MedPath

Bexagliflozin

Generic Name
Bexagliflozin
Brand Names
Brenzavvy
Drug Type
Small Molecule
Chemical Formula
C24H29ClO7
CAS Number
1118567-05-7
Unique Ingredient Identifier
EY00JF42FV
Background

Bexagliflozin is a highly specific and potent sodium-glucose co-transporter 2 (SGLT2) inhibitor. Similar to other SGLT2 inhibitors, bexagliflozin contains three basic moieties: glucose, two benzene rings and a methylene bridge. SGLT2 is responsible for 60% to 90% of renal glucose re-uptake, and unlike other isoforms such as SGLT1, SGLT2 is mainly expressed in the kidney. By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and increases urinary glucose excretion, which reduces blood glucose levels independently of insulin sensitivity. In January 2023, bexagliflozin was approved by the FDA for the treatment of adults with type 2 diabetes. Its use is not recommended in patients with type 1 diabetes since it may increase their risk of diabetic ketoacidosis.

Indication

Bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions
Type 2 Diabetes Mellitus

Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study

Phase 4
Recruiting
Conditions
Sleep Apnea
Interventions
First Posted Date
2022-11-10
Last Posted Date
2024-04-16
Lead Sponsor
Yale University
Target Recruit Count
164
Registration Number
NCT05612594
Locations
🇺🇸

Yale New Haven Health, New Haven, Connecticut, United States

🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment

Phase 1
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2018-06-15
Last Posted Date
2021-06-03
Lead Sponsor
Theracos
Target Recruit Count
16
Registration Number
NCT03557658
Locations
🇺🇸

Clinical Research Site 2, Saint Paul, Minnesota, United States

🇺🇸

Clinical Research Site 1, Boston, Massachusetts, United States

An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension

Phase 2
Completed
Conditions
Essential Hypertension
Interventions
Drug: Placebo
First Posted Date
2018-05-02
Last Posted Date
2021-09-21
Lead Sponsor
Theracos
Target Recruit Count
673
Registration Number
NCT03514641
Locations
🇺🇸

Clinical Research Site, Tacoma, Washington, United States

🇺🇸

Clinical Research Site 2, Anderson, South Carolina, United States

Absolute Bioavailability Study With Bexagliflozin

Phase 1
Withdrawn
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2018-01-31
Last Posted Date
2019-09-30
Lead Sponsor
Theracos
Registration Number
NCT03417076
Locations
🇺🇸

Clinical Research Site, Madison, Wisconsin, United States

Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2017-09-28
Last Posted Date
2021-07-01
Lead Sponsor
Theracos
Target Recruit Count
48
Registration Number
NCT03296800
Locations
🇺🇸

Covance Clinical Research Unit, Daytona Beach, Florida, United States

Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

Phase 3
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2017-08-24
Last Posted Date
2021-07-07
Lead Sponsor
Theracos
Target Recruit Count
351
Registration Number
NCT03259789
Locations
🇺🇸

Clinical Research Site 1382, Norwalk, Connecticut, United States

🇺🇸

Clinical Research Site 1373, Pembroke Pines, Florida, United States

🇺🇸

Clinical Research Site 1366, Chicago, Illinois, United States

and more 40 locations

Bexagliflozin Drug/Drug Interaction Study With Digoxin

Phase 1
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2017-06-23
Last Posted Date
2021-07-23
Lead Sponsor
Theracos
Target Recruit Count
20
Registration Number
NCT03197324
Locations
🇺🇸

Covance CRU, Daytona Beach, Florida, United States

Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection

Phase 1
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2017-05-30
Last Posted Date
2021-05-28
Lead Sponsor
Theracos
Target Recruit Count
20
Registration Number
NCT03167411
Locations
🇺🇸

Clinical Research Site, Evansville, Indiana, United States

Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

First Posted Date
2017-04-14
Last Posted Date
2021-06-22
Lead Sponsor
Theracos
Target Recruit Count
386
Registration Number
NCT03115112
Locations
🇵🇱

Clinical Research Site 7138, Lublin, Poland

🇵🇱

Clinical Research Site 7137, Gdańsk, Poland

🇵🇱

Clinical Research Site 7141, Kraków, Poland

and more 53 locations

Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

Phase 1
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2016-11-04
Last Posted Date
2021-07-22
Lead Sponsor
Theracos
Target Recruit Count
54
Registration Number
NCT02956044
Locations
🇺🇸

Clinical Research Site, Evansville, Indiana, United States

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