FARXIGA
Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the management of type 2 diabetes, heart failure, and chronic kidney disease. In patients with type 2 diabetes, it is used to improve glycemic control and reduce the risk of hospitalization for heart failure in those with established cardiovascular disease or multiple risk factors. The medication also serves to reduce the risk of cardiovascular death and renal complications in adults with heart failure or progressing chronic kidney disease.
How FARXIGA Works
Dapagliflozin functions by inhibiting sodium-glucose cotransporter 2 (SGLT2) in the proximal renal tubules, which is the site responsible for the majority of glucose reabsorption in the kidneys. By blocking this transporter, the drug reduces the reabsorption of filtered glucose and promotes its excretion through the urine. This mechanism also reduces sodium reabsorption, which helps lower cardiac pre- and afterload and decreases intraglomerular pressure.
Details
- Status
- Prescription
- First Approved
- 2014-01-08
- Routes
- ORAL
- Dosage Forms
- TABLET
FARXIGA Approval History
What FARXIGA Treats
3 indicationsFARXIGA is approved for 3 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Kidney Disease
- Heart Failure
- Type 2 Diabetes
FARXIGA 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.
FARXIGA Competitors
Pro10 other drugs also target SGLT2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (SGLT2). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
FARXIGA FDA Label Details
ProIndications & Usage
FDA Label (PDF)FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • As an adjunct to diet and exercise to...
FARXIGA Patents & Exclusivity
Patents (124 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.