Jardiance
SGLT2 inhibitor. Developed by Boehringer Ingelheim. Clinical, regulatory, and source evidence are connected below.
Latest signals
The three most recent source-backed changes linked to this drug.
EARLY/Phase 1 · RECRUITING · University of Minnesota
Phase 2 · NOT_YET_RECRUITING · Virginia Commonwealth University
Phase 2 · RECRUITING · University of Alberta
Approved uses
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.
1 INDICATIONS AND USAGE JARDIANCE is indicated: • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. • to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. • as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use JARDIANCE is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1) ] . JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 . JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action. JARDIANCE is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease [see Clinical Studies (14.5) ] . JARDIANCE is not expected to be effective in these populations.
Type 2 diabetes mellitus Jardiance 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 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 Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Jardiance is indicated in adults for the treatment of chronic kidney disease.
EMA's summary; the full indication is in the product information on the EPAR page.
Not covered here: Synjardy, Synjardy XR, Glyxambi and Trijardy XR (US); Synjardy and Glyxambi (EU) (Combinations with other diabetes drugs; combination products are not covered yet.)
Regulatory history
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.
Patents and exclusivity
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.
*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.
The current US label has no boxed warning.
None on FDA's list names this drug.
Clinical trials
A focused view of recently updated studies · 18 linked records.
University of Minnesota · Updated Oct 20, 2026
Virginia Commonwealth University · Updated Oct 20, 2026
University of Alberta · Updated Oct 15, 2026
Boehringer Ingelheim · Updated Oct 15, 2026
Boehringer Ingelheim · Updated Oct 14, 2026
Boehringer Ingelheim · Updated Oct 14, 2026
Regulatory timeline
Verified regulatory records in reverse chronological order.
Related intelligence
Records connected through the current intelligence graph.
Source evidence
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.
