Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral Insulin
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 oral small molecule developed by Oramed Pharmaceuticals Inc. (ticker ORMP) for type 2 diabetes mellitus. It is a Phase 2 candidate in the metabolic therapeutic area and has been studied in a single completed clinical trial. It is not an approved medicine.
ORMD-0801 Dose # 1 is being developed for the treatment of type 2 diabetes mellitus, a metabolic condition. Its clinical testing has focused on adult patients with type 2 diabetes. The program remains investigational, so the drug is not available as a prescribed treatment outside of clinical research.
ORMD-0801 Dose # 1 is developed by Oramed Pharmaceuticals Inc., which trades under the ticker ORMP. The company is the sponsor of the clinical program evaluating this oral small molecule candidate for type 2 diabetes mellitus. No other developer is associated with the asset.
ORMD-0801 Dose # 1 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The candidate is investigational and has not been approved by the FDA or any other regulator for type 2 diabetes mellitus.
ORMD-0801 Dose # 1 has been evaluated in one completed Phase 2 study, NCT01889667, titled Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM). The trial enrolled 30 adults in the United States and was randomized, double blind, and placebo controlled.