18, 2019

mesalamine development status

FDA approval on record Jan 5, 2001
Approval holderAbbvie
ApplicationNDA021252
Highest phase Phase 3 run by AbbVie (NCT05316220)
Phase scored for BHCPhase 1
Registered trials 6 across 6 sponsors since Aug 2007

Label indication CANASA is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. CANASA is an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. ( 1 ) FDA label

mesalamine target and mechanism

Molecular targetALOX5, PTGS2, PTGS1, PPARG
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL704

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

mesalamine clinical trials

mesalamine · 1 trial · 1 indication

Phase 1 1
NCT00622375PK Study of Encapsulated Mesalamine Granules in Healthy VolunteersHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
14 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
mesalamineDRUGencapsulated mesalamine granules
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about mesalamine

What is mesalamine?

Mesalamine is a small molecule drug being developed by Bausch Health Companies Inc. (ticker BHC). It is in Phase 1 clinical development, and the specific indication has not been disclosed. The program includes one completed Phase 1 pharmacokinetic study conducted in healthy volunteers in the United States.

What does mesalamine target?

Mesalamine targets ALOX5, PTGS2, PTGS1, and PPARG. It is classified as an inhibitor of these targets. ALOX5 and PTGS1/PTGS2 are enzymes involved in inflammatory pathways, while PPARG is a nuclear receptor. This target profile is consistent with the drug's classification as a small molecule.

Who makes mesalamine?

Mesalamine is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor of the clinical program for this asset.

What phase is mesalamine in?

Mesalamine is in Phase 1 clinical development. It is an investigational drug and is not approved. The program includes one completed Phase 1 trial, and there are currently no active trials listed for this asset.

What clinical trials is mesalamine in?

Mesalamine has been studied in one completed Phase 1 trial, NCT00622375, titled a pharmacokinetic study of encapsulated mesalamine granules in healthy volunteers. The trial enrolled 24 participants in the United States, with an age minimum of 18 years and all sexes eligible. It was an uncontrolled study without randomization or blinding.