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Details:
ORMD-0801 (oral insulin) capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Oramed Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2023
Details:
The collaboration will focus on the integration of Novo Nordisk's new generation of connected pens, NovoPen® 6 and NovoPen Echo® Plus with DBL-4pen™. Diabeloop is planning a study for Type 2 diabetes to evaluate the efficacy and clinical benefits of the combined technologies.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Peptide
Partner/Sponsor/Collaborator: Novo Nordisk
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 21, 2023
Details:
Under the agreement, Californians with diabetes will have access to Civica’s low-cost insulins via the CalRx Biosimilar Insulin Initiative. Civica will produce three insulins, glargine, lispro and aspart, available both in vials and prefilled pens under the CalRx label.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undislcosed
Highest Development Status: UndisclosedProduct Type: Peptide
Partner/Sponsor/Collaborator: CalRx Biosimilar Insulin Initiative
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Partnership March 18, 2023
Details:
Insulet’s latest innovation, the Omnipod® 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections and zero fingersticks.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Omnipod
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Insulet Corporation
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition February 13, 2023
Details:
ORMD-0801 (oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2023
Details:
ORMD-0801 (Oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
Article presents results of 12-week multicenter, randomized, placebo-controlled trial assessing safety and efficacy of multiple active doses of ORMD-0801 in patients with T2DM on chronic background therapy with Metformin or combination oral therapy.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2022
Details:
The trial demonstrated that ORMD-0801, an oral insulin candidate, was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
The agreement grants Medicox an exclusive license to apply for regulatory approval for and distribute Oramed's oral insulin candidate, ORMD-0801, for ten years in the Republic of Korea.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Medicox Co.
Deal Size: $18.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 14, 2022
Details:
Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2022
Details:
The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 (insulin) was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
Details:
Primary endpoint of trial is to compare efficacy of ORMD-0801 (Insulin) to placebo in improving glycemic control by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycemic control over a 52-week treatment period.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2022
Details:
MannKind will also publish an abstract on “Augmenting Clinical Trial Data within Silico Evidence to Evaluate Initial Conversion Dose Changes for Technosphere® Insulin (Afrezza).” The abstract will be published in category 12-E Clinical Therapeutics/New Technology – Insulins.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Afrezza
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
ORMD 0901 is an Oral GLP-1 for T2DM, is an incretin hormone that stimulates the secretion of insulin from the pancreas, significantly increase compliance and become a valuable tool in the treatment of diabetes.
Lead Product(s): ORMD-0901,Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0901
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
The proof-of-concept study demonstrated that a simplified 2x dose of Technosphere® Insulin (TI) provided significant reductions in post-prandial glucose excursions (PPGE) versus current label dosage guidelines, with no new safety concerns.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Afrezza
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Data from a prior pilot study of ORMD-0801 (insulin), the first commercial oral insulin capsule showed a reduction in liver fat content, in type 2 diabetes patients with non-alcoholic steatohepatitis.
Lead Product(s): Insulin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
The trial is assessing the safety and potential efficacy of ORMD-0801, an oral insulin capsule to be evaluated for the treatment of Type 2 diabetes patients with non-alcoholic steatohepatitis.
Lead Product(s): Insulin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Company enrolled and randomized over 75% of 675 patients planned for its Phase 3 ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes. ORA-D-013-1 is the larger of Oramed's two Phase 3 studies being conducted to treat T2D patients.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2021
Details:
Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Afrezza
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2021
Details:
The double-blind, multi-center trial is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH.
Lead Product(s): Insulin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2021
Details:
The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c over a 26-week treatment period.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2021
Details:
The final results from the phase 2 pediatric study revealed that serum insulin concentrations peaked rapidly within 10-15 minutes of inhaled administration of TI, similar to the results observed previously in adults.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Afrezza
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
The double-blinded, placebo-controlled, multi-center randomized studies will recruit a total of 1,125 patients to evaluate the efficacy and safety of ORMD-0801.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
Randomization of patients in Oramed's first Phase 3 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D) is under way. The study is being conducted in accordance with U.S. Food and Drug Administration (FDA) approved protocols.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2021
Details:
Oramed has screened the first patients in a global trial of its oral insulin capsule ORMD-0801 for the treatment of Nonalcoholic steatohepatitis (NASH). The trial will measure efficacy endpoints via MRI-PDFF for 12-weeks dosing.
Lead Product(s): Insulin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2020
Details:
Oramed has screened the first patients in its global Phase 3 trials of its oral insulin capsule ORMD-0801 to treat type 2 diabetes. Both Phase 3 trials, ORA-D-013-1 and ORA-D-013-2, will treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
The poster titled, “Glycemic Effects of Bedtime Oral Insulin (ORMD-0801) in Uncontrolled Type 2 Diabetes Mellitus Patients” will be presented at American Association of Pharmaceutical Scientists 2020 PharmSci 360 Conference.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Based on guidance received from the U.S FDA as part of the End-of-Phase 2 meeting process for our oral insulin candidate, ORMD-0801, Oramed has submitted to the FDA the protocols for its upcoming pivotal Phase 3 studies.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
The presentation will highlight study titled: Evening oral insulin (ORMD-0801) glycaemic effects in uncontrolled type 2 diabetes patients.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: MiniMed 770G
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. Oramed plans to conduct the two Phase 3 trials concurrently.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
XP-3924 resulted in 62% reduction of hyperglycemia after a glucose challenge. XP-3924 showed promising glucose control when compared to both Humulin R and co-administered injections of Humulin R & Symlin and it showed improved glucose control when compared to Humulin R alone.
Lead Product(s): Pramlintide,Insulin
Therapeutic Area: Endocrinology Product Name: Xerisol
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
Details:
Oramed announced that its pilot study of its oral insulin candidate ORMD-0801 in type 2 diabetes patients with non-alcoholic steatohepatitis (NASH), has shown ORMD-0801 to be safe and well tolerated thus far, with an encouraging lowering of fatty liver content.
Lead Product(s): Insulin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Diasome presented new positive data from its Phase 2b OPTI-1 clinical trial in people with type 1 diabetes (T1D) at the American Diabetes Association’s 80th Annual Scientific Sessions.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Company announced that new data from clinical studies of Afrezza® demostrating safe and effective dosing, its association with weight loss in patients with type 2 diabetes, and an evaluation of a comprehensive two year safety study showing that significant changes in FEV1.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Afrezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Funding will support Medtronic's Diabetes R&D, including a series of near-term programs such as the MiniMed™ 780G insulin pump system, its Personalized Closed Loop (PCL) system, extended wear infusion set, and Zeus and Synergy sensors.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: MiniMed 780G
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Blackstone Life Sciences
Deal Size: $337.0 million Upfront Cash: Undisclosed
Deal Type: Funding June 12, 2020
Details:
The presesntation will highlight data from company's Phase I study investigating the PD, PK and safety of AT247 in comparison with NovoRapid® and Fiasp.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
The presentations will focus on Oramed's oral insulin candidate, ORMD-0801 and its impact on type-2 diabetes mellitus, as well as its impact on fatty liver in nonalcoholic steatohepatitis (NASH).
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2020
Details:
During this meeting the FDA provided feedback on key issues relating to Drug Product manufacture and supported continuing to Phase 3 clinical development.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2020
Details:
Primary endpoints were successfully met; results confirm significant clinical benefits of ORMD-0801 at lower dose treatment, 0.95% A1C reduction in patients treated once daily at 8mg.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2020
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