ORMD-0801

Phase 3Small molecule

OOramed, Ltd.

ORMD-0801 is one of 108 small molecule programs targeting Hepatitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

107

Competitors

Pipeline

Status by Indication[3][1]

Indication

HepatitisActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Type 2 DiabetesActive, not recruiting

Type 1 DiabetesActive, not recruiting

HepatitisPhase 2

Active, not recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Type 2 DiabetesPhase 2

Active, not recruiting

Type 1 DiabetesPhase 2

Active, not recruiting

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

ORMD-0801

OOramed, Ltd.

Phase 3

1 2

Byetta

AstraZeneca

Preclinical

55 3

Jardiance

Boehringer Ingelheim

Preclinical

31 4

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 5

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 6

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 7

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 8

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

1 9

Forxiga

AstraZeneca

Preclinical

3 10

Acipimox

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Not yet recruiting

Type 2 Diabetes Mellitus

NCT06731075

Clinical

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

Terminated·OOramed, Ltd.·Phase 3·NCT04606576·710 enrolled

Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)

Completed·OOramed, Ltd.·Phase 2·NCT01889667·30 enrolled

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

Terminated·OOramed, Ltd.·Phase 3·NCT04754334·346 enrolled

Show 6 more trials

Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus

Completed·OOramed, Ltd.·Phase 2·NCT02496000·188 enrolled

A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus

Completed·OOramed, Ltd.·Phase 2·NCT03467932·373 enrolled

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus.

Not yet recruiting·OOramed, Ltd.·Phase 3·NCT06731075·300 enrolled

A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus

Completed·OOramed, Ltd.·Phase 2·NCT02954601·31 enrolled

A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus

Completed·OOramed, Ltd.·Phase 2·NCT04564846·49 enrolled

Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

Unknown status·KKing Hamad University Hospital, Bahrain·Phase 3·NCT04817215·608 enrolled

Type 1 Diabetes2 trials

A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes

Completed·OOramed, Ltd.·Phase 2·NCT04150107·30 enrolled

Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Completed·HHadassah Medical Organization·Phase 2·NCT00867594·12 enrolled

Hepatitis1 trial

A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)

Completed·OOramed, Ltd.·Phase 2·NCT04618744·32 enrolled

Type 2 Diabetes1 trial

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

Completed·OOramed, Ltd.·Phase 2·NCT04616014·7 enrolled

Type 1 Diabetic1 trial

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

Completed·OOramed, Ltd.·Phase 2·NCT02094534·25 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for ORMD-0801. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ORMD-0801 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ORMD-0801. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Oramed, Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: OOramed, Ltd.

ORMD-0801

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Type 1 Diabetes2 trials

Hepatitis1 trial

Type 2 Diabetes1 trial

Type 1 Diabetic1 trial

References

Drug Info

Quick Facts

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