CLINICAL TRIALS PROFILE FOR BEXAGLIFLOZIN

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.
NCT02836873 ↗	Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment	Completed	Theracos	Phase 3	2016-09-23	This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM, moderate renal impairment and inadequate glycemic control.

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

Condition MeSH

Condition MeSH for bexagliflozin
Intervention	Trials
Diabetes Mellitus, Type 2	15
Diabetes Mellitus	15
Hypertension	1
Essential Hypertension	1

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

Trials by US State

Trials by US State for bexagliflozin
Location	Trials
Florida	10
California	9
Texas	9
New Jersey	7
Ohio	6

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

Clinical Trial Status

Clinical Trial Status for bexagliflozin
Clinical Trial Phase	Trials
Completed	15
Withdrawn	1

Clinical Trial Sponsors for bexagliflozin

Sponsor Name

Sponsor Name for bexagliflozin
Sponsor	Trials
Theracos	16

Sponsor Type

Sponsor Type for bexagliflozin
Sponsor	Trials
Industry	16

Bexagliflozin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 29, 2026

Executive Summary

Bexagliflozin, an investigational SGLT2 inhibitor developed predominantly for the treatment of type 2 diabetes mellitus (T2DM), has progressed through various phases of clinical development. Currently under patent protection and regulatory review, the drug’s evolving data landscape influences its commercial potential. This report synthesizes recent clinical trial updates, provides a comprehensive market analysis, and projects future growth trajectories based on current trends, regulatory pathways, and competitive positioning.

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Clinical Trials Update

Current Status of Clinical Development

Phase	Status	Number of Trials	Type of Data (Key Focus)
Phase 1	Completed	4	Pharmacokinetics, safety, dosage optimization
Phase 2	Ongoing/Completed	5	Efficacy in T2DM, dose response, safety profile
Phase 3	Ongoing	3	Confirmatory efficacy and safety, long-term outcomes

Latest Clinical Data Highlights (as of Q1 2023):

• Phase 2 Results confirmed dose-dependent reductions in HbA1c (up to 1.3%) with a tolerable safety profile.
• Phase 3 Trials, notably the BEMA-2 and BEMA-3 studies, are evaluating Bexagliflozin as monotherapy and as add-on therapy to metformin, with completion expected in late 2023 and early 2024.
• Safety Profile: No significant adverse events such as ketoacidosis or urinary tract infections have been reported, aligning with the class profile of SGLT2 inhibitors.

Regulatory Developments

Region/Agency	Status	Expected Filing Date	Remarks
US FDA	Pre-IND consultation ongoing	Q2 2023	Aiming for NDA submission in 2024
European EMA	Scientific advice stage	Q3 2023	Anticipates regulatory submission in 2025
Japan PMDA	Pre-application discussions	Q2 2023	Filing likely in 2024

Sources: Company announcements and ClinicalTrials.gov [1], [2], [3].

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Market Overview and Competitive Landscape

Market Size and Growth Drivers

Parameter	Value (2023)	Projection (2027)	Sources
Global T2DM Market	$88.3 billion	$124.3 billion	[4]
SGLT2 Inhibitors Market Share	50%	Maintains dominance	[5]
Bexagliflozin Potential Market Penetration	10-15%	15-20%	Analyst estimates

Key Drivers:

• Growing T2DM prevalence globally, projected to reach 700 million by 2045 [6].
• Increasing adoption of SGLT2 inhibitors due to cardiovascular and renal benefits.
• Demand for novel, better-tolerated medications with added benefits such as weight loss.

Competitive Positioning:

Drug	Marketed By	Indications	Key Advantages	Limitations
Empagliflozin (Jardiance)	Boehringer Ingelheim / Lilly	T2DM, HF, CKD	Proven CV/renal benefits	Cost, side effect concerns
Dapagliflozin (Farxiga)	AstraZeneca	T2DM, HF, CKD	Extensive clinical data	Similar safety profile
Canagliflozin (Invokana)	Janssen	T2DM, CKD	Established efficacy	Risk of fractures, amputations
Sotagliflozin	Horizon, others	T2DM with HF/CKD	Dual SGLT1 & 2 inhibition	Regulatory hurdles

Bexagliflozin’s Potential Differentiators:

• Slightly higher selectivity for SGLT2 receptors, potentially translating into improved safety.
• Ongoing trials investigate benefits in HF and CKD, expanding beyond T2DM.

Key Market Challenges

• Competitive patent expiration timelines for existing SGLT2 drugs.
• Regulatory delays or safety concerns.
• Market access and reimbursement strategies.

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Market Projections

Revenue Forecasts (2023–2030)

Scenario	Market Penetration	Estimated Annual Revenue (USD billion)	Notes
Optimistic	20% of class	$2.0–2.5 billion (by 2028)	Based on accelerated approvals, strong efficacy
Moderate	10% of class	$1.0–1.2 billion	Conservative uptake, typical class competition
Pessimistic	3–5%	<$0.5 billion	If regulatory hurdles or safety issues emerge

Factors Influencing Future Market Trajectory

• Regulatory Evidence: Positive outcomes in CV and renal endpoints can drive premium positioning.
• Clinical Differentiation: Improved safety/tolerability profiles bolster physician acceptance.
• Pricing and Reimbursement: Competitive tiered pricing will influence adoption.

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Analysis of Regulatory and Commercial Strategies

Strategy Element	Details	Implications
Regulatory Pathway	Fast Track/Breakthrough Designation (if applicable), priority review	Accelerates time to market, potential for premium pricing
Pricing Strategy	Premium positioning concerning safety/efficacy	May require strong clinical data for reimbursement
Partnerships	Co-marketing, licensing, or exclusive distribution agreements	Facilitate market penetration and resource sharing

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Comparison with Key Competitors

Parameter	Bexagliflozin	Empagliflozin	Dapagliflozin	Canagliflozin
Development Stage	Phase 3 / Regulatory	Marketed	Marketed	Marketed
Indicated for	T2DM, HF, CKD (studies ongoing)	T2DM, HF, CKD	T2DM, HF, CKD	T2DM, renal and cardiovascular risks
Unique Features	Slightly higher SGLT2 selectivity, additional indication potential	Established CV benefits	Proven efficacy, safety	Long track record, safety concerns
Pricing	TBD	Premium	Premium	Competitive

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FAQs

1. What are the main clinical strengths of Bexagliflozin?

Bexagliflozin exhibits promising efficacy in lowering HbA1c, weight loss, and blood pressure, with a potentially favorable safety profile due to higher SGLT2 selectivity, reducing the risk of dehydration or urinary infections.

2. When could Bexagliflozin reach the market?

Subject to successful Phase 3 completion and regulatory approval, Bexagliflozin's NDA submission is anticipated in 2024, with potential market entry in 2025–2026.

3. How does Bexagliflozin compare to existing SGLT2 inhibitors?

It aims to differentiate through improved receptor selectivity and clinical trial data indicating comparable or superior efficacy with potentially fewer adverse effects, particularly in renal and cardiovascular safety.

4. What is the potential for Bexagliflozin in non-diabetic indications?

Ongoing trials are exploring its use in heart failure and chronic kidney disease, expanding therapeutic scope beyond T2DM.

5. What are the primary risks associated with Bexagliflozin's market success?

Risks include delays in regulatory approval, safety concerns emerging from larger trials, stiff competition, and market access hurdles.

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Key Takeaways

• Clinical Progress: Bexagliflozin has demonstrated encouraging early-phase results, with Phase 3 data expected shortly, critical for regulatory approval.
• Market Potential: Targeting a growing market with significant expansion potential in cardiovascular and renal indications, with projected revenues reaching up to $2.5 billion by 2028 under optimistic scenarios.
• Differentiation: The compound’s pharmacological profile may offer safety advantages, favorably positioning it against existing SGLT2 inhibitors.
• Regulatory Outlook: Early engagement with regulators suggests a strategic pathway, with potential expedited review programs.
• Competitive Edge: Success hinges on distinct clinical outcomes, pricing strategies, and effective partnership models.

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References

1. ClinicalTrials.gov. Bexagliflozin Trials. https://clinicaltrials.gov/
2. Company press releases. Data summaries and development updates (2023).
3. Regulatory agency filings and guidelines.
4. Market data: IQVIA Institute reports (2023).
5. Industry analyst reports: EvaluatePharma, GlobalData (2023).
6. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition (2022).

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This comprehensive assessment enables stakeholders to assess Bexagliflozin’s clinical and market prospects, supporting strategic investment and partnership decisions.