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 investigational oral insulin being developed for Type 2 Diabetes Mellitus. It was studied in patients with Type 2 diabetes who also have nonalcoholic steatohepatitis (NASH). The drug is a small molecule being evaluated for its safety and efficacy in this patient population.
ORMD-0801 BD is being developed by Oramed Pharmaceuticals Inc., a biopharmaceutical company. Oramed's stock is traded under the ticker symbol ORMP. The company is focused on developing oral formulations of drugs that are traditionally delivered by injection, including insulin.
ORMD-0801 BD is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial assessing its safety and efficacy in Type 2 diabetes patients with NASH has been completed.
ORMD-0801 BD has one completed Phase 2 clinical trial registered as NCT04618744. The study assessed the safety and efficacy of oral insulin in Type 2 diabetes patients with nonalcoholic steatohepatitis (NASH). The trial enrolled 32 participants and was conducted in the United States and Israel.
ORMD-0801 BD is an oral insulin formulation designed to deliver insulin to the body through the gastrointestinal tract. By providing insulin orally, it aims to help manage blood glucose levels in patients with Type 2 diabetes. The drug is being studied for its potential effects on both diabetes and NASH.
ORMD-0801 BD is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial evaluated its safety and efficacy, but the drug has not yet received regulatory approval for any indication.