Drugs / Empagliflozin
Empagliflozin
Regulatory milestones approvals, filings & regulatory actions · 23 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic kidney disease 2 milestones | |||||
| Filed | US (FDA) | Jardiance | chronic kidney disease | 2023-01-20 | “The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets” lilly.com ↗ “FDA and European Medicines Agency acceptance of regulatory submissions for Jardiance® for adults with chronic kidney disease” lilly.com ↗ |
| Filed | EU (EMA) | Jardiance | chronic kidney disease | — | “FDA and European Medicines Agency acceptance of regulatory submissions for Jardiance® for adults with chronic kidney disease” lilly.com ↗ |
| Filed heart failure 1 milestone | |||||
| Filed | US (FDA) | Jardiance | heart failure | 2021-01-11 | “FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin)” lilly.com ↗ |
| Filed symptomatic heart failure 2 milestones | |||||
| Filed | EU (EMA) | Jardiance | symptomatic heart failure | 2021-10-26 | “The companies submitted Jardiance for regulatory approval in this indication to the FDA and in Europe.” lilly.com ↗ |
| Filed | US (FDA) | Jardiance | symptomatic heart failure | 2021-10-26 | “The companies submitted Jardiance for regulatory approval in this indication to the FDA and in Europe.” lilly.com ↗ |
| Filed type 2 diabetes mellitus 8 milestones | |||||
| Filed | US (FDA) | Jardiance | type 2 diabetes mellitus | 2023-03-08 | “The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin)” lilly.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2019-06-04 | “The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and...” lilly.com ↗ |
| Filed | US (FDA) | Jardiance | type 2 diabetes mellitus | 2016-01-25 | “The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application for Jardiance® (empagliflozin)” lilly.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2014-10-21 | “has accepted the filing of a New Drug Application (NDA) for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination” lilly.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2014-06-17 | “today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin” lilly.com ↗ |
| Rejected (CRL) | US (FDA) | — | type 2 diabetes mellitus | 2014-03-05 | “FDA has issued a complete response letter for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.” lilly.com ↗ |
| Filed | EU (EMA) | — | type 2 diabetes mellitus | 2013-03-26 | “U.S. and European regulatory submissions for two medicines to treat type 2 diabetes: empagliflozin (with partner Boehringer Ingelheim)” lilly.com ↗ “European Medicines Agency accepted for review a marketing authorization application for empagliflozin.” lilly.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2013-03-25 | “submitted a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin to the U.S. Food and Drug Administration (FDA)” lilly.com ↗ “empagliflozin* was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of type 2 diabetes” lilly.com ↗ “U.S. and European regulatory submissions for two medicines to treat type 2 diabetes: empagliflozin (with partner Boehringer Ingelheim)” lilly.com ↗ |
| Rejected type 1 diabetes mellitus 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | type 1 diabetes mellitus | 2020-03-20 | “The U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin...” lilly.com ↗ “The FDA issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for...” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (7) | US (FDA) | JARDIANCE | — | 2015-06-26 – 2023-09-21 | fda.gov ↗ |
| Approved | US (FDA) | JARDIANCE | — | 2014-08-01 | fda.gov ↗ |
| Approved | EU (EMA) | Jardiance | — | 2014-05-22 | europa.eu ↗ |
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News releases announcing trial results or a regulatory action · 85
| Date | Issuer | Release |
|---|---|---|
| 2025-06-05 | Bayer | Results Simultaneous treatment start with Finerenone and SGLT-2-inhibitor demonstrated positive data in patients with CKD associated with type 2 diabetes bayer.com ↗
The CONFIDENCE study showed that simultaneous initiation with finerenone and empagliflozin in patients with CKD associated with T2D led to an early and additive reduction in UACR from baseline of 52% at Day 180. |
| 2024-04-06 | Eli Lilly and Company | Results Results announced from EMPACT-MI phase III trial investigating the effect of Jardiance® (empagliflozin) on risk of heart failure hospitalization and death in adults following a heart attack lilly.com ↗
The EMPACT-MI phase III clinical trial showed a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization due to heart failure or all-cause mortality for Jardiance® (empagliflozin) versus placebo, which did not reach statistical significance. |
| 2023-11-06 | Boehringer Ingelheim | Results Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial prnewswire.com ↗
The results showed a significant reduction of albuminuria, a marker of kidney damage, 2 by up to 39.5% when BI 690517 was given on top of empagliflozin, a sodium glucose cotransporter (SGLT2) inhibitor, vs. placebo. |
| 2023-09-22 | Eli Lilly and Company | Regulatory US FDA approves Jardiance® for the treatment of adults with chronic kidney disease lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. |
| 2023-06-21 | Eli Lilly and Company | Regulatory US FDA approves Jardiance® (empagliflozin) for the treatment of type 2 diabetes in children 10 years and older lilly.com ↗ |
| 2023-03-08 | Eli Lilly and Company | Regulatory US FDA accepts supplemental New Drug Application for Jardiance® for children 10 years and older with type 2 diabetes lilly.com ↗ |
| 2023-01-20 | Eli Lilly and Company | Regulatory US FDA accepts supplemental New Drug Application for Jardiance® for adults with chronic kidney disease lilly.com ↗ |
| 2022-12-07 | Eli Lilly and Company | Results Phase III trial demonstrated Jardiance® is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes lilly.com ↗
The DINAMO phase III clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c (a marker of average blood sugar) with Jardiance® (empagliflozin) compared with placebo for children and adolescents aged 10-17 years living with type 2 diabetes. |
| 2022-11-04 | Eli Lilly and Company | Results Landmark EMPA-KIDNEY trial showed significant benefit of Jardiance® in reducing kidney disease progression or cardiovascular death by 28% vs. placebo in people with chronic kidney disease lilly.com ↗
When treated with Jardiance® (empagliflozin), the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to 0.82; P<0.0001). |
| 2022-08-04 | Zydus Lifesciences Limited | Regulatory Zydus Receives Final Approval From The USFDA For Empagliflozin Tablets zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Empagliflozin Tablets USP 10 mg and 25 mg. |
| 2022-06-05 | Eli Lilly and Company | Results Jardiance® decreased relative risk of hospitalization for heart failure by 50% versus DPP-4 inhibitors and by 30% versus GLP-1 receptor agonists in adults with type 2 diabetes in real-world evidence study lilly.com ↗
Jardiance® (empagliflozin) was associated with a reduction in risk of hospitalization for heart failure compared with two other classes of glucose-lowering therapies in adults with type 2 diabetes in routine care. |
| 2022-03-16 | Eli Lilly and Company | Results Jardiance® phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease lilly.com ↗
The EMPA-KIDNEY trial, evaluating the effect of Jardiance® (empagliflozin) in adults with chronic kidney disease (CKD), will stop early based on a recommendation from the trial's Independent Data Monitoring Committee. |
| 2022-03-01 | Eli Lilly and Company | Results Jardiance® provided a significant clinical benefit in adults stabilized in hospital following acute heart failure in EMPULSE phase III trial lilly.com ↗
Adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance® (empagliflozin) following stabilization and prior to discharge compared with placebo in the phase III EMPULSE trial, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. |
| 2022-02-24 | Eli Lilly and Company | Regulatory US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-11-11 | Eli Lilly and Company | Regulatory US FDA accepts supplemental New Drug Application and grants Priority Review for Jardiance® for adults with heart failure independent of left ventricular ejection fraction lilly.com ↗
The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance® (empagliflozin) 10 mg, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction (LVEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. |
| 2021-11-05 | Eli Lilly and Company | Results Jardiance® shows consistent cardio-renal benefits in adults with heart failure with left ventricular ejection fraction over 40% regardless of chronic kidney disease status lilly.com ↗
Jardiance® (empagliflozin) reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved® phase III trial. |
| 2021-09-09 | Eli Lilly and Company | Regulatory FDA grants Jardiance® Breakthrough Therapy designation for heart failure with preserved ejection fraction lilly.com ↗
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Jardiance® (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-08-27 | Eli Lilly and Company | Results Landmark trial demonstrates Jardiance® (empagliflozin) is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction lilly.com ↗
Key secondary endpoint analyses from the trial showed that Jardiance also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% and significantly slowed kidney function decline. |
| 2021-08-18 | Eli Lilly and Company | Regulatory US FDA approves Jardiance® (empagliflozin) to treat adults living with heart failure with reduced ejection fraction lilly.com ↗
Jardiance® (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-07-06 | Eli Lilly and Company | Results Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction lilly.com ↗
When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance's efficacy in all forms of heart failure regardless of ejection fraction. |
| 2021-05-31 | Hua Medicine Limited | Results Hua Medicine to present additional dorzagliatin data at ADA 2021 huamedicine.com ↗
Dorzagliatin is synergistic with sitagliptin or empagliflozin in improving blood glucose reduction and optimizing the islet β-cell function of T2D patients, improving patients’ insulin secretion. |
| 2021-01-11 | Eli Lilly and Company | Regulatory US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin) for adults with heart failure with reduced ejection fraction lilly.com ↗
The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) |
| 2020-11-18 | Eli Lilly and Company | Results Jardiance® reduced the risk of first plus recurrent cardiovascular events in adults with type 2 diabetes and established cardiovascular disease in new analysis from the EMPA-REG OUTCOME® trial lilly.com ↗ |
| 2020-10-23 | Eli Lilly and Company | Results New Jardiance® findings showed improved cardio-renal outcomes in adults with heart failure with reduced ejection fraction regardless of chronic kidney disease status lilly.com ↗ |
| 2020-09-15 | Eli Lilly and Company | Regulatory US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack lilly.com ↗ |
| 2020-08-29 | Eli Lilly and Company | Results Jardiance® reduced the combined relative risk of cardiovascular death and hospitalization for heart failure by 25% in adults with and without diabetes who had heart failure with reduced ejection fraction lilly.com ↗
Key secondary endpoint analyses from the trial demonstrated that Jardiance reduced the relative risk of first and recurrent hospitalization for heart failure by 30%. |
| 2020-08-04 | Lupin Limited | Regulatory Lupin Receives Tentative Approval for Empagliflozin Tablets lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received tentative approval for its Empagliflozin Tablets, 10 mg and 25 mg, from the United States Food and Drug Administration (U.S. FDA) to market a generic version of Jardiance® Tablets, 10 mg and 25 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2020-07-30 | Eli Lilly and Company | Results Jardiance® meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes lilly.com ↗
EMPEROR-Reduced met its primary endpoint, demonstrating superiority with Jardiance® (empagliflozin) 10 mg compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care. |
| 2020-06-19 | Eli Lilly and Company | Results Full results from EMPERIAL exercise ability trials presented lilly.com ↗
As previously reported, the EMPERIAL trials showed no significant difference in change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. |
| 2020-04-27 | Hua Medicine Limited | Results Hua Medicine Announces Positive Results of the Combination Study of Dorzagliatin with Empagliflozin (a SGLT-2 inhibitor) huamedicine.com ↗
Following OGTT, the combination treatment achieved significantly enhanced glucose lowering effect (AUEC: 279 h•mg/dL) over empagliflozin (AUEC: 452 h•mg/dL, P<0.01) or dorzagliatin (AUEC: 364 h•mg/dL, P<0.05) monotherapy. |
| 2020-04-10 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Empagliflozin Tablets zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Empagliflozin Tablets, in the strengths of 10 mg and 25 mg (US RLD: Jardiance® Tablets). |
| 2020-03-20 | Eli Lilly and Company | Regulatory US FDA issues complete response letter for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for adults with type 1 diabetes. |
| 2020-03-12 | Eli Lilly and Company | Regulatory US FDA grants Fast Track designation to Jardiance® for the treatment of chronic kidney disease lilly.com ↗
This Fast Track designation for Jardiance underscores the urgent need for additional treatment options for the over 30 million Americans living with chronic kidney disease, many of whom are at risk of progressing to end-stage kidney disease. |
| 2020-01-27 | Eli Lilly and Company | Regulatory US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. |
| 2019-12-13 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure lilly.com ↗
In both trials, there was no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. |
| 2019-11-17 | Eli Lilly and Company | Results Interim analysis from EMPRISE real-world study shows Jardiance® decreased risk of hospitalization for heart failure compared with DPP-4 inhibitors and GLP-1 receptor agonists lilly.com ↗
A new interim analysis of three-year data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study on effectiveness shows that Jardiance® (empagliflozin) was associated with a decreased risk of hospitalization for heart failure and a similar risk of non-fatal atherosclerotic cardiovascular events compared with DPP-4 inhibitors and GLP-1 receptor agonists. |
| 2019-11-13 | Eli Lilly and Company | Regulatory Boehringer Ingelheim and Lilly announce outcome of FDA Advisory Committee meeting for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14 to 2 that the benefits of empagliflozin 2.5 mg do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes. |
| 2019-06-26 | Eli Lilly and Company | Regulatory U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure lilly.com ↗
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin |
| 2019-06-10 | Eli Lilly and Company | Results New analysis shows cardiorenal risk reductions of Jardiance® are consistent in adults with type 2 diabetes, cardiovascular disease and kidney disease without overt proteinuria lilly.com ↗
The results support the need for additional studies aimed at addressing important unmet medical needs for people with various forms of kidney disease. |
| 2019-06-04 | Eli Lilly and Company | Regulatory U.S. FDA Accepts New Drug Application for Triple Combination Tablet for Adults with Type 2 Diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. |
| 2018-11-05 | Eli Lilly and Company | Results Initial results from EMPRISE real-world evidence study show Jardiance® was associated with reduced risk for hospitalization for heart failure compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease lilly.com ↗
These first results from the EMPRISE study show that empagliflozin is associated with a reduction in hospitalization for heart failure, and the effect is consistent in people with type 2 diabetes with and without history of cardiovascular disease. |
| 2018-10-10 | Eli Lilly and Company | Results New analysis estimates the positive impact of Jardiance® on life expectancy in adults with type 2 diabetes and established cardiovascular disease lilly.com ↗
Jardiance was estimated to extend life expectancy by 1 to 4.5 years on average, depending on age, when compared with placebo. |
| 2018-10-04 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly present full results from EASE Phase III program for empagliflozin as adjunct to insulin in type 1 diabetes lilly.com ↗
In EASE-2, placebo-corrected mean change from baseline in A1C at week 26 was -0.54 percent and -0.53 percent for empagliflozin 10 and 25 mg, respectively. |
| 2018-06-25 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly announce positive top-line Phase III data results for empagliflozin as adjunct to insulin in type 1 diabetes lilly.com ↗
The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in A1C after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10 and 25 mg). |
| 2018-06-23 | Eli Lilly and Company | Results Jardiance® reduced risk of kidney disease progression in adults with type 2 diabetes and established cardiovascular (CV) disease independent of control of conventional CV risk factors lilly.com ↗
This new post-hoc analysis of the EMPA-REG OUTCOME trial showed Jardiance consistently reduced the risk of new or worsening kidney disease versus placebo irrespective of control of blood pressure, low-density lipoprotein (LDL) cholesterol or A1C levels, individually or combined. |
| 2018-05-29 | Novo Nordisk A/S | Results Oral semaglutid viser større forbedring i langtidsblodsukker sammenlignet med empagliflozin i PIONEER 2-studiet novonordisk.com ↗
Studiet opfyldte sit primære mål vurderet ud fra den primære statistiske metode, idet det viste en statistisk signifikant og større forbedring i langtidsblodsukkeret (HbA1c) ved behandling med oral semaglutid sammenlignet med empagliflozin ved 26 uger. |
| 2018-05-29 | Novo Nordisk A/S | Results Oral semaglutide shows superior improvement in HbA1c vs empagliflozin in the PIONEER 2 trial novonordisk.com ↗
The trial achieved its primary objective according to the primary statistical approach by demonstrating a statistically significant and superior improvement in HbA1c with oral semaglutide compared to empagliflozin at 26 weeks. |
| 2017-11-13 | Eli Lilly and Company | Results Jardiance® reduced risk of cardiovascular death in adults with type 2 diabetes and peripheral artery disease lilly.com ↗
New data presented today showed that Jardiance® reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease. |
| 2017-09-12 | Eli Lilly and Company | Results Jardiance® (empagliflozin) tablets reduced risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease independent of background blood sugar control lilly.com ↗
New analyses of the landmark EMPA-REG OUTCOME® trial showed that Jardiance® (empagliflozin) tablets reduced the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study. |
| 2017-06-13 | Eli Lilly and Company | Results Jardiance® (empagliflozin) analysis reinforces established safety profile lilly.com ↗
The overall safety profile of Jardiance in EMPA-REG OUTCOME was consistent with that of previous studies of Jardiance and current label information. |
| 2016-12-12 | Eli Lilly and Company | Regulatory U.S. FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. |
| 2016-12-05 | Eli Lilly and Company | Regulatory U.S. FDA approves Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease lilly.com ↗
The U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. |
| 2016-11-13 | Eli Lilly and Company | Results Jardiance® (empagliflozin) consistently reduced the risk of cardiovascular death in adults with type 2 diabetes regardless of the type of cardiovascular disease at baseline lilly.com ↗
Over a median of 3.1 years, JARDIANCE significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. |
| 2016-07-19 | Eli Lilly and Company | Regulatory U.S. FDA expands indication for type 2 diabetes treatment Synjardy® (empagliflozin/metformin hydrochloride) to include treatment-naïve adults lilly.com ↗
The U.S. Food and Drug Administration has approved an expanded indication for Synjardy® (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). |
| 2016-06-28 | Eli Lilly and Company | Regulatory FDA Advisory Committee recommends approval of Jardiance® (empagliflozin) for cardiovascular indication in 12-11 vote lilly.com ↗
A U.S. Food and Drug Administration (FDA) Advisory Committee today voted 12-11 that substantial evidence exists to establish that Jardiance® (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. |
| 2016-06-14 | Eli Lilly and Company | Results Jardiance® (empagliflozin) significantly reduced the risk of progressive kidney disease in adults with type 2 diabetes with established cardiovascular disease lilly.com ↗
New data showed Jardiance® (empagliflozin) reduced the risk for new-onset or worsening kidney disease by 39 percent versus placebo when added to standard of care in adults with type 2 diabetes with established cardiovascular disease. |
| 2016-06-12 | Eli Lilly and Company | Results New Jardiance® (empagliflozin) data show that reduced risk for cardiovascular (CV) death was consistent across age groups in adults with type 2 diabetes lilly.com ↗
Consistent reduction in the risk of CV death was seen independent of age groups. |
| 2016-01-25 | Eli Lilly and Company | Regulatory U.S. FDA Accepts Filing of Cardiovascular Outcomes Data for Jardiance® (empagliflozin) lilly.com ↗
The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application for Jardiance® (empagliflozin) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME® trial. |
| 2015-11-09 | Eli Lilly and Company | Results New Jardiance® (empagliflozin) data show improved CV outcomes regardless of heart failure status at baseline lilly.com ↗
New sub-analysis data presented today showed the reduction in risk for hospitalization for heart failure or cardiovascular death with Jardiance® (empagliflozin) compared with placebo |
| 2015-09-17 | Eli Lilly and Company | Results Jardiance® (empagliflozin) is the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death in a dedicated outcome trial lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company's (NYSE: LLY) Jardiance® (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in patients with type 2 diabetes (T2D) at high risk of CV events. |
| 2015-08-27 | Eli Lilly and Company | Regulatory U.S. FDA approves Synjardy® (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Synjardy® (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), for the treatment of adults with type 2 diabetes (T2D). |
| 2015-08-20 | Eli Lilly and Company | Results Jardiance® demonstrated cardiovascular (CV) risk reduction in people with type 2 diabetes at high risk for CV events lilly.com ↗
EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of JARDIANCE, when added to standard of care, in CV risk reduction. |
| 2015-02-02 | Eli Lilly and Company | Regulatory U.S. FDA approves first-in-class Glyxambi® (empagliflozin/linagliptin) tablets for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Glyxambi® (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. |
| 2014-11-17 | Eli Lilly and Company | Results New retrospective data showed empagliflozin reduced A1C, body weight and markers of abdominal fat in adults with type 2 diabetes lilly.com ↗
In both groups, treatment with empagliflozin significantly reduced A1C, body weight and several markers of abdominal fat compared with placebo. |
| 2014-10-21 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration accepts filing of new drug application for empagliflozin/metformin fixed-dose combination lilly.com ↗
The U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). |
| 2014-08-01 | Eli Lilly and Company | Regulatory FDA approves Jardiance® (empagliflozin) tablets for adults with type 2 diabetes lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Jardiance® (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). |
| 2014-06-17 | Eli Lilly and Company | Regulatory Type 2 diabetes: Boehringer Ingelheim and Eli Lilly and Company announce resubmission of New Drug Application for empagliflozin to FDA lilly.com ↗
The Class 1 resubmission follows a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. |
| 2014-06-16 | Eli Lilly and Company | Results Type 2 diabetes: Investigational compound empagliflozin as an add-on therapy significantly reduced blood glucose and body weight in two newly presented phase III trials lilly.com ↗
In a two-year study, empagliflozin demonstrated significantly greater decreases in hemoglobin A1C (a measure of average blood glucose over the past two to three months), body weight and blood pressure compared with glimepiride as add-on to metformin in adults with T2D. |
| 2014-06-15 | Eli Lilly and Company | Results Type 2 Diabetes: Investigational Empagliflozin/Linagliptin Combination Tablet Showed Reduction in Blood Glucose in Two Phase III Trials lilly.com ↗
Two phase III clinical trials found the investigational combination tablet of empagliflozin and linagliptin reduced blood glucose levels in adults with type 2 diabetes (T2D), Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) announced. |
| 2014-06-09 | Eli Lilly and Company | Results Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 43 Presentations at the 74th American Diabetes Association Scientific Sessions® lilly.com ↗
SGLT2 inhibition with empagliflozin reduces microalbuminuria in patients with T2D |
| 2014-05-23 | Eli Lilly and Company | Regulatory Type 2 diabetes: European Commission approves Jardiance® (empagliflozin) tablets for use in adults in Europe lilly.com ↗
The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycemic control. |
| 2014-04-14 | Eli Lilly and Company | Regulatory Boehringer Ingelheim and Eli Lilly and Company Announce New Drug Application Filing in the U.S. for the Combination Tablet of Empagliflozin and Linagliptin lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application (NDA) |
| 2014-03-21 | Eli Lilly and Company | Regulatory CHMP Recommends Empagliflozin for Approval to Reduce Blood Sugar Levels in Adults with Type 2 Diabetes in Europe lilly.com ↗ |
| 2014-03-05 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin lilly.com ↗
The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. |
| 2013-06-22 | Eli Lilly and Company | Results Phase III study finds investigational agent empagliflozin significantly reduced blood glucose in adults with type 2 diabetes and impaired kidney function lilly.com ↗
Results from the study, presented at the American Diabetes Association 73rd Scientific Sessions®, also demonstrated a significant reduction in body weight and blood pressure with empagliflozin versus placebo in patients with mild to moderate kidney impairment. |
| 2013-06-22 | Eli Lilly and Company | Results Phase III data show significant reductions in blood glucose with investigational compound empagliflozin used as monotherapy in adults with type 2 diabetes lilly.com ↗ |
| 2013-06-22 | Eli Lilly and Company | Results Phase III data show significant reduction in blood glucose with investigational compound empagliflozin added to metformin or metformin plus sulfonylurea in adults with type 2 diabetes lilly.com ↗
The results showed statistically significant improvements in blood glucose as measured by reductions in HbA1c (average blood glucose) after 24 weeks among people who received empagliflozin.1,2 |
| 2013-06-22 | Eli Lilly and Company | Results Phase III data show investigational compound empagliflozin plus insulin significantly reduced HbA1c in adults with type 2 diabetes lilly.com ↗
The study, presented at the American Diabetes Association 73rd Scientific Sessions®, showed that empagliflozin 10 mg or 25 mg, plus insulin, produced statistically significant reductions in HbA1c (average blood glucose) compared with insulin alone at the study's primary endpoint, week 18, as well as at week 78. |
| 2013-06-22 | Eli Lilly and Company | Results Phase III data show investigational compound empagliflozin significantly reduced blood glucose in adults with type 2 diabetes lilly.com ↗
In the pooled analysis, presented at the American Diabetes Association 73rd Scientific Sessions®, people with T2D treated with empagliflozin versus placebo achieved significant reductions in HbA1c, fasting plasma glucose (FPG), weight and blood pressure after 24 weeks. |
| 2013-06-11 | Eli Lilly and Company | Results Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 34 Presentations on Type 1 and Type 2 Diabetes at the 73rd American Diabetes Association Scientific Sessions® lilly.com ↗
Empagliflozin Improves Glycemic Parameters and Cardiovascular Risk Factors in Patients with Type 2 Diabetes (T2DM): Pooled Data from Four Pivotal Phase III Trials |
| 2013-03-26 | Eli Lilly and Company | Regulatory European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Company's empagliflozin*, an investigational type 2 diabetes treatment lilly.com ↗
The acceptance of the MAA marks the beginning of the review process in the European Union for this potential oral diabetes treatment. |
| 2013-03-25 | Eli Lilly and Company | Regulatory Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment lilly.com ↗
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin* was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of type 2 diabetes mellitus (T2D) in adults. |
| 2013-01-07 | Eli Lilly and Company | Results Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin lilly.com ↗
In all four studies, the primary efficacy endpoint, defined as significant change in HbA1c from baseline compared to placebo, was met with empagliflozin (10 and 25 mg) taken once daily. |
| 2012-10-02 | Eli Lilly and Company | Results Pooled analysis demonstrated reductions in systolic blood pressure with empagliflozin, an investigational SGLT-2 inhibitor, independent of changes in blood glucose and weight in adults with type 2 diabetes lilly.com ↗
The new analysis showed a reduction in systolic blood pressure with empagliflozin, which, in the study, was independent of the reductions observed in blood glucose or weight, based on a statistical measure called the Pearson correlation coefficient. |
| 2012-06-09 | Eli Lilly and Company | Results 90-week data suggest sustained glucose reduction and weight loss with investigational SGLT-2 inhibitor, empagliflozin lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) presented results that showed empagliflozin (BI 10773), alone or as an add-on to metformin, reduced hemoglobin A1c (HbA1c or A1C) levels, fasting plasma glucose (FPG) levels and body weight when given to adults with type 2 diabetes for up to 90 weeks. |
All press releases naming this drug 100 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 512 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Empagliflozin | “Subjects not receiving antidiabetes therapy for ≥12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136),...” PMID 25633662 ↗ Jan 2015469“Participants randomized to the intervention group will receive empagliflozin (10 mg once daily, with optional titration to 25 mg according to clinical judgement and...” NCT07694596 ↗ “Patients with acute decompensated HF will be open-label randomly assigned to be treated with or without SGLT2 inhibitors (either empagliflozin 10 mg once daily or dapagliflozin...” NCT06142474 ↗ “BACKGROUND: The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients...” PMID 26378978 ↗ Sep 2015 “Empagliflozin 10mg (Jardiance®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM patients who had inadequate glycemic control (7% \<HbA1c ≤ 10%) with...” NCT04013581 ↗ “Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With...” NCT01301742 ↗ “The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and clinical guidelines applicable to patients with end-stage renal...” NCT06929169 ↗ “Sequential discontinuation of angiotensin receptor-neprilysin inhibitor (ARNI; e.g., sacubitril/valsartan) and sodium-glucose cotransporter-2 inhibitor (SGLT2i; e.g.,...” NCT07631156 ↗ “The purpose of our study is to see if a small dose of empagliflozin (2.5 mg and 5 mg) is enough to help those who cannot achieve adequate glucose control on a closed-loop...” NCT04450563 ↗ “Patients with inadequate glycaemic control despite stable-dose metformin received open-label empagliflozin 10 mg (study 1) or 25 mg (study 2) as add-on therapy for 16 weeks.” PMID 27762093 ↗ Nov 2016 “Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial.” PMID 24948511 ↗ Jun 2014 |
| Known as | BI 10773 | “Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers” NCT01284621 ↗46“24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension” NCT02182830 ↗ “Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food” NCT01189201 ↗ “Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects” NCT01195675 ↗ “Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment” NCT01164501 ↗ “Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes” NCT01167881 ↗ “Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus” NCT01193218 ↗ “Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers” NCT01111331 ↗ “Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension” NCT00881530 ↗ “A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773)” NCT01649297 ↗ “Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus” NCT01370005 ↗ |
| Known as | BI 10773 XX | “Empagliflozin (BI 10773 XX)” NCT01242176 ↗ |
| Known as | EMPA | “This double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov NCT02453555) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add-on to...” PMID 29766636 ↗ Jun 201815“Newly diagnosed patients with type 2 diabetes (T2D) will be randomly allocated to once daily 25 mg empagliflozin (EMPA) or placebo for 24 weeks with a computer-generated random...” NCT02637973 ↗ “evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg and linagliptin (Lina) 5 mg fixed-dose combinations (FDCs) in Japanese patients with type 2 diabetes...” PMID 30091172 ↗ Sep 2018 “This study aimed to investigate the complementary effects of combination therapy with pioglitazone (PIO) and empagliflozin (EMPA) on MASLD in individuals with type 2 diabetes.” PMID 40336058 ↗ May 2025 “We hypothesized that empaglifozin (EMPA) could modulate ectopic fat stores and myocardial energetics in high-fat-high-sucrose (HFHS) diet mice and in type 2 diabetics (T2D).” PMID 33648515 ↗ Mar 2021 “Empagliflozin (Empa) belongs to a novel class of anti-hyperglycemic drugs which was approved by the FDA on August 1, 2014.” NCT06641128 ↗ “adults with T1D received 5 mg/day empagliflozin (EMPA) or no drug (NOEMPA) as adjunct to insulin therapy.” PMID 35255229 ↗ Mar 2022 “vicadrostat/empagliflozin (vica/empa)” NCT07857772 ↗ “Drug: Empagliflozin (EMPA)” NCT07866235 ↗ “Drug: Empagliflozin (EMPA)” NCT07591077 ↗ “Empagliflozin (EMPA)” NCT07146880 ↗ |
| Known as | empagliflozin (Jardiance) | “empagliflozin (Jardiance®)” NCT07325435 ↗1“Empagliflozin, Jardiance” NCT05129722 ↗ |
| Known as | Jardiance | “A placebo-controlled randomized trial of our group has shown that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin (Jardiance)® in addition to...” NCT04447911 ↗27“All participants received a single oral dose of empagliflozin (JARDIANCE ®; 10 mg film coated tablet) in the evening, and after a seven-day washout period, the morning.” PMID 34123370 ↗ Apr 2021 “Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2.” NCT02729766 ↗ “Empagliflozin, which is sold under the name of Jardiance, is FDA approved for patients 10 years of age and older to improve glycemic control in type 2 diabetes.” NCT07228195 ↗ “Empagliflozin (Jardiance®; Boehringer Ingelheim (Schweiz) GmbH) is a highly selective, reversible inhibitor of the sodium glucose co-transporter 2 (SGLT2).” NCT05174507 ↗ “This new drug (Jardiance®, substance: empagliflozin) is currently approved in Switzerland for the treatment of patients with diabetes.” NCT04911660 ↗ “A Bioequivalence Study of Empagliflozin 10 mg Tablets Relative to Jardiance 10 mg, in Healthy Thai Volunteers Under Fasting Condition” NCT06232239 ↗ “The preferred prescription will be empagliflozin (Jardiance) 10mg daily with a 90-day fill and no refills” NCT06124924 ↗ “Empagliflozin (Jardiance™) is licensed in the UK for use in type 2 diabetes management.” NCT02798744 ↗ “10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries.” NCT06083675 ↗ “Standard dose of empagliflozin (Jardiance®; Boehringer Ingelheim GmbH), i. e. 10 mg.” NCT05036317 ↗ |
| Action | Inhibit | “a sodium glucose cotransporter 2 inhibitor” PMID 23940010 ↗ Aug 2013 |
| Modality | Small molecule | “Whether the SGLT2 inhibitor empagliflozin would improve or worsen frailty status when given to HFpEF patients is also not known.” PMID 38158636 ↗ Dec 2023 |
| Route | Oral | “Three Oral Doses of BI 10773” NCT00558571 ↗ |