Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/11/10 | Phase 4 | Recruiting | |||
2018/06/15 | Phase 1 | Completed | Theracos | ||
2018/05/02 | Phase 2 | Completed | Theracos | ||
2018/01/31 | Phase 1 | Withdrawn | Theracos | ||
2017/09/28 | Phase 1 | Completed | Theracos | ||
2017/08/24 | Phase 3 | Completed | Theracos | ||
2017/06/23 | Phase 1 | Completed | Theracos | ||
2017/05/30 | Phase 1 | Completed | Theracos | ||
2017/04/14 | Phase 3 | Completed | Theracos | ||
2016/11/04 | Phase 1 | Completed | Theracos |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| TheracosBio, LLC | 82381-2000 | ORAL | 20 mg in 1 1 | 3/21/2024 | |
| TheracosBio, LLC | 82381-2174 | ORAL | 20 mg in 1 1 | 2/8/2024 | |
| Golden State Medical Supply, Inc. | 51407-918 | ORAL | 20 mg in 1 1 | 4/15/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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