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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/13 | Not Applicable | Recruiting | Erbil Polytechnic University | ||
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/07/24 | Not Applicable | Recruiting | |||
2025/07/24 | Not Applicable | Recruiting | |||
2025/07/24 | Not Applicable | Recruiting | |||
2025/07/22 | Not Applicable | Recruiting | May Mohamed Abdalla | ||
2025/07/09 | Not Applicable | Not yet recruiting | |||
2025/06/17 | Phase 3 | Not yet recruiting | |||
2025/06/13 | Phase 1 | Active, not recruiting | Amira Bisher,PhD | ||
2025/06/12 | Phase 2 | Active, not recruiting | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AstraZeneca Pharmaceuticals LP | 0310-6225 | ORAL | 2.5 mg in 1 1 | 9/12/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-6210 | ORAL | 10 mg in 1 1 | 1/15/2024 | |
A-S Medication Solutions | 50090-3482 | ORAL | 5 mg in 1 1 | 9/12/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-6250 | ORAL | 5 mg in 1 1 | 9/12/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-6780 | ORAL | 10 mg in 1 1 | 9/29/2023 | |
Bryant Ranch Prepack | 63629-3253 | ORAL | 10 mg in 1 1 | 2/6/2024 | |
PRASCO, LLC | 66993-456 | ORAL | 5 mg in 1 1 | 9/12/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-6270 | ORAL | 10 mg in 1 1 | 9/12/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-6770 | ORAL | 5 mg in 1 1 | 9/29/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-6260 | ORAL | 5 mg in 1 1 | 9/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 1/16/2014 | ||
Astra Zeneca AB,51 85 Södertälje,Sweden | Authorised | 7/15/2016 | |
Authorised | 11/15/2015 | ||
Authorised | 3/24/2023 | ||
Authorised | 11/11/2012 | ||
Authorised | 11/9/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
XIGDUO XR TABLETS 5MG/500MG | SIN15077P | TABLET, FILM COATED, EXTENDED RELEASE | 5mg | 8/30/2016 | |
SIDAPVIA FIXED DOSE COMBINATION TABLET 10 MG/100 MG | SIN16958P | TABLET, FILM COATED | 10mg | 2/20/2024 | |
XIGDUO XR TABLETS 5MG/1000MG | SIN15080P | TABLET, FILM COATED, EXTENDED RELEASE | 5mg | 8/30/2016 | |
FORXIGA TABLET 5MG | SIN14541P | TABLET, FILM COATED | 5mg | 4/28/2014 | |
FORXIGA TABLET 10mg | SIN14542P | TABLET, FILM COATED | 10mg | 4/28/2014 | |
XIGDUO XR TABLETS 10MG/500MG | SIN15078P | TABLET, FILM COATED, EXTENDED RELEASE | 10mg | 8/30/2016 | |
XIGDUO XR TABLETS 10MG/1000MG | SIN15079P | TABLET, FILM COATED, EXTENDED RELEASE | 10mg | 8/30/2016 | |
EDISTRIDE FILM-COATED TABLET 10MG | SIN17048P | TABLET, FILM COATED | 10mg | 7/22/2024 | |
DAPAGLIFLOZIN SANDOZ FILM COATED TABLET 10MG | SIN17199P | TABLET, FILM COATED | 10.000mg | 3/7/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
AURO-DAPAGLIFLOZIN / METFORMIN | auro pharma inc | 02533081 | Tablet - Oral | 5 MG | 5/16/2023 |
AURO-DAPAGLIFLOZIN / METFORMIN | auro pharma inc | 02533073 | Tablet - Oral | 5 MG | 5/16/2023 |
TARO-DAPAGLIFLOZIN | 02520591 | Tablet - Oral | 5 MG | N/A | |
ACCEL-DAPAGLIFLOZIN | accel pharma inc | 02543184 | Tablet - Oral | 5 MG | N/A |
NAT-DAPAGLIFLOZIN | natco pharma (canada) inc | 02535874 | Tablet - Oral | 10 MG | N/A |
TEVA-DAPAGLIFLOZIN | teva canada limited | 02523590 | Tablet - Oral | 5 MG | N/A |
RIVA-DAPAGLIFLOZIN | laboratoire riva inc. | 02528983 | Tablet - Oral | 10 MG | 6/6/2023 |
PRO-DAPAGLIFLOZIN | PRO DOC LIMITEE | 02537664 | Tablet - Oral | 10 MG | 5/29/2023 |
NAT-DAPAGLIFLOZIN | natco pharma (canada) inc | 02535866 | Tablet - Oral | 5 MG | N/A |
APO-DAPAGLIFLOZIN | 02527189 | Tablet - Oral | 5 MG | 5/16/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
XIGDUO 5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 13900003IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
EBYMECT 5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151051003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
EDISTRIDE 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151052007 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
XIGDUO 5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 113900003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
QTERN 5 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161108002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
XIGDUO 5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 13900009IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DAPAGLIFLOZINA TEVA 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 88073 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
XIGDUO 5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA | 13900003IP1 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DAFORBIS 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 87469 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
XIGDUO 5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 113900009 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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