Author: Hemeda, Mohamed S ; Elsayed, Almoatazbellah Mahmoud ; Ezzat, Amgad A ; Rohym, Heba Hussein ; Makloph, Mohammed ; Ibrahim, Mohamed A ; Farrag, Mayada Saad ; Elsayed, Heba A

Azithromycin is a broad-spectrum antibiotic commonly used to treat bacterial infections but is associated with adverse cardiac effects, including oxidative damage and myocardial inflammation. This study aims to explore the histopathological and biochemical changes, including serum interleukin-10 levels, induced by azithromycin in the hearts of male albino rats and to evaluate the protective role of combined selenium and vitamin E treatment. Forty rats were divided into four groups: a control group, an azithromycin treatment group, selenium and vitamin E treatment group, and a combined treatment group receiving both azithromycin, selenium, and vitamin E. Results showed that the azithromycin-treated group exhibited significant increases in interleukin-10 levels, myocardial fibrosis, and cell structure degeneration, while combined selenium and vitamin E treatment markedly reduced these adverse effects, indicating a protective effect. This study concludes that selenium and vitamin E provide a protective effect against azithromycin-induced cardiac toxicity, suggesting that concurrent antioxidant therapy may help safeguard the heart during azithromycin treatment.

03 May 2025·Journal of biomolecular structure & dynamics

Phytochemical composition, anti-microbial, anti-oxidant and anti-diabetic effects of Solanum elaeagnifolium Cav. leaves: in vitro and in silico assessments

Article

Author: K., Shine ; A. K., Freeda Rose ; S., Balavivekananthan ; T., Francis Xavier ; M., Thiruvengadam ; S., Prabhu ; R., Sabitha ; S., Amalraj ; S., Vijayakumar ; M., Ayyanar ; R., Kariyat

The aim of this study was to screen the chemical components of Solanum elaeagnifolium leaves and assess their therapeutic attributes with regard to their antioxidant, antibacterial, and antidiabetic activities. The antidiabetic effects were explored to determine the α-amylase and α-glucosidase inhibitory potential of the leaf extract. To identify the active antidiabetic drugs from the extracts, the GC-MS-screened molecules were docked with diabetes-related proteins using the glide module in the Schrodinger Tool. In addition, molecular dynamics (MD) simulations were performed for 100 ns to evaluate the binding stability of the docked complex using the Desmond module. The ethyl acetate had a significant total phenolic content (TPC), with a value of 79.04 ± 0.98 mg/g GAE. The ethanol extract was tested for its minimum inhibitory concentration (MIC) for its bacteriostatic properties. It suppressed the growth of B. subtilis, E. coli, P. vulgaris, R. equi and S. epidermis at a dosage of 118.75 µg/mL. Moreover, the IC50 values of the ethanol extract were determined to be 17.78 ± 2.38 in the α-amylase and and 27.90 ± 5.02 µg/mL in α-glucosidase. The in-silico investigation revealed that cyclolaudenol achieved docking scores of -7.94 kcal/mol for α-amylase. Likewise, the α-tocopherol achieved the docking scores of -7.41 kcal/mol for glycogen phosphorylase B and -7.21 kcal/mol for phosphorylase kinase. In the MD simulations, the cyclolaudenol and α-tocopherol complexes exhibited consistently stable affinities with diabetic proteins throughout the trajectory. Based on these findings, we conclude that this plant could be a good source for the development of novel antioxidant, antibacterial, and antidiabetic agents.Communicated by Ramaswamy H. Sarma.

01 May 2025·FOOD CHEMISTRY

Deciphering the antioxidant capacity of common vitamins against specific reactive oxygen species by nuclear magnetic resonance

Article

Author: Zhang, Peng ; Park, Juhyeon ; Tang, Hong

Antioxidant studies are important for understanding oxidative stress and developing preservative techniques for food and medicine. There has been increasing interest in the study of natural antioxidants, such as vitamins, due to their biocompatibility, relatively low cost, and high antioxidant capacity. Spectroscopic tools, including fluorescence and electron spin resonance, have been developed to evaluate the antioxidant capacity. However, it is difficult for these methods to measure the antioxidant capacity against specific reactive oxygen species (ROS). Based on a recently developed ¹⁹F NMR method to differentiate and quantify specific ROS, we have hypothesized that the antioxidant capacity of chemicals against specific ROS (¹O₂, H₂O₂, and OH^•) can be determined. In this work, we have investigated the antioxidant capacity of some common vitamins (provitamin A, vitamin B₂, vitamin C, and vitamin E) against specific ROS. This work showcases the capability and potential of our ¹⁹F NMR method for other ROS-pertinent studies.

News (Medical) associated with Vitamin E

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

14 Jan 2025

·www.prnewswire.com

LOLA Introduces Postpartum Care Line, Extending Commitment to Women's Health

NEW YORK, Jan. 14, 2025 /PRNewswire/ -- LOLA, a pioneer in organic feminine care and reproductive wellness, today announced its expansion into postpartum care. This strategic launch reflects LOLA's ongoing commitment to supporting women through every stage of their reproductive journey with products focused on ingredient transparency. "Every woman deserves access to clean, non-toxic, and effective postpartum care," said Kelly Murphy, General Manager of LOLA. "By bringing our expertise in women's wellness to the postpartum experience, we aim to empower new mothers to embrace their changing bodies with the peace of mind that they don't have to sacrifice safety and comfort for convenience." The initial postpartum collection, now available at Walmart stores nationwide and online at mylola.com, features three essentials that support new mothers. Each is crafted with LOLA's signature commitment to quality, clean ingredients: The Stretch Mark Prevention Cream combines 15 botanical oils and extracts, including apricot oil, shea butter, and vitamin E, delivering deep hydration while supporting skin elasticity and collagen production. The hypoallergenic formula excludes parabens, phthalates, and synthetic additives. The Organic Cotton Postpartum Pads are engineered to be three times more absorbent than standard heavy pads, with LOLA's signature commitment to organic materials. The extra-long pads include a moisture-wicking topsheet and are free from chlorine bleach, dyes, fragrances, and PFAS. The pads, made with 100% organic cotton, are FSA approved. The Hot and Cold Perineal Gel Pads offer versatile temperature therapy with a convenient two-pack system and 24 disposable liners, providing targeted relief exactly when needed. The flexible design allows for use with or without pads, maximizing comfort and convenience. The hot and cold gel pads are FSA approved. "LOLA is committed to enabling consumers to use their health benefit accounts, and we've been a proud partner since 2023," says Ami Kumordzie, Founder of SIKA Health. "HSA/FSA spending shouldn't be filled with confusing coverage rules and stressful paperwork just to use your own money, especially while prioritizing and navigating your postpartum recovery and family bonding. HSA/FSA spending is a benefit, not a burden, and we are thrilled that LOLA's clean postpartum care is available for checkout through SIKA." This launch builds upon LOLA's suite of period care products made with 100% organic cotton and gynecologist-approved sexual wellness products made with natural ingredients. Going forward, LOLA plans to grow its postpartum collection with additional products launching exclusively at Target stores nationwide in March 2025. About LOLA Grounded in advocacy for women's health and safety, LOLA offers clean, organic period care and reproductive wellness products to help women and menstruators feel comfortable and in control from puberty through menopause and beyond, while prioritizing customer education. For more information, visit . SOURCE LOLA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

12 Nov 2024

·pipelinereview.com

KOSELUGO® (selumetinib) Showed Significant and Clinically Meaningful Improvement in Objective Response Rate Versus Placebo in Adults With Neurofibromatosis Type 1 who Have Symptomatic, Inoperable Plexiform Neurofibromas in Global Phase 3 KOMET Trial

These results showed reduction in tumor volume, building on the established safety and efficacy profile of KOSELUGO in certain children and has the potential to support expanded use in certain adults RAHWAY, NJ, USA I November 12, 2024 I Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KOMET trial, which is the largest, global randomized double-blind placebo-controlled multicenter Phase 3 trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Topline results showed that KOSELUGO, an oral, selective MEK inhibitor, demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the study’s primary endpoint, versus placebo, in these adult patients. Neurofibromatosis type 1 is a rare, progressive genetic condition affecting an estimated 1.7 million people worldwide, approximately 70% of whom are adults. In 30-50% of patients, tumors develop on the nerve sheaths and may cause debilitating symptoms. Neurofibromatosis type 1 is usually diagnosed in early childhood; however, NF1 often progresses into adulthood.There are no approved treatments for adults, leaving many to experience disfigurement, dysfunction, persistent pain or endure multiple surgeries. Professor Ignacio Blanco Guillermo, M.D., Ph.D., chairman, genetic counseling and clinical genetics program at the Germans Trias i Pujol University Hospital, chairman, Spanish National Reference Center for Adult Patients with Neurofibromatosis and principal investigator of the KOMET trial, said, “With limited options to manage NF1 plexiform neurofibromas in adults, many patients experience functional impairment and symptoms, which can substantially impact their lives. These clinically meaningful data show KOSELUGO has the potential to make a positive impact in patient care by reducing the size of plexiform neurofibromas.” Marc Dunoyer, chief executive officer, Alexion, said, “These promising results demonstrate that KOSELUGO, the first and only approved targeted therapy for certain children with NF1 plexiform neurofibromas, now has the potential to benefit adult patients for whom there are no approved targeted therapies. As the largest and only global placebo-controlled Phase 3 trial in adults with NF1 plexiform neurofibromas, KOMET reinforces our leadership in advancing potential treatment options for people living with this debilitating disease. We look forward to sharing these findings with regulatory authorities.” Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories, said, “Adults with NF1 are in critical need of treatment options to help manage symptomatic, inoperable plexiform neurofibromas. These positive results from the Phase 3 KOMET trial demonstrate the potential to expand the use of KOSELUGO beyond pediatric patients to also treat adult patients living with this rare and challenging genetic condition.” In the trial, ORR was defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumor volume) by cycle 16 (28 days per cycle) as determined by independent central review (ICR) per response evaluation in neurofibromatosis and schwannomatosis (REiNS) criteria. The safety profile of KOSELUGO in this study was consistent with that observed in clinical trials among children and adolescents. No new safety signals were identified. Alexion, AstraZeneca Rare Disease will share these data with regulatory authorities and present these data at a forthcoming medical meeting. AstraZeneca and Merck are jointly developing and commercializing KOSELUGO globally. About KOMET KOMET is a global randomized, double-blind, placebo-controlled, multi-center Phase 3 trial (ClinicalTrials.gov, NCT04924608 ) designed to evaluate the efficacy and safety of KOSELUGO in adults with NF1 who have symptomatic, inoperable PNs. The trial enrolled 145 adults from 13 countries across the U.S., Asia, Australia, South America and Europe, with participants’ baseline characteristics, including gender and distribution of PNs, reflective of the global adult NF1 patient population. Patients were enrolled and randomized 1:1 to receive KOSELUGOor placebo for twelve 28-day cycles.Participants were required to have diagnosis of NF1 at least one, symptomatic, inoperable target PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrollment. The primary endpoint is confirmed ORR by cycle 16 as assessed by ICR. Objective response rate is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumor volume). After 12 cycles, patients on placebo were switched to KOSELUGO and patients on KOSELUGO remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete both treatment periods 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive KOSELUGO. About NF1 Neurofibromatosis type 1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene. Neurofibromatosis type 1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in 30-50% of patients, tumors develop on the nerve sheaths (PNs). These PNs can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.Plexiform neurofibromas begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years. About KOSELUGO ® (selumetinib) KOSELUGOis a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumor cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, KOSELUGOslows down the growth of tumor cells, and, therefore, the PN growth. KOSELUGO is approved in the U.S., European Union (EU), Japan, China and has been granted Orphan Drug Designation in the U.S., EU, Japan and other countries for the treatment of pediatric patients with NF1 PN who have symptomatic, inoperable PN. KOSELUGO (selumetinib) Indication in the U.S. KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Cardiomyopathy. A decrease in left ventricular ejection fraction (LVEF) ≥10% below baseline occurred in pediatric patients who received KOSELUGO in SPRINT with some experiencing decreased LVEF below the institutional lower limit of normal (LLN), including one patient with Grade 3. All patients with decreased LVEF were asymptomatic and identified during routine echocardiography. The safety of KOSELUGO has not been established in patients with a history of impaired LVEF or a baseline ejection fraction that is below the institutional LLN. Assess ejection fraction by echocardiogram prior to initiating treatment, every 3 months during the first year of treatment, every 6 months thereafter, and as clinically indicated. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. In patients who interrupt KOSELUGO for decreased LVEF, obtain an echocardiogram or a cardiac MRI every 3 to 6 weeks. Upon resolution of decreased LVEF, obtain an echocardiogram or a cardiac MRI every 2 to 3 months. Ocular Toxicity. Blurred vision, photophobia, cataracts, and ocular hypertension occurred. Retinal pigment epithelial detachment (RPED) occurred in the pediatric population during treatment with single agent KOSELUGO and resulted in permanent discontinuation. Conduct ophthalmic assessments prior to initiating KOSELUGO, at regular intervals during treatment, and for new or worsening visual changes. Permanently discontinue KOSELUGO in patients with retinal vein occlusion (RVO). Withhold KOSELUGO in patients with RPED, conduct ophthalmic assessments every 3 weeks until resolution, and resume KOSELUGO at a reduced dose. Gastrointestinal Toxicity. Diarrhea occurred, including Grade 3. Diarrhea resulting in permanent discontinuation, dose interruption or dose reduction occurred. Advise patients to start an anti-diarrheal agent (eg, loperamide) and to increase fluid intake immediately after the first episode of diarrhea. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. Skin Toxicity. Rash occurred in 91% of 74 pediatric patients. The most frequent rashes included dermatitis acneiform (54%), maculopapular rash (39%), and eczema (28%). Grade 3 rash occurred, in addition to rash resulting in dose interruption or dose reduction. Monitor for severe skin rashes. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. Increased Creatinine Phosphokinase (CPK). Increased CPK occurred, including Grade 3 or 4 resulting in dose reduction. Increased CPK concurrent with myalgia occurred, including one patient who permanently discontinued KOSELUGO for myalgia. Obtain serum CPK prior to initiating KOSELUGO, periodically during treatment, and as clinically indicated. If increased CPK occurs, evaluate for rhabdomyolysis or other causes. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. Increased Levels of Vitamin E and Risk of Bleeding. KOSELUGO capsules contain vitamin E which can inhibit platelet aggregation and antagonize vitamin K-dependent clotting factors. Supplemental vitamin E is not recommended if daily vitamin E intake (including the amount of vitamin E in KOSELUGO and supplement) will exceed the recommended or safe limits due to increased risk of bleeding. An increased risk of bleeding may occur in patients who are coadministered vitamin-K antagonists or anti-platelet antagonists with KOSELUGO. Monitor for bleeding in these patients and increase international normalized ratio (INR) in patients taking a vitamin-K antagonist. Perform anticoagulant assessments more frequently and adjust the dose of vitamin K antagonists or anti-platelet agents as appropriate. Embryo-Fetal Toxicity. Based on findings from animal studies, KOSELUGO can cause fetal harm when administered during pregnancy. In animal studies, administration of selumetinib to mice during organogenesis caused reduced fetal weight, adverse structural defects, and effects on embryo-fetal survival at approximate exposures >5 times the human exposure at the clinical dose of 25 mg/m2 twice daily. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with KOSELUGO and for 1 week after the last dose. ADVERSE REACTIONS Common adverse reactions ≥40% include vomiting, rash (all), abdominal pain, diarrhea, nausea, dry skin, musculoskeletal pain, fatigue, pyrexia, acneiform rash, stomatitis, headache, paronychia, and pruritus. DRUG INTERACTIONS Effect of Other Drugs on KOSELUGO Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inhibitor or fluconazole increased selumetinib plasma concentrations, which may increase the risk of adverse reactions. Avoid coadministration with KOSELUGO. If coadministration cannot be avoided, reduce KOSELUGO dosage. Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations, which may reduce KOSELUGO efficacy. Avoid concomitant use with KOSELUGO. SPECIAL POPULATIONS Pregnancy & Lactation. Verify the pregnancy status of patients of reproductive potential prior to initiating KOSELUGO. Due to the potential for adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with KOSELUGO and for 1 week after the last dose. About the AstraZeneca and Merck strategic collaboration In July 2017, AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced a global strategic collaboration to co-develop and co-commercialize LYNPARZA (olaparib), a first-in-class PARP inhibitor, and KOSELUGO. Working together, the companies will develop LYNPARZA and KOSELUGO in combination with other potential new medicines and as monotherapies. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www-merck-com.libproxy1.nus.edu.sg/research/oncology/ . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck

Clinical ResultPhase 3Orphan DrugDrug ApprovalLicense out/in

100 Deals associated with Vitamin E

External Link

KEGG	Wiki	ATC	Drug Bank
-	Vitamin E	A11HA03	DB00163

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vitamin E Deficiency	CN	Sinopharm Group Co., Ltd.	-
Vitamin E Deficiency	CA	-	-
Vitamin E Deficiency	GB	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Preclinical	CN	Hangzhou Normal University Affiliated Hospital	18 Feb 2025
Nonalcoholic Steatohepatitis	Preclinical	CN	Zhejiang Medicine Co., Ltd.	18 Feb 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03669133 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis \| HIV Infections	3	Vitamin E (Group A)	gyccmirfwj(ezadeovlpo) = myyrlsyhwb gtkbcxdnqy (cehxomuoha, mbryekcczv - hlnbjcxfha) View more	-	25 Jul 2023
				Placebo (Group B)	gyccmirfwj(ezadeovlpo) = zddhmydtza gtkbcxdnqy (cehxomuoha, cthnotbmej - uwcovolaev) View more
NCT04198805 (PUVENAFLD, CTgov)	Phase 2	Insulin Resistance \| Nonalcoholic Steatohepatitis \| Hypertension	205	Omega-3 fatty acid+Vitamin E (DHA EE (1.89 g) and Vitamin E (1000 mg))	mkcfzfltjs(uemqjxbeic) = alzcsrwcei tvmwscfzmn (fvmodkgjqj, gsndiaxfpx - opfqqvnsvr) View more	-	25 May 2023
				Placebo (Placebo)	mkcfzfltjs(uemqjxbeic) = lbyqozwdig tvmwscfzmn (fvmodkgjqj, ngynsfcrwk - axfkcaxrij) View more
ESC2023	Not Applicable	Atrial Fibrillation	-	Dabigatran	xjcsuvxxks(kkdoaqjour): HR = 0.76 (95% CI, 0.74 - 0.79)	-	16 Apr 2023
				Vitamin K antagonists (VKAs)
ChiCTR2100050910 (not available, ASTRO2022)	Phase 4	-	102	Sanyrene	yvwsmyoatr(iqcqunajax) = cqzabrhemh cokdyvvqxj (vsbzbbheti ) View more	Positive	01 Nov 2022
				Vitamin E	yvwsmyoatr(iqcqunajax) = touabujeui cokdyvvqxj (vsbzbbheti ) View more
ESC2022	Not Applicable	Aortic Valve Stenosis	38	Non-vitamin K antagonist oral anticoagulants (NOACs)	erxjjxhphs(aozssnnquz) = mhyepdxsps dfkyuizdxj (ajhroljckw ) View more	-	29 Aug 2022
				Non-vitamin K antagonist oral anticoagulants (NOACs)	erxjjxhphs(aozssnnquz) = kbliwsxchp dfkyuizdxj (ajhroljckw ) View more
NCT03274596 (Pubmed \| Medicine (Baltimore))	Not Applicable	Retinopathy of Prematurity	-	Treatment group	qgkpriascn(vcfritmuhq) = odikufqxmi tqajlsjvmc (sjoagagpcw, 0.10 - 0.96)	-	06 Aug 2021
				Control group	qgkpriascn(vcfritmuhq) = fuvwqotfho tqajlsjvmc (sjoagagpcw )
ESMO_ASIA_VIRTUAL2020	Not Applicable	Mucositis	171	Vitamin E	focnevscrm(ccykoyvloj) = there were no severe adverse effects reported in the studies izogxbbwhs (jlenikgglb ) View more	Positive	22 Nov 2020
				Placebo
NCT00862433 (Pubmed \| Am J Clin Nutr)	Phase 1	-	50	Vitamin E (600-kcal DLM with 40% fat)	iclkrvyzwm(mgjdiuihad) = hcnprrtelz uyillilfxn (bynmdnzgzt, ± 3)	-	01 Nov 2019
				Vitamin E (600-kcal DLM with 0% fat)	iclkrvyzwm(mgjdiuihad) = grcsknptdr uyillilfxn (bynmdnzgzt, ± 3)
UEGW2019	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	-	Upper tertile of vitamin E intake/1000 Kcal	gcsmlzcybn(mmebajonst): OR = 0.64, P-Value = 0.024	-	01 Oct 2019
				Recommended vitamin E intake

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