Brenzavvy (bexagliflozin) / TheracosBio - LARVOL DELTA

Sodium-glucose co-transporter 2 inhibitors: a pleiotropic drug in humans with promising results in cats. (PubMed, Front Vet Sci) - "We also review the available literature regarding other benefits of these drugs in humans as well as the effects of SGLT2i in cats. Adverse effects related to the use of these hypoglycemic drugs are also discussed."

Journal • Review • Cardiovascular • Cognitive Disorders • Diabetes • Heart Failure • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A renal indication for semaglutide (Ozempic). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Redefining outcomes of ventricular arrhythmia for SGLT2 inhibitor medication in heart failure patients: a meta-analysis of randomized controlled trials. (PubMed, Syst Rev) - "SGLT2 inhibitors have beneficial effects on lowering risks of VAs and SCD in patients with type 2 diabetes, cardiovascular diseases, heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF), and heart failure with mildly reduced ejection fraction (HFmrEF), with longer follow-up duration reinforcing these findings. However, future prospective trials are needed to verify the effects of SGLT2 inhibitors on VAs and SCD."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

Novel FDA-approved bexagliflozin drug for treating type 2 diabetes mellitus. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

SGLT2 inhibitor use in the management of feline diabetes mellitus. (PubMed, J Vet Pharmacol Ther) - "Two SGLT2 inhibitors, namely bexagliflozin and velagliflozin, were recently FDA approved for the treatment of uncomplicated feline diabetes mellitus...Suitable candidates must have some residual β-cell function, as some endogenous insulin production is required to prevent ketosis. Appropriate patient selection and monitoring are necessary, and practitioners should be aware of serious complications such as euglycemic diabetic ketoacidosis."

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

Bexagliflozin as an Adjunct Therapy to Diet and Exercise to Improve Glycaemic Control in Adults with Type 2 Diabetes. (PubMed, touchREV Endocrinol) - "On 20 January 2023, bexagliflozin became the fifth orally administered sodium-glucose transporter 2 inhibitor to be approved by the US Food and Drug Administration for the treatment of T2D as an adjunct therapy to diet and exercise in the USA after dapagliflozin, canagliflozin, empagliflozin and ertugliflozin. This review aims to discuss the current evidence on the efficacy and safety of bexagliflozin, which provides an important alternative treatment option for patients with T2D."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study (clinicaltrials.gov) - P4 | N=164 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Advancing Diabetes Care: Novel Drug Interventions in the Management and Control of Type 2 Diabetes Mellitus (ISPOR 2024) - " The study examines ongoing clinical trials evaluating the efficacy and safety of drugs like Cotadutide, Enavogliflozin, Retatrutide, ORMD-0801, and Imeglimin for T2DM, and reported data for at least 1 outcome of interest...Cotadutide, an insulinotropic drug, has shown promising results in improving glycemic control and weight loss in T2DM patients through delayed gastric emptying. Enavogliflozin had a slightly larger reduction in HbA1c levels (-0.99%) than Bexagliflozin...As monotherapy or adjunctive therapy (with metformin), it is found to be effective, has low risk of hypoglycemia, and enhances insulin action and sensitivity. Over the past decade, numerous glucose-lowering medications have been approved, requiring careful consideration of their risks and benefits. It is critical to establish the strongest evidence for improving glycemic control and reducing the risk of complications ."

Diabetes • Gastroenterology • Gastrointestinal Disorder • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of bexagliflozin compared with dapagliflozin as an adjunct to metformin in Chinese patients with type 2 diabetes mellitus: A 24-week, randomized, double-blind, active-controlled, phase 3 trial. (PubMed, J Diabetes) - "Bexagliflozin showed nearly identical effects and a similar safety profile to dapagliflozin when used in Chinese patients on metformin."

Clinical • Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Independent Pharmacy Cooperative (IPC) Secures Exclusive Distribution Rights to Independent Retail Pharmacies for BRENZAVVY (bexagliflozin) with TheracosBio Partnership (PRNewswire) - "Independent Pharmacy Cooperative (IPC)...proudly announces an exclusive distribution partnership with TheracosBio to make BRENZAVVY (bexagliflozin) accessible to its 6,000 member pharmacies. IPC, renowned for its commitment to supporting independent pharmacies, is set to be the first pharmaceutical wholesaler in the United States to carry and distribute BRENZAVVY....BRENZAVVY, an FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, presents a groundbreaking approach to diabetes care."

Licensing / partnership • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bexagliflozin. (PubMed, Clin Diabetes) - No abstract available

Journal

Meta-analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin. (PubMed, Diabetes Obes Metab) - "Bexagliflozin did not increase the risk of MACE in participants with T2D when compared with placebo or active control. Both the preapproval and postapproval thresholds for CV safety were met and bexagliflozin has been approved by the US Food and Drug Administration."

Adverse events • Journal • Retrospective data • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus

A Meta-Analysis of the Efficacy and Safety of Bexagliflozin Versus Other Sodium-Glucose Cotransporter-2 Inhibitors (ASHP 2023) - No abstract available

Retrospective data

In brief: Empagliflozin (Jardiance) for chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Kidney Disease • Nephrology • Renal Disease

Bexagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for improvement of glycemia in type 2 diabetes mellitus: a systematic review and meta-analysis. (PubMed, Expert Opin Pharmacother) - "The safety outcomes of bexagliflozin were consistent with the placebo arm. This study concluded that bexagliflozin seems to be a promising oral anti-diabetic drug for enhancing glycemic management in adult patients with T2DM."

Journal • Retrospective data • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bexagliflozin (Brenzavvy) - A fifth SGLT2 inhibitor for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Review of the Safety and Efficacy of Bexagliflozin for the Management of Type 2 Diabetes. (PubMed, Ann Pharmacother) - "However, given lack of cardiovascular and renal outcome data, empagliflozin, dapagliflozin, or canagliflozin may be preferred. Bexagliflozin appears safe and effective as monotherapy and add-on pharmacological therapy for the treatment of T2D."

Journal • Review • Cardiovascular • Diabetes • Infectious Disease • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

The Impact of SGLT2 Inhibitors on Cardiovascular Outcomes in Patients With Heart Failure With Preserved Ejection Fraction. (PubMed, Ann Pharmacother) - "The treatment of HFpEF has made progress, but there is still work to be done. Now, SGLT2 inhibitor therapy can be used to further help with symptom control and reduce overall hospitalizations for heart failure."

Journal • Review • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders

Cardiovascular Diseases: Therapeutic Potential of SGLT-2 Inhibitors. (PubMed, Biomedicines) - "In our paper, we discuss the role of empagliflozin, dapagliflozin, canagliflozin, ertugliflozin, and the relatively recently approved bexagliflozin, the class of SGLT-2 inhibitors, as potential therapeutic targets for cardiovascular diseases. These novel therapeutic approaches aim to develop more effective treatments that improve patient outcomes and reduce the burden of these conditions. However, the major scientific achievements of recent years and the many new discoveries and mechanisms still require careful attention and additional studies."

Journal • Review • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

"Sotagliflozin should follow the example of bexagliflozin and set a competitive price." (@kaulcsmc)

Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24-week, randomized, double-blind, placebo-controlled trial. (PubMed, Diabetes Obes Metab) - "Bexagliflozin produced clinically meaningful improvement in glycaemic control, estimated glomerular filtration rate and SBP when added to metformin in a population of adults with diabetes."

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

Safety and effectiveness of the sodium-glucose cotransporter inhibitor bexagliflozin in cats newly diagnosed with diabetes mellitus. (PubMed, J Vet Intern Med) - "Bexagliflozin decreased hyperglycemia and observed clinical signs in cats newly diagnosed with DM. As a once-daily PO medication, bexagliflozin may simplify management of DM in cats."

Journal • Anorexia • Diabetes • Metabolic Disorders

EFFICACY AND SAFETY OF BEXAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: A SYSTEMATIC REVIEW AND META-ANALYSIS. (PubMed, Diabetes Obes Metab) - "In this meta-analysis, the use of bexagliflozin was associated with improved clinical and laboratory measures in patients with DM2 compared to placebo, with a similar profile of side effects. These findings support the efficacy of bexagliflozin in the treatment of DM2."

Clinical • Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Mycosis Fungoides • Nephrology • Pain • Type 2 Diabetes Mellitus

Bexagliflozin: First Approval. (PubMed, Drugs) - "Bexagliflozin is undergoing clinical development for the treatment of essential hypertension in the USA. This article summarizes the milestones in the development of bexagliflozin leading to this first approval for the treatment of T2D."

Journal • Review • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

TheracosBio Announces FDA Approval of Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes (Businesswire) - "TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor....The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of BRENZAVVY in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus."

NDA • Diabetes • Type 2 Diabetes Mellitus