Overview
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and it was the first SLGT2 inhibitor to be approved. indicated for managing diabetes mellitus type 2. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron and causing glycosuria. Dapagliflozin has been investigated either as monotherapy or as an adjunct treatment with insulin or other oral hypoglycemic agents. Dapagliflozin was originally approved by the FDA on Jan 08, 2014, to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. It was later approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease in April 2021.
Background
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and it was the first SLGT2 inhibitor to be approved. indicated for managing diabetes mellitus type 2. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron and causing glycosuria. Dapagliflozin has been investigated either as monotherapy or as an adjunct treatment with insulin or other oral hypoglycemic agents. Dapagliflozin was originally approved by the FDA on Jan 08, 2014, to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. It was later approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease in April 2021.
Indication
Dapagliflozin is indicated as an adjunct treatment to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.For patients with chronic kidney disease at risk of progression, dapagliflozin in used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure. Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Combination products with dapagliflozin also exist, either as a dapagliflozin-saxagliptin or dapagliflozin-metformin hydrochloride formulation. Both are used as an adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Associated Conditions
- Cardiovascular Mortality
- End Stage Renal Disease (ESRD)
- Hospitalizations
- Type 2 Diabetes Mellitus
- Decreased estimated glomerular filtration rate
- Hospitalization due to cardiac failure
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/19 | Phase 1 | Not yet recruiting | |||
2024/09/19 | Phase 3 | Recruiting | Shandong Suncadia Medicine Co., Ltd. | ||
2024/08/29 | Phase 4 | Recruiting | Fundación para la Investigación del Hospital Clínico de Valencia | ||
2024/08/28 | Phase 3 | Recruiting | |||
2024/08/27 | N/A | Recruiting | King's College Hospital NHS Trust | ||
2024/08/20 | Phase 4 | Recruiting | Vastra Gotaland Region | ||
2024/08/19 | Phase 4 | Recruiting | University of Erlangen-Nürnberg Medical School | ||
2024/08/19 | Phase 3 | Not yet recruiting | Eurofarma Laboratorios S.A. | ||
2024/08/02 | Phase 3 | Recruiting | |||
2024/08/01 | Phase 4 | Active, not recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dapagliflozin Tablets | 国药准字H20244145 | 化学药品 | 片剂 | 6/25/2024 | |
| Dapagliflozin Tablets | 国药准字HJ20170205 | 化学药品 | 片剂 | 9/2/2021 | |
| Dapagliflozin Tablets | 国药准字HJ20170119 | 化学药品 | 片剂 | 9/2/2021 | |
| Dapagliflozin Tablets | 国药准字H20249660 | 化学药品 | 片剂 | 12/1/2024 | |
| Dapagliflozin Tablets | 国药准字H20233316 | 化学药品 | 片剂 | 3/21/2023 | |
| Dapagliflozin Tablets | 国药准字H20249659 | 化学药品 | 片剂 | 12/1/2024 | |
| Dapagliflozin Tablets | 国药准字HJ20170118 | 化学药品 | 片剂 | 9/2/2021 | |
| Dapagliflozin Tablets | 国药准字H20233762 | 化学药品 | 片剂 | 6/21/2023 | |
| Dapagliflozin Tablets | 国药准字H20244736 | 化学药品 | 片剂 | 8/27/2024 | |
| Dapagliflozin Tablets | 国药准字H20234463 | 化学药品 | 片剂 | 11/7/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||