Evaluate the Efficacy and Safety of the Combined Use of a Sodium-glucose Cotransporter 2 (iSGLT2) Inhibitor and a Dipeptidyl Peptidase-4 (iDPP -4) Inhibitor in the Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin

The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

Start Date30 Nov 2026

Sponsor / Collaborator

Eurofarma Laboratórios SA

TCTR20241220001

/ Not yet recruitingPhase 1IIT

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Dapagliflozin Tablets 10 mg in healthy adult human subjects under fasted conditions

Start Date06 May 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

TCTR20250102004

/ Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Dapagliflozin 10 mg Film-coated Tablets (Dapagliflozin 10 mg FCT) and Reference Product (FORXIGA (10 MG FILM - COATED TABLETS)) in Healthy Thai Volunteers under Fasting Conditions

Start Date05 May 2025

Sponsor / Collaborator-

100 Clinical Results associated with Dapagliflozin

100 Translational Medicine associated with Dapagliflozin

100 Patents (Medical) associated with Dapagliflozin

3,137

Literatures (Medical) associated with Dapagliflozin

31 Dec 2025·RENAL FAILURE

Dapagliflozin improves diabetic kidney disease by inhibiting ferroptosis through β-hydroxybutyrate production

Article

Author: Feng, Bo ; Song, Jun ; Li, Ziyi ; Yan, Qun ; Zhou, Chenxia ; Tian, Yan ; Chen, Da

BACKGROUND:

Diabetic kidney disease (DKD) is the leading cause of end-stage renal disease. Sodium-glucose cotransporter protein 2 inhibitors (SGLT2i) are antihyperglycemic agents that provide additional renal-protective effects in patients with DKD, independent of their glucose-lowering effects. However, the underlying mechanism remains unclear. This study hypothesized that SGLT2i could alleviate diabetic kidney injury by inhibiting ferroptosis and explored its potential mechanisms.

METHODS:

C57BL/6J mice were randomly divided into the control, DKD, DKD+dapagliflozin, and DKD+insulin treatment groups. Blood glucose levels and body weight were monitored. Renal function, tissue pathology, mitochondrial morphology and function, and lipid peroxidation biomarkers (lipid peroxidation [LPO], malondialdehyde [MDA], glutathione peroxidase 4 [GPX4], glutathione [GSH], and cystine transporter solute carrier family 7 member 11 [SLC7A11]) were evaluated. Human proximal tubule cells (HK2 cells) were exposed to high glucose alone or in combination with dapagliflozin. The mitochondrial membrane potential (MMP), adenosine triphosphate (ATP) level, NAD+/NADH ratio (oxidized/reduced ratio of nicotinamide adenine dinucleotide), and lipid peroxidation were measured. In addition, the role of the β-hydroxybutyrate- Calcium/Calmodulin Dependent Protein Kinase Kinase 2 (BHB-CaMKK2) axis in mediating dapagliflozin regulating ferroptosis was examined.

RESULTS:

Dapagliflozin significantly ameliorated kidney injury in mice with DKD. Typical changes in ferroptosis, including lipid peroxidation and impaired antioxidant capacity, increased in mice with DKD and HG-treated HK-2 cells. Dapagliflozin significantly improves ferroptosis-related lipid peroxidation and mitochondrial dysfunction. Furthermore, dapagliflozin suppressed the expression of CaMKK2, a key ferroptosis regulator. Specific CaMKK2 inhibitors alleviated mitochondrial damage and ferroptosis, whereas a CaMKK2 agonist counteracted the protective effects of dapagliflozin against mitochondrial, antioxidant, and anti-ferroptosis effects. In addition, dapagliflozin increased BHB production, which mediates its nephroprotective effects.

CONCLUSION:

Dapagliflozin improves DKD by inhibiting ferroptosis, promoting BHB production, and regulating CaMKK2.

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 Feb 2025·DIABETES OBESITY & METABOLISM

The role of the glucagon‐FGF21 axis in improving beta cell function during glucose intolerance and SGLT2 inhibition

Article

Author: Moreno‐Lopez, Maria ; Thevenet, Julien ; Pasquetti, Gianni ; Delalleau, Nathalie ; Kerr‐Conte, Julie ; Gmyr, Valery ; Pattou, Francois ; Acosta‐Montalvo, Ana ; Bonner, Caroline ; Saponaro, Chiara ; Louvet, Isaline

Abstract:

Objective:

Although primarily secreted by the liver, Fibroblast Growth Factor 21 (FGF21) is also expressed in the pancreas, where its function remains unclear. This study aims to elucidate the role of the glucagon‐FGF21 interaction in the metabolic benefits of SGLT2 inhibition (SGLT2i) and hypothesizes it is key to enhancing glucose and lipid metabolism in individuals with glucose intolerance or type 2 diabetes (T2D).

Methods:

FGF21, FGF1R, and β‐klotho expression in human pancreas was analysed by RNAscope, qPCR and immunofluorescent techniques. Glucose‐stimulated insulin secretion (GSIS) assay was used to investigate the effects of recombinant FGF21 (rFGF21) on islets from donors with glucose intolerance or T2D. To explore the role of the glucagon‐FGF21 axis in the benefits of SGLT2i, we used WT and Sglt2 knockout (KO) mice fed a chow diet (CD) or a high‐fat diet (HFD) and chronically treated with vehicle or dapagliflozin.

Results:

Chronic rFGF21 treatment enhanced GSIS in islets from donors with glucose intolerance, with increased FGFR1 expression, suggesting FGF21's greater efficacy in the early stages of disease. In diet‐induced insulin‐resistant mice, dapagliflozin reduced postprandial glycaemia and elevated plasma glucagon and FGF21 levels. Sglt2 KO mice on a CD showed increased fasting plasma glucagon without changes in FGF21. In diet‐induced insulin‐resistant Sglt2 KO mice, elevated glucagon and FGF21 levels paralleled chronic dapagliflozin treatment, indicating similar metabolic adaptations in both models.

Conclusion:

Our findings indicate FGF21 as a crucial mediator in liver‐pancreas crosstalk, improving lipid and glucose metabolism, enhancing pancreatic function, and potentiating the therapeutic efficacy of SGLT2i, thereby representing a target for prediabetes treatment.

190

News (Medical) associated with Dapagliflozin

22 Jan 2025

·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

15 Jan 2025

·endpts.com

Drugmakers tout limits of IRA impact ahead of next negotiation round

Johnson & Johnson, AstraZeneca and Pfizer leaders reiterated during the JP Morgan Healthcare Conference that the federal government’s price negotiations still won’t have a material effect on their bottom lines. As early as this week, CMS may release the names of the next 15 drugs subject to Medicare drug price negotiations for 2027. The Trump administration is taking over on Monday. J&J CEO Joaquin Duato said Monday during a fireside chat that the company’s revenue estimate for 2025 includes the IRA’s impact. J&J’s Xarelto, Stelara, and Imbruvica were among the drugs selected in the first round of negotiations for 2026, and Duato says those products “are not core to our growth.” “So we feel confident about being able to deliver in our estimates,” he said, according to an AlphaSense transcript. The IRA-negotiated prices for a 30-day supply of J&J’s drugs for 2026 are: $197 for Xarelto, $4,695 for Stelara and $9,319 for Imbruvica. Those prices are 62%, 66% and 38% lower than the drugs’ list prices, respectively. AstraZeneca’s chief financial officer and executive director Aradhana Sarin noted in a presentation on Tuesday that the company faces “headwinds,” including “pricing pressures” and the IRA. But she said she still expects “the base business to have strong momentum in terms of revenue going into 2025,” according to an AlphaSense transcript. Sarin said the company expects total revenue to rise by a “high teens percentage,” and that it will report its full-year results on Feb. 6. AstraZeneca’s blockbuster drug Farxiga was included in the first round of negotiations and has a negotiated price of $178, or 68% lower than the list price. Meanwhile, Pfizer CEO Albert Bourla said during a fireside chat that he expects a “$1 billion negative impact because of the IRA,” according to an AlphaSense transcript. He still says he expects “strong performance” from the company’s newer acquisition products, including Biohaven Pharmaceuticals’ migraine drug Nurtec. “The IRA clearly affects us, but there are also many bigger things that are affected by [the] IRA, which is the tech and all the renewables and a lot of the stuff. For a complete rebuild … I don’t know if they would go for anything like that now, but improvements on the IRA we will certainly advocate for,” Bourla said during a lunch with reporters. Pfizer’s Eliquis was included in the first round of IRA drug price negotiations and has a negotiated price of $231, which is 56% lower than the list price. The IRA’s other drug pricing provisions include a $2,000 annual out-of-pocket cap and new manufacturer discounts, among other provisions. Pfizer said in a December press release that it expects an unfavorable impact from a new manufacturer discount program , which requires companies to provide certain discounts on applicable drugs to Medicare beneficiaries. The first round of negotiations, which ended in August, is expected to save Medicare $6 billion in 2026. Negotiated prices for the second round of drugs are slated to take effect on Jan. 1, 2027, according to CMS guidance. Manufacturers of the second round’s selected drugs have until Feb. 28 to agree to participate in the negotiations. — Jaimy Lee contributed reporting.

100 Deals associated with Dapagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D09763	Dapagliflozin	A10BK01	DB06292

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	JP	AstraZeneca Pharmaceuticals Co. Ltd.	26 Mar 2019
Chronic heart failure	EU	AstraZeneca AB	11 Nov 2012
Chronic heart failure	IS	AstraZeneca AB	11 Nov 2012
Chronic heart failure	LI	AstraZeneca AB	11 Nov 2012
Chronic heart failure	NO	AstraZeneca AB	11 Nov 2012
Chronic Kidney Diseases	AU	AstraZeneca Pty Ltd.	22 Oct 2012
Diabetes Mellitus, Type 2	AU	AstraZeneca Pty Ltd.	22 Oct 2012
Heart Failure	AU	AstraZeneca Pty Ltd.	22 Oct 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	SE	AstraZeneca PLC	22 Dec 2020
Acute myocardial infarction	Phase 3	GB	AstraZeneca PLC	22 Dec 2020
COVID-19	Phase 3	US	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	AR	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	BR	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	CA	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	IN	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	MX	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	GB	AstraZeneca PLC	22 Apr 2020
Respiratory Failure	Phase 3	US	AstraZeneca PLC	22 Apr 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03036150 (DAPA-CKD, Pubmed \| Clin J Am Soc Nephrol)	Phase 3	Chronic Kidney Diseases type 2 diabetes	4,304	Dapagliflozin 10mg	vrxcpvzvey(akomgbdguq) = ftjitqeiwn taengqhivu (cqpzzknfpe, 30.2% - 42.5%)	Positive	01 Dec 2024
				Placebo	vrxcpvzvey(akomgbdguq) = bektxlgrcc taengqhivu (cqpzzknfpe, 12 - 30%)
NCT04595370 (MIRACLE, CTgov)	Phase 2	Heart Failure \| Chronic Kidney Diseases	153	Dapagliflozin	ttuaptjmng(eeveqagtiq) = aqeixddida dqavktgads (fimktthjdm, xpiicuwmko - awxmnsvpxi) View more	-	19 Nov 2024
NCT04445714 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	196	Saxagliptin+Dapagliflozin	hbwdwvuprc(sjvtazlrus) = oiscajyldf cnyrbzytpy (uhsebolwrk, iwhglufrgb - ltuyifpbtq) View more	-	12 Nov 2024
NCT03030235 \| NCT02653482 (DEFINE-HF;PRESERVED-HF, Pubmed \| Circ Heart Fail)	Phase 3	Heart Failure ketone \| fatty acid \| 3-hydroxybutyrate	527	Dapagliflozin	xchjxdwwdc(gvzcfsgeiu) = wungmkeezb zjsuzwfjwg (dcitxffdej )	Positive	01 Nov 2024
				Placebo	xchjxdwwdc(gvzcfsgeiu) = yyqbhttolq zjsuzwfjwg (dcitxffdej )
NCT05014594 (Pubmed \| Dig Dis Sci) Manual	Phase 2	Ascites	40	Dapagliflozin 10 mg/day	wmsuzlytgs(pbdfljlydr): P-Value = 0.04 View more	Negative	09 Oct 2024
				Placebo
EANM2024	Not Applicable	Cardiotoxicity	37	Dapagliflozin	nhdfcjkpeq(yxgkkqbdrx) = clygdxygdr csiexdssjs (wfauwswyuj, 220.88) View more	Positive	27 Sep 2024
				Placebo	nhdfcjkpeq(yxgkkqbdrx) = hgmxlfwigq csiexdssjs (wfauwswyuj, 277.92) View more
ESC2024	Not Applicable	Myocardial Infarction	-	Dapagliflozin 10 mg	srkvmzjuam(hiptiqtyuh) = bpcopszmqo pmgvlywfhm (eosnlqmram ) View more	-	02 Sep 2024
				Placebo	srkvmzjuam(hiptiqtyuh) = vzfhnldvux pmgvlywfhm (eosnlqmram ) View more
ESC2024	Not Applicable	Diabetes Mellitus, Type 1	-	dapagliflozin (Control)	obhtonbhbf(sposxjrvhh) = One rat died in Control and two in Diabetes treated with Dapagliflozin ftjrqarozc (bgnpcmcumd )	-	01 Sep 2024
				dapagliflozin (Diabetes)
ESC2024	Not Applicable	Diabetes Mellitus, Type 1	40	Dapagliflozin	dnztumgpfo(dsbmwyrbab) = xfgycseqas wdiqsvaluf (qbjrpuoodz )	Positive	01 Sep 2024
				Intensification of insulin treatment	dnztumgpfo(dsbmwyrbab) = kpbkjziilb wdiqsvaluf (qbjrpuoodz ) View more
ESC2024	Not Applicable	Heart failure with reduced ejection fraction	-	Dapagliflozin 10 mg	yyfbdayxoo(meatfaiqdc) = mkxewgvlmu tslsvxkhuw (dvifugvlcu ) View more	-	01 Sep 2024
				Standard HF therapy	yyfbdayxoo(meatfaiqdc) = ofywqapoth tslsvxkhuw (dvifugvlcu ) View more

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