dapagliflozin
Trade name: farxiga
Small moleculeapproved
Approved
Jan 8, 2014
Dapagliflozin (trade name Farxiga in the U.S. and Forxiga in the EU and Russia) is a drug of the gliflozin class, developed by Bristol-Myers Squibb in partnership with AstraZeneca. Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. — NCATS
Clinical trial activity
552 trials · 384 clinical orgs · 24 marketing orgs
Phase 1
94
Phase 2
228
Phase 3
161
Phase 4
181
Earliest trial started Apr 1, 2005 (NCT00162305)
Timeline
2000s
- Jan 1, 2005
AstraZeneca — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
AstraZeneca — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2007
AstraZeneca — Earliest Phase 3 Sponsor(trial)
2010s
- Jan 8, 2014
Bristol-Myers Squibb — Earliest FDA Approval
- Jan 8, 2014
AstraZeneca — NDA Secondary Org
- Jan 8, 2014
Bristol-Myers Squibb — NDA Organization
- Jan 4, 2019
Apotex — Marketing Organization
- Jan 18, 2019
Hetero Labs Ltd — Marketing Organization
- Feb 4, 2019
Teva — Marketing Organization
- Sep 27, 2019
Aizant — Marketing Organization
2020s
- Mar 20, 2020
Glenmark Pharmaceuticals — Marketing Organization
- Feb 26, 2021
MSN Laboratories — Marketing Organization
- Feb 22, 2022
Zydus Discovery DMCC — Marketing Organization
- Aug 1, 2022
Jiangsu Hansoh Pharmaceutical Co., Ltd. — Marketing Organization
- Sep 15, 2025
Aurobindo Pharma — Marketing Organization
- Oct 15, 2025
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Jan 8, 2026
Sciegen Pharmaceticals — Marketing Organization
- Apr 6, 2026
Ajanta Pharma Ltd — Marketing Organization
- Apr 6, 2026
Alembic — Marketing Organization
- Apr 6, 2026
Alkem Labs Ltd — Marketing Organization
- Apr 6, 2026
Biocon Limited — Marketing Organization
- Apr 6, 2026
Cipla — Marketing Organization
- Apr 6, 2026
Inventia Hlthcare — Marketing Organization
- Apr 6, 2026
Lupin — Marketing Organization
- Apr 6, 2026
Micro Labs Ltd India — Marketing Organization
- Apr 6, 2026
Sandoz — Marketing Organization
- Apr 6, 2026
Sun Pharmaceuticals — Marketing Organization
- Apr 6, 2026
Torrent Pharmaceuticals Limited — Marketing Organization
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 2/Phase 3
- Acute Kidney Injury · Phase 4
- Adenocarcinoma of Lung · Early Phase 1
- Aging · Phase 1/Phase 2
- Albuminuria · Phase 4
- Alzheimer Disease · Phase 1/Phase 2
- Amyloidosis · Phase 2
- Anemia · Phase 4
- Angina, Unstable · Phase 3
- Aortic Valve Disease · Phase 4
- Aortic Valve Stenosis · Phase 4
- Arrhythmias, Cardiac · Phase 4
- Ascites · Phase 2
- Atrial Fibrillation · Phase 4
- Biomarkers · Phase 2/Phase 3
- Blood Glucose · Phase 4
- Blood Platelet Disorders · Phase 2/Phase 3
- Body Fluids · Phase 2
- Bone Diseases, Metabolic · Phase 4
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 4
- Carbohydrates · Phase 4
- Cardiac Catheterization · Phase 4
- Cardiomegaly · Phase 2
- Cardiomyopathies · Phase 2
- Cardiomyopathy, Dilated · Phase 3
- Cardio-Renal Syndrome · Phase 2
- Cardiotoxicity · Phase 2
- Cardiovascular Diseases · Phase 4
- Carotid Artery Diseases · Phase 4
- Catheter Ablation · Phase 2/Phase 3
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 2/Phase 3
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- COVID-19 · Phase 3
- Critical Illness · Phase 3
- Cystinuria · Phase 2
- Death · Phase 3
- Dementia, Vascular · Phase 2/Phase 3
- Depression · Phase 1/Phase 2
- Depressive Disorder · Phase 2
- Dexamethasone · Phase 3
- Diabetes Complications · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Ketoacidosis · Phase 1
- Diabetic Nephropathies · Phase 4
- Diabetic Neuropathies · Phase 4
- Diabetic Retinopathy · Phase 3
- Diet, Ketogenic · Phase 4
- Drug Evaluation · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 1
- Drug Therapy · Phase 4
- Dyslipidemias · Phase 3
- Electrolytes · Phase 2
- Endocrine System Diseases · Phase 3
- Endomyocardial Fibrosis · Phase 4
- Endothelial Cells · Phase 4
- Endothelium · Phase 4
- Essential Hypertension · Phase 3
- Exercise · Phase 2
- Eye Diseases · Phase 2
- Fabry Disease · Phase 2
- Fatty Liver · Phase 4
- Fibrosis · Phase 2
- Fontan Procedure · Phase 2
- Geographic Atrophy · Phase 2
- Glioma · Phase 3
- Glomerulonephritis · Phase 2
- Glomerulosclerosis, Focal Segmental · Phase 4
- Glucocorticoids · Phase 2
- Glucose Intolerance · Phase 4
- Glucose Metabolism Disorders · Phase 4
- Glucose Tolerance Test · Phase 3
- Glycemic Control · Phase 4
- Graft vs Host Disease · Phase 2
- Hamartoma · Phase 2
- Healthy Volunteers · Phase 2
- Heart Defects, Congenital · Phase 4
- Heart Disease Risk Factors · Phase 2
- Heart Diseases · Phase 3
- Heart Failure · Phase 4
- Heart Failure, Diastolic · Phase 4
- Heart Failure, Systolic · Phase 4
- Heart Ventricles · Phase 4
- Hepatitis B, Chronic · Phase 4
- HIV Infections · Phase 3
- Hypercholesterolemia · Phase 4
- Hyperglycemia · Phase 4
- Hyperinsulinism · Phase 1
- Hyperoxaluria · Phase 4
- Hypertension · Phase 4
- Hypertension, Pregnancy-Induced · Phase 4
- Hypertension, Pulmonary · Phase 2
- Hypertrophy, Left Ventricular · Phase 4
- Hyperuricemia · Phase 2
- Hypoglycemia · Phase 4
- Hypotension · Phase 4
- Hypoxia · Phase 4
- Inflammation · Phase 2
- Inflammatory Bowel Diseases · Phase 2/Phase 3
- Insulin · Phase 4
- Insulin Resistance · Phase 3
- Iron Deficiencies · Phase 3
- Ischemic Stroke · Phase 2/Phase 3
- Ketosis · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Function Tests · Phase 4
- Kidney Transplantation · Phase 4
- Lewy Body Disease · Phase 4
- Lipomatosis · Phase 4
- Liver Cirrhosis · Phase 2
- Liver Diseases · Phase 4
- Lung Diseases · Early Phase 1
- Lung Neoplasms · Early Phase 1
- Lupus Erythematosus, Systemic · Phase 4
- Lupus Nephritis · Phase 4
- Macular Edema · Phase 2
- Maze Procedure · Phase 4
- Metabolic Diseases · Phase 3
- Metabolic Syndrome · Phase 4
- Metabolism · Phase 4
- Mitochondrial Diseases · Phase 4
- Mitral Valve · Phase 4
- Mitral Valve Stenosis · Phase 3
- Myocardial Infarction · Phase 4
- Myocardial Ischemia · Phase 4
- Myocardium · Phase 4
- Neoplasms · Phase 2
- Nephritis, Hereditary · Phase 4
- Nephrotic Syndrome · Phase 4
- Non-alcoholic Fatty Liver Disease · Phase 4
- Non-ST Elevated Myocardial Infarction · Phase 3
- Obesity · Phase 4
- Obesity, Morbid · Phase 2/Phase 3
- Overweight · Phase 4
- Pancreatic Neoplasms · Phase 1
- Parkinson Disease · Phase 4
- Pathological Conditions, Anatomical · Phase 2
- Percutaneous Coronary Intervention · Phase 4
- Pharmacokinetics · Phase 2/Phase 3
- Polycystic Ovary Syndrome · Phase 3
- Prediabetic State · Phase 4
- Pre-Eclampsia · Phase 4
- Prehypertension · Phase 4
- Prostatic Neoplasms · Phase 1
- Proteinuria · Phase 4
- Pulmonary Arterial Hypertension · Phase 2
- Pulmonary Valve Insufficiency · Phase 4
- Renal Dialysis · Phase 2
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Reperfusion Injury · Phase 1
- Retinal Degeneration · Phase 2
- Retinal Diseases · Phase 2
- Rheumatic Heart Disease · Phase 3
- Risk Reduction Behavior · Phase 3
- Semen · Phase 4
- Sepsis · Phase 3
- Sleep Apnea, Obstructive · Phase 3
- Sleep Apnea Syndromes · Phase 2
- Sodium-Glucose Transporter 2 Inhibitors · Phase 4
- Sports Medicine · Early Phase 1
- ST Elevation Myocardial Infarction · Phase 4
- Stroke · Phase 2
- Tetralogy of Fallot · Phase 4
- Therapeutic Equivalency · Phase 1
- Thoracic Surgery · Phase 4
- Urolithiasis · Phase 4
- Vascular Diseases · Phase 4
- Vascular Stiffness · Phase 2
- Vasculitis · Phase 4
- Ventricular Dysfunction · Phase 2/Phase 3
- Ventricular Dysfunction, Left · Phase 3
- Ventricular Remodeling · Phase 4
- Weight Gain · Phase 3
- Weight Loss · Phase 2/Phase 3
Mechanism of action
- Sodium/glucose cotransporter 2INHIBITOR
SLC5A2 inhibitor
Combination products
qtern
with saxagliptin
qternmet xr
with metformin, saxagliptin
xigduo xr
with metformin
Approval history
- approvedJan 8, 2014
Chemistry & pharmacology
Loading structure…
SMILES
CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1- Mol. weight
- 408.88 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL429910 ↗
- WikipediaDapagliflozin ↗
- NCATS1ULL0QJ8UC ↗
- ChEMBLCHEMBL2103802 ↗
Also known as
- 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
- (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
- (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
- (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
- bms512148
- bms 512148
- bms 512148
- bms-512148
- bms-512148
- bms-512148
- bms-512148
- bms-512148-05
- bms-512148-05
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin
- dapagliflozin propanediol
- dapagliflozin propanediol
- dapagliflozin propanediol
- dapagliflozin propanediol monohydrate
- dapagliflozin propanediol monohydrate
- dapagliflozin propanediol monohydrate
- dapagliflozin propanediol monohydrate
- dapagliflozin propanediol monohydrate
- dapagliflozin propanediol monohydrate
- dapagliflozin propanediol monohydrate / metformin hydrochloride
- dapagliflozin propylene glycol
- dapagliflozin propylene glycol
- dapagliflozin propylene glycolate hydrate
- dapaglifozin
- dapaglifozin
- dapaglifozin
- farxiga
- farxiga
- farxiga
- farxiga
- forxiga
- forxiga
- forxiga
- forxiga
- metformin hydrochloride / dapagliflozin propanediol monohydrate
- saxagliptin / dapagliflozin propanediol monohydrate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06560333 | Phase 3 | Nov 30, 2026 | Eurofarma Laboratorios S.A. |
| NCT07310433 | Phase 2 | Jun 1, 2026 | Fudan University, Jiao Tong University, The University of Hong Kong |
| NCT07225465 | Phase 2 | Feb 28, 2026 | Austin Health, Baker Heart and Diabetes Institute, Melbourne Health, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Melbourne, University of New South Wales |
| NCT07273838 | Phase 2 | Jan 31, 2026 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University |
| NCT07056699 | Phase 3 | Jan 30, 2026 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio |
| NCT07297589 | Phase 3 | Dec 30, 2025 | Instituto Mexicano del Seguro Social, Universidad de Guanajuato |
| NCT07235280 | Early Phase 1 (Phase 1) | Dec 30, 2025 | University of California, Los Angeles |
| NCT07311551 | Phase 4 | Dec 24, 2025 | All India Institute of Medical Sciences |
| NCT07295223 | Phase 3 | Dec 15, 2025 | Instituto Mexicano del Seguro Social, Universidad de Guanajuato |
| NCT07280585 | Phase 3 | Dec 11, 2025 | German Research Foundation, University of Cologne |
| NCT07222917 | Phase 2 | Dec 5, 2025 | AstraZeneca |
| NCT07239440 | Phase 2 | Nov 30, 2025 | Dong-A Pharmaceutical |
| NCT07214818 | Phase 2/Phase 3 (Phase 3) | Nov 15, 2025 | Mansoura University |
| NCT07096986 | Phase 2 | Nov 1, 2025 | University of Nice Sophia Antipolis |
| NCT07239011 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2025 | Tanta University |
| NCT07174687 | Phase 2 | Oct 31, 2025 | Washington University in St. Louis |
| NCT07239453 | Phase 1 | Oct 20, 2025 | Dong-A Pharmaceutical |
| NCT07035834 | Phase 4 | Sep 30, 2025 | University of Naples Frederico II |
| NCT06922656 | Phase 4 | Sep 15, 2025 | Dasman Diabetes Institute |
| NCT07025629 | Phase 3 | Sep 2, 2025 | Assistance Publique - Hôpitaux de Paris, University of Paris |
Showing 20 of 552 trials
Page 1 / 28
Organizations
Research & Development (384)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 173 | 118 | 5 | 2005 |
| Bristol-Myers Squibb | For profit | 60 | 1 | 3 | 2005 |
| Parexel | For profit | 13 | 0 | 3 | 2007 |
| University of Texas, San Antonio | Academic/Hospital | 13 | 13 | 4 | 2011 |
| University of Groningen | Academic/Hospital | 10 | 5 | 3 | 2017 |
| Dong-A Pharmaceutical | For profit | 9 | 8 | 4 | 2018 |
| Seoul National University | Academic/Hospital | 9 | 6 | 3 | 2014 |
| Ain Shams University | Academic/Hospital | 8 | 7 | 4 | 2021 |
| Mansoura University | Academic/Hospital | 8 | 8 | 3 | 2022 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 7 | 0 | 4 | 2011 |
| University of Copenhagen | Academic/Hospital | 7 | 5 | 2 | 2015 |
| University of Guadalajara | Academic/Hospital | 7 | 5 | 2 | 2014 |
| Assiut University | Academic/Hospital | 6 | 6 | 4 | 2020 |
| Instituto Mexicano del Seguro Social | Government | 6 | 5 | 4 | 2021 |
| Nanjing Medical University | Academic/Hospital | 6 | 5 | 3 | 2019 |
| Sun Yat-Sen University | Academic/Hospital | 6 | 4 | 2 | 2018 |
| Tanta University | Academic/Hospital | 6 | 6 | 3 | 2023 |
| University of New South Wales | Academic/Hospital | 6 | 4 | 3 | 2022 |
| Uppsala University | Academic/Hospital | 6 | 3 | 3 | 2014 |
| Washington University in St. Louis | Academic/Hospital | 6 | 6 | 2 | 2021 |
384 organizations
Page 1 / 20
Marketing (30)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aizant | For profit | MKTG | Sep 27, 2019 |
| Ajanta Pharma Ltd | For profit | MKTG | Apr 6, 2026 |
| Alembic | For profit | MKTG | Apr 6, 2026 |
| Alkem Labs Ltd | For profit | MKTG | Apr 6, 2026 |
| Apotex | For profit | MKTG | Jan 4, 2019 |
| AstraZeneca | For profit | NDA2 | Jan 8, 2014 |
| Aurobindo Pharma | For profit | MKTG | Sep 15, 2025 |
| Aurobindo Pharma | For profit | SYN | Apr 6, 2026 |
| Biocon Limited | For profit | MKTG | Apr 6, 2026 |
| Bristol-Myers Squibb | For profit | NDA | Jan 8, 2014 |
| Cipla | For profit | MKTG | Apr 6, 2026 |
| Cipla | For profit | SYN | Apr 6, 2026 |
| Glenmark Pharmaceuticals | For profit | MKTG | Mar 20, 2020 |
| Hetero Labs Ltd | For profit | MKTG | Jan 18, 2019 |
| Inventia Hlthcare | For profit | MKTG | Apr 6, 2026 |
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | For profit | MKTG | Aug 1, 2022 |
| Lupin | For profit | MKTG | Apr 6, 2026 |
| MSN Laboratories | For profit | MKTG | Feb 26, 2021 |
| MSN Laboratories | For profit | SYN | May 28, 2020 |
| MSN Laboratories | For profit | SYN | Apr 6, 2026 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Oct 15, 2025 |
| Macleods Pharmaceuticals, Ltd | For profit | SYN | Apr 6, 2026 |
| Micro Labs Ltd India | For profit | MKTG | Apr 6, 2026 |
| Sandoz | For profit | MKTG | Apr 6, 2026 |
| Sciegen Pharmaceticals | For profit | MKTG | Jan 8, 2026 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 6, 2026 |
| Teva | For profit | MKTG | Feb 4, 2019 |
| Teva | For profit | SYN | Apr 6, 2026 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Apr 6, 2026 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 22, 2022 |