efpeglenatide (HM11260C) / Hanmi - LARVOL DELTA

Hanmi is accelerating its global market entry with efpeglenatide, Korea's first domestically developed GLP-1 class obesity and metabolic disease treatment. (PRNewswire) - "Hanmi Pharmaceutical...announced on January 28 that it has signed an exclusive distribution agreement with Mexican pharmaceutical company Laboratorios Sanfer for efpeglenatide, its GLP-1 obesity therapy, as well as the Dapalon Family, Hanmi's flagship diabetes treatment portfolio (Dapalon Tab. and Dapalon Duo SR Tab.)...Under the agreement, Hanmi will supply efpeglenatide and the Dapalon Family, while Laboratorios Sanfer will be responsible for regulatory approval, marketing, distribution, and sales within Mexico."

Launch non-US • Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

Meanwhile, Hanmi completed its regulatory application for efpeglenatide to the Ministry of Food and Drug Safety on December 17, 2025. (PRNewswire) - "Hanmi is pursuing an expansion of efpeglenatide's indications from obesity into diabetes, with obesity approval targeted for the second half of 2026 and an additional diabetes indication planned for 2028."

Korea approval • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin (clinicaltrials.gov) - P3 | N=118 | Not yet recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hanmi Pharm announced on January 21 that it has received approval from the Ministry of Food and Drug Safety for a domestic Phase 3 clinical trial plan (IND) for the development of 'HM11260C' (efpeglenatide), a treatment for type 2 diabetes. (The Asia Business Daily) - "This clinical trial is designed to confirm the efficacy and safety of HM11260C in patients with type 2 diabetes whose condition is not controlled by metformin and dapagliflozin...The purpose of the trial is to demonstrate the superiority of HM11260C in blood glucose control compared to placebo when administered in combination, and to comparatively assess its safety....The trial will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel-design study involving 118 domestic patients."

New P3 trial • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical said on the 17th that it has applied to the Ministery of Food and Drug Safety for domestic approval of Efpeglenatide, a glucagon-like peptide (GLP)-1 drug developed as a Korea-tailored obesity treatment. (Chosun Biz) - "Ministery fast-tracks review as Hanmi targets next-year launch..."

Korea filing • Launch non-US • Obesity

Cardiorenal Safety Markers With Injectable Glucagon-Like Peptide-1 (GLP-1) Agonists in Type 2 Diabetes: A Network Meta-Analysis. (PubMed, Cureus) - "Efpeglenatide ranked highest for both MACE (OR: 0.74; 95% CI: 0.62-0.87; SUCRA: 81.5%) and renal outcomes (OR: 0.68; 95% CI: 0.57-0.81; SUCRA: 81.33%), underscoring its clinical significance over other effective agents such as albiglutide and semaglutide. Albiglutide, semaglutide, dulaglutide, and liraglutide also provided significant benefits, albeit with lower rankings. No major inconsistency or publication bias was detected. In conclusion, this NMA reinforces the class-wide cardiorenal benefits of GLP-1 receptor agonists while emphasizing variations in efficacy among individual agents, the limited evidence base for certain drugs, and the need for future head-to-head trials specifically designed to evaluate cardiovascular and renal endpoints."

Journal • Retrospective data • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical announced on Dec. 5 that its glucagon-like peptide-1 (GLP-1) obesity new drug under development, “efpeglenatide ,“ has been designated for expedited domestic product approval review by the Ministry of Food and Drug Safety. [Google translation] (Business Korea) - "The company plans to apply for product approval of efpeglenatide with the ministry within this year, and the launch timing, which was targeted for the second half of next year, is expected to be moved up earlier than anticipated."

Korea filing • Launch non-US • Obesity

Hanmi Pharmaceutical is targeting the second half of next year for the launch of its anti-obesity drug, efpeglenatide. (The Asia Business Daily)

Launch non-US • Obesity

Glucagon-like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter-2 Inhibitors Reduce Dementia Risk in Type 2 Diabetes: A Comprehensive Bayesian Network Meta-Analysis (AHA 2025) - "For all-cause dementia versus control according to the SUCRA: albiglutide (RR: 0.03, 95% CrI: 0.00 to 0.08; SUCRA: 94.4%), lixisenatide (RR: 0.08, 95% CrI: 0.00 to 0.20; SUCRA: 93.62%), efpeglenatide (RR: 0.24, 95% CrI: 0.00 to 1.38; SUCRA: 70.09%), canagliflozin (RR: 0.31, 95% CrI: 0.01 to 1.47; SUCRA: 61.81%), semaglutide (RR: 0.50, 95% CrI: 0.03 to 1.98; SUCRA: 50.06%), liraglutide (RR: 2.12, 95% CrI: 0.02 to 9.89; SUCRA: 41.91%), empagliflozin (RR: 0.68, 95% CrI: 0.05 to 2.35; SUCRA: 39.63%), exenatide (RR: 4.13, 95% CrI: 0.02 to 20.28; SUCRA: 35.41%), dulaglutide (RR: 3.38, 95% CrI: 0.03 to 15.72; SUCRA: 32.89%), dapagliflozin (RR: 1.19, 95% CrI: 0.09 to 4.96; SUCRA: 30.37%), ertugliflozin (RR: 6.79, 95% CrI: 0.02 to 29.23; SUCRA: 30.1%), control (SUCRA: 19.67%). GLP-1RAs and SGLT2is reduce dementia risk, with albiglutide and lixisenatide excelling for all-cause dementia, dapagliflozin and ertugliflozin for vascular dementia, and dulaglutide for Alzheimer's...."

Retrospective data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Targeting Cerebrovascular Risk in Diabetes: GLP-1 Receptor Agonists as Neuroprotective Agents (AHA 2025) - "Agent-specific effects and subgroup analyses in patients with established cardiovascular disease (CVD) were also evaluated.A total of thirteen trials involving liraglutide, semaglutide, dulaglutide, exenatide, lixisenatide, and efpeglenatide were analyzed. In adults with T2D, GLP-1 RA therapy significantly lowers the risk of nonfatal stroke, especially with dulaglutide and semaglutide, while no definitive reduction in stroke-related death was detected. These findings support preferential GLP-1 RA selection for cerebrovascular risk reduction in high-risk diabetic populations"

Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison of the renal outcomes of novel antidiabetic agents in patients with type 2 diabetes with chronic kidney disease: A systematic review and network meta-analysis of randomized controlled trials. (PubMed, Diabetes Obes Metab) - "In patients with T2DM and CKD, SGLT2 inhibitors provide the most consistent renal protection, while GLP-1 receptor agonists offer additional but variable benefits. Dapagliflozin showed the greatest efficacy, and canagliflozin most strongly reduced albuminuria, highlighting meaningful heterogeneity across agents. DPP-4 inhibitors conferred no renal benefit. Overall, evidence from placebo-controlled trials was robust, whereas certainty was lower for indirect estimates, highlighting the need for drug-specific evaluation in clinical practice."

Journal • Retrospective data • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical's obesity treatment "HM11260C" (material name Epeglenatide) showed a weight loss effect of nearly 10% in phase 3 clinical trials. (Maeil Business Newpaper) - "The plan is to apply for domestic permission within this year to open the era of 'domestic obesity drugs' next year'..According to Hanmi Pharmaceutical on the 27th, the average weight loss rate at 40 weeks of clinical trial was 9.75% in the Epeglenatide administration group and 0.95% in the placebo group. The proportion of patients who lost more than 5% of their weight was 79.42% (14.49% in the placebo group)."

Korea filing • P3 data • Obesity

COMPARATIVE EVALUATION OF GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS AND THEIR ASSOCIATION WITH THE RISK OF ASTHMA INCIDENCE: A COMPREHENSIVE BAYESIAN NETWORK META-ANALYSIS (CHEST 2025) - "For the reduction of asthma incidence, Semaglutide ranked highest (RR: 0.20, 95% CrI: 0.01 to 2.08; SUCRA: 84.83%), compared to Control (SUCRA: 44.9%), with Liraglutide ranked second (RR: 0.55, 95% CrI: 0.08 to 4.07; SUCRA: 64.4%). Other interventions included Exenatide (RR: 0.56, 95% CrI: 0.07 to 4.57; SUCRA: 63.57%), Lixisenatide (RR: 0.56, 95% CrI: 0.06 to 5.00; SUCRA: 63.08%), Cotadutide (RR: 0.81, 95% CrI: 0.05 to 39.67; SUCRA: 50.67%), Efpeglenatide (RR: 1.08, 95% CrI: 0.09 to 16.37; SUCRA: 43.95%), Dulaglutide (RR: 1.52, 95% CrI: 0.20 to 11.46; SUCRA: 32.65%), Albiglutide (RR: 1.77, 95% CrI: 0.24 to 12.90; SUCRA: 28.16%) and Tirzepatide (RR: 2.81, 95% CrI: 0.18– 115.35; SUCRA: 23.77%)... In conclusion, our Bayesian network meta-analysis demonstrates that Semaglutide is the most effective GLP-1 receptor agonist in reducing asthma incidence in patients with type 2 diabetes. In contrast, Tirzepatide and Albiglutide were associated with an increased risk of asthma...."

Retrospective data • Asthma • Diabetes • Immunology • Inflammation • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

The Preventive Effects of GLP-1 Receptor Agonists and SGLT2 Inhibitors on Cancer Metastasis: A Network Meta-Analysis of 67 Randomized Controlled Trials. (PubMed, Int J Mol Sci) - "These findings indicate that efpeglenatide may possess a broad, systemic preventive effect against metastatic cancers, potentially operating through mechanisms that are not restricted to individual organ systems. Further research is warranted to elucidate the molecular pathways underlying its anti-metastatic properties and to explore its role in preventive oncology."

Journal • Retrospective data • Oncology

Efficacy and safety of incretin co-agonists: Transformative advances in cardiometabolic healthcare. (PubMed, World J Cardiol) - "The GLP-1 receptor agonists (GLP-1RAs), namely liraglutide, dulaglutide, albiglutide, exenatide, and semaglutide, have been found to have beneficial effects on glycated hemoglobin, weight, lipid profile, and liver fat and thereby improving cardiometabolic health. Other drugs of the same group in development include Orforglipron, which has a high weight loss efficacy (-15% weight reduction). Long-acting GLP-1RAs in trials are Ecnoglutide, Efpeglenatide, TG103, and Visepegenatide...Retatrutide and Efocipegtrutide belong to this novel group of drugs. The newer drugs in the broad category of incretin co-agonists include the GLP-1/amylin receptor agonist like CagriSema and Amycretin, oral GLP-1 agonists other than semaglutide, and the peptide YY/GLP-1 receptor dual agonists. The profound biochemical and weight loss outcomes associated with incretin co-/poly-agonists are expected to translate into outstanding cardiometabolic benefits, the theme of this evidence review."

Journal • Review • Cardiovascular • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Cardiovascular Effects and Tolerability of GLP-1 Receptor Agonists: A Systematic Review and Meta-Analysis of 99,592 patients. (PubMed, J Am Coll Cardiol) - "GLP-1 RAs reduce mortality and MACE in high-risk populations, highlighting benefits beyond glycemic control. These come at increased GI and gallbladder risks. Variation in efficacy and tolerability supports tailoring GLP-1 RA therapy to individual patient characteristics and treatment goals."

Journal • Retrospective data • Acute Kidney Injury • Cardiovascular • Congestive Heart Failure • Diabetes • Genetic Disorders • Heart Failure • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Nephrology • Obesity • Oncology • Pancreatic Cancer • Pancreatitis • Renal Disease

Effect of glucagon-like peptide 1 receptor agonists on systolic blood pressure in patients with obesity, with or without diabetes: A systematic review and network meta-analysis. (PubMed, Clin Obes) - "MEDLINE and Cochrane were searched until January 2022 for randomized control trials (RCTs) on patients with obesity, evaluating the impact of semaglutide, liraglutide, efpeglenatide, or exenatide on SBP. GLP-1RAs result in mild reductions in SBP in patients with obesity. The change in SBP varies only slightly by the drug-dose combination and appears to be related to the amount of weight loss."

Journal • Retrospective data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effect of Efpeglenatide on Heart Failure Outcomes: A Participant-Level Exploratory Analysis of the Randomized AMPLITUDE-O Trial. (PubMed, Diabetes Care) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus (clinicaltrials.gov) - P3 | N=420 | Active, not recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Risk of Hearing Loss in Patients Treated with Exendin-4 Derivatives: A Network Meta-Analysis of Glucagon-like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors. (PubMed, Pharmaceuticals (Basel)) - " This comprehensive NMA identifies a significant association between exendin-4 derivatives (lixisenatide and efpeglenatide) and potential ototoxicity. Clinicians should carefully consider this potential ototoxicity when prescribing exendin-4 derivatives, particularly in patients with pre-existing hearing loss risk factors."

Journal • Retrospective data • Review • Otorhinolaryngology

Cardiovascular safety of GLP-1 Receptor Agonists in Type 2 Diabetes: A Network Meta-Analysis of Cardiovascular Outcomes Trials (ISPOR 2025) - "Efpeglenatide and oral semaglutide gave the largest MACE reduction, with hazard ratios of 0.73 [0.58; 0.92] and 0.74 [0.58; 0.95], respectively. For cardiovascular death, IV semaglutide demonstrated the greatest risk reduction (HR 0.49 [0.27; 0.90]), followed by efpeglenatide and liraglutide... This NMA highlights the significant cardioprotective effects of GLP-1 RAs across multiple cardiovascular outcomes in T2D patients. These findings underscore their potential as valuable therapeutic options for managing cardiovascular risk in this population, warranting further investigation and clinical consideration."

Retrospective data • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical's GLP-1 Triple Agonist 'HM15275' Opens New Horizons in Obesity and Metabolic Disease Treatment [Google translation] (The Korea Economic Daily) - "Currently, HM15275 is scheduled to enter phase 2 clinical trials in the second half of this year. If the clinical development is successful in the future, it is highly likely that it will establish itself as a new game changer in the global obesity treatment market....In addition, 'Efpeglenatide', which was the first HOP project, is currently progressing smoothly in phase 3 clinical trials in Korea. The clinical trial is expected to end in the second half of 2026..."

New P2 trial • Trial completion date • Obesity • Type 2 Diabetes Mellitus

Preoperative Weight Loss Before Total Joint Arthroplasty Using Novel GLP-1 Agonists (AAOS 2025) - "GLP-1s were categorized as Food and Drug Administration (FDA)-approved for weight loss (Group 1: semaglutide and liraglutide) versus FDA-approved for diabetes or under investigation for weight loss (Group 2: dulaglutide, exenatide, lixisenatide, efpeglenatide, tirzepatide plus Group 1 medications). The prevalence of preoperative GLP-1s before TJA tripled to 4.6% from 2019 to 2022, and preoperative weight change on GLP-1s varied considerably. GLP-1s were not associated with increased postoperative risks but investigational GLP-1s before TJA require further study."

Anesthesia • Diabetes • Infectious Disease • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics

The pleiotropic effects of glucagon-like peptide-1 receptor agonists in patients with metabolic dysfunction-associated steatohepatitis: a review for gastroenterologists. (PubMed, Expert Opin Investig Drugs) - "Our narrative review of English articles included four GLP-1RAs (subcutaneous semaglutide, liraglutide, dulaglutide, and efpeglenatide), a dual GLP-1/GIP agonist (tirzepatide), a dual GLP-1/glucagon receptor agonist (survodutide), MASLD/MASH, related disorders, clinical management, treatment outcomes and landscape. Effects on cardiometabolic parameters align with type 2 diabetes/obesity Phase III data, comprising substantial improvements in glycemic, weight, and cardiovascular outcomes. Promising data also suggest benefits in common comorbidities, including obstructive sleep apnea, polycystic ovary syndrome, chronic kidney disease, and heart failure with preserved ejection fraction.GLP-1RAs represent a valuable pharmacotherapeutic option for gastroenterologists managing individuals with MASLD/MASH and cardiometabolic comorbid conditions."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetes • Fibrosis • Gastroenterology • Genetic Disorders • Heart Failure • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Obesity • Obstructive Sleep Apnea • Polycystic Ovary Syndrome • Renal Disease • Respiratory Diseases • Sleep Disorder • Type 2 Diabetes Mellitus

'Korean-style obesity drug' to be launched next year···Hanmi Pharmaceuticals to conduct phase 3 new drug trial [Google translation] (Nate) - "According to industry sources on the 4th, Hanmi Pharmaceutical plans to commercialize its obesity drug candidate 'Efpeglenatide', which is currently undergoing domestic phase 3 clinical trials, by the second half of 2026. This is about half a year earlier than the original target date of the first half of 2027....In addition, 'HM17321', which shows a weight loss effect similar to Wegovy and Mounjaro while also increasing muscle, is scheduled to enter phase 1 clinical trials in the second half of this year."

Launch • New P1 trial • Obesity