MedPath

Dapagliflozin

Generic Name
Dapagliflozin
Brand Names
Edistride, Farxiga, Forxiga, Qtern, Qternmet, Xigduo, Dapagliflozin Viatris, Ebymect
Drug Type
Small Molecule
Chemical Formula
C21H25ClO6
CAS Number
461432-26-8
Unique Ingredient Identifier
1ULL0QJ8UC

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

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
DAPAGLICIP dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet bottle
369310
Medicine
A
3/30/2022
SIDAPVIA 10/100 dapagliflozin 10 mg (as propanediol monohydrate)/sitagliptin 100 mg (as phosphate monohydrate) film coated tablets blister pack
405540
Medicine
A
6/7/2024
CIPLA DAPAGLIFLOZIN dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet bottle
369270
Medicine
A
3/30/2022
XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blister pack
211294
Medicine
A
7/18/2014
FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet blister pack
180147
Medicine
A
10/22/2012
QTERN 5/10 saxagliptin (as hydrochloride) / dapagliflozin (as propanediol monohydrate) 5 mg / 10 mg film-coated tablet blister pack
255632
Medicine
A
10/25/2016
XIGDUO XR 10/1000 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack
211295
Medicine
A
7/18/2014
XIGDUO XR 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack
211296
Medicine
A
7/18/2014
FOCIPRA dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet bottle
369311
Medicine
A
3/30/2022

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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