How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Improves HbA1c in type 2 diabetes

60%Moderate confidence

Uncertainty ±8%Evidence coverage: HighUpdated 1 August 2026

Evidence is mixed — 39 supporting evidence families · 3 well-powered no-effect results

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.

Effect differs by population

General population:: 62%
comorbid disease:: 27%

Evidence in comorbid disease reaches a different conclusion (weak) from the general population (supported).

Reduces major adverse cardiovascular events in type 2 diabetes or cardiovascular disease

0%Very low confidence

Uncertainty ±34%Evidence coverage: MinimalUpdated 1 August 2026

High point estimate, but substantial uncertainty remains.

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Dapagliflozin

Aliases & brands

FarxigaQternXigduoDapagliflozina(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol

RxNorm CUI

1488564

ChEMBL ID

CHEMBL429910

ATC codes

A10BK01

UNII

1ULL0QJ8UC

Primary mechanism

Sodium/glucose cotransporter 2 inhibitor

Regulatory jurisdictions

emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium/glucose cotransporter 2

SLC5A2 · P31639

INHIBITORSodium/glucose cotransporter 2 inhibitor

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2012-11-11

Latest approval

2023-03-24

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 3 events

2023-03-24Approval

Approval: Dapagliflozin Viatris (EMA)

Indication: Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus… Show full indication

Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.

Evidence ↗

2015-11-09Approval

Approval: Edistride (EMA)

Indication: Type 2 diabetes mellitus Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an… Show full indication

Type 2 diabetes mellitus Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Edistride is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Edistride is indicated in adults for the treatment of chronic kidney disease.

Evidence ↗

2012-11-11Approval

Approval: Forxiga (EMA)

Indication: Type 2 diabetes mellitus Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct… Show full indication

Type 2 diabetes mellitus Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Forxiga is indicated in adults for the treatment of chronic kidney disease.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2021-12-10Safety communicationSafety

Drug Safety Update: Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

193 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

193

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

143

Late-stage (III+)

102

Completed

Discontinued

PHASE DISTRIBUTIONn = 193

Early Phase 12Phase 114Phase 1 / 22Phase 232Phase 2 / 312Phase 349Phase 461Phase N / A21

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Sodium-glucose Co-transporter-2 Inhibitor (SGLT2i) to Prevent of Liver Complications in Patients With Chronic Hepatitis B and Diabetes Mellitus: a Double-blind, Randomised, Placebo-controlled Trial

RecruitingPH IVChinese University of Hong Kongn=4122031

A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies

RecruitingPH IVUniversity of Michigann=2002028

SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized, Placebo Controlled, Multi-center Trial

RecruitingPH IVUniversity Hospital Tuebingenn=1702027

Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?

Not yet recruitingPH IVDasman Diabetes Instituten=602027

Efficacy and Mechanism of Dapagliflozin Combined With Insulin in the Treatment of Early Diabetic Nephropathy in Patients With Type 1 Diabetes

Active, not recruitingPH IVThe First Affiliated Hospital with Nanjing Medical Universityn=542026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)

CompletedPH IIIShandong Suncadia Medicine Co., Ltd.n=8102026

Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome

CompletedPH IIIBeni-Suef Universityn=2002026

Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial

CompletedN/AMedanta, The Medicity, Indian=1002026

Natriuretic-ureothelic Adaptation of Body Fluid Homeostasis During SGLT-2 Inhibition and/or Mineralocorticoid Receptor Modulation in Patients With Chronic Kidney Disease. A 4-arm, Double-blind, Double-dummy, Parallel-group, Phase 2 Study to Investigate the Mechanistic Effects of Dapagliflozin, Dapagliflozin + Balcinrenone, Balcinrenone and Placebo on Body Solute and Water Homeostasis and Energy Metabolism in Male and Female Participants Over 50 Years of Age With Chronic Kidney Disease.

CompletedPH IIKlinikum Nürnbergn=1032026

Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy: a Pilot Study

CompletedN/ANational Medical Research Center for Cardiology, Ministry of Health of Russian Federationn=502025

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)

CompletedPH IIIEli Lilly and Companyn=9622025

Research activity

12 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20092025

Most influential

Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction.

The New England journal of medicine · 2019 · 4,923 cites

Dapagliflozin in Patients with Chronic Kidney Disease.

The New England journal of medicine · 2020 · 3,783 cites

Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes.

JAMA · 2020 · 369 cites

Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy.

Diabetes care · 2012 · 307 cites

A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment.

Diabetes care · 2009 · 275 cites

Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial.

International journal of clinical practice · 2012 · 232 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Diabetes Mellitus, Type 23 Heart Failure2

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Liraglutide

Studied across 11 of the same disease areas as Dapagliflozin in the shared literature.

11 shared diseases1 shared paper

Insulin

Studied across 6 of the same disease areas as Dapagliflozin in the shared literature.

6 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.