Product Description
Dapagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). It is also used to reduce the risk of needing to be hospitalized for heart failure in adults who have type 2 diabetes along with heart and blood vessel disease or who have multiple risk factors for developing heart and blood vessel disease. Dapagliflozin is also used in adults with heart failure to reduce the risk of needing to be hospitalized and death due to heart and blood vessel disease. It is also used to reduce the risk of worsening kidney disease, the need to be hospitalized for heart failure, and the risk of death due to heart disease in adults with kidney disease. Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Dapagliflozin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). (Sourced from: https://medlineplus.gov/druginfo/meds/a614015.html)
Mechanisms of Action: SGLT2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: Heart Failure | Heart Failure, Chronic | Heart Failure, Systolic | Acidosis | Diabetic Ketoacidosis | General Diabetes | Type 2 Diabetes | Kidney Diseases | Kidney Failure, Chronic | Heart Failure | Heart Failure, Chronic | Heart Failure, Systolic | Acidosis | Diabetic Ketoacidosis | General Diabetes | Type 2 Diabetes | Kidney Diseases | Kidney Failure, Chronic | Acidosis | Diabetic Ketoacidosis | General Diabetes | Type 2 Diabetes | Type 1 Diabetes
Known Adverse Events: Nasopharyngitis | Pharyngitis | Urinary Tract Infections | Headache | Diarrhea | Respiratory Tract Infections | Dyslipidemia
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 69
Highest Development Phases
Phase 3: Acute Kidney Injury|Anemia, Iron-Deficiency|Coronary Disease|Dyslipidemia|Glucose Metabolism Disorders|Heart Failure|Heart Failure, Acute|Heart Failure, Chronic|Heart Failure, Diastolic|Heart Failure, Systolic|Heart Transplant|Hypertension|Hypertension, Renal|Kidney Diseases|Kidney Failure, Chronic|Kidney Transplant|Myocardial Infarction|Proteinuria|Renal Transplant|Type 2 Diabetes|Ventricular Dysfunction, Left
Phase 2: Albuminuria|Hypertension, Portal|Inflammation|Liver Cirrhosis|Type 1 Diabetes
Phase 1: Fatty Liver, Alcoholic|Healthy Volunteers|Hypothyroidism|Liver Diseases, Alcoholic|Non-alcoholic Fatty Liver Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| BaxDuo-Pacific | P3 |
Not yet recruiting |
Hypertension, Renal|Kidney Failure, Chronic |
2030-04-18 |
|
| Prevent-HF | P3 |
Not yet recruiting |
Heart Failure |
2029-12-17 |
|
| D6972C00003 | P3 |
Unknown Status |
Kidney Diseases|Hypertension |
2028-04-10 |
|
| jRCT2031240043 | P3 |
Not yet recruiting |
Kidney Diseases|Hypertension |
2027-12-31 |