Drugs / Efpeglenatide
Efpeglenatide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | obesity disorder | 2025-12-17 | “Hanmi completed its regulatory application for efpeglenatide to the Ministry of Food and Drug Safety on December 17, 2025.” hanmipharm.com ↗ “에페글레나타이드 오토인젝터주 식품의약품안전처 품목허가 신청” hanmi.co.kr ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02059564 | Dec 2013 → Oct 2014 | diabetes mellitus | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 1 | NCT01093729 | Feb → Oct 2010 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT02075281 | Feb 2014 → Jan 2015 | obesity disorder | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT02081118 | Feb 2014 → Mar 2015 | type 2 diabetes mellitus | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT02057172 | Jan → Oct 2014 | type 2 diabetes mellitus | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT07379333 | Apr 2026 → Nov 2027 expected | type 2 diabetes mellitus | Hanmi Pharmaceutical Company Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT06174779 | Jan 2024 → Aug 2025 | obesity disorder | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 3 | NCT03770728 | Aug 2019 → Nov 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03713684 | Nov 2018 → Nov 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03684642 | Sep 2018 → Oct 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03496298 | Apr 2018 → Dec 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03353350 | Dec 2017 → Jan 2020 | type 2 diabetes mellitus | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01452451 Comparator | Dec 2011 → Jun 2013 | diabetes mellitus | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-12-17 | Hanmi Pharmaceutical Company Limited | Regulatory 한미약품, 에페글레나타이드 국내 허가 신청 완료...밸류업 여정 본격화 hanmi.co.kr ↗
한미약품이 독자 개발한 국내 최초의 GLP-1 계열 비만·대사질환 치료제 ‘에페글레나타이드 오토인젝터주(HM11260C)’의 국내 허가 신청을 완료했다. |
| 2025-10-27 | Hanmi Pharmaceutical Company Limited | Results “Korea’s Homegrown GLP 1 obesity therapy with Favorable Efficacy and Safety Nears Filing” ― Hanmi Targets Approval Submission This Year hanmipharm.com ↗
Among the 448 Korean participants enrolled in the study, some achieved weight reduction of up to 30% by Week 40, confirming strong efficacy. |
| 2015-06-09 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “월 1회 투여, 당뇨-비만치료 가능성 확인” hanmi.co.kr ↗
발표에 따르면 모든 투약군에서 HbA1c가 7% 이하로 감소했으며, HbA1c 목표치인 7%에 도달한 환자 비율도 60% 이상이었다. |
| 2015-06-08 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “주1회 투여 인슐린 콤보, 당뇨치료 새 패러다임 제시” hanmi.co.kr ↗
이번 연구결과는 공동연구자인 Micheal E. Trautmann 의학박사(Profil institute)가 발표했으며, 두 약제의 결합에 따른 치료적 장점과 우수한 효력, 인슐린에 의한 저혈당 쇼크 및 체중증가 등 부작용을 경감할 수 있다는 가능성을 확인했다. |
| 2015-06-03 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 퀀텀프로젝트 등 당뇨신약 ADA 발표 hanmi.co.kr ↗
이번 학회에서 한미약품은 GLP-1 계열 당뇨신약 에페글레나타이드(efpeglenatide)의 월1회 용법 등 약효지속성과 체중감소 효과 등을 확인한 후기2상 연구과제(3건)를 비롯해, 1주제형 인슐린으로 개발 중인 LAPSInsulin115, 에페글레나타이드와 LAPSInsulin115를 결합한 LAPSInsulin Combo 등 퀀텀프로젝트의 주요 연구과제를 발표한다. |
| 2015-04-17 | Hanmi Pharmaceutical Company Limited | Regulatory WHO granted Hanmi INN : ‘Efpeglenatide’ for LAPS CA-Exendin4 hanmipharm.com ↗
April 16, Hanmi pharm reported that INN ‘efpeglenatide’ and ‘eflapegrastim’ was granted to its new bio drug LAPSCA-Exendin4 (drug for diabetes) and LAPSGCSF (new drug for neutropenia) respectively, and these names will be used globally. |
| 2015-04-17 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 한미약품 바이오신약 2종, WHO 국제일반명 등재 hanmi.co.kr ↗
한미약품(대표이사 이관순, www.hanmi.co.kr)은 바이오신약 LAPSCA-Exendin4(당뇨치료제)와 LAPSGCSF(호중구감소증치료제) 성분의 국제일반명이 각각 에페글레나타이드(efpeglenatide), 에플라페그라스팀(eflapegrastim)으로 결정돼 전 세계적으로 통용된다고 16일 밝혔다. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-17 | Hanmi Pharmaceutical Company Limited | 한미약품, 에페글레나타이드 국내 허가 신청 완료...밸류업 여정 본격화 hanmi.co.kr ↗ |
| 2025-10-27 | Hanmi Pharmaceutical Company Limited | “Korea’s Homegrown GLP 1 obesity therapy with Favorable Efficacy and Safety Nears Filing” ― Hanmi Targets Approval Submission This Year hanmipharm.com ↗ |
| 2015-06-09 | Hanmi Pharmaceutical Company Limited | <보도자료> “월 1회 투여, 당뇨-비만치료 가능성 확인” hanmi.co.kr ↗ |
| 2015-06-08 | Hanmi Pharmaceutical Company Limited | <보도자료> “주1회 투여 인슐린 콤보, 당뇨치료 새 패러다임 제시” hanmi.co.kr ↗ |
| 2015-06-03 | Hanmi Pharmaceutical Company Limited | <보도자료> 퀀텀프로젝트 등 당뇨신약 ADA 발표 hanmi.co.kr ↗ |
| 2015-04-17 | Hanmi Pharmaceutical Company Limited | WHO granted Hanmi INN : ‘Efpeglenatide’ for LAPS CA-Exendin4 hanmipharm.com ↗ |
| 2015-04-17 | Hanmi Pharmaceutical Company Limited | <보도자료> 한미약품 바이오신약 2종, WHO 국제일반명 등재 hanmi.co.kr ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efpeglenatide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03684642 ↗ |
| Known as | HM11260C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01452451 ↗ |
| Known as | Langlenatide | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650470 ↗ |
| Known as | SAR439977 | “Drug: efpeglenatide (SAR439977)” NCT03353350 ↗3“Drug: Efpeglenatide SAR439977” NCT03770728 ↗ “Efpeglenatide (SAR439977)” NCT03496298 ↗ “Efpeglenatide SAR439977” NCT03713684 ↗ |
| Action | Activate | “Glucagon-like peptide 1 receptor agonist” CHEMBL4650470 ↗1“the GLP 1 Agonist HM11260C” NCT01452451 ↗ |
| Modality | Peptide | “Glucagon-like peptide-1 analogue” NCT02075281 ↗ |
| Route | Subcutaneous | “After Subcutaneous Administration” NCT01093729 ↗ |
| Target | GLP1R | “Glucagon-like peptide 1 receptor agonist” CHEMBL4650470 ↗ |