BRENZAVVY (bexagliflozin)
Brenzavvy helps adults with type 2 diabetes manage their blood sugar levels more effectively. It is used alongside improvements in diet and exercise to help patients achieve better glycemic control. This medication is specifically for those with type 2 diabetes and is not recommended for individuals with type 1 diabetes.
How BRENZAVVY Works
Bexagliflozin works by inhibiting SGLT2, a transporter in the kidneys that normally reabsorbs glucose from filtered blood. By blocking this protein, the drug reduces the amount of sugar the kidneys take back into the body and lowers the renal threshold for glucose. This results in increased glucose excretion through the urine, which helps lower overall blood sugar levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-01-20
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
BRENZAVVY Approval History
What BRENZAVVY Treats
1 indicationsBRENZAVVY is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
BRENZAVVY Target & Pathway
ProTarget
A transporter in the kidney that reabsorbs glucose back into the bloodstream. Blocking SGLT2 causes excess glucose to be excreted in urine, lowering blood sugar. These drugs also provide cardiovascular and kidney protection beyond glucose control.
BRENZAVVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BRENZAVVY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BRENZAVVY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BRENZAVVY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT03514641 results posted | THR-1442-C-603 | Ph 2, Ph 3 | completed | An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension |
| NCT03197324 results posted | THR-1442-C-443 | Ph 1 | completed | Bexagliflozin Drug/Drug Interaction Study With Digoxin |
| NCT02956044 results posted | THR-1442-C-453 | Ph 1 | completed | Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin |
| NCT02558296 BEST results posted | THR-1442-C-476 | Ph 3 | completed | Bexagliflozin Efficacy and Safety Trial |
| NCT03296800 results posted | THR-1442-C-454 | Ph 1 | completed | Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects |
| NCT02836873 results posted | THR-1442-C-448 | Ph 3 | completed | Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment |
| NCT02715258 results posted | THR-1442-C-450 | Ph 3 | completed | Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes |
| NCT03115112 results posted | THR-1442-C-423 | Ph 3 | completed | Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects |
| NCT02820298 results posted | THR-1442-C-481 | Ph 1 | completed | Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects |
| NCT03557658 results posted | THR-1442-C-455 | Ph 1 | completed | Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment |
| NCT03167411 results posted | THR-1442-C-458 | Ph 1 | completed | Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection |
| NCT02769481 results posted | THR-1442-C-480 | Ph 3 | completed | Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects |
| NCT03417076 | THR-1442-C-446 | Ph 1 | withdrawn | Absolute Bioavailability Study With Bexagliflozin |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BRENZAVVY FDA Label Details
Indications & Usage
FDA Label (PDF)BRENZAVVY is indicated for the treatment of Type 2 Diabetes.
BRENZAVVY Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for BRENZAVVY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 7 active patents
Trial Analysis
- • 14 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment