Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ORMD-0801
ORMD 0801 · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| ORMD 0801 | DRUG | 1 capsule ORMD 0801 3 times a day, before each meal |
Inclusion Criteria: * Type 1 diabetes mellitus * Male or female aged 18-50 years inclusive * Body weight between 50-100kg and BMI between 18 and 30 kg/m2 * Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia * No other medical problems Exclusion Criteria: * Hi...
ORMD-0801 is an investigational oral insulin capsule being developed for metabolic conditions, including Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, and Nonalcoholic Steatohepatitis (NASH). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ORMD-0801 is being developed by Oramed Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ORMP. The company is focused on oral delivery of proteins and peptides for metabolic diseases.
ORMD-0801 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Multiple Phase 2 trials have been completed, and the drug remains under clinical investigation for diabetes and NASH indications.
ORMD-0801 has been studied in several Phase 2 trials, including NCT02094534 in Type 1 Diabetes, NCT02496000 in Type 2 Diabetes, NCT02954601 in Type 2 Diabetes Mellitus, and NCT04616014 in NASH. These trials were conducted in the United States and Belgium, with a total enrollment of 251 participants across the four studies.
Yes, ORMD-0801 is also known as ORMD-0801 8 mg. The 8 mg designation refers to a specific dose strength of the oral insulin capsule being evaluated in clinical trials. Both names refer to the same investigational drug product developed by Oramed Pharmaceuticals.
ORMD-0801 is an oral insulin formulation designed to deliver insulin through the gastrointestinal tract. It is being studied to assess its impact on glucose control in diabetic patients and to reduce liver fat content in patients with NASH. The drug aims to provide an oral alternative to injectable insulin.