Hanmi’s First-in-Class Obesity Therapy with Muscle-Building Potential Gains FDA Clearance for Phase 1 Trial

Hanmi’s First-in-Class Obesity Therapy with Muscle-Building Potential Gains FDA Clearance for Phase 1 Trial First-in-class obesity therapy that builds muscle while reducing fat Delivers superior weight-loss quality as monotherapy or when co-administered with existing incretin-based therapies (November 6, 2025) Hanmi Pharmaceutical has initiated a Phase 1 clinical trial for a first-in-class obesity therapy designed to achieve both fat reduction and muscle gain. Existing GLP-1？based obesity therapies primarily focus on weight reduction but are associated with lean mass loss. HM17321, by contrast, utilizes a novel selective fat-reducing mechanism and is emerging as a potential first-in-class therapy capable of addressing this critical limitation. Hanmi announced on November 6 (KST) that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HM17321 (LA-UCN2) on November 4(EST), allowing the company to initiate a Phase 1 clinical trial in the United States. The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 in healthy adults and people with obesity. HM17321 is being developed as a first-in-class obesity drug designed not only to prevent muscle loss, but also to achieve what has long been regarded as unattainable ― muscle mass gain alongside selective fat reduction. Unlike incretin-based therapies such as GLP-1 receptor agonists, HM17321 is a UCN2 (Urocortin-2) analog selectively targeting CRFR2 (corticotropin-releasing factor receptor 2). The molecule was engineered using Hanmi’s advanced AI and structural modeling platform. According to the company, selective CRFR2 activation can directly induce fat reduction, muscle hypertrophy, and improvement of muscle function. HM17321 has the potential to redefine obesity treatment as a monotherapy while also demonstrating quantitatively and qualitatively superior weight-loss efficacy when combined with existing incretin-based therapies. Most antibody-based muscle-preserving therapies require intravenous administration, limiting convenience for patients. They also present challenges when combined with subcutaneously administered incretin drugs and generally preserve muscle mass without functional improvement. In contrast, HM17321 is a peptide therapy, enabling subcutaneous administration, flexible combination use, and improved patient convenience at a competitive cost. In addition, HM17321 has demonstrated the potential to improve muscle function, addressing a key unmet need unmet by existing muscle-preserving therapies, which typically fail to deliver functional benefits. HM17321 selectively acts on the CRFR2 (On-Target), inducing both muscle growth and fat reduction simultaneously. This dual mechanism supports muscle mass increase, metabolic and functional improvement, high-quality weight loss, and cardiovascular benefits. Hanmi’s obesity R&D strategy, the H.O.P (Hanmi Obesity Pipeline) project, currently comprises six programs, each advancing differentiated mechanisms to improve weight-loss efficacy, quality and metabolic outcomes. The company recently reported positive Phase 3 interim topline results of efpeglenatide, the first H.O.P candidate expected to reach the market, highlighting its potential as a widely used obesity therapy with a well-established safety profile. HM15275, the second H.O.P pipeline candidate ― a next-generation triple-agonist obesity therapy (LA-GLP/GIP/GCG) ― received FDA approval to enter Phase 2 clinical trials, with a target of commercialization in 2030. As the third H.O.P program, HM17321 has demonstrated strong efficacy in obese primate study, further improving confidence in its clinical success. Hanmi plans to accelerate clinical development with a target of commercialization in 2031. “HM17321 is not merely a weight-loss drug,” said Dr. In Young Choi, Head of Hanmi’s R&D Center. “HM17321 is unique in that it simultaneously promotes fat reduction, muscle growth, and functional and metabolic improvement. We see obesity not simply as a matter of weight, but as a metabolic disease that requires tailored, patient-focused solutions. Our aim is to redefine obesity treatment.” PREV Hanmi Pharmaceutical Enters Vietnamese Market through Hypertension Therapy Partnership with Viet-Phap LIST NEXT Hanmi Highlights Next-Generation Obesity Pipelines at ObesityWeek 2025

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