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 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FARXIGA (dapagliflozin) is an oral small-molecule SGLT2 inhibitor approved since January 2014 and currently at peak commercial maturity. It treats type 2 diabetes mellitus, type 1 diabetes mellitus, heart failure, and chronic kidney disease by blocking sodium-glucose cotransporter 2 in the proximal renal tubules, promoting urinary glucose excretion while reducing sodium reabsorption and decreasing intraglomerular pressure. Beyond glycemic control, dapagliflozin provides cardio-renal protective effects through hemodynamic and neurohormonal mechanisms, positioning it as a preferred agent across multiple chronic disease indications.
$4.3BPart D
15.4 years to LOEMechanism 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)
OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD
Started Feb 2026
14,308 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
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Started Feb 2026
118 enrolled
Type 2 Diabetes
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Started Jan 2026
36 enrolled
Type 1 Diabetes Mellitus With Diabetic Nephropathy
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.
Started Dec 2025
218 enrolled
Chronic Kidney Disease and Hypertension
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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.