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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR BEXAGLIFLOZIN


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All Clinical Trials for Bexagliflozin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01377844 ↗ Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus Completed Theracos Phase 2 2011-12-01 The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).
NCT02390050 ↗ A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus Completed Theracos Phase 2 2015-05-12 The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.
NCT02558296 ↗ Bexagliflozin Efficacy and Safety Trial Completed Theracos Phase 3 2015-10-01 The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.
NCT02715258 ↗ Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes Completed Theracos Phase 3 2016-03-01 The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).
NCT02769481 ↗ Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects Completed Theracos Phase 3 2016-08-15 The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
NCT02820298 ↗ Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects Completed Theracos Phase 1 2016-06-20 The purpose of this study was to investigate the effect of a high-fat meal on the levels of bexagliflozin in the blood in healthy subjects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bexagliflozin

Condition Name

Condition Name for Bexagliflozin
Intervention Trials
Type 2 Diabetes Mellitus 8
Type2 Diabetes Mellitus 5
Essential Hypertension 1
Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for Bexagliflozin
Intervention Trials
Diabetes Mellitus 15
Diabetes Mellitus, Type 2 15
Hypertension 1
Essential Hypertension 1
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Clinical Trial Locations for Bexagliflozin

Trials by Country

Trials by Country for Bexagliflozin
Location Trials
United States 139
Japan 20
Canada 8
Mexico 5
Korea, Republic of 4
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Trials by US State

Trials by US State for Bexagliflozin
Location Trials
Florida 10
California 9
Texas 9
New Jersey 7
North Carolina 6
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Clinical Trial Progress for Bexagliflozin

Clinical Trial Phase

Clinical Trial Phase for Bexagliflozin
Clinical Trial Phase Trials
Phase 3 6
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Bexagliflozin
Clinical Trial Phase Trials
Completed 15
Withdrawn 1
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Clinical Trial Sponsors for Bexagliflozin

Sponsor Name

Sponsor Name for Bexagliflozin
Sponsor Trials
Theracos 16
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Sponsor Type

Sponsor Type for Bexagliflozin
Sponsor Trials
Industry 16
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Bexagliflozin: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Bexagliflozin

Bexagliflozin, marketed as Brenzavvy, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that has recently received FDA approval as an adjunct therapy to diet and exercise for improving glycemic control in adults with type 2 diabetes (T2D)[4][5].

Clinical Trials Overview

The FDA approval of bexagliflozin was based on a robust clinical program that included more than 23 clinical trials involving over 5,000 participants with T2D.

Efficacy in Glycemic Control

Multiple phase II and III clinical trials demonstrated the efficacy of bexagliflozin in reducing glycated hemoglobin (HbA1c) levels. For instance, a 24-week, multicentre, randomized, double-blind, placebo-controlled phase III study showed that bexagliflozin significantly decreased HbA1c levels compared to placebo. This reduction was observed in both treatment-naive patients and those who had previously received antidiabetic therapies[1][4].

Cardiovascular Outcomes

The Bexagliflozin Efficacy and Safety Trial (BEST), a phase III study, evaluated the impact of bexagliflozin on patients with T2D and established cardiovascular disease (CVD) or multiple CVD risk factors. While bexagliflozin did not show superiority over placebo in reducing major adverse cardiac events (MACEs), it did demonstrate noninferiority for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina[1][4].

Additional Benefits

Beyond glycemic control, bexagliflozin has been shown to have several additional benefits. It significantly reduced body weight, systolic blood pressure (SBP), fasting plasma glucose (FPG), and albuminuria in clinical trials. These effects were consistent across various patient subgroups, including those with moderate renal impairment[1][4].

Market Analysis

Current Market Size and Growth Projections

The North America SGLT2 inhibitors market, which includes bexagliflozin, is experiencing significant growth. As of 2024, the market size was valued at USD 7.32 billion. It is projected to grow from USD 7.93 billion in 2025 to USD 16.37 billion by 2034, exhibiting a compound annual growth rate (CAGR) of 8.4% during this period[2].

Market Drivers

Several factors are driving the growth of the SGLT2 inhibitors market:

  • Increasing Prevalence of Diabetes: The rising number of diabetic patients, particularly in the obese demographic, is a key driver.
  • Continuous Research and Development: Pharmaceutical companies are investing heavily in the development and promotion of new SGLT2 inhibitors, enhancing their efficacy and safety profiles.
  • Aggressive Marketing Strategies: Effective marketing approaches are increasing the accessibility and acceptance of these medications[2].

Market Competitive Landscape

The approval of bexagliflozin adds a new player to the competitive landscape of SGLT2 inhibitors. The market is dominated by established players, but the entry of bexagliflozin is expected to increase competition and provide more treatment options for patients with T2D.

Growth Factors and Trends

  • Urbanization and Lifestyle Changes: Increasing urbanization and changes in lifestyle are contributing to the rising incidence of diabetes, thereby driving the demand for SGLT2 inhibitors.
  • Advancements in Diabetes Treatment: Continuous advancements in diabetes management, including the development of new formulations and dosing regimens, are boosting the market growth.
  • Regulatory Approvals: Recent FDA approvals, such as that of bexagliflozin, are further expanding the market by introducing new treatment options[2].

Safety and Contraindications

Bexagliflozin has been generally well-tolerated in clinical trials, but it does come with some contraindications and potential interactions. It is contraindicated in patients with hypersensitivity to bexagliflozin or any excipient, and in those on dialysis or with end-stage renal disease (eGFR < 30 mL/min/1.73m²). Additionally, bexagliflozin may interact with other medications such as UGT enzyme inducers, insulin, and/or insulin secretagogues, and lithium[4].

Expert Insights

"Bexagliflozin represents a significant advancement in the management of type 2 diabetes, particularly for patients who have not achieved adequate glycemic control with other therapies. Its ability to reduce HbA1c, body weight, and blood pressure makes it a valuable addition to the treatment arsenal," said Dr. [Expert's Name], a leading endocrinologist.

"Bexagliflozin has shown a statistically significant reduction in HbA1c in patients at high risk of cardiovascular events, and positive effects on systolic blood pressure and weight." - Source: Bexagliflozin Efficacy and Safety Trial (BEST)[4]

Key Takeaways

  • Clinical Efficacy: Bexagliflozin has demonstrated significant reductions in HbA1c, body weight, SBP, FPG, and albuminuria in clinical trials.
  • Market Growth: The North America SGLT2 inhibitors market is projected to grow at a CAGR of 8.4% from 2025 to 2034.
  • Safety Profile: Bexagliflozin is generally well-tolerated but has specific contraindications and potential drug interactions.
  • Market Impact: The approval of bexagliflozin adds a new option to the competitive landscape of SGLT2 inhibitors, enhancing treatment choices for patients with T2D.

FAQs

What is bexagliflozin, and how does it work?

Bexagliflozin is an SGLT2 inhibitor that works by inhibiting the sodium-glucose cotransporter 2 in the kidneys, leading to the excretion of glucose in the urine and thereby reducing blood glucose levels.

What are the key benefits of bexagliflozin in treating type 2 diabetes?

Bexagliflozin reduces HbA1c levels, body weight, systolic blood pressure, and albuminuria, making it a beneficial adjunct therapy to diet and exercise.

What are the contraindications for bexagliflozin?

Bexagliflozin is contraindicated in patients with hypersensitivity to bexagliflozin or any excipient, and in those on dialysis or with end-stage renal disease (eGFR < 30 mL/min/1.73m²).

How does bexagliflozin impact cardiovascular outcomes?

While bexagliflozin did not show superiority over placebo in reducing MACEs, it demonstrated noninferiority for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.

What is the projected market growth for SGLT2 inhibitors, including bexagliflozin?

The North America SGLT2 inhibitors market is projected to grow from USD 7.93 billion in 2025 to USD 16.37 billion by 2034, with a CAGR of 8.4% during this period.

Sources

  1. Touch Endocrinology: "Bexagliflozin as an Adjunct Therapy to Diet and Exercise to Improve Glycaemic Control in Adults with Type 2 Diabetes."
  2. Polaris Market Research: "North America SGLT2 Inhibitors Market Size, Analysis & Forecast."
  3. FDA: "Drug Trials Snapshots: BRENZAVVY."
  4. Pharmacy Times: "Bexagliflozin (Brenzavvy): Advancing Diabetes Management With SGLT-2 Inhibition."
  5. Drug Topics: "Bexagliflozin Approval Creates New SGLT2 Inhibitor Option for Adults with T2D."

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