To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).

Start Date01 Feb 2026

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

[+1]

NCT07044700

/ Not yet recruitingNot Applicable

Non-interventional Study of the Effectiveness and Safety of Jardiance in Patients With Heart Failure (HF) of Reduced Ejection Fraction (HFrEF) Compared to Guideline-recommended Non-SGLT2i Therapy Regimens in China: A Sub-study of the Postmarketing Study of Jardiance Among Patients With Heart Failure in China

This study is to provide the effectiveness and safety evidence in patients with heart failure of reduced ejection fraction (HFrEF) initiating Jardiance in real clinical practice in a larger Chinese population.
The primary objective is to compare the risk of the composite outcome of cardiovascular (CV) death or hospitalisation for heart failure (HHF) in heart failure with reduced ejection fraction (HFrEF) patients initiating Jardiance with propensity score (PS) matched HFrEF patients initiating guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (SGLT2i) medications (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) in China, measured by the hazard ratio of the two groups.

Start Date31 Jan 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06625073

/ Not yet recruitingPhase 4IIT

Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients

Heart transplant (HTx) is an established therapy for advanced heart disease that restores quality of life and improves survival. However, due to preexisting comorbidities combined with the immunosuppressive therapies required after transplantation, HTx recipients remain at high risk for kidney, cardiovascular (CV), and metabolic disease. Large randomized clinical trials have recently shown that sodium-glucose cotransporter 2 inhibitors (SGLT2i) have potent kidney protective and CV benefits in many populations of patients with chronic kidney disease (CKD), CV disease and/or diabetes. SGLT2i have not been studied prospectively in HTx recipients, which represents a barrier to their use in this population.
In this multicenter randomized controlled trial in Veterans with HTx, investigators will evaluate the potential benefits of empagliflozin on kidney function, cardiometabolic risk, erythropoiesis, and functional status. A total of 200 Veterans will be randomly assigned to receive either empagliflozin 10 mg daily or a matching placebo for 12 months.

Start Date02 Jan 2026

Sponsor / Collaborator

VA Office of Research and Development

100 Clinical Results associated with Empagliflozin

100 Translational Medicine associated with Empagliflozin

100 Patents (Medical) associated with Empagliflozin

3,598

Literatures (Medical) associated with Empagliflozin

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-utility analysis of empagliflozin for heart failure in the Philippines

Article

Author: Llanes, Elmer Jasper ; Salvador, Dante ; Añonuevo, John ; Montilla, Precious Juzenda ; Ong-Garcia, Helen ; Encarnacion, Patrick James ; Taneo, Mary Joy ; Orolfo, Diana Dalisay ; Aquino, Camilo Oliver ; Permejo, Chito ; Villanueva, Anthony Russell ; Cunanan, Elaine

AIMS:

Empagliflozin confers cardioprotective benefits among patients with heart failure, across the range of ejection fraction (EF), regardless of type 2 diabetes status. The long-term cost-effectiveness of empagliflozin for the treatment of heart failure (HF) in the Philippines remains unclear. This study aims to determine the economic benefit of adding empagliflozin to the standard of care (SoC) vs the SoC alone for HF in the Philippines.

METHODS:

Using a Markov model, we predicted lifetime costs and clinical outcomes associated with treating HF in the Philippine setting. We used estimates of treatment efficacy, event probabilities, and derivations of utilities from the EMPEROR trials. Costs were derived from hospital tariffs and expert consensus. Separate analyses were performed for patients with left ventricular EF > 40%, categorized under mid-range ejection fraction or preserved ejection fraction (HFmrEF/HFpEF), and patients with left EF ≤ 40%, categorized under HF with reduced ejection fraction (HFrEF).

RESULTS:

Our model predicted an average of 0.09 quality-adjusted life year (QALY) gains among HFmrEF/HFpEF patients and HFrEF patients when empagliflozin was compared to SoC. The addition of empagliflozin in the treatment results in a discounted incremental lifetime cost of PHP 62,692 (USD 1,129.99) and PHP 17,215 (USD 308.67) for HFmrEF/HFpEF and HFrEF, respectively. The incremental cost-effectiveness ratio (ICER) of empagliflozin is PHP 198,270 (USD 3,570.72)/QALY and PHP 742,604 (USD 13,385.08)/QALY for HFrEF and HFmrEF/HFpEF, respectively.

LIMITATIONS:

This study employed parameters derived from short-term clinical trial data, alongside metrics representative of Asian populations, which are not specific to the Philippine cohort.

CONCLUSIONS:

Adding empagliflozin to the SoC in comparison to the SoC is associated with improved clinical outcomes and quality-of-life, at additional costs for both HFrEF and HFmrEF/HFpEF.

31 Dec 2025·ANNALS OF MEDICINE

Efficacy and safety of empagliflozin for the acute myocardial infarction: a systematic review and meta-analysis of randomized controlled trials

Review

Author: He, Youfu ; Peng, Lei ; Yin, Jing ; Fan, Jun ; Zhang, Zhongnan

OBJECTIVE:

This study aims to evaluate the efficacy and safety of empagliflozin in acute myocardial infarction (AMI) treatment by synthesizing evidence from published randomized controlled trials (RCTs).

METHODS:

PubMed, Web of Science, Embase, and Cochrane databases were thoroughly retrieved from inception to November 30, 2024, to identify eligible RCTs comparing empagliflozin with placebo in AMI treatment. The Cochrane Risk of Bias tool was leveraged to detect potential bias. The robustness of the results was examined via sensitivity analyses. Publication bias was evaluated via funnel plots and Egger's test.

RESULTS:

Data from 9 RCTs involving 7,237 AMI patients were analyzed. Meta-analysis revealed that empagliflozin significantly reduced the total hospitalization rate for heart failure (HF) in AMI patients in comparison to placebo (relative risk [RR] = 0.70, 95% confidence interval [CI] = 0.57-0.85). Additionally, empagliflozin significantly improved their ejection fraction (EF) (standard mean difference [SMD] = 1.01, 95% CI = 0.63-1.38), left ventricular global longitudinal strain (LVGLS) (SMD = -0.27, 95% CI = -0.48 to -0.06), body weight (SMD = -0.80, 95% CI = -1.15 to -0.45), and systolic blood pressure (SBP) (SMD = -0.54, 95% CI = -0.88 to -0.20). Statistically significant differences were not noted in other parameters (all p > 0.05). The incidence of adverse events (AEs), such as hepatic dysfunction, contrast-induced nephropathy, and urinary tract infections, did not differ significantly across groups (all p > 0.05). The GRADE rating indicated the evidence for HF hospitalization rate and body weight was of high certainty.

CONCLUSION:

Empagliflozin lowers the total hospitalization rate for HF in AMI patients and significantly improves EF, LVGLS, body weight, and SBP without raising the likelihood of AEs.

01 Dec 2025·Current Neurology and Neuroscience Reports

The Role of Diabetes and SGLT2 Inhibitors in Cerebrovascular Diseases

Review

Author: Moustafa, Bayan ; Trifan, Gabriela

PURPOSE OF REVIEW:

Diabetes is a well-established risk factor for stroke. Understanding the pathophysiology of this connection is crucial to implementing appropriate prevention strategies. Lately, there has been a paradigm shift in the care of individuals with diabetes toward the use of glucose-lowering medications with potential cardiovascular, cerebrovascular or cardiorenal benefits. The aim of this article is to provide a critical analysis of the role of diabetes in cerebrovascular disease and current evidence and recommendations for the use of glucose-lowering medication with particular focus on the sodium glucose cotransporter-2 inhibitor (SGLT2i) class.

RECENT FINDINGS:

Intensive glycemic control in individuals with diabetes reduces the risk of microvascular complications, but there is less clear evidence for decreasing risk of macrovascular events (e.g., stroke). A multifaceted management of diabetes addressing healthy lifestyle practices, glycemic control, and optimization of other cardiovascular risk factors is highly recommended. SGLT2i are the latest class of antihyperglycemic agents available for diabetes management. Canagliflozin and empagliflozin are associated with reduction in major adverse cardiovascular events (MACE). Dapagliflozin did not reduce the rate of MACE but is associated with reduction in heart-failure related death and hospitalization and has the potential to decrease dementia risk. Ertugliflozin decreases rates of hospitalization related to heart failure however it was non-inferior to placebo in reducing MACE. There is increasing evidence that the use of SGLT2i may reduce the risk of stroke, particularly hemorrhagic stroke, in individuals with type 2 diabetes and a high risk of cardiovascular events, and that SGLT2i may also be beneficial for brain health by decreasing risk of cognitive decline and dementia. Antihyperglycemic therapy should be tailored to patients' circumstances. SGLT2i treatment should be considered in patients with type 2 diabetes and established or high-risk cardiovascular disease, heart failure, or chronic kidney disease, to reduce the overall cerebro-cardiovascular and renal risks.

326

News (Medical) associated with Empagliflozin

17 Oct 2025

·www.prnewswire.com

FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

Rybelsus® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events1 In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to placebo, in addition to standard therapies Milestone underscores the robust data supporting oral semaglutide and demonstrates Novo Nordisk's cardiometabolic leadership and commitment to people living with chronic disease PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Oct. 17, 2025 /PRNewswire/ -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-1 medication available, for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention). Results of the SOUL trial reinforce the clinical profile of the semaglutide molecule, which has been studied across a variety of therapeutic areas.2 "Even in the absence of a previous heart attack or stroke, adults with type 2 diabetes face an increased risk of cardiovascular events, underscoring the need for therapies that go beyond managing blood sugar," said John B. Buse, MD, PhD, Distinguished Professor of Medicine, Director of the UNC Diabetes Care Center, and Steering Committee Co-Chair of the SOUL trial. "Having an oral GLP-1 therapy to help improve glycemic control was an innovation in and of itself. This new indication, based on the SOUL data, marks even further advancement and showcases the versatility of semaglutide while expanding options for millions of people." This new indication makes Rybelsus® the only oral GLP-1 medicine approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events. It serves for both primary prevention (reducing the risk of major adverse cardiovascular events by preventing or managing risk factors in adults who are at high risk for these events) and secondary prevention (reducing the risk of another event in people who have had a serious CV event). The primary objective of the phase 3b SOUL trial was to evaluate the effects of oral semaglutide 14 mg, in addition to standard of care, on reducing the risk of MACE in adults with type 2 diabetes at high risk for major cardiovascular events. The primary endpoint of the study was the time to first occurrence of MACE (a 3-point composite of CV death, non-fatal myocardial infarction, or nonfatal stroke). MACE events occurred in 579/4825 participants (12.0%) of the semaglutide group and 668/4825 participants (13.8%) of the placebo group (HR 0.86; 95% CI, 0.77-0.96; p=0.006).2 Oral semaglutide 14 mg demonstrated a statistically significant 14% relative reduction in risk of MACE at 4 years (2% absolute risk reduction at 3 years) compared with placebo.2 These results add to the extensive body of randomized clinical trial and real-world evidence supporting semaglutide. "As the only FDA-approved GLP-1 therapy in a pill, now recognized for its proven cardiovascular benefits, a new benchmark has been set for future oral innovations," said Dave Moore, Executive Vice President, US Operations of Novo Nordisk Inc. "The semaglutide molecule has consistently demonstrated robust outcomes across multiple, large-scale trials, further reinforcing the already established cardiovascular profile it delivers for patients." The overall safety profile of oral semaglutide 14 mg in SOUL was consistent with that seen in previous trials, with safety data collection focused on serious adverse events, those of special interest, and those leading to discontinuation.2 The most common serious adverse events (SAEs) in the oral semaglutide 14 mg and placebo groups were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively). SAEs were less common with oral semaglutide 14 mg (47.9%) than with placebo (50.3%), although there was a higher incidence of gastrointestinal disorders with oral semaglutide 14 mg (5.0% versus 4.4%). Adverse events that led to permanent discontinuation of oral semaglutide or placebo occurred in 749 participants (15.5%) in the oral semaglutide group and in 559 participants (11.6%) in the placebo group. Such events were mainly gastrointestinal disorders as well as infections or infestations.2 The FDA initially approved Rybelsus® in 2019 as the first and only GLP-1 medicine in pill form, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.1 Separately, Novo Nordisk has also submitted a supplemental application in the US for a once-daily oral formulation of semaglutide under the trade name Wegovy® for the treatment of obesity. A decision is expected later this year. Only Novo Nordisk manufactures FDA-approved semaglutide medicines. Novo Nordisk is continuing to take multiple proactive measures to prevent both unlawful compounded and counterfeit versions of semaglutide. Novo Nordisk believes it is vitally important to make patients aware of the potential dangers of these unsafe and unapproved knockoff alternatives and informed of how to access authentic, FDA-approved Novo Nordisk semaglutide medicines. More information can be found on semaglutide.com. About SOUL SOUL was a multicenter, international, randomized, double-blind, parallel-group, placebo-controlled, phase 3b cardiovascular outcomes trial, with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide versus placebo, when added to standard of care, on cardiovascular outcomes in people with type 2 diabetes who are at high risk of MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). The SOUL trial was initiated in 2019 with a mean follow up of 4 years. The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE; a composite endpoint consisting of cardiovascular death, heart attack, and stroke).2 Oral semaglutide 14 mg demonstrated a statistically significant 14% relative reduction in risk of MACE at 4 years (2% absolute risk reduction at 3 years) compared with placebo.2 About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise.3,4 Rybelsus® is administered once daily and is currently available for use in two therapeutic dosages: 7 mg and 14 mg.5,6 Rybelsus® is currently commercially marketed in 45 countries. 2.4 million people have been prescribed Rybelsus® worldwide.7 What is RYBELSUS®? RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used: along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus who are at high risk for these events It is not known if RYBELSUS® is safe and effective for use in children Important Safety Information What is the most important information I should know about RYBELSUS®? RYBELSUS® may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS® and medicines that work like RYBELSUS® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use RYBELSUS® if: you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS®. See symptoms of serious allergic reaction in What are the possible side effects of RYBELSUS ®?" Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you: have or have had problems with your pancreas or kidneys have a history of vision problems related to your diabetes are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or plan to become pregnant. It is not known if RYBELSUS® will harm your unborn baby. You should stop using RYBELSUS® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS® Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works. How should I take RYBELSUS®? Take RYBELSUS® exactly as your healthcare provider tells you to Do not take more than 1 tablet each day Take RYBELSUS® by mouth on an empty stomach in the morning with a sip of plain water (no more than 4 ounces). Do not take RYBELSUS® with any other liquids besides water Do not split, crush, or chew. Swallow RYBELSUS® whole After 30 minutes, you can eat, drink, or take other oral medicines If you miss a dose of RYBELSUS®, skip the missed dose and go back to your regular schedule What are the possible side effects of RYBELSUS®? RYBELSUS® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using RYBELSUS® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS® low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting or diarrhea that does not go away severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use RYBELSUS®. Tell your healthcare provider if you have stomach problems that are severe or will not go away serious allergic reactions. Stop using RYBELSUS® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, and clay-colored stools food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). RYBELSUS® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS® before you are scheduled to have surgery or other procedures The most common side effects of RYBELSUS ® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®. Please click here for Prescribing Information and Medication Guide for RYBELSUS®. Please click here for Prescribing Information for Wegovy® including Medication Guide. About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com , Facebook , Instagram , and X . References Rybelsus® (oral semaglutide) [package insert]. Plainsboro, NJ: Novo Nordisk Inc. McGuire DK, Marx N, Mulvagh SL, et al. Oral semaglutide and cardiovascular outcomes in high-risk type 2 diabetes.N Engl J Med. 2025;392(20):2001-2012. Rybelsus® (oral semaglutide): US Prescribing Information. Available at: . Last accessed: October 2025. Rybelsus® (oral semaglutide): Summary of Product Characteristics. Available at: Rybelsus | European Medicines Agency (EMA). Last accessed: September 2025. Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated haemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial. JAMA. 2019;321(15):1466-1480. Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: the PIONEER 2 trial. Diabetes Care. 2019;42(12):2272-2281. Novo Nordisk Data on File. IQVIA Jun'25 Patients R3M Vol. data. 2025. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25RYB00345 October 2025 SOURCE Novo Nordisk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3

08 Sep 2025

·thryvtrx.com

Thryv Therapeutics Receives FDA IND Clearance of THRV-1268 for Heart Failure and Atrial Fibrillation and Presents SGK1 Inhibition Results Combined with Jardiance in Pressure Overload Model at ESC 2025

Montreal, Quebec – September 8, 2025 – Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced the presentation of preclinical results demonstrating improvements in adverse cardiac remodeling beyond empagliflozin (EMPA) by reducing inflammation and fibrosis mechanisms in heart failure. These findings were presented by Saumya Das, MD, PhD, Co-Director of the Resynchronization and Advanced Cardiac Therapeutics Program at Massachusetts General Hospital, at the European Society of Cardiology (ESC) Congress 2025, held in Madrid, Spain. In addition, Thryv is pleased to announce the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate its clinical program in heart failure (HF) and atrial fibrillation. New Preclinical Data Presented at ESC 2025 On August 31, 2025, Thryv presented new preclinical data from a pressure overload HF model at ESC Congress. This in vivo study evaluated the effects of THRV-1268, both as a monotherapy and in combination with empagliflozin (Jardiance®), an SGLT2 inhibitor, in a transverse aortic constriction (TAC) model. Results demonstrated that treatment with THRV-1268, alone or in combination with Jardiance, improved mechanical and structural function over vehicle and Jardiance alone, as measured by left ventricular ejection fraction, end systolic volume, and posterior wall thickness. Biomarker analyses demonstrated that THRV-1268 attenuated the dysregulation of pro-inflammatory, pro-fibrotic, and metabolic pathways beyond Jardiance in this model. The combination of THRV-1268 with Jardiance represents a promising potential therapeutic strategy for patients with heart failure. A Phase 1 study (NCT06507839) evaluating the safety, tolerability and pharmacokinetics of THRV-1268 demonstrated that the compound was well-tolerated with predictable pharmacokinetics. IND Clearance of THRV-1268 for the Heart Failure and Atrial Fibrillation Clinical Programs Thryv announced that it has received a Study May Proceed letter from the FDA for its IND application to evaluate THRV-1268 in obese healthy volunteers and screening for that study has begun. “This IND clearance represents a significant milestone for Thryv as we transition into mid-stage clinical development,” said Debra Odink, PhD, President and Chief Development Officer of Thryv. “The FDA’s agreement for us to proceed with the Phase 1 clinical investigation is an important step towards the goal of advancing THRV-1268 into Phase 2 proof of efficacy studies, where we aim to demonstrate its potential as a novel, mechanism-based therapy for patients living with heart failure and atrial fibrillation.” The role of SGK1 inhibition in mediating beneficial structural and electrical remodeling well suits the company’s plans to initiate the Phase 2 proof of efficacy Aspire study in heart failure and obesity-associated paroxysmal atrial fibrillation in 2026. About Thryv Therapeutics Inc. Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv is pioneering a precision medicine approach to treat Long QT Syndrome, heart failure and atrial fibrillation with potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK-1). For more information, please visit www.thryvtrx.com. Media Inquiries brittany@thryvtrx.com | 514 973 0915

INDPhase 1

04 Sep 2025

·www.prnewswire.com

Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 26-29

WASHINGTON, Sept. 4, 2025 /PRNewswire/ -- The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 26-29, at the at the Minneapolis Convention Center in Minneapolis, MN. Late breaking clinical research to be featured during two plenary sessions includes results and updates from these major randomized trials: Continue Reading Heart Failure Society of America Annual Scientific Meeting 2025 takes place September 26-29 in Minneapolis, MN. Sunday, September 28 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 1: Devices and Cardiomyopathies Integra-D Trial Effects of a Novel Cardiac Contractility Modulation-Defibrillator (CCM-D) on NYHA Functional Class in ICD-Indicated Patients: Post-Implant Results from the Integra-D Trial FUTURE-HF Development of an Individualized Congestion Score using a Novel Implantable Inferior Vena Cava Sensor: the FUTURE-HF Trial Portfolio DETECT-HF Development and Training of a Voice-Based Algorithm for Heart Failure Monitoring: Performance results from 599 Patients over 360,000 Patient-Days FOREST-HCM Safety and Efficacy of Aficamten in Patients with Nonobstructive Hypertrophic Cardiomyopathy: a 96-week analysis from FOREST-HCM MAPLE-HCM Divergent Effect of Aficamten Versus Metoprolol on Exercise Performance in Obstructive Hypertrophic Cardiomyopathy: A Prespecified Analysis of MAPLE-HCM ATTRibute-CM Acoramidis Reduces Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Transthyretin Amyloid Cardiomyopathy: Results From ATTRibute-CM HELIOS-B Reduction in Gastrointestinal Events in ATTR-CM Patients Treated with Vutrisiran Compared with Placebo: Analysis from HELIOS-B Monday, September 29 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 2: Novel Therapies VICTOR Trial Vericiguat Efficacy and Safety Across Baseline Background Therapy in Contemporary Ambulatory Patients with HFrEF Enrolled in the VICTOR trial Tolerability and Safety of Vericiguat in Chronic Heart Failure with Reduced Ejection Fraction SEISMiC C Safety and Efficacy of Intravenous Administration of Istaroxime for 48 hours in Patients with SCAI C Cardiogenic Shock due to Acute Heart Failure SUMMIT Trial Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis from the SUMMIT Trial GARDEN TIMI-74 GDF-15 Neutralization in Patients with Heart Failure: Primary Results of the GARDEN-TIMI 74 Trial Danicamtiv Trial Danicamtiv Restores Ventricular and Atrial Function in Patients with Dilated Cardiomyopathy Caused by Genetic Variants that Depress Sarcomere Function Late Breaking Clinical Research showcases novel results of major randomized trials and rapidly evolving research. Due to the quantity of remarkable trials submitted, HFSA will also feature late breaking research through Rapid Fire Oral Sessions. These Rapid Fire sessions are fast-paced oral presentations spotlighting key data from late breaking clinical research. Sessions take place on Sunday and Monday with Q&A and new topics each day. Sunday September 28 | Rapid Fire 1 | 10:45 AM - 11:45 AM Phase 1 Study of Daratumumab-Hyaluronidase for Reduction of Circulating Antibodies in Patients with High Allosensitization Awaiting Heart Transplantation Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Post-Heart Transplant Patients: A Multi-Center Retrospective Cohort Study Long Term Outcomes after LVAD Weaning for Myocardial Recovery: Results from the VAD Wean Recovery Network First-In-Human Implantation of a Next-Generation Membrane-Based LVAD Long Term Trajectory of Glomerular Filtration Rate Post-LAVD and the Impact on Clinical Outcomes: An analysis of the MOMEMTUM 3 Study Increased LVEF at Six Months Following LVAD Implant is Associated with Improved Long-Term Outcomes - A MOMENTUM-3 Analysis Screening for advanced heart failure in stable outpatients (The SAINTS study) Sunday, September 28 | Rapid Fire 2: | 2:15 PM - 3:15 PM Clinical Outcomes for Heart Failure at High Risk of Hyperkalemia according to Optimization of Agents Targeting the Renin-Angiotensin-Aldosterone System Intravenous Ferric Carboxymaltose in Patients With Ischemic Versus Non-Ischemic Etiology of Heart Failure and Iron Deficiency Residual Risk of Hyperkalemia Among Patients with Heart Failure Treated with SGLT2i and ARNI Instead of ACEI/ARB High-Dose IV Loop Diuretic Therapy and Ototoxicity Risk in Patients with Acute Heart Failure: Insights from the FASTR Trial Expanded Results from a Guideline-Directed Medical Therapy Clinic Optimized Heart Failure Therapy in Patients at Risk of Cardiac Wasting in Patients with Advanced Cancer: Results from the EMPATICC trial Supervised Exercise Training Improves Outcomes in Heart Failure: Evidence from the PACT-HF 2×2 Factorial Trial Sunday, September 28 | Rapid Fire 3 | 4:15 PM - 5:15 PM Cardiac Contractility Modulation Reduces Mortality and Heart Failure Hospitalizations: A Matched Comparison of Patients Receiving and Not Receiving CCM Derived from a Real-World Dataset PROACTIVE-HF: 2-year outcomes, stratified by LVEF Outcomes of Poor Clinical Responders After Transcatheter Aortic Valve Replacement in Older Patients Invasive Hemodynamic Risk Stratification and Transcatheter Edge-to-Edge Tricuspid Repair: One-Year Results from TRILUMINATE Pivotal Trial Relationship between changes in seated pulmonary artery pressure, blood pressure, heart rate, and weight prior to heart failure hospitalization A Randomized Trial of a Remote, Digital Intervention Targeting Heart Failure Medical Therapy Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-invasive Multisensor Device Deep learning assisted prediction for occurrence of pacing-induced cardiomyopathy in the atrio-ventricular block Monday, September 29 | Rapid Fire 4 | 12:00 PM – 1:00 PM Effect of vericiguat, compared with placebo, across baseline risk categories in chronic heart failure with reduced ejection fraction in the VICTOR Trial Effect of Vericiguat on Heart Failure Hospitalisation Events in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Effect of Vericiguat on Mortality in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Regional Variation in Outcomes and Response to Vericiguat in Heart Failure with Reduced Ejection Fraction: The VICTOR Trial Effect of the Soluble Guanylate Cyclase Stimulator Vericiguat on Health Status in the Phase 3 VICTOR Trial The Effect of Vericiguat on Mode of Death in Patients with Heart Failure with Reduced Ejection Fraction in the VICTOR Trial Rapidity of benefit of simultaneous initiation of finerenone and empagliflozin in people with chronic kidney disease and type 2 diabetes: the CONFIDENCE trial Dapagliflozin in Patients with Heart Failure: A Meta-Analysis of DAPA-HF, DELIVER, and DAPA ACT HF-TIMI 68 The meeting kicks off in just three weeks. A full schedule at a glance is available online, as well as information on the science and research and networking available at the meeting. Learn more about the meeting and register at hfsa.org/asm2025. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. Media Contact: Laura Poko, 301-798-4493, ext. 226, [email protected] SOURCE Heart Failure Society of America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 1

100 Deals associated with Empagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10459	Empagliflozin	A10BK03	DB09038

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cardiovascular Diseases	China	Boehringer Ingelheim GmbH	26 May 2023
Cardiovascular Diseases	China	Boehringer Ingelheim International GmbH	26 May 2023
Heart failure with normal ejection fraction	China	Boehringer Ingelheim International GmbH	30 Aug 2022
Heart failure with normal ejection fraction	China	Boehringer Ingelheim (China) Investment Co., Ltd.	30 Aug 2022
Heart failure with reduced ejection fraction	China	Boehringer Ingelheim GmbH	10 Jun 2022
Heart failure with reduced ejection fraction	China	Boehringer Ingelheim International GmbH	10 Jun 2022
Chronic heart failure	European Union	Boehringer Ingelheim International GmbH	22 May 2014
Chronic heart failure	Iceland	Boehringer Ingelheim International GmbH	22 May 2014
Chronic heart failure	Liechtenstein	Boehringer Ingelheim International GmbH	22 May 2014
Chronic heart failure	Norway	Boehringer Ingelheim International GmbH	22 May 2014
Chronic Kidney Diseases	Australia	Boehringer Ingelheim Pty Ltd.	30 Apr 2014
Diabetes Mellitus, Type 2	Australia	Boehringer Ingelheim Pty Ltd.	30 Apr 2014
Heart Failure	Australia	Boehringer Ingelheim Pty Ltd.	30 Apr 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Defects, Congenital	Phase 3	Canada	Boehringer Ingelheim GmbH	01 May 2025
Glycosuria, Renal	Phase 3	-	Tanta University	01 Jan 2023
Schizophrenia	Phase 3	-	Tanta University	01 Jan 2023
Metabolic Dysfunction Associated Steatohepatitis	Phase 3	Egypt	Tanta University	01 Nov 2022
Hypoglycemia	Phase 3	Switzerland	Boehringer Ingelheim GmbH	11 Mar 2022
Acute myocardial infarction	Phase 3	United States	Boehringer Ingelheim International GmbH	16 Dec 2020
Acute myocardial infarction	Phase 3	United States	Boehringer Ingelheim Pharma GmbH & Co., KG	16 Dec 2020
Acute myocardial infarction	Phase 3	United States	Eli Lilly & Co.	16 Dec 2020
Acute myocardial infarction	Phase 3	United States	Boehringer Ingelheim GmbH	16 Dec 2020
Acute myocardial infarction	Phase 3	China	Eli Lilly & Co.	16 Dec 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05081219 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	47	Aptar Pharma CPS Intranasal Delivery Device+Insulin (Humulin® R U-100) (Intranasal Insulin and Empagliflozin Placebo)	mojbqqbfph = jtfwgaqraf xabsbpjznp (enrhdnfglk, qhksfukqvp - vnhpntsund) View more	-	21 Oct 2025
				Aptar Pharma CPS Intranasal Delivery Device+Empagliflozin 10 MG (Empagliflozin and Intranasal Insulin Placebo)	mojbqqbfph = mquakchell xabsbpjznp (enrhdnfglk, aygegemjjt - gtrsoawdkc) View more
NCT03215069 (Pubmed \| Diabetes Obes Metab)	Phase 2	Diabetes, Gestational	91	Empagliflozin 10 mg/day	tehsldlfmu(uhhvqmlkhm): P-Value = 0.43 View more	Negative	18 Sep 2025
				Placebo
NCT05254002 (CONFIDENCE, Pubmed \| Nephrol Dial Transplant)	Phase 3	-	818	Finerenone plus empagliflozin	sysaiukbfd(hvkbznevxb) = lhjnztzyzk hhhepwekxm (vgowhbsokr ) View more	Positive	31 Aug 2025
NCT03594110 (EMPA-KIDNEY, Pubmed \| EClinicalMedicine)	Phase 3	Chronic Kidney Diseases	6,609	Empagliflozin 10 mg	mofwoqvgvj(auypyixmfs) = xsgrgeaamz rzjxuffbyt (cxtykxlzsv )	Positive	01 Jul 2025
NCT05262764 (Pubmed \| Expert Opin Drug Saf)	Not Applicable	Heart Failure type 2 diabetes	-	Empagliflozin	bjigyczqrj(akohehcglw) = xahfhtdgnk rkcvcstkvf (futuiquouy ) View more	Positive	18 Jun 2025
NCT03753087 (Pubmed \| Cardiovasc Diabetol)	Phase 4	Diabetes Mellitus, Type 2 \| Heart failure with normal ejection fraction N-terminal pro-brain natriuretic peptide (NT-proBNP) \| sST2	70	Empagliflozin 10 mg	ohcidahkls(qrveakyymc) = nywzuoiaot idgssjyogd (lkcktlfert )	Positive	09 May 2025
				empagliflozin (Control Group)	ohcidahkls(qrveakyymc) = nqntsirfvq idgssjyogd (lkcktlfert )
NCT05282121 (CTgov)	Phase 2	Hepatitis A \| Esophageal and Gastric Varices \| Metabolic Dysfunction Associated Steatohepatitis ... View more	90	Avenciguat (Patients With HBV - Avenciguat)	jfpagadurd(lmetlhdxos) = vttlbjivsk gkkjqhvsgj (rrzxbpxaru, 6.66) View more	-	29 Apr 2025
				Avenciguat (Patients With HCV - Avenciguat)	jfpagadurd(lmetlhdxos) = oxgymicvkw gkkjqhvsgj (rrzxbpxaru, 7.09) View more
NCT03485092 (SUGAR-DM-HF, Pubmed \| Eur J Heart Fail)	Phase 4	Heart failure with reduced ejection fraction	105	Empagliflozin 10 mg	pcvwfbivmx(rznxyvvkuk) = uwcvbjhqog znogwmgevq (ppprgdvtyp, 2.5)	Positive	10 Jan 2025
				Placebo	-
NCT04509674 (EMPACT-MI, CTgov)	Phase 3	Heart Failure \| Acute myocardial infarction	6,522	Placebo (Placebo)	sqizdertey = lnubydzula lejiyqmery (wqzuslcogb, fkqdrnlvbc - ouivftknwe) View more	-	07 Jan 2025
				Empagliflozin (Empagliflozin 10 mg)	sqizdertey = jqcnlxqfjl lejiyqmery (wqzuslcogb, bzpxeflthv - njdapffjdu) View more
NCT03594110 (EMPA-KIDNEY, Pubmed \| N Engl J Med)	Phase 3	Chronic Kidney Diseases estimated glomerular filtration rate (eGFR) \| urinary albumin-to-creatinine ratio	6,609	Empagliflozin 10 mg	rqvmrhovvs(xcwpqsqusm) = zgoecjkqxp msqjtdksra (whnqlinazh ) View more	Positive	25 Oct 2024
				Placebo	rqvmrhovvs(xcwpqsqusm) = diinlwsotu msqjtdksra (whnqlinazh ) View more

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