Rybelsus (semaglutide oral) / Novo Nordisk - LARVOL DELTA

Re-Estimation of Medicare Spending for Semaglutide After Most Favored Nation and Medicare Drug Price Negotiation Announcements. (PubMed, Value Health) - "Incorporating revised 30-day MFPs for Ozempic, Rybelsus, and Wegovy, as well as patient cost-sharing assumptions and future generic entry, we now estimate Medicare savings of $463 million under base-case MFP conditions, with alternative uptake scenarios producing $328-$599 million in savings and up to $1.78 billion with loss-of-exclusivity assumptions. Using the lower MFN price of $245 per month and a $600 annual patient copay, estimated Medicare savings increase substantially to $1.76 billion, ranging from $1.03 to $2.50 billion across uptake scenarios and reaching $2.63 billion with generic entry. These findings highlight the significant fiscal impact of recent price negotiations and underscore uncertainties regarding the durability and future scope of MFN-based drug pricing arrangements."

Journal • Medicare • Reimbursement • US reimbursement

Impact of oral semaglutide on quality of life and metabolic parameters in patients with type 2 diabetes mellitus: A multicenter observational study. (PubMed, Endocrinol Diabetes Nutr (Engl Ed)) - "Oral semaglutide significantly improves quality of life and metabolic parameters in T2DM patients, with good tolerance and low discontinuation rates. These findings support its utility in the comprehensive management of T2DM."

HEOR • Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Deep Venous Thrombosis Within Two Weeks of Initiating Oral Semaglutide (Rybelsus): A Case Report. (PubMed, Cureus) - "Anticoagulation with low molecular weight heparin followed by apixaban resulted in significant clinical improvement. Clinicians should maintain vigilance, especially in adolescents and individuals self-prescribing for weight loss. Further pharmacovigilance and mechanistic studies are warranted to clarify this potential association."

Journal • Cardiovascular • Diabetes • Hematological Disorders • Metabolic Disorders • Obesity • Pain • Thrombosis • Type 2 Diabetes Mellitus • Venous Thromboembolism

Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL) (clinicaltrials.gov) - P=N/A | N=20000 | Active, not recruiting | Sponsor: Brigham and Women's Hospital

HEOR • New trial • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

Rybelsus: Patent protection in EU until 2031 and in US until 2032 (Novo Nordisk) - FY2025 Results

Patent • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide. (clinicaltrials.gov) - P=N/A | N=90 | Not yet recruiting | Sponsor: Institute of Liver and Biliary Sciences, India

New trial • Chronic Kidney Disease • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Renal Disease • CST3

Semaglutide Inhibits Neuronal Apoptosis and Improves Cognitive Function in Mice after Traumatic Brain Injury, Mainly via the Caspase-Dependent Pathway. (PubMed, Neurocrit Care) - "Semaglutide inhibited apoptosis, increased neuronal survival rate, and inhibited M1 microglial activation to improve cognitive function in TBI mice. This neuroprotective effect of semaglutide may be regionally and time dependent."

IO biomarker • Journal • Preclinical • CNS Disorders • Inflammation • Vascular Neurology • BAX • BCL2

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (5 February 2026) updated product information for healthcare professionals and patients regarding the risk of the very rare occurrence of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide. (GOV.UK) - "Patients taking semaglutide who notice a change in their eyesight, such as sudden impairment to their vision, or if their eyesight gets worse very quickly in one or both eyes, should urgently attend eye casualty (if available in the area) or A&E."

European regulatory • Obesity • Type 2 Diabetes Mellitus

Modulation of metabolic syndrome components by oral semaglutide in hypothyroid-T2DM patients: a retrospective analysis. (PubMed, J Med Life) - "Metabolic syndrome (MetS) represents the concurrent manifestation of multiple cardiometabolic risk factors, including visceral obesity, hyperglycemia, hypertension, hypertriglyceridemia, and low HDL-cholesterol, cumulatively predisposing to accelerated atherosclerosis and type 2 diabetes mellitus (T2DM). While these findings suggest a potential therapeutic role for semaglutide in complex metabolic profiles, they should be interpreted with caution due to the study's design limitations. Further prospective studies are warranted to confirm these observations and to explore the interaction between semaglutide and levothyroxine."

Journal • Retrospective data • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Endocrine Disorders • Genetic Disorders • Hypertension • Hypertriglyceridemia • Inflammation • Metabolic Disorders • Obesity • Pulmonary Arterial Hypertension • Type 2 Diabetes Mellitus

Effect of glucagon-like peptide-1 receptor agonists on heart rate in non-diabetic individuals with overweight or obesity: a systematic review and pairwise and network meta-analysis of randomized controlled trials. (PubMed, Eur J Med Res) - "GLP-1RAs were associated with the increasing of HR in patients with overweight or obesity. Orforglipron 36 mg was associated with the most pronounced increase, and tirzepatide 5 mg the least."

Journal • Retrospective data • Review • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes: A Secondary Analysis of the SOUL Randomized Clinical Trial. (PubMed, JAMA Intern Med) - P3 | "These data support the potential benefit of oral semaglutide in reducing HF events in people with T2D and HF. ClinicalTrials.gov Identifier: NCT03914326."

Clinical • Journal • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Myocardial Infarction • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

PROJECTED REDUCTION IN MAJOR ADVERSE CARDIOVASCULAR EVENTS AMONG HIGH-RISK U.S. ADULTS WITH TYPE 2 DIABETES ELIGIBLE FOR ORAL SEMAGLUTIDE: A SOUL TRIAL BASED ANALYSIS USING NHANES 1988-2018 CYCLES (ACC 2026) - "Abstract is embargoed at this time."

Adverse events • Clinical • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

EFFECT OF ORAL SEMAGLUTIDE VERSUS PLACEBO ON FIRST AND TOTAL MACE IN SOUL TRIAL PARTICIPANTS WITH T2D AND ASCVD AND/OR CKD (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Cardiovascular • Chronic Kidney Disease • Type 2 Diabetes Mellitus

Hemoglobin A1c levels in patients with type 2 diabetes mellitus receiving oral semaglutide with versus without proton pump inhibitors: An exploratory study. (PubMed, Int J Clin Pharmacol Ther) - "HbA1c reduction at 52 weeks was significantly greater in the PPI co-administration group than in the group without PPI. Future research should include larger sample sizes and pharmacokinetic studies to clarify the clinical implications and interactions between oral semaglutide and PPIs."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy And Safety of Semaglutide In Non-Diabetic Adults With Overweight Or Obesity: A Meta-Analysis Of Randomized Controlled Trials. (PubMed, Eur J Pharmacol) - "Both oral and subcutaneous semaglutide significantly improve weight management in non-diabetic adults. While the safety profile is generally acceptable, elevated serious adverse events warrant careful patient selection and monitoring. Optimal outcomes occur with lifestyle interventions at doses ≥2.4 mg weekly."

Journal • Retrospective data • Genetic Disorders • Obesity

Short-Term Semaglutide Improves Safety in High Body Weight Recipients Undergoing Living Donor Liver Transplant: A Case Report. (PubMed, Exp Clin Transplant) - "This case report describes the use of oral semaglutide, a glucagon-like peptide-1 receptor agonist, to faci-litate pretransplant weight loss in an obese patient (body mass index 39.1, in kg/m2) undergoing living donor liver transplant. The patient experienced a significant weight loss of 10 kg during a period of 19 days with semaglutide treatment, which improved the graft-to-recipient weight ratio (from 0.66% to 0.786%) and resulted in an uneventful living donor liver transplant procedure with no postoperative issues. This case marks the first documented case of using semaglutide for pretransplant weight loss in liver transplant recipients, highlighting its potential to improve surgical outcomes for overweight patients awaiting transplant."

Journal • Obesity • Transplantation

A cardiovascular indication for oral semaglutide (Rybelsus). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Oral semaglutide (Wegovy) for weight loss. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Retrospective comparison of the clinical effects of oral semaglutide and SGLT2 inhibitors treatment in patients with type 2 diabetes. (PubMed, J Diabetes Investig) - "While both drugs elicited comparable effects on glycemic management and body weight reduction in patients with type 2 diabetes, caution is needed when using SGLT2is in patients at potential risk for sarcopenia, as they may lead to less favorable changes in skeletal muscle mass compared to oral semaglutide."

Journal • Retrospective data • Cardiovascular • Diabetes • Metabolic Disorders • Sarcopenia • Type 2 Diabetes Mellitus

SOLSTICE: Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. (clinicaltrials.gov) - P2 | N=406 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=148 | Completed | Sponsor: Lexaria Bioscience Corp. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Letter by Zhao Regarding Article, "Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial". (PubMed, Circulation) - No abstract available

Journal • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Baseline characteristics from evoke and evoke+: Two phase 3 randomized placebo-controlled trials of semaglutide in participants with early-stage symptomatic Alzheimer's disease. (PubMed, Alzheimers Dement (N Y)) - P3 | "Evoke (+) are the only large-scale, phase 3 trials investigating the longer-term efficacy and safety of semaglutide in early AD as a potential disease-modifying treatment. The baseline characteristics from evoke (+) reflect a varied, global population with early-stage symptomatic AD. Primary readouts are expected in the second half of 2025."

Clinical • Journal • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation

Health Canada approves RYBELSUS (semaglutide tablets) to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (Canada Newswire) - "The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, which demonstrated that RYBELSUS decreased the risk of major adverse cardiovascular events."

Canada approval • Cardiovascular • Type 2 Diabetes Mellitus

Discontinuation of oral semaglutide due to adverse effects: a database study on Japanese individuals with type 2 diabetes. (PubMed, Diabetol Int) - "These findings suggest that careful consideration should be given when initiating oral semaglutide, particularly in individuals with high HbA1c levels or those receiving metformin therapy. The online version contains supplementary material available at 10.1007/s13340-025-00868-0."

Adverse events • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus