Empagliflozin

New Delhi: Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic diabetes drug . The company has received tentative approval from the US Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin tablets, a statement said. The tablets in a combination are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate. The product will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad, the drug maker said. As per the IQVIA MAT September-2025 data, Empagliflozin and Linagliptin tablets had annual sales of USD 215.8 million in the US.

BOSTON, Nov. 09, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, today announced that positive interim data from its ongoing MUSIC-HFpEF Phase 1/2a clinical trial was presented at the American Heart Association (AHA) Scientific Sessions 2025 taking place November 7-10, 2025, in New Orleans, Louisiana. The late-breaking presentation, titled "First-in-Human Gene Therapy Trial for Patients with Heart Failure with Preserved Ejection Fraction (HFpEF): MUSIC-HFpEF – Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction," was delivered by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Center, during the Featured Science session on Biological and Pragmatic Interventions in Heart Failure: From Present to Future on Sunday, November 9, 2025, at 8:00 AM CST. The MUSIC-HFpEF trial is investigating SRD-002, a one-time gene therapy treatment for heart failure with preserved ejection fraction (HFpEF) delivered through a proprietary minimally invasive intracoronary infusion methodology. SRD-002 utilizes an adeno-associated type 1 virus vector carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase pump (SERCA2a) to directly target the molecular pathways underlying the core pathology of HFpEF by enhancing myocardial relaxation and reducing stiffness. The presentation highlighted data from the ongoing trial, which, as of the interim data cutoff date of October 15, 2025, has treated five patients in Cohort A with a low dose of 3E13 viral genomes (vg) who completed the twelve-month follow-up and five patients in Cohort B with a high dose of 4.5E13 vg. SRD-002 demonstrated a favorable safety profile and early clinical benefits. With follow-up ranging from 6 to 12 months, no gene therapy-related serious adverse events have been reported. Patients in the low-dose cohort have shown improvements in New York Heart Association (NYHA) heart failure classification and Kansas City Cardiomyopathy Questionnaire at both 6 and 12 months, with clinically meaningful stabilizations and improvements in pulmonary capillary wedge pressure (PCWP) at rest and peak exercise. The data support progression to the Phase 2 portion of the ongoing trial to test durable disease-modification in HFpEF by SRD-002. Patients in Cohort A and B received higher optimized doses of 3.0E13 vg and 4.5E13 vg, respectively—substantially higher than in prior studies, yet still significantly lower than systemic intravenous (IV) infusion. The dosing strategy was rationally designed and optimized using Medera’s proprietary human-based mini-Heart™ technology platform, including its HFpEF disease model co-developed with AstraZeneca, which has contributed to a US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance and Fast Track Designation. "The data presented today at the AHA Scientific Sessions demonstrate continued safety and clinical benefits with SRD-002," said Marat Fudim, MD, MHS. "These results reinforce the potential of gene therapy to address the fundamental pathophysiological mechanisms in HFpEF and provide hope for patients with this challenging condition." "We are pleased to announce the completion of enrollment for this innovative clinical trial and are encouraged by the outcomes observed in the low dose cohort,” said Ronald Li, PhD, CEO and Founder of Medera. “We remain dedicated to advancing this investigational gene therapy, which targets a condition characterized by significant unmet medical needs." The AHA Scientific Sessions is the premier global event in cardiovascular health and science offering unmatched access to groundbreaking research, dynamic learning, and career-defining connections. For additional information about the MUSIC-HFpEF trial, visit ClinicalTrials.gov using the study identifier NCT06061549. About Heart Failure with Preserved Ejection Fraction (HFpEF) Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide and a rising prevalence trend. Accounting for 50% or more of the overall HF population, HFpEF is an age-related condition that has become increasingly prevalent in recent years. This surge is partly due to better awareness and identification of the condition and partly due to lifestyle changes affecting cardiac myocytes. Individuals affected by HFpEF experience similar morbidity and mortality to patients with HF with reduced ejection fraction (HFrEF). Despite the growing epidemic of this emerging syndrome, HFpEF-focused interventional trials have had little success, except for the use of sacubitril-valsartan (Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance™) for reducing cardiovascular mortality and heart failure hospitalization. However, these agents are not disease-modifying, highlighting the critical need for therapeutic interventions targeting the physiological mechanisms involved in HFpEF. About Medera Inc. Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively. Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials. Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases. For more information, please visit www.medera.bio. Contacts Ally StubinPublic RelationsICR HealthcareAlly.stubin@icrhealthcare.com 646.667.1861 Stephanie CarringtonInvestor RelationsICR HealthcareStephanie.carrington@icrhealthcare.com 646.277.1282