NDAORALTABLET3 Generics Approved
Approved
Jan 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
IRA Negotiated
Drug data last refreshed 17m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FARXIGA (dapagliflozin) is an oral small-molecule SGLT2 inhibitor approved in 2014 for type 2 diabetes and heart failure indications. It works by inhibiting sodium-glucose cotransporter 2 in the kidneys, promoting urinary glucose excretion and reducing blood glucose levels. The drug has expanded beyond diabetes into cardiovascular and renal disease management.
$4.3BPart D
PeakStable
15.3 years to LOEPeak lifecycle product with strong $4.3B annual spending generating substantial brand team and field force requirements despite IRA price negotiations.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Started Sep 2026
2,800 enrolled
Renal Insufficiency, Chronic
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Started Apr 2026
118 enrolled
Type 2 Diabetes
OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD
Started Feb 2026
12,894 enrolled
Chronic Kidney Disease
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food
Started Feb 2026
26 enrolled
Healthy Participants
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Started Jan 2026
36 enrolled
Type 1 Diabetes Mellitus With Diabetic Nephropathy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.