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ORMD-0801

Recombinant protein · Agonist of insulin receptor (INSR) · developed by Oramed

Phase 3 Most advanced trial
ORMP Developer
12 Registered trials

What is ORMD-0801?

ORMD-0801 is recombinant human insulin in an oral capsule formulation. It is studied as a potential therapeutic option in patients with type 1 diabetes, type 2 diabetes, brittle type 1 diabetes, and nonalcoholic fatty liver disease.

Summary written with AI from the sources listed at the end of this page.

At a glance

Drug type
Recombinant protein
Targets
insulin receptor (INSR)
Mechanism
Agonist of insulin receptor (INSR)
Pathways
glucose homeostasis, PI3K/Akt signaling
Therapy area
Endocrine, Metabolic
Developer
Oramed, Ltd. (ORMP)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 3

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06731075 Phase 3 Type 2 Diabetes Mellitus Not yet recruiting ORMP
NCT04754334 Phase 3 T2DM (Type 2 Diabetes Mellitus) Terminated ORMP
NCT04606576 Phase 3 Type 2 Diabetes Mellitus Terminated ORMP
NCT04618744 Phase 2 Diabetes Mellitus, Type 2 Completed ORMP
NCT04150107 Phase 2 Type 1 Diabetes Completed ORMP
NCT02653300 Phase 2 Non-Alcoholic Steatohepatitis (NASH) Completed ORMP
NCT03467932 Phase 2 T2DM (Type 2 Diabetes Mellitus) Completed ORMP
NCT02954601 Phase 2 Type 2 Diabetes Mellitus Completed ORMP
NCT02535715 Phase 2 Type 1 Diabetes Completed ORMP
NCT02094534 Phase 2 Diabetes Mellitus Type 1 Completed ORMP
NCT01889667 Phase 2 Diabetes Mellitus Type 2 Completed ORMP
NCT00867594 Phase 2 Brittle Type I Diabetes Mellitus Completed ORMP

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Brittle Type I Diabetes MellitusDiabetes Mellitus Type 1Diabetes Mellitus Type 2NASH - Nonalcoholic SteatohepatitisT2DM (Type 2 Diabetes Mellitus)Type 1 DiabetesType 2 Diabetes Mellitus

Other drugs acting on INSR

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the ORMP page.

Follow ORMP, the company behind ORMD-0801

See ORMP's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.