Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rowasa 4 gm · 1 trial · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Mesalamine | EXPERIMENTAL | Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period |
| Rowasa® | ACTIVE_COMPARATOR | Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Rowasa® 4 gm/60 mL Rectal Enema | DRUG | 1 x 4 gm/60 mL, single-dose |
| Mesalamine 4 gm/60 mL Rectal Enema | DRUG | 1 x 4 gm/60 mL, single-dose |
Inclusion Criteria: * Males and females, 18 years or older, with a body mass index (BMI) of 30 or less. * Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. * Signed informed consent form, which meets all criteria of current FDA r...
Rowasa 4 gm is a small molecule therapy developed by Teva Pharmaceutical Industries Limited. It is identified in clinical development as Rowasa 4 gm/60 mL Rectal Enema and has been studied in a Phase 1 trial. The specific therapeutic indication for this asset is not publicly disclosed.
Rowasa 4 gm is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor associated with the clinical development of this asset.
Rowasa 4 gm is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials listed for this asset. It remains an investigational therapy and is not approved.
Rowasa 4 gm has been evaluated in one completed Phase 1 trial, NCT00840203, titled Mesalamine 4 gm/60 mL Rectal Enema. The trial enrolled 72 healthy adult volunteers in the United States and used an active-controlled, randomized design without double blinding.