Drug
Dapagliflozin is an SGLT2 inhibitor used in heart failure, chronic kidney disease and type 2 diabetes.
Sources: FDA label · 25 registered trials · 1 guideline recommendation
Mechanism: sodium-glucose cotransporter 2 (SGLT2) inhibitor · FDA label (DailyMed)
Guideline:Class I · LOE AHeart failureFDA-approved indications
Source: Farxiga label (DailyMed), label dated Jul 10, 2026
Guideline position
In patients with symptomatic chronic HFrEF, SGLT2i are recommended to reduce hospitalization for HF and cardiovascular mortality, irrespective of the presence of type 2 diabetes.
FDA actions
28 generic approvals naming dapagliflozin on record (FDA; tentative approvals and combination products included), latest Apr 30, 2026.
Dosing is left to the label.
Primary results of 4 trials behind the evidence on dapagliflozin, as each trial’s own publication reports them.
Left of the line at 1 favours the intervention; square size tracks trial size.Favours the interventionNo significant differenceFavours the comparator
dapagliflozin vs placebo · 6,263 patients · N Engl J Med 2022
In patients with heart failure and a left ventricular ejection fraction of more than 40%
Primary outcome: a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death
HR 0.82 (0.73–0.92)
dapagliflozin vs placebo · 4,304 patients · N Engl J Med 2020
In patients with chronic kidney disease, regardless of the presence or absence of diabetes
Primary outcome: a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes
HR 0.61 (0.51–0.72)
dapagliflozin vs placebo · 4,744 patients · N Engl J Med 2019
In patients with heart failure and a reduced ejection fraction
Primary outcome: a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death
HR 0.74 (0.65–0.85)
DECLARE-TIMI 58primary efficacy 1: MACE
dapagliflozin vs placebo · 17,160 patients · N Engl J Med 2019
In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease
Primary outcome: MACE and a composite of cardiovascular death or hospitalization for heart failure
HR 0.93 (0.84–1.03)
DECLARE-TIMI 58primary efficacy 2: CV death or HF hospitalization
dapagliflozin vs placebo · 17,160 patients · N Engl J Med 2019
In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease
Primary outcome: MACE and a composite of cardiovascular death or hospitalization for heart failure
HR 0.83 (0.73–0.95)
Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention.
Registered trials with dapagliflozin in an arm, past phase 1 with at least 50 participants: the largest in each indication, newest first. Trials that give it only as the comparator are tagged; trials that give it in every arm are listed last.
Heart failure4 of 12
NCT06642272 · Phase 4 · Recruiting · 17,200 participants · started 2024
NCT06307652 · Phase 3 · Recruiting · 4,800 participants · started 2024
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
NCT03619213 · Phase 3 · Completed · 6,263 participants · started 2018
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
NCT03036124 · Phase 3 · Completed · 4,744 participants · started 2017
NCT05179668 · Phase 2 · Completed · 220 participants · started 2022
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
NCT03036150 · Phase 3 · Completed · 4,304 participants · started 2017
NCT07539259 · Phase 2 · Not yet recruiting · 445 participants · started 2026
NCT07741890 · Phase 2 · Not yet recruiting · 120 participants · started 2026
Other trials
NCT07624305 · Phase 3 · Not yet recruiting · 2,800 participants · started 2026
NCT06888505 · Phase 2 · Completed · 94 participants · started 2024
NCT05321706 · Phase 3 · Active not recruiting · 430 participants · started 2022
Source: ClinicalTrials.gov registry records.
Label updates and FDA notices
Source: FDA (Drugs@FDA and FDA announcements).
The class has its own page: SGLT2 inhibitors in heart failure.
Class membership: Synapse curated drug classes
A clinical question appears here only when its condition matches this topic, an outcome and a comparator were extracted from the studies, at least two studies and a patient count are on file, and the certainty is low or higher.
Supports benefit, no benefit shown, and mixed describe the direction of the measured effect. No benefit shown means the evidence does not support a benefit. It is not a finding of harm. Too little evidence means the question did not clear that bar.
Study count, RCT count, and patient count are separate. The patient total adds only studies that are linked into a study family and whose sample size is not flagged as implausible. A reversal is listed only when at least one randomized trial sits on each side of the change.
The overview is drafted from the guideline recommendations, trials, papers, and questions on this page, and every sentence has to cite one of them. It stays unverified until an NPI-verified clinician or a Synapse admin approves it. Approving records that person's name.
NCT05516498 · Phase 2 · Terminated · 205 participants · started 2022
Outcomes in patients with diabetes, atherosclerotic cardiovascular disease, and heart failure treated with tirzepatide or dulaglutide: SURPASS-CVOT analysis
Most-cited researchers publishing on Dapagliflozin.
