efpeglenatide (HM11260C) / Hanmi - LARVOL DELTA

Efpeglenatide Attenuates Psoriasis in Both Obese and Lean Mice (OBESITY WEEK 2026) - No abstract available

Preclinical • Dermatology • Immunology • Obesity • Psoriasis

Sustained Weight Loss with Once-Weekly Efpeglenatide Through 64 Weeks in Adults with Obesity (OBESITY WEEK 2026) - No abstract available

Clinical • Genetic Disorders • Obesity

On the 23rd, the pharmaceutical industry said Hanmi Pharmaceutical is aiming to launch Efpeglenatide within the year and sell it directly (Chosun Biz) - "The company plans to leverage its existing sales network to target the obesity drug market....Efpeglenatide is an obesity drug tailored to Koreans, whose body mass index (BMI) is lower than that of Westerners. It is known to have relatively fewer side effects such as vomiting. The company applied for product approval with the Ministry of Food and Drug Safety at the end of last year."

Launch non-US • Obesity

A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus (clinicaltrials.gov) - P3 | N=448 | Completed | Sponsor: Hanmi Pharmaceutical Company Limited | Active, not recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Potential Mediators of Efpeglenatide's Cardiovascular Benefit: An Exploratory Analysis of the AMPLITUDE-O Trial. (PubMed, Diabetes Obes Metab) - "In this post hoc analysis from the AMPLITUDE-O trial, changes in LDL cholesterol together with UACR but not weight were estimated to statistically account for a modest portion of the reduction in risk of MACE with efpeglenatide."

Journal • Cardiovascular • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical said on the 18th that it held an investor relations (IR) session at the Pyeongtaek bio plant, the production base for Efpeglenatide, an obesity and metabolic disease treatment slated for launch in the second half of this year. (Chosun Biz) - "Hanmi Pharmaceutical said the Pyeongtaek bio plant has a current good manufacturing practice (cGMP) system that meets U.S. Food and Drug Administration (FDA) standards and can produce up to 20 million prefilled syringes a year for finished drugs."

Launch non-US • Obesity

The Impact of GLP-1-Based Therapies on Cardiovascular Outcomes in Type 2 Diabetes: A Comprehensive Systematic Review and Network Meta-Analysis. (PubMed, Diabetes Obes Metab) - "GLP-1-based therapies were associated with an overall favourable cardiovascular profile in T2DM. Pairwise analyses supported class-level benefit, whereas between-agent differences were more evident for MACE than for mortality outcomes in the NMA."

Journal • Retrospective data • Cardiovascular • Diabetes • Metabolic Disorders • Myocardial Infarction • 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 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Preferred GLP-1 Receptor Agonists in Type 2 Diabetes With Established Cardiovascular Disease or High Cardiovascular Risk: A Network Meta-Analysis of Randomized Trials. (PubMed, Can J Diabetes) - "Several GLP-1-based therapies reduced MACE versus placebo, with 3-point MACE emerging as the most consistent efficacy signal. Overall, these findings support guideline-based use of GLP-1 RAs in high-risk T2DM while highlighting the need for individualized treatment selection."

Journal • Retrospective data • Review • Cardiovascular • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Type 2 Diabetes Mellitus

Drug-specific Effects of GLP-1 Receptor Agonists on Dementia Risk: A Network Meta-analysis (AAN 2026) - "Other agents showed non-significant trends: albiglutide 30–50 mg weekly (OR 0.14; 95% CI 0.0074–2.77), efpeglenatide 2–6 mg weekly (OR 0.07; 95% CI 0.0031–1.39), lixisenatide 20 mcg daily (OR 0.33; 95% CI 0.014–8.18), semaglutide 0.5–1 mg weekly (OR 0.60; 95% CI 0.14–2.51), semaglutide 14 mg daily (OR 0.20; 95% CI 0.010–4.17), semaglutide 2.4 mg weekly (OR 0.75; 95% CI 0.17–3.35), dulaglutide 1.5 mg weekly (OR 0.78; 95% CI 0.29–2.09), and exenatide 2 mg weekly (OR 1.01; 95% CI 0.14–7.14). Conclusions Liraglutide is associated with a significant reduction in all-cause dementia, while other GLP-1 receptor agonists showed non-significant trends. These findings highlight the importance of drug-level analyses and warrant further research into cognitive effects across agents."

Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

Hanmi Pharmaceutical said Friday that it has formally launched a company-wide task force to accelerate the commercialization of its GLP-1–based obesity drug EFPE (efpeglenatide), targeting market approval within the year. (Korea Biomedical Review)

Approval • Commercial • Obesity

Renal Outcomes of GLP-1 Receptor Agonists and Tirzepatide Across CKD Stages and Metabolic Phenotypes (Type 2 Diabetes and/or Overweight/Obesity): A Scoping Review. (PubMed, Diabetes Ther) - "GLP-1-based therapies demonstrate consistent renoprotective signals across CKD stages and metabolic phenotypes, particularly in type 2 diabetes. Evidence is strongest for semaglutide and dulaglutide, with emerging data for tirzepatide and other incretin-based agents. These findings provide a structured evidence map to inform future consensus and clinical decision-making."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

HARMONIZED META-ANALYSIS OF GLP-1 RECEPTOR AGONIST CARDIOVASCULAR OUTCOME TRIALS: CONSISTENT REDUCTION IN 3-POINT MACE (ACC 2026) - " To assess GLP-1RA effects on 3-point MACE (CV death, nonfatal MI, nonfatal stroke) and the impact of endpoint harmonization, we meta-analyzed eight placebo-controlled CV outcome trials: ELIXA (lixisenatide), LEADER (liraglutide), SUSTAIN-6 (semaglutide s.c.), EXSCEL (exenatide), HARMONY (albiglutide), REWIND (dulaglutide), PIONEER-6 (oral semaglutide), and AMPLITUDE-O (efpeglenatide). Across >60,000 T2D patients, GLP-1RAs reduced 3-point MACE by ~14%. By harmonizing endpoints and eliminating trial-level variation, this analysis clarified a consistent class effect, contrasting prior heterogeneous reports and reinforcing GLP-1RAs as a cornerstone of ASCVD prevention."

Retrospective data • Cardiovascular • Diabetes • Metabolic Disorders • 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 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

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