Drug
Empagliflozin is an SGLT2 inhibitor used in heart failure, chronic kidney disease and type 2 diabetes.
Sources: FDA label · 19 registered trials · 1 guideline recommendation
Mechanism: sodium-glucose co-transporter 2 (SGLT2) inhibitor · FDA label (DailyMed)
Guideline:Class I · LOE AHeart failureFDA-approved indications
Source: Jardiance label (DailyMed), label dated Aug 26, 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
4 generic approvals naming empagliflozin on record (FDA; tentative approvals and combination products included), latest Sep 22, 2026.
1 other approval naming empagliflozin without one of its brands (another manufacturer's product, such as a new dosage form), latest Sep 17, 2026.
Dosing is left to the label.
Primary results of 4 trials behind the evidence on empagliflozin, 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
empagliflozin vs placebo · 6,609 patients · N Engl J Med 2023
In patients with chronic kidney disease who were at risk for disease progression
Primary outcome: a composite of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 ml per minute per 1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from cardiovascular causes
HR 0.72 (0.64–0.82)
empagliflozin vs placebo · 5,988 patients · N Engl J Med 2021
In patients with heart failure and a preserved ejection fraction
Primary outcome: a composite of cardiovascular death or hospitalization for heart failure
HR 0.79 (0.69–0.90)
empagliflozin vs placebo · 3,730 patients · N Engl J Med 2020
In patients with class II, III, or IV heart failure and an ejection fraction of 40% or less
Primary outcome: a composite of cardiovascular death or hospitalization for worsening heart failure
HR 0.75 (0.65–0.86)
empagliflozin vs placebo · 7,020 patients · N Engl J Med 2015
In Patients with type 2 diabetes at high risk for cardiovascular events
Primary outcome: death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group
HR 0.86 (0.74–0.99, 95.02% CI)
Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention. Confidence intervals are 95% unless marked.
Registered trials with empagliflozin 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 11
NCT06935370 · Phase 3 · Recruiting · 4,200 participants · started 2025
NCT06642272 · Phase 4 · Recruiting · 17,200 participants · started 2024
NCT06424288 · Phase 3 · Recruiting · 6,000 participants · started 2024
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
NCT03057951 · Phase 3 · Completed · 5,988 participants · started 2017
NCT07799441 · Phase 4 · Not yet recruiting · 100 participants · started 2026
NCT07064473 · Phase 3 · Recruiting · 11,800 participants · started 2025
NCT07541456 · Phase 4 · Completed · 300 participants · started 2025
NCT07749014 · Phase 2 · Not yet recruiting · 480 participants · started 2026
NCT06171802 · Phase 4 · Completed · 206 participants · started 2024
Other trials
NCT06030843 · Phase 2/3 · Recruiting · 200 participants · started 2025
NCT06342141 · Phase 2 · Active not recruiting · 162 participants · started 2024
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.
Outcomes in patients with diabetes, atherosclerotic cardiovascular disease, and heart failure treated with tirzepatide or dulaglutide: SURPASS-CVOT analysis
Most-cited researchers publishing on Empagliflozin.