oral insulin (ORMD-0801) / Oramed - LARVOL DELTA

Pharmacokinetics and pharmacodynamics of oral insulin (ORMD-0801) in healthy subjects: A phase I study using hyperinsulinaemic-euglycaemic clamp. (PubMed, Diabetes Obes Metab) - "This study comprehensively describes the PK/PD characteristics of ORMD-0801 in healthy subjects and provides a basis for future clinical trials."

Journal • P1 data • PK/PD data

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Oramed, Ltd. | Trial completion date: May 2026 ➔ May 2027 | Initiation date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

AI-Based Optimization of Patient Eligibility for Oral Insulin Treatment—A Post Hoc Analysis to Identify Responders (ADA 2025) - "Variability in response to oral insulin can be minimized by segmenting the population based on BMI and other clinical and biological markers. These findings will inform eligibility criteria for a newly planned Phase III study."

Clinical • Retrospective data • Metabolic Disorders • Type 2 Diabetes Mellitus

Oramed Announces Transformative Joint Venture to Accelerate Development and Commercialization of Oral Insulin (PRNewswire) - "Oramed Pharmaceuticals Inc...today announced that it has entered into definitive agreements to spin off its Protein Oral Delivery (POD) technology into a newly formed joint venture, OraTech Pharmaceuticals Inc. ('OraTech'), with Hefei Tianhui Biotech Co., Ltd. ('HTIT'). This transaction is designed to accelerate the development and commercialization of Oramed's ORMD-0801 oral insulin and other POD-based innovative oral drug delivery technologies, reinforcing Oramed's vision of revolutionizing diabetes and chronic disease treatments....Additionally, under the agreements, Oramed and HTIT will contribute a combined $75 million in capital, some of which will be allocated for services rendered via a supply agreement. This financial backing will provide substantial resources to drive development, commercialization, and clinical advancement."

Licensing / partnership • Diabetes

A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Oramed, Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Oral Insulin Alleviates Liver Fibrosis and Reduces Liver Steatosis in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes: Results of Phase II Randomized, Placebo-controlled Feasibility Clinical Trial. (PubMed, Gastro Hep Adv) - P2 | "The results of this feasibility study support the safety and potential therapeutic effect of orally delivered insulin on liver fibrosis, fat accumulation, and inflammatory processes (NIH Clinical Trials No. NCT04618744)."

Journal • P2 data • Diabetes • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Transplantation • Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=49 | Completed | Sponsor: Oramed, Ltd. | Phase classification: P2b ➔ P2

Phase classification • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Advancing Diabetes Care: Novel Drug Interventions in the Management and Control of Type 2 Diabetes Mellitus (ISPOR 2024) - " The study examines ongoing clinical trials evaluating the efficacy and safety of drugs like Cotadutide, Enavogliflozin, Retatrutide, ORMD-0801, and Imeglimin for T2DM, and reported data for at least 1 outcome of interest...Cotadutide, an insulinotropic drug, has shown promising results in improving glycemic control and weight loss in T2DM patients through delayed gastric emptying. Enavogliflozin had a slightly larger reduction in HbA1c levels (-0.99%) than Bexagliflozin...As monotherapy or adjunctive therapy (with metformin), it is found to be effective, has low risk of hypoglycemia, and enhances insulin action and sensitivity. Over the past decade, numerous glucose-lowering medications have been approved, requiring careful consideration of their risks and benefits. It is critical to establish the strongest evidence for improving glycemic control and reducing the risk of complications ."

Diabetes • Gastroenterology • Gastrointestinal Disorder • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=710 | Active, not recruiting | Sponsor: Oramed, Ltd. | Terminated ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=710 | Terminated | Sponsor: Oramed, Ltd. | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2022 ➔ Jan 2023; ORA-D-013-1 was terminated based on the primary results analyzed at the end of the treatment, week 26.

Trial primary completion date • Trial termination • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=346 | Terminated | Sponsor: Oramed, Ltd. | Trial completion date: Oct 2023 ➔ Jan 2023 | Active, not recruiting ➔ Terminated; The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.

Monotherapy • Trial completion date • Trial termination • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=339 | Active, not recruiting | Sponsor: Oramed, Ltd. | Terminated ➔ Active, not recruiting | Trial completion date: Jan 2023 ➔ Oct 2023

Enrollment closed • Monotherapy • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=339 | Terminated | Sponsor: Oramed, Ltd. | Trial completion date: Oct 2023 ➔ Jan 2023 | Recruiting ➔ Terminated; The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.

Monotherapy • Trial completion date • Trial termination • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=710 | Terminated | Sponsor: Oramed, Ltd. | Active, not recruiting ➔ Terminated; ORA-D-013-1 was terminated based on the primary results analyzed at the end of the treatment, week 26.

Trial termination • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Oral Insulin (ORMD-0801) in Type 2 Diabetes Mellitus: Dose-Finding 12-Week Randomized Placebo-Controlled Study. (PubMed, Diabetes Obes Metab) - "Oral insulin (ORMD-0801) induced greater reductions in HbA1c when compared to placebo and was safe and well-tolerated in individuals with uncontrolled T2DM. The efficacy and safety findings support continued development of the 8 mg dose at bedtime, which is currently being evaluated in two Phase 3 trials."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=7 | Completed | Sponsor: Oramed, Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis • Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2b | N=50 | Completed | Sponsor: Oramed, Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=33 | Completed | Sponsor: Oramed, Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis • Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2b | N=40 | Active, not recruiting | Sponsor: Oramed, Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: Oramed, Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis • Type 2 Diabetes Mellitus

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=7 | Active, not recruiting | Sponsor: Oramed, Ltd. | Recruiting ➔ Active, not recruiting | N=40 ➔ 7

Enrollment change • Enrollment closed • Diabetes • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis • Type 2 Diabetes Mellitus

A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Oramed, Ltd. | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=710 | Active, not recruiting | Sponsor: Oramed, Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Apr 2023

Enrollment closed • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Oramed, Ltd. | Trial completion date: Mar 2024 ➔ Oct 2023 | Trial primary completion date: Jan 2024 ➔ Apr 2023

Monotherapy • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Oramed, Ltd. | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Jan 2024

Monotherapy • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus