[Translation] An open, randomized, two-period, two-crossover study to evaluate the pharmacodynamics, pharmacokinetics, relative bioavailability and relative bioavailability of human insulin enteric-coated capsules in healthy Chinese male subjects

主要目的：本研究采用高胰岛素-正葡萄糖钳夹技术作为测试方法，对人胰岛素肠溶胶囊进行药效动力学研究，对比人胰岛素肠溶胶囊与人胰岛素注射液(天麦霖® R)的相对生物有效性。次要目的：对人胰岛素肠溶胶囊进行药代动力学研究，对比人胰岛素肠溶胶囊与人胰岛素注射液(天麦霖® R)的相对生物利用度。

[Translation]

Main purpose: This study used the hyperinsulinemic-euglycemic clamp technique as the test method to conduct a pharmacodynamic study on human insulin enteric-coated capsules and compare the relative bioavailability of human insulin enteric-coated capsules and human insulin injection (Tianmailin® R). Secondary purpose: The pharmacokinetic study of human insulin enteric-coated capsules was conducted to compare the relative bioavailability of human insulin enteric-coated capsules and human insulin injection (Tianmailin® R).

Start Date17 Jul 2024

Sponsor / Collaborator

Israel Oramd Co Ltd

[+3]

EUCTR2021-004226-30-HU

/ Unknown statusPhase 3

A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Glucose-lowering Agents as Monotherapy.

Start Date22 Mar 2022

Sponsor / Collaborator

Oramed Ltd.

NCT04817215

/ Unknown statusPhase 3IIT

A Double-Blinded, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Uncontrolled Type 2 DM Subjects on Diet Control Alone, Metformin Monotherapy, or Two or Three Oral Glucose-lowering Agents

To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.

Start Date01 Oct 2021

Sponsor / Collaborator

King Hamad General Hospital

[+2]

100 Clinical Results associated with Insulin (Oramed)

100 Translational Medicine associated with Insulin (Oramed)

100 Patents (Medical) associated with Insulin (Oramed)

Literatures (Medical) associated with Insulin (Oramed)

01 Apr 2023·Diabetes, obesity & metabolism

Oral insulin (ORMD‐0801) in type 2 diabetes mellitus: A dose‐finding 12‐week randomized placebo‐controlled study

Article

Author: Neutel, Joel ; Kidron, Miriam ; Fleming, Alexander ; Homer, Kenneth ; Eldor, Roy ; Rosenstock, Julio ; Francis, Bruce H.

Abstract:

Aims:

To assess the safety and efficacy of multiple daily doses of oral insulin (ORMD‐0801) in subjects with type 2 diabetes (T2DM) over 12 weeks.

Materials and Methods:

Participants with T2DM on metformin or combination oral therapy with glycated haemoglobin (HbA1c) levels ≥ 7.5% (58 mmol/mol) were randomized to receive ORMD‐0801 8 mg or 16 mg once (QD) or twice (BID) daily, or 32 mg QD, BID or three times daily (TID) over a 12‐week period.

Results:

A total of 373 subjects were randomized to active treatment or placebo (~60% male, age ~ 56 years, HbA1c 9%‐9.8%; 75‐84 mmol/mol). Placebo‐adjusted HbA1c changes from baseline to Week 12 were observed with ORMD‐0801 8 mg BID (−7.15 ± 3.57 mmol/mol [−0.65% ± 0.33%]; P = 0.046). However, a significant site interaction was observed in two sites. After excluding these, HbA1c reduction was observed with 8 mg QD (−0.81 ± 0.37%; −8.89 ± 4.01 mmol/mol; P = 0.028, n = 15), 8 mg BID (−0.82 ± 0.37%; −8.95 ± 4.08 mmol/mol; P = 0.029, n = 17), 32 mg QD (−0.54 ± 0.26%; −5.89 ± 2.78 mmol/mol;P = 0.036, n = 69) and 32 mg BID (−0.53 ± 0.26%; −5.80 ± 2.83 mmol/mol; P = 0.042, n = 68). No effect was observed with 16 mg QD (0.25 ± 0.37%; 2.76 ± 3.99 mmol/mol; P = 0.48, n = 18), 16 mg BID (−0.36 ± 0.40%; −3.97 ± P = 0.36, n = 15) or 32 mg TID (−0.45 ± 0.27%, −4.89 ± 2.90 mmol/mol; P = 0.093, n = 69). Continuous glucose monitor and serum glucose measurements showed similar trends but were not significant. ORMD‐0801 was safe, well tolerated and not associated with weight gain or hypoglycaemia.

Conclusions:

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.

01 May 2022·Clinical pharmacology in drug development

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Insulin Administration in Healthy Subjects: A Randomized, Double‐Blind, Phase 1 Trial

Article

Author: Ning, Guang ; Sheng, Haiyuan ; Zhang, Yifei ; Lang, Liqun ; Huang, Xing ; Wang, Weiqing ; Shen, Liyun ; Zhou, Weiwei

Abstract:

Oral delivery is an ideal method of insulin administration and is currently a promising research field. Here, we evaluated the safety, pharmacokinetic, and pharmacodynamic characteristics of oral administration of an insulin capsule (ORMD‐0801) with 2 different sources of recombinant human insulin. This was a single‐center, randomized, double‐blind, placebo‐controlled, dose‐escalating phase 1 trial. Single dosing of the oral insulin capsule was administered in 70 healthy Chinese subjects. In stage 1, four dose groups (8, 16, 32, and 48 mg) for capsules containing Sanofi insulin and in stage 2, three dose groups (8, 32, and 48 mg) containing Hefei Tianmai insulin were evaluated consequently. The results showed that the oral insulin formulations with either source in the dose range 8 to 48 mg were safe, and no serious adverse events were observed. After a standard breakfast 45 minutes after dosing, the area under the concentration‐time curve (AUC) from time 0 to time t and AUC from time 0 to infinity for insulin in the 8‐mg and 48‐mg dose groups in stage 1 and for 8‐ to 48‐mg groups in stage 2 were slightly increased compared with placebo, but no significant dose‐related changes in the pharmacokinetic parameters were observed for either stage. The peak‐valley difference and the change in value of the AUC for glucose from baseline showed a dose‐related increase in the dose range from 8 to 48 mg in both stages. Together, this study indicated that in healthy Chinese subjects, this oral capsule containing 2 different insulin formulations was safe and well tolerated after a single‐dose administration.

01 Nov 2021·Diabetes, obesity & metabolismQ2 · MEDICINE

Efficacy and safety of 28‐day treatment with oral insulin (ORMD‐0801) in patients with type 2 diabetes: A randomized, placebo‐controlled trial

Q2 · MEDICINE

Article

Author: Neutel, Joel ; Kidron, Miriam ; Eldor, Roy ; Homer, Kenneth

Abstract:

Aim:

To assess the safety and efficacy of oral insulin (ORMD‐0801) in patients with type 2 diabetes (T2D).

Materials and Methods:

After a 2‐week washout of other medications, adult metformin‐treated patients with T2D were randomized to receive placebo or 16 or 24 mg ORMD‐0801, once daily, at bedtime, for 28 days. The mean change from baseline weighted mean night‐time glucose levels was determined from 2 nights of continuous glucose monitoring (CGM) recordings during the placebo run‐in and last week of treatment.

Results:

In total, 188 patients (HbA1c: 7.82% ± 0.88% [placebo] and 8.08% ± 1.11% [pooled ORMD‐0801 group]) were enrolled. In the placebo group, mean night‐time CGM increased from baseline by 13.7 ± 26.1 mg/dL, whereas the increase was significantly smaller in the pooled ORMD‐0801 group (1.7 ± 23.5 mg/dL, P = .0120). Glycaemic control variables (24‐hour, fasting and daytime CGM glucose) also displayed smaller increases with ORMD‐0801 versus placebo. Change from baseline HbA1c was −0.01% in the pooled ORMD‐0801 group versus +0.20% in the placebo group (P = .0149). ORMD‐0801 was well tolerated, with similar adverse event and hypoglycaemia rates as placebo.

Conclusions:

In patients with T2D, bedtime ORMD‐0801 curbed increases in night‐time glycaemia, 24‐hour glycaemia and HbA1c, without increasing the risk of hypoglycaemia or safety events compared with the control arm.

News (Medical) associated with Insulin (Oramed)

24 Jul 2023

·medcitynews.com

Closing the Oral Drug Gap

There is a substantial amount of evidence that shows patient preference for oral alternatives to injectable therapies is reshaping therapeutic markets, as noted in part one of this two-part series. Catering to that preference can have an immense impact not only on drugmakers’ product sales and revenue but also on treatment adherence and potential clinical outcomes. For biologics, the so-called “holy grail” of patient preference innovation is transforming injectables into orally administered treatments. If making injectable therapies into pills were simple, every drug on the market would have an oral alternative. Many attempts at oral therapies have failed due to the intricacies of our physiological environment and the complicated structures of the molecules themselves. The drugs are easily and rapidly degraded by the highly acidic environment of the stomach if not properly protected, and it can be difficult to ensure enough of the drug substance is absorbed via the intestinal tract. This is especially the case for biologics, which tend to be larger and more fragile than small molecules. One common approach to meet patient demand for an oral alternative – though perhaps most expensive and time-consuming – is developing a novel small molecule program. Within the last three years, AbbVie (with Ubrelvy) and Celgene/Amgen (with Otezla) have proven their small molecule oral therapies could successfully compete against market-leading biologics. Some of the latest attempts include GSK’s Jesduvroq for anemia caused by chronic kidney disease and Menarini Group’s oral SERD for breast cancer, while companies such as DICE Therapeutics and Structure Therapeutics are also developing promising approaches. However, the small molecule development approach can come with high risks. Small molecules lack the high specificity of biologics and can introduce off-target effects and unwanted side effects – JAK inhibitors are a notable example. As new chemical entities or NCEs, these new therapies need to run the full gamut of safety, tolerability, and efficacy studies in order to get approval. Furthermore, this approach is only feasible for certain therapies. Changing the formula Drug developers have long sought to develop a chemistry-based method for oral biologics, with limited success. This approach typically involves adding an additional molecule to the drug formulation, such as a protease inhibitor to protect peptides in the gastrointestinal tract, or an absorption enhancer to improve uptake in the intestinal lining. Similar technology has recently shown promise in orally delivering a candidate Covid-19 vaccine. Among the chemistry based approaches, there have been more failures than successes. Most recently, Oramed announced a failure of their phase III study for their oral insulin product (ORMD-0801). This outcome was unsurprising given the ultra low-bioavailability of their formulation. In their trial, patients were dosed daily with 8 mg of their insulin. But despite this incredibly high dose – equivalent to over 230 units of insulin – they were unable to show statistically significant movement in HBA1C over placebo. Rybelsus, the oral semaglutide developed by Novo Nordisk, is a rare instance of reformulation success for a biologic. To formulate Rybelsus, Novo Nordisk combined its Ozempic (semaglutide) with a small fatty acid derivative that temporarily modifies pH for more hospitable gut conditions, and improves absorption across gut mucosa. Even with the improved absorption, Rybelsus® only has a bioavailability between 0.4-1% compared to subcutaneous injections, and the approach has not yet been replicable for delivering other biologics via the stomach. Furthermore, Novo Nordisk recently submitted new regulatory filings for higher oral doses of their semaglutide formulation for diabetes, in the 25 to 50 mg per day range, up to 350 mg per week. When compared to Wegovy, an injectable semaglutide medication dosed at 2.4 mg per week with 67% higher efficacy, this significant increase in dose clearly shows the limitation to this technology. Several companies are instead targeting delivery in the small intestine, in most cases using specialized enteric coatings that can prevent capsules from premature digestion in the stomach. Chiasma (now part of Chiesi Farmaceutici S.p.A.) took this approach with Mycapssa (octreotide), the first approved oral somatostatin analog for patients with acromegaly. Its capsules also include a permeability enhancer to improve peptide uptake in the small intestine. However, similar to Rybelsus, to obtain comparable bioavailability to that of a subcutaneous injection, the oral formulation uses 200 times the dose. This is fairly common with chemistry-based approaches, since the overall bioavailability of the drug can be as low as 0.1%, making it extremely difficult to reach therapeutic levels without significantly increasing the dose. For that reason, Mycapssa is only given to patients who have already been managed successfully on injectable therapies. Robotic possibilities The commercial success of Rybelsus and Ubrelvy demonstrate the impact of meeting patient preferences. But like many other approaches, each may be limited to a small subset of molecules and indications – and cause other issues due to their formulations. Mechanical approaches to changing the route of delivery, such as miniaturized injectors or motors to power a tunneling motion, have the potential for a broader wave of oral biologic delivery. These so-called robotic pills (robopills) provide a way to deliver a dose across gut barriers and into circulation with more accuracy and significantly higher bioavailability. The most advanced mechanical method for oral delivery is an oral robotic capsule that is designed to deliver any biologic drug directly into the intestinal wall via a dissolvable microneedle. This approach has demonstrated safety, tolerability, and high bioavailability in clinical trials, with data showing drug bioavailability comparable to or higher than a subcutaneous injection, without having to dramatically increase the dosage. The capsule is protected by a special pH-sensitive polymer coating, which ensures the pill arrives in the small intestine without first dissolving in the stomach. Because robopills are not tied to a specific chemistry or limited to specific types of molecules, they can deliver a range of biologics including hormones, proteins and antibodies, for a variety of conditions. This creates a platform technology opportunity, with the potential to deliver almost any molecule to treat millions of patients suffering from chronic diseases. When oral alternatives to injectables become a widespread reality, we believe patients and physicians will respond eagerly and push the market as swiftly and forcefully as they have across other segments in recent years.

Phase 3Drug ApprovalClinical ResultVaccine

02 Mar 2023

·www.prnewswire.com

DelveInsight Evaluates a Robust Diabetes Pipeline as 200+ Influential Pharma Players to Set Foot in the Domain

The prevalence of diabetes has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Diabetes and the growing research and development activities to develop novel therapies to treat diabetes to drive the market. The companies developing the potential therapies in the last stage of development include Eli Lilly and Company, Daewoong Pharmaceutical, Janssen Biotech, and several others. LAS VEGAS, March 2, 2023 /PRNewswire/ -- DelveInsight's ' Diabetes Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline diabetes therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the diabetes pipeline domain. Key Takeaways from the Diabetes Pipeline Report DelveInsight's diabetes pipeline report depicts a robust space with 200+ active players working to develop 200+ pipeline therapies for diabetes treatment. Key diabetes companies such as Daewoong Pharmaceutical, Janssen Biotech, Zealand Pharma, BioRestorative Therapies, Elevian, Oramed Pharmaceuticals, ImCyse, Novo Nordisk, Enthera, Precigen, Inc., Japan Tobacco, Avotres, AstraZeneca, Landos Biopharma, Vertex Pharmaceuticals, REMD Biotherapeutics, Inc., Eledon Pharmaceuticals, Eli Lilly and Company, Novo Nordisk A/S, Diamyd Medical, NextCell Pharma, ViaCyte, Op-T LLC, Dompé Farmaceutici S.p.A, ILTOO Pharma, Throne Biotechnologies, Oramed Pharmaceuticals, Janssen Research & Development, LLC, Jaguar Gene Therapy, SQZ Biotechnologies, Genprex, Inc., CRISPR Therapeutics, Biora Therapeutics, Genprex, Inc., and others are evaluating new diabetes drugs to improve the treatment landscape. Promising diabetes pipeline therapies in various stages of development include Enavogliflozin, Golimumab, Dasiglucagon, ThermoStem, rGDF11, IMCY-0098, Insulin icodec, CagriSema, FDC Sema-OW GIP, SemaDapa FDC, ENT-001, AG019, JTT-662, AVT-001, AZD-0186, Cotadutide, LABP-111, VX-880, Encapsulated islet cell program, CPP-1X-T, REMD-477, AT-1501, LY 3209590, Orforglipron, LY3437943, Mazdutide, Peptide YY analogue agonist, GIPR agonist long acting, GIPR Agonist Long Acting II, LY 3493269, NNC0363-0845, Diamyd, ProTrans, VC-02, OPT101, Ladarixin, ILT-101, Stem Cell Educator Therapy, ORMD-0801, Golimumab, JAG301, SQZ TAC research program, VCTX 211, and others. In February 2023, Genprex, Inc. announced that data highlighting the potential of its gene therapy for Type 1 diabetes was being presented by its research collaborators at the University of Pittsburgh at the four-day International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2023).These results were compelling as they demonstrated the potential for this gene therapy to create newly formed beta-like cells that can produce insulin. They also validated earlier studies of this approach in diabetic mouse models that showed restoration of normal blood glucose levels for several months. In February 2023, Provention Bio, Inc. announced the closing of the $35 million equity investment from Sanofi US under the previously announced Co-Promotion Agreement and Securities Purchase Agreement (the "Purchase Agreement").Pursuant to the Purchase Agreement, Sanofi purchased 2,712,497 shares of the Company's common stock, par value $0.0001 per share, at a price of $12.90 per share, representing a total investment of $35 million. In January 2023, iTolerance, Inc. announced it has entered into a Master Services Agreement (MSA) with the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine, for the advancement of its novel iTOL-100 platform technology as a potential cure for Type 1 Diabetes. In November 2022, Biocon Limited announced the signing of a semi-exclusive partnership agreement with Zentiva, a leading pharmaceutical company in Europe, for the commercialization of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity.Under the terms of this agreement, Biocon is responsible for the manufacturing and supply of Liraglutide to Zentiva for its commercialization across 30 countries in Europe. Biocon also retained the right to commercialize this product under its own brand in the region. In November 2022, The US Food and Drug Administration (FDA) approved Provention Bio's biologics license application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D. Request a sample and discover the recent advances in diabetes drug treatment @ Diabetes Pipeline Report The diabetes pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage diabetes drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the diabetes clinical trial landscape. Diabetes Overview Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin or when the body does not use the insulin that is produced effectively. The vast majority of diabetes can be divided into two types: type 1 and type 2. Diabetes symptoms include polyuria, polydipsia, weight loss, sometimes accompanied by polyphagia and blurred vision. Chronic hyperglycemia may also cause growth impairment and susceptibility to certain infections. Diabetes long-term complications include retinopathy, which can lead to vision loss, nephropathy, which can lead to renal failure, peripheral neuropathy, which can lead to foot ulcers, amputations, and Charcot joints, and autonomic neuropathy, which can cause gastrointestinal, genitourinary, and cardiovascular symptoms. Diabetes is diagnosed through a thorough physical examination, medical history, and a battery of specialized tests. The A1C, or glycated hemoglobin test, is the primary test used to diagnose both type 1 and type 2 diabetes. Diabetes treatment typically consists of diet control, exercise, home blood glucose testing, oral medication, and insulin. Insulin is the primary treatment for type 1 diabetes, and people with type 2 diabetes can be treated with oral medications but may need insulin in some cases. Find out more about drugs for diabetes @ New Diabetes Drugs A snapshot of the Diabetes Pipeline Drugs mentioned in the report: Learn more about the emerging diabetes pipeline therapies @ Diabetes Clinical Trials Diabetes Therapeutics Assessment The diabetes pipeline report proffers an integral view of diabetes emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Diabetes Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Tumor necrosis factor alpha inhibitors, Glucagon receptor agonists, Cytotoxic T lymphocyte stimulants, Apoptosis inhibitors, Caspase inhibitors, Insulin-like growth factor binding protein inhibitors, Gene transference, Interleukin-10 expression modulators, CD40 antigen modulators Key Diabetes Companies: Daewoong Pharmaceutical, Janssen Biotech, Zealand Pharma, BioRestorative Therapies, Elevian, Oramed Pharmaceuticals, ImCyse, Novo Nordisk, Enthera, Precigen, Inc., Japan Tobacco, Avotres, AstraZeneca, Landos Biopharma, Vertex Pharmaceuticals, REMD Biotherapeutics, Inc., Eledon Pharmaceuticals, Eli Lilly and Company, Novo Nordisk A/S, Diamyd Medical, NextCell Pharma, ViaCyte, Op-T LLC, Dompé Farmaceutici S.p.A, ILTOO Pharma, Throne Biotechnologies, Oramed Pharmaceuticals, Janssen Research & Development, LLC, Jaguar Gene Therapy, SQZ Biotechnologies, Genprex, Inc., CRISPR Therapeutics, Biora Therapeutics, Genprex, Inc., and others. Key Diabetes Pipeline Therapies: Enavogliflozin, Golimumab, Dasiglucagon, ThermoStem, rGDF11, IMCY-0098, Insulin icodec, CagriSema, FDC Sema-OW GIP, SemaDapa FDC, ENT-001, AG019, JTT-662, AVT-001, AZD-0186, Cotadutide, LABP-111, VX-880, Encapsulated islet cell program, CPP-1X-T, REMD-477, AT-1501, LY 3209590, Orforglipron, LY3437943, Mazdutide, Peptide YY analogue agonist, GIPR agonist long acting, GIPR Agonist Long Acting II, LY 3493269, NNC0363-0845, Diamyd, ProTrans, VC-02, OPT101, Ladarixin, ILT-101, Stem Cell Educator Therapy, ORMD-0801, Golimumab, JAG301, SQZ TAC research program, VCTX 211 and others. Dive deep into rich insights for new drugs for diabetes treatment; visit @ Diabetes Medications Table of Contents For further information on the diabetes pipeline therapeutics, reach out @ Diabetes Drug Treatment Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. Type 1 Diabetes Epidemiology Forecast Type 1 Diabetes Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted type 1 diabetes epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Diabetes Market Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetes companies, including TikoMed, Avotres, REMD Biotherapeutics, Novo Nordisk, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, AstraZeneca, Novartis, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

AcquisitionLicense out/in

10 Feb 2023

·endpts.com

Oramed to review strategic alternatives, clouding path forward for oral insulin

Oramed Pharmaceuticals will look at strategic alternatives after the biotech’s attempt at creating an insulin pill faltered in a Phase III last month. The New York biotech is still mining through the data from the Phase III of ORMD-0801, the failure of which tanked the stock by 70% in January. But to move forward, the board and executives are taking a fine look at the pipeline and “conducting a comprehensive review of strategic alternatives” that could include selling the business or its assets. Oramed adds to a growing list of biotechs seeking new routes in the wake of a tightening financial market and bad clinical readouts, leading many to lay off staff, close the doors or sell. Oramed said Thursday it’s not working on a defined timetable, and the company has no plans to share any more details until a transaction has been entered, if at all. The company is also investigating ORMD-0801 for nonalcoholic steatohepatitis, or NASH, which is marked by a buildup of liver fat and has been a difficult R&D field for biopharmas to crack. Also in the pipeline is an oral GLP-1, ORMD-0901, for type 2 diabetes. Novo Nordisk’s semaglutide (sold under Ozempic, Rybelsus and Wegovy brands) and Eli Lilly’s Mounjaro have both consumed headlines in recent months for their popular rise in use for obesity.

Phase 3Phase 2

100 Deals associated with Insulin (Oramed)

External Link

KEGG	Wiki	ATC	Drug Bank
D00085	-	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	Hefei Tianhui Incubator of Technologies Co., Ltd.	25 Apr 2023
Diabetes Mellitus, Noninsulin-Dependent, 2	Phase 3	-	Oramed Ltd.	01 Oct 2021
Fibrosis	Phase 2	IL	Oramed Ltd.	20 Sep 2018
Nonalcoholic Steatohepatitis	Phase 2	IL	Oramed Ltd.	20 Sep 2018
Diabetes Mellitus, Type 1	Phase 2	IL	Oramed Pharmaceuticals, Inc.	01 Jul 2008
Diabetes Mellitus	Phase 1	CN	Hefei Haimaitongheng Biotechnology Co., Ltd.	03 Sep 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04618744 (ORA-D-N02 \| Phase II Randomized, Placebo-controlled Feasibility Clinical Trial, CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	32	Placebo (Placebo)	azzevxtfnp(xfbvrmpcfl) = cxuxnzoiqi aygcdevrqo (tvuazsapve, cnuemavzms - vgmarzddys) View more	-	07 Aug 2024
				ORMD-0801 (Insulin) capsule 8 mg BD (ORMD-0801 (Insulin) Capsule 8 mg BD)	azzevxtfnp(xfbvrmpcfl) = ttztduhrlr aygcdevrqo (tvuazsapve, ahiyfppucw - betcjcztmj) View more
NCT04564846 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	49	Placebo (Placebo)	hvbgwkitrl(tjqalscuoy) = agbehswwyo yzgryigzzq (qrdcmaivox, soghxumaef - vqgvtkjkes) View more	-	07 May 2024
				ORMD-0801 (ORMD-0801)	hvbgwkitrl(tjqalscuoy) = gcozhhlvxr yzgryigzzq (qrdcmaivox, ilteylkpqi - mufbnbgzrj) View more
NCT04616014 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	7	ORMD-0801 QD	itylqugivo(rvcbrjkazg) = fxfsemptbk ppzygrjtsl (qpztnjrwhw, oylnimvsgm - yeflecyuzx) View more	-	29 Mar 2024
NCT04618744 (EASD2023)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis insulin resistance \| inflammation	-	Oral insulin 8 mg	cqolmlfitn(bqtisrywmh) = mcytyxwdwr yscqvvfuya (rbyytfkwov, 30.4) View more	Positive	04 Oct 2023
				Placebo	cqolmlfitn(bqtisrywmh) = pknrseijib yscqvvfuya (rbyytfkwov, 26.7) View more
NCT04618744 (ORA-D-N02, Corporate Publications) Manual	Phase 2	Nonalcoholic Steatohepatitis	32	ORMD-0801	getqglvamx(hmeekipxme) = Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and placebo. uclqazooph (rpfxpwzshz )	Positive	17 Nov 2022
				Placebo
NCT04150107 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	30	Placebo (Baseline)	kidrwsakjo(ikajwdbjqz) = yuhjgnusqw ehvtspjopv (qgwyduuhnh, cglqmniebv - xlroiyawux) View more	-	02 Jun 2022
				ORMD-0801+Insulin (Treatment A)	kidrwsakjo(ikajwdbjqz) = vzhnruqqra ehvtspjopv (qgwyduuhnh, wsmkenzvgq - zfdaaqnyxm) View more
NCT02496000 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2	188	ORMD-0801	ebspdzmiqz(slneiqditc) = jdeaymtddo tizwuafwjt (unoxfyyvms, 23.5) View more	Positive	01 Nov 2021
				Placebo	ebspdzmiqz(slneiqditc) = camsehcwrt tizwuafwjt (unoxfyyvms, 26.1) View more
NCT02653300 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis \| Fibrosis	10	Oral Insulin	gfzbruuhes(naommmpulh) = dyvoxfydup wxbccnraos (vfqipltfau, phygtjzoyz - fytdsqciii) View more	-	23 Sep 2021
NCT02653300 (EASD2020)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	8	ORMD-0801	tkpyglwlsb(axynsntngl) = The 12-week ORMD-0801 treatment proved safe and tolerable in all patients, with no serious or severe adverse events recorded throughout the study period. sftdxyfcii (yscnzkonkv )	Positive	24 Sep 2020
NCT02094534 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	25	Placebo	qtobnyaqum(caqbqnttij) = sdcyeqtfrg bfkdqseuli (xuldeubimp, rcunfeknnq - bicerejgki) View more	-	06 Jul 2017

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