Data updated: May 26, 2026
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (dapagliflozin)
Sodium-Glucose Transporter 2 Inhibitors Genetically Validated
Metabolic
Approved 2026-04-06
Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [ see WARNINGS AND PRECAUTIONS ].
Source: FDA Label • TORRENT
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-04-06
- Routes
- ORAL
- Dosage Forms
- TABLET
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
Apr 2026 ORIGINAL
Update
What DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 2026) New
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
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Clinical Trial Registry
193 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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. |
| NCT05429593 | NN9917-4751 U1111-1266-4254, 2022-500007-52-00 | Ph 1 | completed | A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet |
Showing 50 of 193 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE FDA Label Details
Indications & Usage
Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [ see WARNINGS AND PRECAUTIONS ]. Dapagliflozin and saxagliptin tablets is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor and saxagliptin a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.