Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORMD-0801 BD · 1 trial · 2 indications
The Number of Treatment-Emergent Adverse Events (TEAE) according to CTCAE version 4.03. A TEAE is an adverse event for which the start date is on or after the date that the treatment began.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Fish oil |
| ORMD-0801 (Insulin) capsule 8 mg BD | EXPERIMENTAL | ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral |
| Name | Type | Description |
|---|---|---|
| ORMD-0801 (Insulin) capsule 8 mg BD | DRUG | 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening. |
| Placebo | OTHER | Matching Placebo |
Inclusion Criteria: * Male or female aged 18-70 years. * BMI ≥25 * Known type 2 DM according to American Diabetic Association (one of the three needed): Fasting Plasma Glucose ≥126 mg/dl or 2h postprandial (PG) following 75g OGTT ≥200 mg/dl or HbA1c \> 6.5%28 or on treatment with metformin only or ...
ORMD-0801 BD is an oral insulin capsule formulation developed by Oramed Pharmaceuticals Inc. (ticker ORMP). It is an investigational small molecule therapy being studied in type 2 diabetes mellitus. The BD designation refers to twice-daily dosing. It has completed a Phase 2 clinical trial and is not approved for any indication.
ORMD-0801 BD is being developed for the treatment of type 2 diabetes mellitus. It is also being studied in patients with type 2 diabetes who have nonalcoholic steatohepatitis (NASH). The completed Phase 2 trial evaluated its safety and efficacy in this specific patient population.
ORMD-0801 BD is developed by Oramed Pharmaceuticals Inc., a company traded on the Nasdaq under the ticker symbol ORMP. Oramed is the sponsor of the clinical program for this oral insulin candidate.
ORMD-0801 BD has completed a Phase 2 clinical trial. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 2 trial, NCT04618744, is listed as completed.
ORMD-0801 BD has been studied in one completed Phase 2 trial, NCT04618744, titled "A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)." The trial enrolled 32 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States and Israel.