Dapagliflozin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Dapagliflozin 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
Recruiting trials involving Dapagliflozin
- A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
- A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus
- A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus
- A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria
- CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
- DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve
- Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients
- Dapagliflozin in Depression
- Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
- Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
- Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.
- Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
- Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
- SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Common questions
Is Dapagliflozin FDA-approved?
Yes, marketed as DAPAGLIFLOZIN.
How many recruiting trials involve Dapagliflozin?
14 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.