Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ITCA 650/day · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ITCA 650 60 mcg/day | EXPERIMENTAL | ITCA 650 is exenatide in DUROS |
| sitagliptin | ACTIVE_COMPARATOR | sitagliptin 100 mg/day |
| Name | Type | Description |
|---|---|---|
| ITCA 650 60 mcg/day | DRUG | exenatide in DUROS |
| sitagliptin | DRUG | oral sitagliptin 100 mg/day |
Inclusion Criteria: * HbA1c between 7.5% - 10.5% * on metformin monotherapy * BMI between 25 \& 45 kg/m2 Exclusion Criteria: * taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis
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ITCA 650/day is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is a metabolic therapeutic that has been studied as an add-on therapy for patients with this condition. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
ITCA 650/day is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational drug for Type 2 Diabetes, with the asset currently in Phase 3 development.
ITCA 650/day is in Phase 3 clinical development for Type 2 Diabetes. It is an investigational drug, meaning it has not been approved by regulatory agencies. One Phase 3 trial has been completed, and there are no active trials currently listed for this asset.
ITCA 650/day has one completed Phase 3 clinical trial registered under NCT01455870. This study evaluated ITCA 650 compared to sitagliptin as add-on therapy for Type 2 Diabetes, enrolling 535 participants across the United States, Croatia, Denmark, Germany, and Latvia. The trial was randomized, double-blind, and active-controlled.
ITCA 650/day is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this asset. It is being studied specifically for Type 2 Diabetes and is not known to be marketed under any other designation.