List of clinical trials of Oramed Pharmaceuticals

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Insulin

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Endocrinology

Hepatology (Liver, Pancreatic, Gall Bladder)

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Nonalcoholic steatohepatitis

Type 1 diabetes mellitus

Type 2 diabetes mellitus

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Phase II

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India

Israel

United States

Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT01889667

Location: United States

Condition: Type 2 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 19-06-2013

Product Description: ORMD-0801 (Oral Insulin) has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

01

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Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM Who Are Inadequately Controlled With Diet and Exercise or Diet, Exercise and Metformin

Product Description: ORMD-0801 (Oral Insulin) has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 19-06-2013

Condition: Type 2 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT02094534

Location: United States

Condition: Type 1 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 20-03-2014

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

02

BioFlorida Conference
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A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 20-03-2014

Condition: Type 1 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT02496000

Location: United States

Condition: Type 2 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 08-07-2015

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

03

BioFlorida Conference
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BioFlorida Conference
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Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Diet and Metformin

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 08-07-2015

Condition: Type 2 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT02954601

Location: United States

Condition: Type 2 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 13-10-2016

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

04

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BioFlorida Conference
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A Phase 2a, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study to Compare Safety, Efficacy, and Pharmacodynamics of Single and Multiple Doses of ORMD-0801 in Adult Subjects With Type 2 Diabetes Mellitus

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 13-10-2016

Condition: Type 2 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: The University of Texas Health Science C...

Receptors: Insulin receptor agonist

Trial ID: NCT02535715

Location: United States

Condition: Type 1 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Oramed Ltd.

Recruitment Status: Completed

Date Of Registration: 12-08-2015

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

05

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A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Oramed Ltd.

Recruitment Status: Completed

Date Of Registration: 12-08-2015

Condition: Type 1 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT02653300

Location: Israel

Condition: Nonalcoholic steatohepatitis

Product Status: Approved

Dosage Form: Soft gel capsule

Collaborator: Hadassah Medical Organ...

Recruitment Status: Recruiting

Date Of Registration: 24-12-2015

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

06

BioFlorida Conference
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BioFlorida Conference
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An Open-Label Pilot Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential of Oral Insulin to Reduce Liver Fat Content and Fibrosis in Patients With Nonalcolholic Steatohepatitis (NASH)

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Soft gel capsule

Collaborator: Hadassah Medical Organ...

Recruitment Status: Recruiting

Date Of Registration: 24-12-2015

Condition: Nonalcoholic steatohepatitis

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT04150107

Location: United States

Condition: Type 1 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Recruiting

Date Of Registration: 31-10-2019

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

07

BioFlorida Conference
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BioFlorida Conference
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A Phase 2 Randomized, Open Label Crossover Study to Compare ORMD-0801 Given Once Daily at Bedtime to ORMD-0801 Given Three Times Daily (45-90 Minutes Before Meals) in Subjects With Type 1 Diabetes

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Recruiting

Date Of Registration: 31-10-2019

Condition: Type 1 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Ltd.

Receptors: Insulin receptor agonist

Trial ID: NCT03467932

Location: United States

Condition: Type 2 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 01-03-2018

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

08

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BioFlorida Conference
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A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Therapy

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Completed

Date Of Registration: 01-03-2018

Condition: Type 2 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Oramed Inc

Receptors: Insulin receptor agonist

Trial ID: CTRI/2009/091/000371

Location: India

Condition: Type 2 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Recruiting

Date Of Registration: 10-07-2009

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

09

BioFlorida Conference
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BioFlorida Conference
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A Phase 2b, comparative, two arm randomized, placebo-controlled, double blinded multi-centric study to Evaluate the Safety, Tolerability, and Efficacy of Oral Insulin 16 mg /day or placebo in subjects with Type 2 Diabetes Mellitus (DM) who are curren

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Integrium

Recruitment Status: Recruiting

Date Of Registration: 10-07-2009

Condition: Type 2 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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Highest Development Status: Phase II

Therapeutic Area: Endocrinology

Interventions: Insulin

Product Type: Large molecule

Sponsor: Hadassah Medical Organization

Receptors: Insulin receptor agonist

Trial ID: NCT00867594

Location: Israel

Condition: Type 1 diabetes mellitus

Product Status: Approved

Dosage Form: Capsule

Collaborator: Oramed Ltd.

Recruitment Status: Completed

Date Of Registration: 22-03-2009

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

10

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
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Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Product Description: ORMD-0801 (Oral Insulin) capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.

Product Status: Approved

Dosage Form: Capsule

Collaborator: Oramed Ltd.

Recruitment Status: Completed

Date Of Registration: 22-03-2009

Condition: Type 1 diabetes mellitus

Product Type: Large molecule

Receptors: Insulin receptor agonist

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