Dapagliflozin 10mg: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Dapagliflozin 10mg appears in the FDA drug-label database. Marketed as DAPAGLIFLOZIN.
- Drug class
- Sodium-Glucose Cotransporter 2 Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Sodium-Glucose Transporter 2 Inhibitors (as stated on the FDA label)
FDA-approved use
Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ( 5.1 )]. Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets are likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information. Dapagliflozin tablets is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Heart failure | 2 |
| Acute Decompensated Heart Failure | 1 |
| Acute Heart Failure | 1 |
| Breast Cancer | 1 |
| HER2-negative Breast Cancer | 1 |
| Hyperinsulinism | 1 |
Recruiting trials involving Dapagliflozin 10mg
- Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
- Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
- Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
Common questions
Is Dapagliflozin 10mg FDA-approved?
Yes, marketed as DAPAGLIFLOZIN.
How many recruiting trials involve Dapagliflozin 10mg?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.