Drugs / Eflapegrastim
Eflapegrastim
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04187898 | Mar 2020 → Jul 2024 | breast cancer, neutropenia | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01037543 | Nov 2009 → Feb 2011 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00998283 | Oct 2009 → Sep 2010 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04570423 | May 2021 → Oct 2027 expected | cancer, lymphoma | Spectrum Pharmaceuticals, Inc | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05949333 | Nov 2023 → Jan 2025 | breast neoplasm | Eunseong Medical Foundation Good GANG-AN HOSPITAL | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2018-06-05 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “한미약품 차세대 혁신 항암신약 3종 글로벌 임상 순항” hanmi.co.kr ↗
먼저 ‘롤론티스’는 경쟁 약물인 페그필그라스팀(제품명 뉴라스타)과의 비열등성 확인 임상 3상의 세부결과(ADVANCE study)가 발표됐다. |
| 2018-02-06 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “Rolontis, 올해 4분기 미국 시판허가 신청 예정” hanmi.co.kr ↗
한미약품의 Rolontis 개발 파트너사인 미국 스펙트럼社는 5일(현지시각) 배포한 자사 보도자료를 통해 Rolontis의 임상 3상인 ADVANCE Study에서 경쟁약물인 Peg-Filgrastim(상품명 뉴라스타) 대비 비열등성의 1차 유효성 평가변수를 확인했다고 밝히면서 올해 4분기에 미국 시판허가 신청을 할 예정이라고 밝혔다. |
| 2015-12-18 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> ‘에플라페그라스팀’, 글로벌 임상3상 진입 hanmi.co.kr ↗
미국 스펙트럼사(Spectrum Pharmaceuticals)는 최근 지속형 호중구감소증 치료를 위한 바이오신약 ‘에플라페그라스팀( LAPS GCSF/SPI-2012)'의 미국 임상3상 수행계획에 대해 FDA의 특별시험계획평가(SPA)를 거쳐 최종 동의를 받았다고 18일 밝혔다. |
| 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. |
| 2014-09-11 | Hanmi Pharmaceutical Company Limited | Results SPI-2012, a novel long-acting GCSF utilizing a proprietary platform technology of Hanmi, advances to Phase 3 hanmipharm.com ↗
SPI-2012 met the primary endpoint in a multicenter Phase 2 study that evaluated the effectiveness and safetyof SPI-2012 compared to a standard dose of pegfilgrastim. |
| 2009-10-15 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 한미 "3주 1회투여 호중구감소약 美 임상진입" hanmi.co.kr ↗
한미약품은 차세대 바이오 신약인 'LAPS-GCSF(HM10460A)'의 1상 임상시험을 미국 FDA가 최종 승인했다고 14일 밝혔다. |
All press releases naming this drug 10 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eflapegrastim | “A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of...” PMID 34993933 ↗ Jan 2022 |
| Known as | HM10460A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00998283 ↗ |
| Known as | HNK460 | “Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects” NCT00998283 ↗ |
| Known as | Rolontis | “Eflapegrastim (Rolontis®) is a novel long-acting pegylated recombinant human granulocyte colony-stimulating factor (G-CSF).” PMID 34993933 ↗ Jan 2022 |
| Modality | Protein / enzyme biologic | “Eflapegrastim (Rolontis®) is a novel long-acting pegylated recombinant human granulocyte colony-stimulating factor (G-CSF).” PMID 34993933 ↗ Jan 2022 |
| Route | Subcutaneous | “Subcutaneously administrate at 0 hour on Day 1” NCT00998283 ↗ |