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

NCT03867487

/ Not yet recruitingPhase 2IIT

SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease

This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.

Start Date01 May 2025

Sponsor / Collaborator

Ann & Robert H. Lurie Children's Hospital of Chicago

NCT06653738

/ Not yet recruitingPhase 3

Randomized Placebo-controlled Trial to Assess Efficacies of EMPAgliflozin and Personalized Dietary Counselling for Kidney STONE Prevention in Patients With Calcium Kidney Stones Acronym: EMPASTONE Trial

The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones.
Study interventions:
* Empagliflozin 25 mg once daily per os for 36 months
* Personalized dietary counseling for 36 months.
Control interventions:
* Placebo once daily per os for 36 months
* Generic dietary counseling for 36 months.

Start Date01 May 2025

Sponsor / Collaborator

Insel Gruppe AG

100 Clinical Results associated with Empagliflozin

100 Translational Medicine associated with Empagliflozin

100 Patents (Medical) associated with Empagliflozin

3,212

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 ; Villanueva, Anthony Russell ; Cunanan, Elaine ; Permejo, Chito

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.

01 Mar 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Sodium-Glucose Cotransporter 2 Inhibitors for the Primary Prevention of Glaucoma in Patients With Type 2 Diabetes: A Target Trial Emulation

Article

Author: Lo, Jui-En ; Ma, Kevin Sheng-Kai ; Friedman, David S. ; Boland, Michael V ; Boland, Michael V. ; Eng, Kathleen ; Swaminathan, Swarup S. ; Friedman, David S ; Swaminathan, Swarup S ; Zebardast, Nazlee

PURPOSE:

Pleiotropic cardiovascular benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) due to vascular remodeling effects have been demonstrated in patients with type 2 diabetes mellitus. It is unclear whether a similar benefit may be seen for glaucoma. The purpose of this study was to assess the effect of SGLT2i on the risk of glaucoma in patients with type 2 diabetes.

DESIGN:

Target trial emulation using observational data from multiple healthcare organizations.

METHODS:

This population-based cohort study included adults with type 2 diabetes in the United States who newly initiated treatment with SGLT2i, dipeptidyl peptidase 4 inhibitors (DPP4i), or glucagon-like peptide-1 receptor agonists (GLP1RA) between 2013 and 2023. Propensity score matching was conducted to control for sociodemographic characteristics comorbidities, and concomitant use of medications. The exposure considered was treatment with SGLT2i for type 2 diabetes, and the outcomes were new-onset glaucoma and its subtypes after initiation of antidiabetic treatments. Subgroup analyses were performed to evaluate the effect of individual SGLT2i on incident glaucoma.

RESULTS:

After propensity score matching, 722,446 patients were included in the SGLT2i arm and the DPP4i arm, respectively. Patients on SGLT2i, compared with those on DPP4i, had a lower risk of glaucoma (hazard ratio [HR] 0.815, 95% confidence interval [CI] 0.794, 0.837), including open-angle glaucoma (HR 0.755, 95% CI 0.729, 0.781) and primary angle-closure glaucoma (HR 0.702, 95% CI 0.636, 0.781). Among all SGLT2i, ertugliflozin (HR 0.668, 95% CI 0.512, 0.871) was associated with the lowest risk of glaucoma, followed by empagliflozin (HR 0.727, 95% CI 0.696, 0.759), dapagliflozin (HR 0.814, 95% CI 0.774, 0.855), and canagliflozin (HR 0.893, 95% CI 0.862, 0.926). The protective effect of SGLT2i on glaucoma was validated when compared with GLP1RA (HR 0.932, 95% CI 0.906, 0.959).

CONCLUSIONS:

Patients on SGLT2i, including canagliflozin, empagliflozin, dapagliflozin, and ertugliflozin, had a significantly lower risk of incident glaucoma compared to those on DPP4i. SGLT2i demonstrated a protective effect for both open-angle glaucoma and angle-closure glaucoma.

01 Mar 2025·Translational Research

Sodium-glucose co-transporter 2 (SGLT-2) inhibitors ameliorate renal ischemia-reperfusion injury (IRI) by modulating autophagic processes

Article

Author: Tan, Fangyan ; Hu, Rong ; Yuan, Xin ; Jiang, Yonghong ; Du, Jianlin ; Wang, Jing ; Liu, Mengmeng ; Yao, Yuanqing

Renal ischemia-reperfusion injury (IRI) is a common clinical condition that currently lacks effective treatment options. Inhibitors targeting the sodium-glucose co-transporter-2 (SGLT-2), recognized for their role in managing hyperglycemia, have demonstrated efficacy in enhancing the health outcomes for diabetic patients grappling with chronic kidney disease. Nevertheless, the precise impact of SGLT-2 inhibitors on renal ischemia-reperfusion injury (IRI) and the corresponding transcriptomic alterations remain to be elucidated. In our research, we developed a model of IRI using male C57BL/6 mice by clamping the unilateral renal artery and administering empagliflozin Transcriptomic alterations were analyzed using RNA sequencing (RNA-Seq), complemented by proteomic analysis to investigate the effects of empagliflozin. Histological assessments revealed increased renal inflammatory cell infiltration, widespread renal tubular injury, and elevated autophagosomes formation in the IRI group compared to controls. These pathological changes were significantly attenuated following empagliflozin treatment. Besides, renal function impairment can be alleviated in empagliflozin-treated group. RNA-Seq analysis identified lysosomal autophagy as a key biological process in IRI mice. Empagliflozin exerted a renoprotective effect by downregulating lysosome-associated membrane proteins, primarily LAMP1, LAMP2, and LAMP4 (CD68), through the PI3K-Akt, MAPK, and mTOR signaling pathways, thereby inhibiting autophagic processes. In conclusion, this study highlights enhanced inflammation and disrupted metabolism as hallmark transcriptomic signatures of renal. Furthermore, it demonstrates the renoprotective effects of empagliflozin in alleviating renal IRI by modulating autophagic processes.

200

News (Medical) associated with Empagliflozin

22 hours ago

·www.prnewswire.com

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalLicense out/in

16 Jan 2025

·fabrydiseasenews.com

Diabetes medications may be option for Fabry-related kidney damage

SGLT2 inhibitors, medications approved for diabetes, could be used in Fabry disease to reduce albuminuria, which occurs when damaged kidneys let a large protein called albumin pass into the urine, according to a real-world study in adults with Fabry disease.Because patients were followed for a short period of up to about 1.5 years, larger and longer studies are needed to confirm the effectiveness of SGLT2 inhibitors over time and to explore their effects on kidney health in Fabry disease.“Given the nature of the study design and small case numbers, further long-term controlled studies are required to evaluate the long-term efficacy of this medication class,” researchers wrote.The study, “Sodium-glucose cotransporter 2 inhibitors reduce albuminuria in patients with Fabry disease: a real-world case series,” was published in the International Medicine Journal.Fabry disease is caused by genetic mutations leading to a deficiency of the enzyme alpha-galactosidase A. Without this enzyme, fatty molecules called glycosphingolipids build up to toxic levels in cells, causing damage to organs and resulting in symptoms.When glycosphingolipids damage the kidneys, patients may develop proteinuria, where too much protein leaks into the urine. SGLT2 inhibitors, which are used to treat diabetes by helping the kidneys to remove sugar from the body through urine, may also reduce proteinuria.To explore this, researchers analyzed changes in the amount of albumin present in the urine of 11 adults with genetically confirmed Fabry disease, ages 48 to 59, who had been taking SGLT2 inhibitors for at least one month. All had evidence of albuminuria.Eight patients (72%) also had signs of cardiomyopathy, or damage to the heart’s muscle, and two (18%) had diabetes. Eight (72%) had genetic mutations linked to classic Fabry disease, and three (27%) had non-classic genetic mutations.Nearly two-thirds of patients (64%) were on enzyme replacement therapy, two (18%) were on chaperone therapy, one (9%) was on substrate reduction therapy, and one (9%) was not being treated with any Fabry disease-specific medications.SGLT2 inhibitors — dapagliflozin, marketed as Farxiga or generics, or empagliflozin, available under the brand name Jardiance among others — were prescribed to reduce albuminuria, and used for an average of nine months. Ten patients reported no missed doses.At the study’s start, median urine albumin-creatinine ratio (uACR), a measure of how well the kidneys are working, was 76 milligrams per millimole (mg/mmol). After treatment with SGLT2 inhibitors, uACR nearly halved, to a median 39 mg/mmol.A reduction in albuminuria was observed in seven patients, with those experiencing severe proteinuria demonstrating the most benefit from SGLT2 inhibitors.Side effects from SGLT2 inhibitors were mainly “transient.” Four patients had frequent urination, one felt lightheaded, and two developed urinary tract infections requiring antibiotics. One infection led to sepsis, which arises when the body’s immune response damages its own organs, causing the treatment to be stopped.While these findings can’t be widely applied due to limitations in sample size, they suggest another possible treatment for kidney damage related to Fabry disease, where treatment choices are limited. “Larger-scale research is recommended to assess the efficacy and safety of [SGLT2 inhibitors],” the researchers wrote.

Clinical Result

17 Dec 2024

·www.drugs.com

Empagliflozin Not Tied to Risk for New Nonproliferative Diabetic Retinopathy

TUESDAY, Dec. 17, 2024 -- Empagliflozin initiation is not associated with incident nonproliferative diabetic retinopathy (NPDR) compared with initiation of a dipeptidyl peptidase 4 inhibitor (DPP4i), according to a study published online Dec. 5 in JAMA Ophthalmology . Helen Tesfaye, Pharm.D., from Brigham and Women’s Hospital in Boston, and colleagues compared the risk for incident NPDR and DR progression in patients with type 2 diabetes (T2D) initiating empagliflozin versus a DPP4i. The analysis included 34,239 pairs of propensity score-matched adults in the incident NPDR cohort and 7,831 pairs in the DR progression cohort. The researchers found that during a mean follow-up period of eight months receiving treatment, the risk for incident NPDR did not differ across groups (hazard ratio [HR], 1.04; 95 percent confidence interval [CI], 0.94 to 1.15; rate difference [RD], 1.30; 95 percent CI, −1.83 to 4.44). The risk for DR progression was lower among individuals who initiated empagliflozin versus those who began DPP4i therapy (HR, 0.78; 95 percent CI, 0.63 to 0.96; RD, −9.44; 95 percent CI, −16.90 to −1.98). Across multiple subgroups and sensitivity analyses, results were similar. "Although residual confounding cannot be entirely ruled out due to the observational nature of our study, these findings may be helpful when weighing the risks and benefits of various glucose-lowering agents in adults with T2D," the authors write. Several authors disclosed ties to pharmaceutical companies, including Boehringer Ingelheim and Eli Lilly, which manufacture empagliflozin; Boehringer Ingelheim funded the study.

Clinical ResultAHA

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	CN	Boehringer Ingelheim International GmbH	26 May 2023
Cardiovascular Diseases	CN	Boehringer Ingelheim GmbH	26 May 2023
Heart failure with normal ejection fraction	CN	Boehringer Ingelheim International GmbH	30 Aug 2022
Heart failure with normal ejection fraction	CN	Boehringer Ingelheim (China) Investment Co., Ltd.	30 Aug 2022
Heart failure with reduced ejection fraction	CN	Boehringer Ingelheim GmbH	10 Jun 2022
Heart failure with reduced ejection fraction	CN	Boehringer Ingelheim International GmbH	10 Jun 2022
Chronic heart failure	EU	Boehringer Ingelheim International GmbH	22 May 2014
Chronic heart failure	IS	Boehringer Ingelheim International GmbH	22 May 2014
Chronic heart failure	LI	Boehringer Ingelheim International GmbH	22 May 2014
Chronic heart failure	NO	Boehringer Ingelheim International GmbH	22 May 2014
Chronic Kidney Diseases	AU	Boehringer Ingelheim Pty Ltd.	30 Apr 2014
Diabetes Mellitus, Type 2	AU	Boehringer Ingelheim Pty Ltd.	30 Apr 2014
Heart Failure	AU	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	MX	Boehringer Ingelheim GmbH	06 Feb 2023
Glycosuria, Renal	Phase 3	-	Tanta University	01 Jan 2023
Schizophrenia	Phase 3	-	Tanta University	01 Jan 2023
Nonalcoholic Steatohepatitis	Phase 3	EG	Tanta University	01 Nov 2022
Hypoglycemia	Phase 3	CH	Boehringer Ingelheim GmbH	11 Mar 2022
Acute myocardial infarction	Phase 3	US	Boehringer Ingelheim Pharma GmbH & Co., KG	16 Dec 2020
Acute myocardial infarction	Phase 3	US	Boehringer Ingelheim International GmbH	16 Dec 2020
Acute myocardial infarction	Phase 3	US	Boehringer Ingelheim GmbH	16 Dec 2020
Acute myocardial infarction	Phase 3	US	Eli Lilly & Co.	16 Dec 2020
Acute myocardial infarction	Phase 3	CN	Boehringer Ingelheim GmbH	16 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03485092 (SUGAR-DM-HF, Pubmed \| Eur J Heart Fail)	Phase 4	Heart failure with reduced ejection fraction	105	Empagliflozin 10 mg	tlbwnzwvhx(diafcwckve) = xfvybtjncu infmitzevx (mbrcpbyrky, 2.5)	Positive	10 Jan 2025
				Placebo	-
NCT04509674 (EMPACT-MI, CTgov)	Phase 3	Heart Failure \| Acute myocardial infarction	6,522	Placebo (Placebo)	mnypnushkn(mfyeeoarpw) = ycddkjwhxb hmcylzpyrb (ipanrwuydv, lrgsacoduq - eieqkxqwhc) View more	-	07 Jan 2025
				Empagliflozin (Empagliflozin 10 mg)	mnypnushkn(mfyeeoarpw) = ylmepkrozh hmcylzpyrb (ipanrwuydv, fyozhdmgud - kidnnkcxyj) 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	jsodnuslxb(zcmnyupmds) = eaasdzifwe nixfupgkvb (vyfstidtxd ) View more	Positive	25 Oct 2024
				Placebo	jsodnuslxb(zcmnyupmds) = foxgdpwlph nixfupgkvb (vyfstidtxd ) View more
NCT03087773 (EMMY, Pubmed \| Clin Res Cardiol)	Phase 3	Myocardial Infarction	313	Empagliflozin	pzolpxuvza(nipqygwdjj) = parameters for diastolic function showed a distinct trend between groups but did not meet statistical significance in this cohort tolugmwnme (cyhxphdzpo ) View more	Positive	16 Sep 2024
				Placebo
NCT04509674 (EMPACT-MI, NEWS) Manual	Phase 3	Acute myocardial infarction	-	Empagliflozin	rjfhzyrpcy(fxzcxzkhej) = ccugetsvpo qndqyrqlel (tnayeaoixn )	Positive	09 Sep 2024
				Placebo	rjfhzyrpcy(fxzcxzkhej) = hraevyinfx qndqyrqlel (tnayeaoixn )
ESC2024	Not Applicable	-	-	Empagliflozin 25mg	zigbzlmeqo(sbavaehbfx) = 13.3% experiencing mostly Level 1 hypoglycemia egcxiqddsw (uhtxretthl ) View more	-	02 Sep 2024
ESC2024	Not Applicable	-	-	Empagliflozin 10 mg	buolvaabhl(ixyyrgcjgk) = kkucdyubcq hzxsocozna (jbzppzyrze, 6)	-	02 Sep 2024
ESC2024	Not Applicable	ST Elevation Myocardial Infarction	-	Empagliflozin 10mg	scdgvugpey(cryhjiiplk) = gspnmpirqe ptjxhprnwq (akorircqnl ) View more	-	01 Sep 2024
				Standard medical therapy	scdgvugpey(cryhjiiplk) = ksjzuyyszr ptjxhprnwq (akorircqnl ) View more
ESC2024	Not Applicable	Diabetes Mellitus, Type 2 \| Prediabetic State \| Heart failure with reduced ejection fraction	-	Empagliflozin 10mg daily	xborniwnkt(akhqqqcdkm) = fxsoocrofw kkcfxqxlkp (ivutxlzgsz ) View more	-	01 Sep 2024
				Placebo	xborniwnkt(akhqqqcdkm) = xyndcyozlo kkcfxqxlkp (ivutxlzgsz ) View more
ESC2024	Not Applicable	Heart Failure NT-proBNP levels	450	Empagliflozin	crjxyorayo(uxzuozubkm) = showed a more substantial decrease in the Empagliflozin group compared to the placebo oggoxzuuup (qopeidkxdb ) View more	Positive	31 Aug 2024

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

Chat with Hiro

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