A Bioequivalence study of a randomized, single dose, two-way crossover design with two-period, two-treatment and two-sequence of EMPAGLINAZ 25 (Empagliflozin Tablets 25 mg) relative to JARDIANCE film-coated tablets 25 mg in healthy Thai adult volunteers under fasting condition

Start Date07 Oct 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

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 Date01 Aug 2025

Sponsor / Collaborator

VA Office of Research and Development

NCT06992440

/ Not yet recruitingPhase 2IIT

Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension

Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.

Start Date01 Jul 2025

Sponsor / Collaborator

The Cleveland Clinic Foundation

[+2]

100 Clinical Results associated with Empagliflozin

100 Translational Medicine associated with Empagliflozin

100 Patents (Medical) associated with Empagliflozin

4,419

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·JOURNAL OF MEDICAL ECONOMICS

Cost-utility analysis of empagliflozin on chronic kidney disease progression in Thailand

Article

Author: Satirapoj, Bancha ; Susantitaphong, Paweena ; Singhan, Wanchana ; Ophascharoensuk, Vuddhidej ; Dilokthornsakul, Piyameth

OBJECTIVE:

The prevalence of chronic kidney disease (CKD) in Thailand is high and kidney disease progression remains a problem. Empagliflozin has been known to be used to slow CKD progression, but its accessibility remains limited. This study aimed to assess the cost-utility of empagliflozin for CKD progression in Thailand.

METHODS:

A state-transition model was developed consisting of eight health states: five eGFR health states (G2, G3a, G3b, G4, and G5), dialysis, kidney transplantation, and death. Empagliflozin 10 mg was assessed as an add-on treatment to standard of care (SoC). The efficacy of empagliflozin was derived from the EMPA-KIDNEY trial, while other inputs were obtained from a comprehensive literature review. The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) was calculated. A probabilistic sensitivity analysis (PSA) was performed to explore uncertainties.

RESULTS:

Empagliflozin could improve QALYs by 0.62 and 0.71 for patients with CKD without and with diabetes mellitus (DM) compared with SoC, respectively. However, it required higher total lifetime costs of 77,966 Thai baht (THB) and 59,454 THB for patients with CKD without and with DM, respectively. The ICER for CKD without DM was 126,201 THB/QALY, while the ICER for CKD with DM was 83,473 THB/QALY. The PSA indicated that empagliflozin had a 64.00% probability of being cost-effective for CKD without DM and an 89.18% probability for CKD with DM.

LIMITATIONS:

An important limitation was that the treatment effects of empagliflozin were derived from the EMPA-KIDNEY, which was conducted in DM patients and assumed to be the same for non-DM patients because of the limited evidence in non-DM patients.

CONCLUSION:

At the current willingness-to-pay threshold of 160,000 THB/QALY, empagliflozin was cost-effective for treating patients with CKD without or with DM.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Empagliflozin in diabetic cardiomyopathy: elucidating mechanisms, therapeutic potentials, and future directions

Review

Author: Bhatti, Jasvinder Singh ; Kaur, Maninder ; Rawat, Pushkar Singh ; Navik, Umashanker ; Jaiswal, Aiswarya ; Yadav, Poonam ; Babu, Srivalliputturu Sarath ; Khurana, Amit

Diabetic cardiomyopathy (DCM) represents a significant health burden, exacerbated by the global increase in type 2 diabetes mellitus (T2DM). This condition contributes substantially to the morbidity and mortality associated with diabetes, primarily through myocardial dysfunction independent of coronary artery disease. Current treatment strategies focus on managing symptoms rather than targeting the underlying pathophysiological mechanisms, highlighting a critical need for specific therapeutic interventions. This review explores the multifaceted role of empagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, in addressing the complex etiology of DCM. We discuss the key mechanisms by which hyperglycemia contributes to cardiac dysfunction, including oxidative stress, mitochondrial impairment, and inflammation, and how empagliflozin mitigates these effects. Empagliflozin's effects on reducing hospitalization for heart failure and potentially lowering cardiovascular mortality mark it as a promising candidate for DCM management. By elucidating the underlying mechanisms through which empagliflozin operates, this review underscores its therapeutic potential and paves the way for future research into its broader applications in diabetic cardiac care. This synthesis aims to foster a deeper understanding of DCM and encourage the integration of empagliflozin into treatment paradigms, offering hope for improved outcomes in patients suffering from this debilitating condition.

306

News (Medical) associated with Empagliflozin

10 Jun 2025

·www.businesswire.com

Navitus Drug Trend Report: Keeping Costs Low for Plans and Members in an Era of Accelerating Inflation

MADISON, Wis.--(BUSINESS WIRE)--Navitus, the nation’s first transparent, pass-through pharmacy benefit manager (PBM), released its ninth annual Drug Trend Report today, revealing how commercial plan sponsors saved millions in prescription costs while maintaining high-quality member care. 30% of Navitus clients spent less in 2024 than in the previous year, while overall client book of business drug cost trend was managed to 7%. The data shows that medications such as glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are creating unprecedented financial pressure on plan sponsors as utilization for diabetes treatment increased 26% year-over-year. Overall health spending in the United States is nearly $4.9 trillion and projected to increase nearly 6% annually over the next decade.1 A subset of this, prescription drug spending, was estimated to be $487 billion in 2024, an industry-wide 11.4% increase over the previous year, compared to 7% for Navitus clients. While the industry faces these escalating cost pressures, our latest Drug Trend Report highlights how Navitus continues to outperform industry trends and save clients money in this challenging environment, including companies such as Progressive Insurance. “Navitus stands out for its commitment to transparency and managing to lowest net cost, which has significantly benefited Progressive and its members. From the outset, their 100% pass-through model has ensured that we receive the full value of manufacturer rebates and discounts, directly translating to reduced pharmacy costs,” said Heidi Minter, Data Analyst, Benefits & Design Services, Progressive Insurance. The Navitus Drug Trend Report revealed three critical trends influencing the broader industry: 26% increase in GLP-1 RAs use for treatment of type 2 diabetes. While delivering significant clinical benefits, these medications are contributing substantially to pharmaceutical cost increases for benefit plans: Net trend in the diabetes category increased 8.5%, driven by growth in both the use of GLP-1 RAs, including Ozempic, Mounjaro and Trulicity, and a 16% increase in use of sodium-glucose cotransporter-2 inhibitors (SGLT-2s), including Farxiga and Jardiance. The prevalence and cost of GLP-1 RAs and SLGT-2s resulted in an overall unit cost increase of 3.0% for the diabetes category, in spite of the net cost decrease of more than 28% for insulin in 2024. Biosimilars delivered $315 million in savings with a 60% reduction in Humira costs. Targeted immunomodulators (TIMs) treat a wide range of autoimmune disorders, from rheumatoid arthritis and psoriasis to inflammatory bowel diseases. The launch of Humira biosimilar alternatives in 2023 significantly changed the landscape of the category as these clinically-equivalent, much lower cost options were added to formulary. After adding biosimilars to formulary, Navitus took a decisive step to lower costs further by removing Humira from formulary in June 2024. This led to key results including: Over $315 million in upfront cost savings. 60% reduction in net costs per claim. Specialty medication utilization increased 12%. Approximately 75% of new drug approvals have been for specialty or medical specialty agents, and that trend is expected to continue in the next two years. Key factors included: Oncology net trend increased more than 13%, driven by both higher utilization and unit cost: Utilization of newer breast cancer treatments (Kisqali, Verzenio) increased 20%, driving overall cost. In specialty dermatology, Dupixent (dupilumab) emerged as the most rapidly growing drug of 2024. The category saw a net trend increase of more than 45% and Dupixent represented 96% of category cost and utilization. While increased use of newer, more expensive agents like Kesimpta created upward pressure within the multiple sclerosis category, generics represented more than 50% of prescriptions filled at 10% of the cost. “Our annual Drug Trend Report confirms we were able to control year-over-year costs for commercial clients - both large and small - and deliver savings greater than the estimated industry averages,” said Sharon Faust, PharmD, MBA, CSP, Chief Pharmacy Officer, Navitus Health Solutions. “Deploying generic-first strategies, facilitating adoption of new biosimilars, ensuring 100% pass-through of negotiated rebates and discounts, and supporting clinically appropriate prescribing, utilization and formulary management remain core to our focus.” Access the Navitus Drug Trend Report executive summary here: www.navitus.com/DTR2024 Methodology: The Navitus drug trend is calculated by comparing the net total cost per-member per-month (PMPM) for 2024 to that for 2023. Net cost PMPM represents full-year (Q1-Q4) data for total member copays and plan paid amounts minus manufacturer rebates and fees. This value is divided by the total number of members and by 12 months of the year. The data represents employer plan sponsors and health plans. In order to be included organizations must have been with Navitus for two full calendar years. *Due to varying coverage decisions by clients, GLP-1s for weight loss were not included in the Drug Trend Report, yet they still warrant thoughtful consideration and conversation in the overall picture of trend and future decisions. The DTR only represents prescriptions under the pharmacy benefit. 40% of Rx spend is through the medical benefit and warrants careful consideration by plans. Sources: 1 American Medical Association, Trends in Healthcare Spending. https://www.ama-assn.org/about/research/trends-health-care-spending#:~:text=Health%20spending%20in%20the%20U.S.,%25)%20and%202021%20(18.3%25). Updated April 17, 2025. Accessed April 23, 2025. 2 IQVIA, Understanding the Use of Medicines in the U.S. 2025: Evolving Standards of Care, Patient Access, and Spending. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/understanding-the-use-of-medicines-in-the-us-2025. Published April 2025, Accessed May 15, 2025. About Navitus Navitus remains the nation’s first transparent, pass-through pharmacy benefit manager (PBM). It uniquely brings clarity to drug pricing and takes costs out of the drug supply chain. Unlike traditional PBMs that generate profit by retaining an undisclosed portion of rebates and discounts negotiated with drug manufacturers and pharmacies, Navitus passes along the complete savings to clients, enabling them to make medication more affordable for their members. Navitus was established more than 20 years ago by Navitus Health Solutions, LLC, a pioneering pharmacy solutions company. The organization delivers a range of services through portfolio brands including Navitus, Lumicera, Archimedes. Owned by SSM Health and Costco, Navitus Health Solutions serves over 18 million lives across 800 clients including employers, unions, government plans, payors and health systems. For more information, please visit www.navitus.com.

05 Jun 2025

·pipelinereview.com

Simultaneous treatment start with Finerenone and SGLT-2-inhibitor demonstrated positive data in patients with CKD associated with type 2 diabetes

Results of the Phase II study CONFIDENCE demonstrate that simultaneous initiation of finerenone and an SGLT-2-inhibitor (SGLT-2i) led to significant reductions in urine albumin-to-creatinine ratio (UACR) versus either agent alone in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) These benefits were observed as early as 14 days after treatment initiation, supporting the potential of simultaneous initiation of finerenone and an SGLTI-2i UACR is an early indicator of kidney damage, an important prognostic marker of kidney disease progression, and a predictor of adverse cardiovascular outcomes BERLIN, Germany I June 5, 2025 I Bayer announced today results of the Phase II CONFIDENCE study, demonstrating that simultaneous initiation of finerenone (Kerendia™) and the SGLT-2-inhibitor (SGLT-2i) empagliflozin led to a significantly greater reduction in urine albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) than with either treatment alone. The findings were presented at the 62 nd European Renal Association (ERA) Congress 2025 and simultaneously published in the New England Journal of Medicine . 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. This was a 29% and 32% greater relative reduction in UACR from baseline to Day 180 compared to finerenone alone and empagliflozin alone, respectively. Notably, a reduction of more than 30% in UACR was observed within 14 days of starting both treatments simultaneously – a threshold recommended by the American Diabetes Association (ADA) to slow kidney disease progression in patients with CKD*. Almost 3 out of 4 patients achieved this threshold of a 30% reduction in UACR versus baseline – 20% more than with either treatment alone. The safety profile of simultaneous initiation of finerenone and SGLT-2i was consistent with that of either agent alone, and treatment benefits were seen across all prespecified subgroups enrolled in the study, across a broad spectrum of patient populations with a high comorbidity burden. “The CONFIDENCE study delivers clinical evidence that simultaneous initiation of finerenone and empagliflozin led to an early and additive reduction in UACR of 52% in patients with chronic kidney disease and type 2 diabetes, which was significantly greater than with either treatment alone,” said Rajiv Agarwal, MD, Professor Emeritus of Medicine, Indiana University School of Medicine and VA Medical Centre, Indianapolis, USA and Chair of the study’s Steering Committee. “Given that UACR is an important mediator of kidney and cardiovascular outcomes, these findings provide key insights to clinicians when considering how to optimize disease management, supporting the early combined use of finerenone and an SGLT-2 inhibitor for a positive impact on patient outcomes.” Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, has been investigated in a broad patient population with CKD (stages 1-4) associated with T2D across two completed and published Phase III studies, FIDELIO-DKD and FIGARO-DKD, which evaluated the effects of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. Patients on background therapy with an SGLT2-inhibitor were allowed in those studies. Data from FIDELITY, a prespecified pooled analysis of these Phase III studies, confirm that early albuminuria (UACR) reduction in patients with CKD associated with T2D mediated a large proportion of the treatment effect of finerenone in slowing CKD progression. “The CONFIDENCE data mark an important milestone in our mission to improve care for people living with chronic kidney disease associated with type 2 diabetes,” said Dr. Michael Devoy, Chief Medical Officer at Bayer’s Pharmaceuticals Division. “The findings suggest that a proactive simultaneous initiation can deliver a substantial early and additive UACR reduction, which is associated with kidney and cardiovascular protection. We are excited to share these important results with physicians, as they demonstrate that early combined use of finerenone and an SGLT2-inhibitor has the potential to improve long-term outcomes for millions of patients worldwide.” Diabetes continues to be a substantial public health issue, with an estimated 462 million people globally affected by T2D alone. Approximately 40% of people with T2D go on to develop CKD, highlighting a significant unmet medical need for therapies that can better protect kidney function and slow disease progression. About the CONFIDENCE study The CONFIDENCE ( CO mbinatio N effect of FI nerenone an D E mpagliflozi N in participants with C KD and T2D using an UACR E ndpoint) study was a randomized, double-blind, double-dummy, multicenter, three-arm, parallel-group treatment, Phase II study. The primary objective of the study was to determine whether the simultaneous initiation and combined use of finerenone and empagliflozin would be superior to either treatment alone in reducing UACR in patients with CKD and T2D. The primary endpoint was the relative change in UACR from baseline to Day 180 for the combination therapy group compared to the monotherapy groups. The CONFIDENCE study randomized 818 patients in a 1:1:1 ratio, stratified by estimated glomerular filtration rate (eGFR) and UACR at screening. Patients received either finerenone (10 or 20 mg once daily) and empagliflozin (10 mg), finerenone (10 or 20 mg) and matching placebo, or empagliflozin (10 mg) and matching placebo. About Kerendia™ / Firialta™ (finerenone) Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, as well as inflammatory and fibrotic factors. Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes the completed Phase III study FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD and FIGARO-DKD and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies FIND-CKD, FIONA, FIONA-OLE, and FINE-ONE. About Bayer’s Commitment in Cardiovascular and Kidney Diseases Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma SOURCE: Bayer

Clinical ResultPhase 3Phase 2Drug Approval

27 May 2025

·www.globenewswire.com

Vivoryon Therapeutics N.V. Expands Intellectual Property Portfolio with New U.S. Composition of Matter Patent Granted for Varoglutamstat

Vivoryon Therapeutics N.V. Expands Intellectual Property Portfolio with New U.S. Composition of Matter Patent Granted for Varoglutamstat Newly granted U.S. patent expected to provide exclusivity through 2044 with subsequent opportunity for patent term extensionNew U.S. patent granted after accelerated examination process covers the active polymorph of varoglutamstat, Vivoryon’s lead drug in development Additional patents for medical use and dosing regimens under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors Halle (Saale) / Munich, Germany, May 27, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the Company’s lead drug in development, varoglutamstat. The new patent was granted after an accelerated examination process. “Vivoryon pursues a diligent and comprehensive strategy to continuously strengthen the intellectual property protecting our key assets on multiple levels. This successful patent application demonstrates our strong commitment to protecting the innovation of our lead asset varoglutamstat and is an important milestone for Vivoryon. The fact that it has been granted several months ahead of the anticipated timing is a testament to the outstanding work of our team,” said Frank Weber, MD, CEO of Vivoryon. “We expect that this long patent runway will support our efforts to maximize the full therapeutic potential of varoglutamstat, which we plan to develop in kidney disease.” The newly granted composition of matter US patent (US 12,312,335) covers the only polymorph of the salt form used in the drug product of Vivoryon’s unique QPCT/L inhibitor varoglutamstat. The patent has a scheduled runtime through 2044, with the subsequent opportunity for a patent term extension of up to five years to 2049 under the Hatch-Waxman Act. In addition, the Company has filed a number of different patents in its focus area of kidney disease over the past months. These relate to varoglutamstat and related structures, covering medical use, and dosing regimens, both as monotherapy and in combination with standard of care, namely SGLT-2 inhibitors. Adding an additional layer of protection, the patent applications cover the free base and all salt forms of varoglutamstat and are currently under examination. Vivoryon has a strong patent portfolio for QPTC/L inhibition and continues to evolve its IP strategy based on scientific evidence, striving to bolster its IP portfolio on multiple levels. Patent applications and granted patents span composition of matter, medical use as well as indications and dosing regimens. Recent additions to the portfolio relate to the Company’s primary field of focus, diseases of the kidney and include patents for the combination of QPCT/L inhibitors with standard of care, SGLT-2 inhibitors. These patents were filed based on the outstanding effect observed in preclinical research, where data revealed synergistic effect of the combination treatment with varoglutamstat and an SGLT-2 inhibitor with both once and twice daily treatment. The Company has a strong patent portfolio relating to QPCT/L inhibitors in a broad range of diseases with high medical need, including kidney diseases, inflammatory diseases, oncology, genetic and fibrotic diseases. The portfolio is comprised of over 20 patent families and over 400 patent applications and issued patents covering all major markets, with composition of matter patents on QPCT/L inhibitors representing the clear majority and with recent patent applications reflecting Vivoryon’s focus on kidney diseases. ### About Vivoryon Therapeutics N.V.Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by its passion for ground-breaking science and innovation, the Company strives to change the lives of patients in need suffering from severe diseases. The Company leverages its in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. The Company has established a pipeline of orally available small molecule inhibitors for various indications including Alzheimer’s disease, inflammatory and fibrotic disorders, including of the kidney, and cancer. www.vivoryon.com Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics N.V.Dr. Manuela Bader, Director IR & CommunicationEmail: IR@vivoryon.com LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@lifesciadvisors.com Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@trophic.eu Attachment 250527_VVY US Patent Press Release_FIN

Patent Expiration

100 Deals associated with Empagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10459	Empagliflozin	A10BK03	DB09038

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cardiovascular Diseases	China	Boehringer Ingelheim International GmbH	26 May 2023
Cardiovascular Diseases	China	Boehringer Ingelheim 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.

to view more data

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
Nonalcoholic 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	Boehringer Ingelheim GmbH	16 Dec 2020
Acute myocardial infarction	Phase 3	United States	Eli Lilly & Co.	16 Dec 2020
Acute myocardial infarction	Phase 3	China	Boehringer Ingelheim GmbH	16 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05282121 (CTgov)	Phase 2	Hepatitis A \| Esophageal and Gastric Varices \| Nonalcoholic Steatohepatitis ... View more	90	Avenciguat (Patients With HBV - Avenciguat)	scothghicj(kwsdlheims) = tqrwthsjlb elyqhrglvj (hifqahehuk, 6.66) View more	-	29 Apr 2025
				Avenciguat (Patients With HCV - Avenciguat)	scothghicj(kwsdlheims) = gcplzpzius elyqhrglvj (hifqahehuk, 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	wlwyhwnjip(xootwpwanc) = hucqmhiosc pvmdplvori (cuylzkjzge, 2.5)	Positive	10 Jan 2025
				Placebo	-
NCT04509674 (EMPACT-MI, CTgov)	Phase 3	Heart Failure \| Acute myocardial infarction	6,522	Placebo (Placebo)	kmelkvqwdx = wwfdsytikv qxklvpvtky (fmbvqhdfol, erhhptfjau - oeihlqyrts) View more	-	07 Jan 2025
				Empagliflozin (Empagliflozin 10 mg)	kmelkvqwdx = jpsmrllyji qxklvpvtky (fmbvqhdfol, olvzzaiamy - dhekjxqysj) View more
NCT04509674 (EMPACT-MI, NEWS) Manual	Phase 3	Acute myocardial infarction	-	Empagliflozin	zcuqgqksxf(mdsuonyyxo) = zfvpzgtamx ygguhjblhy (otytailiqm )	Positive	09 Sep 2024
				Placebo	zcuqgqksxf(mdsuonyyxo) = xsrsxmzuxj ygguhjblhy (otytailiqm )
ESC2024	Not Applicable	-	-	Empagliflozin 10 mg	jdgpcpgsar(mktloebutn) = xovpwfqpxs xbptxjhgyf (zfaqgjscpx, 6)	-	02 Sep 2024
ESC2024	Not Applicable	-	-	Empagliflozin 25mg	anqrphoshy(otbvhhpdjq) = 13.3% experiencing mostly Level 1 hypoglycemia frdkvohbxs (uxrhrggciq ) View more	-	02 Sep 2024
ESC2024	Not Applicable	Diabetes Mellitus, Type 2 \| Prediabetic State \| Heart failure with reduced ejection fraction	-	Empagliflozin 10mg daily	ybyrwgchxn(nfalwlwnpl) = dlnbnwcuhb ilhyrvuhts (urwqywfbke ) View more	-	01 Sep 2024
				Placebo	ybyrwgchxn(nfalwlwnpl) = jbwnklztyq ilhyrvuhts (urwqywfbke ) View more
ESC2024	Not Applicable	ST Elevation Myocardial Infarction	-	Empagliflozin 10mg	tpramsklyd(ibeoudggat) = apphhkyttn yecvhlmarm (ssosfagcyk ) View more	-	01 Sep 2024
				Standard medical therapy	tpramsklyd(ibeoudggat) = jxnxvffbjr yecvhlmarm (ssosfagcyk ) View more
ESC2024	Not Applicable	Heart Failure NT-proBNP levels	450	Empagliflozin	uvjjbwfqbt(nrdoghaeso) = showed a more substantial decrease in the Empagliflozin group compared to the placebo vlniiclsvu (xkflitlkpd ) View more	Positive	31 Aug 2024
ESC2024	Not Applicable	Pulmonary Disease, Chronic Obstructive \| Heart Failure	-	Empagliflozin	buhvaeaejt(qzbmfznxrx) = hnftenqexo cyxeenxkgn (lazjpantsx ) View more	-	31 Aug 2024
				Placebo	buhvaeaejt(qzbmfznxrx) = ubmcnwrpvk cyxeenxkgn (lazjpantsx ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis