Drugs / ORMD-0801
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 27 trials · 2 met primary | ||||||
| Phase 2 | NCT04616014 | Mar 2021 → Jul 2022 | metabolic dysfunction-associated steatohepatitis | Oramed, Ltd. | Completed | Met primary |
| Phase 2 | NCT04618744 | Nov 2020 → Jun 2022 | metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04150107 | Oct 2019 → Feb 2020 | type 1 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02496000 | Jul 2015 → Jun 2016 | type 2 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02535715 | Jan 2015 → Apr 2017 | type 1 diabetes mellitus | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 2 | NCT02094534 | Mar → Aug 2014 | type 1 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01889667 | Jun → Nov 2013 | type 2 diabetes mellitus | Oramed, Ltd. | Completed | Met primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT04817215 | Oct 2021 → Apr 2022 | type 2 diabetes mellitus | King Hamad University Hospital, Bahrain | Unknown | No outcome recorded |
| Phase 3 | NCT04754334 | Mar 2021 → Jan 2023 | type 2 diabetes mellitus | Oramed, Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT04606576 | Dec 2020 → Jan 2023 | type 2 diabetes mellitus | Oramed, Ltd. | Terminated | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT04564846 Comparator | Nov 2020 → Jun 2022 | type 2 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03467932 Comparator | May 2018 → Oct 2019 | type 2 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02954601 Comparator | Oct 2016 → Feb 2017 | type 2 diabetes mellitus | Oramed, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06731075 Comparator | Dec 2025 → Apr 2027 expected | type 2 diabetes mellitus | Oramed, Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2023-06-20 | Oramed, Ltd. | Results Oramed to Present at the 83rd American Diabetes Association Conference oramed.com ↗
Oral Insulin Alleviates Liver Fibrosis and Reduces Fat in Patients with NASH and Type 2 Diabetes—Results of Phase II Clinical Trial |
| 2023-05-15 | Oramed, Ltd. | Regulatory Oramed Announces that its Chinese Partner, HTIT, has Successfully Completed a Phase 3 Oral Insulin Clinical Trial and Submitted a Marketing Authorization Application in China oramed.com ↗
HTIT is now moving toward regulatory approval and has submitted the data to the National Medical Products Administration (NMPA, formerly the CFDA). |
| 2023-01-12 | Oramed, Ltd. | Results Oramed Announces Top-line Results from Phase 3 Trial of ORMD-0801 for the Treatment of Type 2 Diabetes oramed.com ↗
The ORA-D-013-1 trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks. |
| 2022-11-29 | Oramed, Ltd. | Results Oramed Announces Publication of Oral Insulin Study in Peer-Reviewed Journal: Diabetes, Obesity, and Metabolism oramed.com ↗
The trial met the primary endpoint of statistically significant reductions of HbA1c from baseline to Week 12. |
| 2022-11-17 | Oramed, Ltd. | Results Oramed Announces Additional Positive Safety and Efficacy Data from Its Phase 2 Clinical Trial of ORMD-0801 for NASH oramed.com ↗ |
| 2022-09-13 | Oramed, Ltd. | Results Oramed Reports Positive Top-Line Results from Phase 2 NASH Trial with its ORMD-0801, Oral Insulin Candidate oramed.com ↗ |
| 2021-08-16 | Oramed, Ltd. | Results Oramed Announces Publication of Oral Insulin Study in Peer-Reviewed Journal: Diabetes, Obesity, and Metabolism oramed.com ↗
The trial met its primary endpoint and found that in patients with T2DM, bedtime ORMD-0801 curbed increases in night-time glycemia, 24-hour glycemia, and HbA1c without increasing the risk of hypoglycemia or safety events as compared to the control arm. |
| 2020-10-16 | Oramed, Ltd. | Regulatory Oramed Issues Shareholder Update on Pivotal Phase 3 Oral Insulin Studies: Protocols Submitted to FDA oramed.com ↗
We are pleased to announce that based on guidance received from the U.S. Food and Drug Administration (FDA) as part of the End-of-Phase 2 meeting process for our oral insulin candidate, ORMD-0801, we have submitted to the FDA the protocols for our upcoming pivotal Phase 3 studies. |
| 2020-06-15 | Oramed, Ltd. | Results Oramed Announces Positive Initial Clinical Trial Results for Treatment of NASH With Oral Insulin oramed.com ↗
The 12-week, once-daily treatment had no serious adverse events, and induced an observed mean 6.9±6.8% reduction in liver fat content (sign test p value: 0.035), and the relative reduction was 30%, [see graph] as measured by MRI-PDFF. |
| 2020-02-26 | Oramed, Ltd. | Results Oramed Reports Positive Results in the Final Cohort of Its Phase 2b Oral Insulin Trial oramed.com ↗
Patients randomized in the trial treated with 8 mg of ORMD-0801 once daily achieved an observed mean reduction of 1.29% from baseline and a least square mean reduction of 0.95% from baseline, or 0.81% adjusted for placebo (p value = 0.028). |
| 2019-11-19 | Oramed, Ltd. | Results Oramed Provides Highlights and Data From Its Phase IIb Oral Insulin Study Investor Event oramed.com ↗
ORMD-0801 dosed once daily reduced A1C by 0.60% compared to only a 0.06% reduction by placebo |
| 2019-11-12 | Oramed, Ltd. | Results Oramed Announces Successful Phase IIb Study of Oral Insulin in Type 2 Diabetes oramed.com ↗
Patients randomized in the trial to once-daily ORMD-0801 achieved a reduction in mean A1C of 0.60% from baseline, or a reduction of 0.54% adjusted for placebo (p value = 0.036). |
| 2019-03-26 | Oramed, Ltd. | Regulatory Chinese Regulatory Authority [NMPA] Approves IND Application of Oramed’s Oral Insulin Capsules oramed.com ↗
The approval of the IND by the Center For Drug Evaluation of the China National Medical Products Administration (“NMPA”, formerly the CFDA) of the oral insulin paves the way for the start of clinical trials in China . |
| 2017-11-14 | Oramed, Ltd. | Regulatory Oramed Receives Regulatory Approval to Conduct Clinical Study for Treatment of NASH with its Oral Insulin Capsule oramed.com ↗
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) ( www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that Israel’s Ministry of Health has granted the Company approval to initiate an exploratory clinical study of its oral insulin capsule ORMD-0801 in patients with nonalcoholic steatohepatitis (NASH). |
| 2017-10-17 | Oramed, Ltd. | Results Endocrinology, Diabetes and Metabolism Journal Publishes Scientific Paper Authored by Oramed Scientists oramed.com ↗
The positive data from the study suggest an additive effect when ORMD-0801 and ORMD-0901 are given in combination. |
| 2017-07-11 | Oramed, Ltd. | Regulatory Oramed Announces End-of-Phase 2 Meeting with FDA to Initiate Phase 3 Program oramed.com ↗
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) ( www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration ( FDA ) has agreed to schedule an End-of-Phase II meeting with Oramed for its successfully completed Phase IIb trial of its oral insulin capsule ORMD-0801 in the treatment of type 2 diabetes. |
All press releases naming this drug 22 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ORMD-0801 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01889667 ↗ |
| Modality | Protein / enzyme biologic | “API (recombinant human insulin USP)” NCT02094534 ↗ |
| Route | Oral | “Multiple Oral Bedtime Doses” NCT01889667 ↗ |