DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (dapagliflozin)
Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure.
Details
- Status
- Prescription
- First Approved
- 2026-04-06
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
Companies
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Approval History
What DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 2026) New
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Boxed Warning
LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ] . Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information [ see D osage and Administration ( 2.1 and 2.4 ), Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7) , and Use in Specific Populations (8.6 , 8.7) ] . If metformin-associated lactic acidosis is suspected, immediately discontinue dapagliflozin and metformin HCl extended-release and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1 )] . WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate le
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 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.
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
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.
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE FDA Label Details
Indications & Usage
Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of prog...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias...
Track DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.