Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORMD-0801 Dose # 1 · 1 trial · 1 indication
Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug
| Arm | Type | Description |
|---|---|---|
| ORMD-0801 Dose # 1 | EXPERIMENTAL | Oral Insulin Formulation |
| ORMD-0801 Dose # 2 | EXPERIMENTAL | Oral Insulin Formulation |
| Placebo | PLACEBO_COMPARATOR | Oil Capsules |
| Name | Type | Description |
|---|---|---|
| ORMD-0801 Dose # 1 | DRUG | Oral Insulin Formulation |
| ORMD-0801 Dose # 2 | DRUG | Oral Insulin Formulation |
| Placebo | DRUG | Oil Capsules |
Inclusion Criteria: * Male or female patients, age 20 to 70 years, inclusive with T2DM; * At randomization, patients are treated for diabetes by diet and exercise, or by diet, exercise and metformin (\>1000 mg/day; any type and regimen). Patients on a stable regimen of metformin (defined as the sam...
ORMD-0801 Dose # 1 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 2 clinical development, with one completed trial that evaluated its safety, pharmacokinetics, and pharmacodynamics in adult patients with Type 2 Diabetes.
ORMD-0801 Dose # 1 is being developed by Oramed Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ORMP. The company is conducting clinical research to evaluate the drug's potential in treating Type 2 Diabetes Mellitus.
ORMD-0801 Dose # 1 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under evaluation for its safety and efficacy in patients with Type 2 Diabetes Mellitus.
ORMD-0801 Dose # 1 has one completed clinical trial, registered as NCT01889667. This Phase 2 study assessed the safety, pharmacokinetics, and pharmacodynamics of multiple oral bedtime doses of ORMD-0801 in 30 adult patients with Type 2 Diabetes Mellitus in the United States.
ORMD-0801 Dose # 1 is a specific dose formulation of the drug candidate ORMD-0801. The clinical trial NCT01889667 evaluated multiple oral bedtime doses of ORMD-0801, and this particular dose is being studied for its effects in patients with Type 2 Diabetes Mellitus.