Drugs / HM17321
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | obesity disorder | — | “한미약품은 지난달 말 미국 식품의약국(FDA)에 ‘신개념 비만치료제(LA-UCN2, HM17321)’의 임상 1상 진입을 위한 임상시험계획(IND)을 신청했다고 1일 밝혔다.” hanmi.co.kr ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07219589 | Nov 2025 → Mar 2027 expected | obesity disorder | Hanmi Pharmaceutical Company Limited | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | Hanmi Pharmaceutical Company Limited | Results Hanmi Captures Attention at ADA 2026 with New Muscle-Gaining Obesity Drug Candidate HM500197 hanmipharm.com ↗
Seon Myeong Lee, Senior Research Scientist at Hanmi’s Future Growth Division, presents key findings on HM17321 during a poster session at ADA 2026. |
| 2026-06-16 | Hanmi Pharmaceutical Company Limited | Results “빅파마 빅딜로 주목받은 한미약품…ADA서 화제 중심으로” hanmi.co.kr ↗
한미약품의 세계 최초 근육 증가 비만신약 ‘LA-UCN2(HM17321)’은 현재 미국 임상 1상 시험이 순항하고 있으며, 이번 학회에서는 다양한 기전의 약물들과 병용 가능성은 물론 체내 작용 기전을 포함해 근골격계과 심혈관, 신장 보호 영역에서의 치료 잠재력을 보다 심층적으로 규명한 7건의 폭넓은 혁신 연구 성과를 발표했다. |
| 2025-11-10 | Hanmi Pharmaceutical Company Limited | Results Hanmi Highlights Next-Generation Obesity Pipelines at ObesityWeek 2025 hanmipharm.com ↗
Researchers from Hanmi’s R&D and Clinical Teams explain study findings on HM17321 and HM15275 to attendees at ObesityWeek 2025 |
| 2025-11-10 | Hanmi Pharmaceutical Company Limited | Results ‘미래의 비만 신약’ 품은 한미 혁신 기술, 美 학회서 집중 조명 hanmi.co.kr ↗
한미약품은 근육 비대와 지방 분해를 동시에 촉진해 ‘고품질 체중 감량’을 실현하도록 설계된 HM17321의 전임상 연구 결과 3건을 발표했다. |
| 2025-11-06 | Hanmi Pharmaceutical Company Limited | Regulatory Hanmi’s First-in-Class Obesity Therapy with Muscle-Building Potential Gains FDA Clearance for Phase 1 Trial hanmipharm.com ↗
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. |
| 2025-11-06 | Hanmi Pharmaceutical Company Limited | Regulatory 한미 세계 첫 ‘근육 증가’ 혁신 비만신약 , 美 FDA 임상 1상 승인 hanmi.co.kr ↗
한미약품은 지난 4일(미국 현지시각) 미국 식품의약국(FDA)으로부터 ‘신개념 비만치료제(LA-UCN2, 코드명: HM17321)’의 임상 1상 진입을 위한 임상시험계획(IND)을 승인 받았다고 6일 밝혔다. |
| 2025-10-01 | Hanmi Pharmaceutical Company Limited | Regulatory Hanmi Files IND with FDA for Novel Obesity Therapy with Muscle-Building Potential hanmipharm.com ↗
Hanmi announced on October 1 that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) at the end of last month for HM17321 (LA-UCN2), a novel obesity therapy. |
| 2025-10-01 | Hanmi Pharmaceutical Company Limited | Regulatory 한미 세계 첫 ‘근육 증가’ 혁신 비만신약 , 美 FDA에 임상 1상 IND 신청 hanmi.co.kr ↗
한미약품은 지난달 말 미국 식품의약국(FDA)에 ‘신개념 비만치료제(LA-UCN2, HM17321)’의 임상 1상 진입을 위한 임상시험계획(IND)을 신청했다고 1일 밝혔다. |
| 2025-09-23 | Hanmi Pharmaceutical Company Limited | Results Hanmi Draws Attention at EASD 2025 with World’s First ‘Muscle-Building’ Obesity Drug hanmipharm.com ↗
Haemin Chon, Vice President of Hanmi R&D Center, unveiled groundbreaking data on the muscle-enhancing mechanism of HM17321, a novel obesity drug, at EASD 2025 in Vienna. |
| 2025-09-23 | Hanmi Pharmaceutical Company Limited | Results 유럽 중심에 선 한미 혁신 비만신약 …EASD서 ‘게임 체인저’ 가능성 타진 hanmi.co.kr ↗
구연 발표에서는 HM17321이 mTOR(mechanistic target of rapamycin, 라파마이신 표적 단백질) 경로 활성화와 당분해(glycolysis) 의존 대사 적응을 통해 근 성장을 유도한다는 연구 데이터가 공개됐다. |
| 2025-08-24 | Hanmi Pharmaceutical Company Limited | Results 한미약품 차세대 비만신약, 미국 이어 유럽도 달군다 hanmi.co.kr ↗
주요 발표 내용은 ▲HM15275의 강력한 항비만 효과에 대한 기전적 통찰 ▲HM17321의 근육 성장 및 대사 개선 효과를 뒷받침하는 골격근 단백체 분석 ▲HM17321의 비만 영장류 모델에서 체중 감량 효능 및 설치류 모델에서 인크레틴 병용 효능 ▲HM17321의 체성분 개선, 에너지 소모 및 대사 건강 증진 효과 입증 ▲혈액단백체 기반 HM17321의 근육 및 골격 건강에 대한 잠재적 이로운 효과 ▲HM101460의 경구용 GLP-1 작용제 가능성 입증 등이다. |
| 2025-08-05 | Hanmi Pharmaceutical Company Limited | Results Hanmi Pharmaceutical Advances World’s First Obesity Drug Targeting Muscle Growth into Clinical Development hanmipharm.com ↗
At the [1] ISMB/ECCB 2025 conference, held July 20-24 in Liverpool, UK, Hanmi presented a scientific poster session showcasing preclinical study results that demonstrated HM17321’s potential to improve obesity outcomes by enhancing metabolic health, including increased muscle mass, improved muscle function, and fat reduction. |
| 2025-08-05 | Hanmi Pharmaceutical Company Limited | Results 한미약품, 세계 첫 ‘근육 증가’ 비만신약 임상 진입 청신호 켰다 hanmi.co.kr ↗ |
| 2025-06-27 | Hanmi Pharmaceutical Company Limited | Results Hanmi’s Next-Gen Obesity Drug Gains Momentum: Nearly 5% Weight Loss After 4 Weeks, Up to 10% in Individual Case hanmipharm.com ↗
Among the highlights were early-stage findings demonstrating more rapid and potent weight loss of HM15275 compared to currently available obesity drugs, as well as compelling results of HM17321 in animal models showing concurrent fat loss and muscle gain. |
| 2025-06-21 | Hanmi Pharmaceutical Company Limited | Results “미래의 비만 치료제, 한미에서 만났다”…한미, ADA서 ‘혁신’ 입증 hanmi.co.kr ↗
또 다른 신약(HM17321), 비인간 영장류 모델서 ‘체중 감량+근육 증가’ 확인 |
| 2024-11-06 | Hanmi Pharmaceutical Company Limited | Results Hanmi Unveils Novel Obesity Drug ‘HM17321’ : A Game-Changer in Overcoming GLP-1-Associated Muscle Loss hanmipharm.com ↗
This groundbreaking drug not only augments fat loss but also significantly increases lean muscle mass, marking it as a potential game-changer in obesity management. |
| 2024-11-06 | Hanmi Pharmaceutical Company Limited | Results “GLP-1 근 손실 한계 뛰어넘은 게임 체인저 될 것” 한미약품, 신개념 비만 신약 ‘HM17321’ 발표 hanmi.co.kr ↗
이번 학회에서 한미약품은 비만 동물 모델에서 HM17321 투약 시, GLP-1 기반 약물인 세마글루타이드(semaglutide)와 유사한 체중 감량 효과를 나타내면서도 제지방량(lean mass)과 근육량(muscle mass)을 증가시키는 차별성을 확인한 결과를 발표했다. |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HM17321 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07219589 ↗ |
| Route | Subcutaneous | “administered by subcutaneous (SC) injection” NCT07219589 ↗ |