Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mesalamine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mesalamine | DRUG | encapsulated mesalamine granules |
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...
Mesalamine is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 pharmacokinetic study of encapsulated mesalamine granules. The drug is not approved and remains in clinical development.
Mesalamine is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical research on this small molecule drug candidate.
Mesalamine is in Phase 1 clinical development. A Phase 1 pharmacokinetic study of encapsulated mesalamine granules in healthy volunteers has been completed. The drug is investigational and not yet approved.
Mesalamine has one completed clinical trial, NCT00622375, a Phase 1 pharmacokinetic study of encapsulated mesalamine granules in healthy volunteers. The study enrolled 24 participants in the United States and was uncontrolled.
Mesalamine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT00622375, was a pharmacokinetic study in healthy volunteers, and the drug has not reached approval.