Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of the SynerG TM CGM sensor Integrated with the Niia Essential Insulin Patch Pump System in Persons with Type 1 Diabetes.

Start Date24 Mar 2025

Sponsor / Collaborator-

NL-OMON57171

/ SuspendedNot Applicable

Phoenix: Clinical evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult subjects with Type 1 Diabetes - Phoenix

Start Date06 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with NNC0268-0965

100 Translational Medicine associated with NNC0268-0965

100 Patents (Medical) associated with NNC0268-0965

121,958

Literatures (Medical) associated with NNC0268-0965

31 Dec 2025·ANNALS OF MEDICINE

Bioengineering and omics approaches for Type 1 diabetes practical research: advancements and constraints

Review

Author: Li, Ling ; An, Zhenmei ; Peng, Yihua ; Peng, Xi ; Zhou, Guangju

Insulin dependency arises from autoimmunity that targets the β cells of the pancreas, resulting in Type 1 diabetes (T1D). Despite the fact that T1D patients require insulin for survival, insulin does not provide a cure for this disease or prevent its complications. Despite extensive genetic, molecular, and cellular research on T1D over the years, the translation of this understanding into effective clinical therapies continues to pose a significant obstacle. It is therefore difficult to develop effective clinical treatment strategies without a thorough understanding of disease pathophysiology. Pancreatic tissue bioengineering models of human T1D offer a valuable approach to examining and controlling islet function while tackling various facets of the condition. And in recent years, due to advances in high-throughput omics analysis, the genotypic and molecular profiles of T1D have become finer tuned. The present article will examine recent progress in these areas, along with their utilization and constraints in the realm of T1D.

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Emergency medicine pharmacists’ interventions in the tertiary hospitals’ emergency departments in Malaysia

Article

Author: Teh, Lih Jiuan ; Tan, Shirlyn ; Tan, Sherene Su Ann ; Bhuvanendran Pillai, Anaanthan ; Sia, Rosalind Guen Lin ; Guee, Xin Nee ; Selvaratanam, Manimegahlai ; Koh, Hock Peng ; Koo, Yee Ping ; Wong, Wai Kit ; Chen, Mary Siew Yng ; Ab Jalal, Haliza

Background:

The emergency medicine (EM) pharmacist is an integrated part of the Emergency Department (ED) interdisciplinary team in many countries, including Malaysia. The presence of EM pharmacists in the ED has positively impacted patient outcomes. Data on EM pharmacists' interventions is scarce in the Asian region. In Malaysia, data on interventions done by EM pharmacists in the EDs was unavailable. This study aimed to assess the type of interventions done by EM pharmacists in the ED of tertiary public hospitals in Malaysia.

Methods:

This cross-sectional, multicenter study involved EM pharmacists from 14 tertiary hospitals in Malaysia. All accepted interventions done by EM pharmacists in the ED for patients admitted to the Red (critical) and Yellow (semi-critical) zones from January to June 2022 were extracted from the Clinical Pharmacy Report Form. All data were analyzed descriptively.

Results:

The EM pharmacists documented 1659 accepted interventions on 1584 patients during the study period. Inappropriate regimens (n = 1117, 67.3%) and incomplete prescriptions (n = 339, 20.4%) were the main categories of accepted interventions in ED. Inappropriate drug (n = 574, 34.6%), dose (n = 292, 17.6%), and frequency (n = 176, 10.6%) were the top three subcategory interventions documented under inappropriate regimens. Antimicrobials, antihypertensives, and proton pump inhibitors were the commonest drug intervened under the categories of inappropriate drug intervention. There were 272 (16.4%) accepted interventions on high-alert medications (HAMs). Insulin, enoxaparin, and noradrenaline were the most intervened HAMs.

Conclusion:

Inappropriate treatment regimens were the most common intervention category done by EM pharmacists in Malaysia. The significant number of interventions done by EM pharmacists demonstrated the importance of EM pharmacists as integral members of the EM team. This data can help improve the quality of clinical pharmacy services in the ED and is important for the future expansion of clinical pharmacy services in all EDs across Malaysia, neighbouring countries, and other developing countries.

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Effect of statins and antihyperglycemics on chronic kidney disease in patients with type 2 diabetes mellitus: a retrospective cohort study with a 12-year follow-up

Article

Author: El-Dahiyat, Faris ; Mohammed, Khuloud Jamal ; Al Jaberi, Asma Khaled ; Al Jawamis, Dina Farhan ; Shahwan, Moyad ; Jairoun, Ammar Abdulrahman ; Ping, Chong Chee ; Dawoud, Tasnim ; Ibrahim, Baharudin

Background:

Chronic Kidney Disease (CKD) represents a significant worldwide health challenge, with far-reaching implications for both patients and healthcare systems. This study aimed to identify the incidence of CKD at stages 3-5, analyzed the impact of statin and other antihyperglycemic interventions, on the CKD progression in individuals with T2DM.

Methods:

This was a single-center retrospective cohort study based on data derived from electronic medical records (EMR) of UAE populations with diabetes mellitus, registered at outpatient clinics at Tawam Hospital in Al Ain, UAE, between January 2011 and December 2021. T2DM patients aged ≥ 18 years who had serum HbA1c level ≥ 6.5% and using one of the statin therapies were inclusion criteria. Patients with T1DM, who had undergone permanent renal replacement therapy, with under 1 year of follow-up and missing or incomplete data were excluded from the study. The collected data encompassed socio-demographics, detailed medical history, anthropometric measurements, laboratory analyses, clinical parameters, disease characteristics, and medications.

Results:

Our study included a cohort of 1,003 individuals. We observed 388 subjects developed CKD stages 3-5 across an average monitoring duration of 11.7 years. This resulted in a cumulative incidence of 38.7%, translating to an incidence rate of 38 cases per 1000 person-years. There was a statistically significant difference in the cumulative incidence of CKD stages 3 ± 5 according to statin therapy (P = 0.047). High intensity statin users are more likely to develop a CKD stage 3-5 compared to low/moderate intensity users and to no statin users respectively (44.3% vs 37.9%), (44.3% vs 30.9%). Conversely, the use of Biguanides was associated with a decreased probability of CKD progression (37.9% vs. 52.8%; P = 0.001), whereas Insulin users demonstrated a heightened risk (54.2% vs. 34.1%; P < 0.001).

Conclusion:

The findings emphasise the pivotal role of personalised treatment strategies, particularly concerning statin therapy and other medications, in populations at high risk.

774

News (Medical) associated with NNC0268-0965

30 May 2025

·www.prnewswire.com

Sun Pharma Completes its Acquisition of Checkpoint Therapeutics

MUMBAI, India and PRINCETON, N.J., May 30, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced the successful completion of its acquisition of Checkpoint Therapeutics, Inc. ("Checkpoint"), an immunotherapy and targeted oncology company. As part of the acquisition, Sun Pharma acquires UNLOXCYT™, the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma. "This acquisition exemplifies Sun Pharma's commitment to supporting patients and growing its innovative therapies business," said Dilip Shanghvi, Chairman & Managing Director of Sun Pharma. "By adding UNLOXCYT™, we will be able to leverage our leadership in the onco-derm space to help patients access an important treatment option while growing our product portfolio." Financial Terms Sun Pharma has acquired all outstanding shares of Checkpoint at a price of $4.10 per share in cash, without interest, plus one non-tradable contingent value right (CVR) per share representing the right to receive up to an additional $0.70 in cash, without interest, if certain specified milestones are met, as set out in the terms and conditions of the contingent value rights agreement. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). About Cutaneous Squamous Cell Carcinoma Cutaneous squamous cell carcinoma ("cSCC") is the second-most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region, and that invade blood vessels, nerves and vital organs, such as the eye or ear. UNLOXCYT™ INDICATION and IMPORANT SAFETY INFORMATION INDICATION UNLOXCYT™ (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, and occur at any time after starting a PD-1/PD-L1 blocking antibody, including UNLOXCYT™. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue UNLOXCYT™ depending on the severity of the adverse reaction (see Dosage and Administration in Prescribing Information). In general, if UNLOXCYT™ requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Immune-Mediated Pneumonitis UNLOXCYT™ can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1 blocking antibody, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 1% (3/223, Grade 2) of patients receiving UNLOXCYT™. Immune-Mediated Colitis UNLOXCYT™ can cause immune-mediated colitis, which may present with diarrhea, abdominal pain, and lower gastrointestinal bleeding. Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 0.4% (1/223, Grade 1) of patients receiving UNLOXCYT™. Immune-Mediated Hepatitis UNLOXCYT™ can cause immune-mediated hepatitis. Immune-Mediated Endocrinopathies Adrenal Insufficiency UNLOXCYT™ can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Adrenal insufficiency occurred in 0.9% (2/223) of patients receiving UNLOXCYT™, including Grade 2 in 0.4% (1/223) of patients. Hypophysitis UNLOXCYT™ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Thyroid Disorders UNLOXCYT™ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Hypothyroidism occurred in 10% (22/223) of patients receiving UNLOXCYT™, including Grade 2 in 5% (10/223) of patients. Hyperthyroidism occurred in 5% (12/223) of patients receiving UNLOXCYT™, including Grade 2 in 0.4% (1/223) of patients. Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis UNLOXCYT™ can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Immune-Mediated Nephritis with Renal Dysfunction UNLOXCYT™ can cause immune-mediated nephritis. Immune-Mediated Dermatologic Adverse Reactions UNLOXCYT™ can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1 blocking antibody. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Immune-mediated dermatologic adverse reactions occurred in 7% (15/223) of patients receiving UNLOXCYT™, including Grade 3 in 0.9% (2/223) of patients and Grade 2 in 4% (9/223) of patients. Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred in <1% of the 223 patients who received UNLOXCYT™ or were reported with the use of other PD-1/PD-L1 blocking antibody. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis. Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy. Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis. Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica. Endocrine: Hypoparathyroidism. Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection. Infusion-Related Reactions UNLOXCYT™ can cause severe or life-threatening infusion-related reactions. Infusion-related infusion reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT™. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT™ based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins. Complications of Allogeneic HSCT Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT. Embryo-Fetal Toxicity Based on its mechanism of action, UNLOXCYT™ can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with UNLOXCYT™ and for 4 months after the last dose. Common Adverse Reactions The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. Please see full Prescribing Information. Sun Pharma Contacts: Investors Dr. Abhishek Sharma +91 22 4324 2929 [email protected] Media (Global) Gaurav Chugh +91 22 4324 5373 [email protected] Media (USA) James Freeman +1 978-808-6956 [email protected] SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionDrug ApprovalImmunotherapy

29 May 2025

·www.prnewswire.com

Breakthrough T1D Center of Excellence in New England Announces New Name to Honor Type 1 Diabetes Champion Barbara Dewey Cammett

NEW YORK, May 29, 2025 /PRNewswire/ -- Breakthrough T1D, formerly JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, is pleased to announce two exciting developments at the Breakthrough T1D Center of Excellence in New England that bolster its commitment to accelerating scientific breakthroughs on the path to cures for T1D. In recognition of the steadfast support of Breakthrough T1D volunteer leader John Cammett, the Breakthrough T1D Center of Excellence in New England has been named after his mother, who lived with T1D for nearly 60 years. The center will now be known as the Breakthrough T1D Barbara Dewey Cammett Center of Excellence in New England. John Cammett helped establish the Breakthrough T1D Center of Excellence in New England and has provided foundational support for Project ACT, Breakthrough T1D's initiative to make curative cell therapies for T1D a reality. "Throughout my childhood, I admired the way my mother lived a full life while navigating her type 1 diabetes. When I was diagnosed with type 1 diabetes as an adult, she became even more of an inspiration to me," said John Cammett. "She helped fuel my passion and commitment to doing all I can to support Breakthrough T1D and help find cures for this disease. The Breakthrough T1D Center of Excellence in New England is driving cell therapy research that may one day allow all of us to walk away from type 1 diabetes. I'm honored that my mother's legacy will be part of this groundbreaking effort." After five years of steady progress and growth in multiple research fronts, the Breakthrough T1D Barbara Dewey Cammett Center of Excellence in New England has been awarded additional funding over the next four years to maintain its momentum in accelerating cell therapy research in pursuit of cures for T1D. Since its inception, it has made significant progress advancing islet cell-based T1D research, enhancing the understanding of the immune response following islet transplantation to prevent rejection, and creating genetically modified islet cells that could withstand the immune attack after transplantation into people living with T1D. The continued funding will support research that builds on this work to further advance cell therapy research with a focus on refined approaches to make islet cells healthier and more resilient to the immune system and metabolic and infectious stressors. It will continue to be led by Dr. David Harlan at UMass Chan Medical School. Significantly, Dr. Harlan and co-investigators have expanded the Center, bringing in leading experts in innovative areas to complement the existing team. "Accelerating cell therapies from our Centers of Excellence is a key priority area for Breakthrough T1D, and one we believe will lead us to cures for type 1 diabetes," said Breakthrough T1D vice president of research Esther Latres, PhD. "Our Centers of Excellence allow for unique collaboration, innovation, and career development that make the accomplishment of joint projects that could not be achieved as individual efforts possible. The Breakthrough T1D Barbara Dewey Cammett Center of Excellence in New England is well-positioned to address the remaining key challenges in cell therapy that provide benefits to the entire type 1 diabetes community." The center's new name announcement coincides with a generous $1 million gift from the Bukhman Foundation for the Breakthrough T1D Barbara Dewey Cammett Center of Excellence in New England. Established in 2023, the Bukhman Foundation supports medical research, access to quality education, and strengthening arts and culture. Breakthrough T1D Centers of Excellence align with the organization's research strategy and seek to leverage the expertise, specialty, and resources of world-class institutions and researchers to accelerate T1D treatments and therapies. Bringing together leading experts from diverse fields and multiple institutions, each Breakthrough T1D Center of Excellence builds on established expertise to accelerate T1D advances. The Center of Excellence model is designed to maximize resources, remove barriers, link research efforts around the world, develop the next generation of scientific leadership, and foster maximum collaboration to drive progress as quickly as possible. The Breakthrough T1D Barbara Dewey Cammett Center of Excellence is one of five around the world, powering advances to deliver cures and life-improving breakthroughs for T1D. About Breakthrough T1D, Formerly JDRF As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. About Type 1 Diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. Contact: Casey Fielder 509-651-0087 [email protected] SOURCE Breakthrough T1D, Formerly JDRF WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell Therapy

28 May 2025

·www.einpresswire.com

Marius Pharmaceuticals Receives Sixth U.S. Patent Allowance for KYZATREX® (testosterone undecanoate) CIII Capsules Extending Coverage to 2040

RALEIGH, N.C., May 28, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals , a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, announced today that the United States Patent and Trademark Office (USPTO) for a new patent related to its oral testosterone therapy, KYZATREX ® (testosterone undecanoate) CIII Capsules. This is the sixth patent in the company’s growing intellectual property portfolio protecting KYZATREX. This newly allowed patent provides additional protection for KYZATREX through 2040 and further underscores the unique formulation and delivery attributes that differentiate it from other testosterone replacement therapies. It reinforces the significant barriers to generic or compounded alternatives, and strengthens Marius Pharmaceuticals’ confidence in the durability of its proprietary, business model. “This patent reinforces our commitment to evidence-based, precision treatment of testosterone deficiency,” said Shalin Shah, CEO at Marius Pharmaceuticals. “By securing additional protection for KYZATREX, we continue to lead the way in oral testosterone innovation, making it easier for providers to deliver safe, effective care tailored to individual patient needs. With six patents now protecting our therapy and more in progress, we are confident in our ability to remain insulated from generic disruption and compounding threats as KYZATREX becomes the go-to therapy option in this 25 million plus patient market.” The USPTO issues a Notice of Allowance when it determines that a patent application has met all formal requirements. This patent will extend protection for KYZATREX in the U.S. through 2040. It adds to Marius’ robust global patent estate, which includes granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand, and other key markets, with pending applications in India and the U.S. About KYZATREX® (testosterone undecanoate) KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com . About Marius Pharmaceuticals Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com . Important Safety Information for KYZATREX® (testosterone undecanoate) Use KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women. Important Safety Information for KYZATREX® (testosterone undecanoate) KYZATREX can increase blood pressure , which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure. If your blood pressure cannot be controlled, KYZATREX may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take : insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin , which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases. If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow. Increased risk of prostate cancer . Blood clots in the legs or lungs . Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Abuse . Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. In large doses, KYZATREX may lower your sperm count. Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain). Swelling of your ankles, feet, or body (edema), with or without heart failure. Enlarged or painful breasts. Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact: Lilly Washburn lilly@mariuspharma.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 3

100 Deals associated with NNC0268-0965

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	Germany	Novo Nordisk A/S	29 Oct 2019
Diabetes Mellitus, Type 1	Phase 1	Germany	Novo Nordisk A/S	05 Jun 2019

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WSC2023	Not Applicable	Sleep Apnea Syndromes	-	Diabetic Patients on Insulin Therapy	alvweozerw(gbojqrudpc) = zjnhgypdbz tamvihehue (udkocrzapw, 0.02) View more	-	23 Oct 2023
STOP study (EASD2023)	Not Applicable	Diabetes Mellitus, Type 2	93	IDegLira	yixtopjsuz(wwekemmnik) = aonydlqqbb svpfsbwtna (hxvgsvxupd ) View more	Positive	05 Oct 2023
EASD2023	Not Applicable	Diabetes Mellitus, Type 1 \| Diabetic Retinopathy \| Retinal Diseases	652	automated insulin delivery systems (Multiple Daily Injections (MDI))	ssxkakbxea(dvqqwrotxa) = Significantly lower rates of dyslipidemia in patients with AID were seen sfddiotsso (auuukawpjb ) View more	Positive	05 Oct 2023
				automated insulin delivery systems (Insulin Pump (IP) without AID)
EASD2023	Not Applicable	-	-	Open-source automated insulin delivery (osAID) system	sjempbaipy(vavloeborg) = soriqlmjzs qtyubnffta (zmwhvdwxhx ) View more	Positive	05 Oct 2023
				insulin (Medtronic 780G with SmartGuard)	sjempbaipy(vavloeborg) = diyctfmlex qtyubnffta (zmwhvdwxhx ) View more
EASD2023	Not Applicable	Diabetes Mellitus, Type 2	514	insulin (Descending mode)	ifqbdfznig(agjiuzqctt) = yvhpaycebl xsnycnuimt (mwndjpczhs, (1.0 - 6.0)) View more	Positive	05 Oct 2023
				insulin (Ascending mode)	ifqbdfznig(agjiuzqctt) = nguynmrnxb xsnycnuimt (mwndjpczhs, (0 - 4.0)) View more
INSENODIAB (ESPE2023)	Not Applicable	Diabetes Mellitus, Type 1	-	Insulin	dqnkcepkmt(kchdrfkheu) = qudpfpskjy rgsltfgjnw (xzpdtzizrw, 0.5)	-	21 Sep 2023
				rINSENODIAB cohort	dqnkcepkmt(kchdrfkheu) = rizypyiors rgsltfgjnw (xzpdtzizrw, 6.9)
ESPE2023	Not Applicable	Familial chylomicronaemia syndrome LPL deficiency	4	Insulin	feajxnkyua(pprivvityy) = xsjpncgzru eknmlffwbb (myuifdyncz )	-	21 Sep 2023
ADA2023	Not Applicable	Diabetes Mellitus, Type 2	96	Basal insulin only	wdbnevuptx(eqgolwwcii) = eodovyxdyc hiohrdodei (kwngdjvozt ) View more	-	23 Jun 2023
				Multiple daily injections (MDI)	wdbnevuptx(eqgolwwcii) = byxppbbhlh hiohrdodei (kwngdjvozt ) View more
ADA2023	Not Applicable	Diabetes Mellitus, Type 1	-	Omnipod 5 Automated Insulin Delivery (AID) System (Children aged <6y)	qwulokzvrg(hmuxwyixvp) = jdnnfmiskw vgupufrqzb (fqdwzscwlh ) View more	-	20 Jun 2023
				Omnipod 5 Automated Insulin Delivery (AID) System (Children aged 6 to 12y)	qwulokzvrg(hmuxwyixvp) = smxyxlnvkr vgupufrqzb (fqdwzscwlh ) View more
CODIAC Study (ADA2023)	Not Applicable	Diabetes Mellitus, Type 1	25	Automated Insulin Delivery Systems—AndroidAPS (AndroidAPS)	uqlytsjuoi(srbnsrecoa) = kjhuvruoqc szkxrxikwf (snswotpuxk ) View more	-	20 Jun 2023
				Automated Insulin Delivery Systems—AndroidAPS (Control-IQ)	uqlytsjuoi(srbnsrecoa) = pnmcztrvui szkxrxikwf (snswotpuxk ) View more

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