Data updated: May 26, 2026
FARXIGA (dapagliflozin)
Genetically Validated
Cardiovascular
Approved 2014-01-08
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.
Source: FDA Label • AstraZeneca
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.
9
Indications
--
Phase 3 Trials
3
Priority Reviews
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2014-01-08
- Patent Cliff
- 2041
- Revenue
- $2.1B (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
FARXIGA Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
46 FDA actions from 2014 to 2024 · 8 indication expansions
Jan 2016 SUPPL
Mfg
Jan 2016 SUPPL
Mfg
Jul 2014 SUPPL
Mfg
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
Source: FDA Label
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 Competitive Set
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Direct competitors
10
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Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in FARXIGA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FARXIGA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FARXIGA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
195 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) |
| NCT03762850 PROTECT results posted | 021IGAN17001 2017-004605-41 | Ph 3 | active not recruiting | A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy |
| NCT06942910 ZODIAC | AZ-RU-00010 | Ph 2 | recruiting | A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria |
| NCT05521984 | 202210013 | Ph 1 | recruiting | Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i) |
| NCT06087835 | D4325C00010 2023-504124-26 | Ph 3 | active not recruiting | Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria) |
| NCT03499704 EPIDOTE | Alogliptin-Pio-4001 U1111-1207-8037 | Ph 4 | completed | A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy |
| NCT03269058 Cinétique DAPA | VERGES AZ 2015 | Ph 4 | completed | Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes |
| NCT06851962 EPHIC-DIA2 | EPHIC-DIA2 2025-520686-46-00 | Ph 4 | active not recruiting | Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. |
| NCT02616666 DECIDE | D1690R00009 2015-001873-42 | Ph 4 | completed | A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients |
| NCT05139914 SFRNDM2 results posted | H-41648 20SFRN35120118 | Ph 4 | terminated | Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes |
| NCT06610526 | D169AC00008 | Ph 4 | active not recruiting | A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease |
| NCT06263673 results posted | 23-008183 | Ph 4 | completed | Anti-Diabetic Medications to Fight PD and LBD |
| NCT07214818 SGLT2-NS | MS.25.08.3285 | Ph 2, Ph 3 | active not recruiting | SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome |
| NCT07351643 DAPA-PCAT | SYNH-Y2025503 Y(2025)503 | Ph 4 | not yet recruiting | CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF |
| NCT06528405 ESS-AKD | 202404095MINE | Ph 2 | recruiting | The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease |
| NCT06415773 HARMONY | HTD1801.PCT109 | Ph 3 | completed | Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin |
| NCT07174687 | 202507116 | Ph 2 | recruiting | SGLT2 Inhibitors in Geographic Atrophy |
| NCT06111768 SGLT2i in CRS | 2000036118 000 | Ph 2 | active not recruiting | Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study |
| NCT07239011 | 8759 | Ph 1, Ph 2 | recruiting | Dapagliflozin in Depression |
| NCT07239570 CKD-bioMatch | 2023-507449-27 | Ph 4 | recruiting | A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease |
| NCT06192108 ACHIEVE-2 | 18566 J2A-MC-GZGV, 2023-507206-13-00 | Ph 3 | completed | A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin |
| NCT04818034 results posted | SGLT2 | Ph 2 | completed | The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study |
| NCT04887935 | 202107070 | Ph 1 | recruiting | Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer |
| NCT06639087 AURORA | D9090C00007 2024-513142-11-00 | Ph 1 | terminated | A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment |
| NCT05058859 | SGLT2 1 Year | Ph 2 | withdrawn | Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics |
| NCT05676684 SOGALDI-PEF | SOGALDI-PEF | Ph 2, Ph 3 | completed | Dapagliflozin With or Without Spironolactone for HFpEF |
| NCT06578520 | DAPA-DP | Ph 4 | recruiting | Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure |
| NCT04451837 | DIAB1 | Ph 2 | active not recruiting | Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology |
| NCT05621551 | 2021-1437 | Ph 4 | completed | Dapagliflozin Therapy In Cardiac Surgery |
| NCT04363697 | D1690C00078 | Ph 4 | completed | Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68) |
| NCT06845163 DAPA-DME | 0202071 | Ph 2 | recruiting | Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema |
| NCT05570305 ZODIAC | 202100178 2021-001324-18 | Ph 2 | completed | Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria |
| NCT06286878 | SDC 4620/17/120 | Ph 2, Ph 3 | recruiting | Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes |
| NCT05748925 results posted | MD.21.10.550 | Ph 4 | completed | Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients |
| NCT03899402 | STUDY00002775 1987 | Ph 2, Ph 3 | active not recruiting | Triple Therapy in T1DM |
| NCT05196347 DAPA-advKD | ESR-21-21200 V1.4 | Ph 3 | completed | Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease |
| NCT04564742 DAPA-MI results posted | D169DC00001 2020-000664-31 | Ph 3 | completed | Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack. |
| NCT06619600 DAPA-STEMI | ESR-19-14489 2018-003105-25 | Ph 3 | active not recruiting | Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients With a ST-segment Elevation Myocardial Infarction |
| NCT06420167 FLORAL | 2023-074 | Ph 2 | recruiting | DapagliFLOzin in Renal AL Amyloidosis (FLORAL) |
| NCT05345327 START | P01148 | Ph 3 | recruiting | SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes |
| NCT05944016 DOUBLE_PROTECT | UMG DOUBLE PRO-TECT 2023 | Ph 3 | recruiting | Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients |
| NCT04234867 Dapa-Stress | ESR-17-13152 | Ph 1 | terminated | Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D) |
| NCT06304857 PROTECTAA | 2022/ABM/01/00039 2023-506631-15-00 | Ph 3 | recruiting | CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL |
| NCT04792190 DAPA-AF results posted | 00005844 | Ph 4 | completed | Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation |
| NCT04595370 MIRACLE results posted | D6402C00001 2020-003126-23 | Ph 2 | completed | Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease |
| NCT04869124 DAPA-VOLVO | ESR-20-20601 2020-004143-89 | Ph 4 | completed | Dapagliflozin on Volume Vascular Outcomes. |
| NCT06576375 | PRC-Ph-2307003 | Ph 3 | recruiting | Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome |
| NCT02987738 DapaDream | ESR-15-11453 | Ph 1 | completed | Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes |
| NCT04899349 EPIK-B4 results posted | CBYL719C2202 | Ph 2 | terminated | Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant |
| NCT04743453 | 41012620.6.1001.0068 | Ph 4 | completed | EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS. |
Showing 50 of 195 trials
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Ongoing clinical trials by development phase
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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
Indications & Usage
FDA Label (PDF)FARXIGA is indicated for the treatment of Chronic Kidney Disease; Heart Failure; Type 2 Diabetes.
View full patent landscape →
33 OB patents · 9 families ·
470 international docs across 50 countries
FARXIGA Patents & Exclusivity
Latest Patent: Oct 2041
Exclusivity: Dec 2027
Patents (33 active)
US12409186*PED
Expires Oct 1, 2041
US12213988*PED
Expires Oct 1, 2041
US12213988
Expires Apr 1, 2041
US12409186
Expires Apr 1, 2041
US11903955*PED
Expires Sep 9, 2040
US10973836*PED
Expires Sep 9, 2040
US10973836
Expires Mar 9, 2040
US11903955
Expires Mar 9, 2040
US12472194*PED
Expires Jan 18, 2040
US11826376*PED
Expires Jan 18, 2040
US12472194
Expires Jul 18, 2039
US11826376
Expires Jul 18, 2039
US8685934*PED
Expires Nov 26, 2030
US8721615*PED
Expires Jul 18, 2030
US7919598*PED
Expires Jun 16, 2030
US8685934
Expires May 26, 2030
US7919598
Expires Dec 16, 2029
US7851502*PED
Expires Feb 19, 2029
US8221786*PED
Expires Sep 21, 2028
US8361972*PED
Expires Sep 21, 2028
US8716251*PED
Expires Sep 21, 2028
US7851502
Expires Aug 19, 2028
US8361972
Expires Mar 21, 2028
US8221786
Expires Mar 21, 2028
US8716251
Expires Mar 21, 2028
US8501698*PED
Expires Dec 20, 2027
US8501698
Expires Jun 20, 2027
US8329648*PED
Expires Feb 18, 2027
US8906851*PED
Expires Feb 18, 2027
US8906851
Expires Aug 18, 2026
US8329648
Expires Aug 18, 2026
US6515117*PED
Expires Apr 4, 2026
US6515117
Expires Oct 4, 2025
Exclusivity
M-298
Until May 2026
NPP
Until Jun 2027
M-298
Until May 2026
NPP
Until Jun 2027
PED
Until Nov 2026
PED
Until Nov 2026
PED
Until Dec 2027
PED
Until Dec 2027
M-298
Until May 2026
NPP
Until Jun 2027
M-298
Until May 2026
NPP
Until Jun 2027
PED
Until Nov 2026
PED
Until Nov 2026
PED
Until Dec 2027
PED
Until Dec 2027
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for FARXIGA
Revenue Insights
- • Q4-2025: $2.1B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 124 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.