Drugs / Olmutinib
Olmutinib
also known as
HM61713 · BI 1482694 · BI-1482694 DIHYDROCHLORIDE · BI1482694CL2 · Olita · Olmutinib dihydrochloride · OLMUTINIB HYDROCHLORIDE
Small molecule targets EGFR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | lung carcinoma | 2015-12-21 | “한편, 한미약품은 최근 HM61713에 대한 국내 신약 품목허가를 식품의약품안전처에 신청했다.” hanmi.co.kr ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04510415 | Mar → Dec 2018 | non-small cell lung carcinoma | Hanmi Pharmaceutical Company Limited | Terminated | No outcome recorded |
| Phase 1 | NCT02722161 | Apr → Jun 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01894399 | Sep → Nov 2013 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01588145 | Mar 2012 → Aug 2017 | non-small cell lung carcinoma | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03228277 | Jul 2017 → Jul 2018 | non-small cell lung carcinoma | Konkuk University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02485652 | Aug 2015 → Dec 2020 | non-small cell lung carcinoma | Hanmi Pharmaceutical Company Limited | Terminated | No outcome recorded |
| Phase 2 | NCT02444819 | Mar 2015 → Aug 2017 | non-small cell lung carcinoma | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2018-03-29 | Hanmi Pharmaceutical Company Limited | Regulatory <공지> 자이랩, 올무티닙의 중국 내 권리 한미약품으로 반환 hanmi.co.kr ↗
한미약품은 29 일 중국 자이랩 (ZAI Lab) 이 신약개발 전략 수정에 따라 내성표적 항암신약 올무티닙 (HM61713) 의 중국 내 권리를 반환했다고 공시했다 . |
| 2016-05-27 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 임상암학회에서 ‘올리타’ 심포지엄 열어 hanmi.co.kr ↗
올무티닙은 EGFR TKI 치료에 내성이 생긴 T790M 변이 양성 환자들을 대상으로 62%의 객관적반응률(Objective response rate)과 91%의 질병조절율(Disease control rate)을 보였고, 조절가능한 수준의 내약성도 보였다 |
| 2016-05-16 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 한국 최초 글로벌 혁신신약 ‘올리타’ 국내 허가 hanmi.co.kr ↗
올리타는 식약처 신속심사에 따라 허가를 받았다. |
| 2015-12-21 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim's third generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation for treatment of patients with non-small cell lung cancer prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its investigational third-generation epidermal growth factor receptor (EGFR) mutant-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). |
| 2015-12-21 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 3세대 내성표적 폐암신약, 美 FDA 혁신치료제 지정 hanmi.co.kr ↗
한미약품은 최근 미국 FDA가 한미약품이 개발한 HM61713(BI 코드명: BI1482694)을 폐암치료의 ‘혁신치료제’로 지정했다고 21일 밝혔다. |
| 2015-06-02 | Hanmi Pharmaceutical Company Limited | Results <보도자료> HM61713, 우수한 종양감소 효과 확인 hanmi.co.kr ↗
한미약품(대표이사 이관순, www.hanmi.co.kr)은 지난 달 29일부터 6월 2일까지 미국 시카고에서 열린 제51회 미국임상종양학회(이하 ASCO)에서 HM61713의 1/2상 중간결과를 발표했다. |
| 2015-04-27 | Hanmi Pharmaceutical Company Limited | Results Hanmi Pham made a presentation on its next generation targeted cancer drug at the American Association for Cancer Research hanmipharm.com ↗ |
| 2015-04-23 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 차세대 표적항암제 미국암학회 발표 hanmi.co.kr ↗
이번 학회에서 한미약품은 동물모델에서 확인한 HM61713 투약용량에 따른 인체에서의 효력용량 예측 결과를 발표했다. |
| 2014-06-03 | Hanmi Pharmaceutical Company Limited | Results Results from clinical trial of Hanmi's new drug (HM61713) were presented at ASCO hanmipharm.com ↗
The results from our clinical trial are significant since HM61714 has shown its possibility to overcome the tolerance of first generation EGFR TIK which is being used as the standard treatment line for patients with EGFR mutation-positive lung cancer. |
All press releases naming this drug 11 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Olmutinib | “Olmutinib (BI 1482694) ADME Study” NCT02722161 ↗ |
| Known as | BI 1482694 | “Olmutinib (BI 1482694) ADME Study” NCT02722161 ↗ |
| Known as | BI-1482694 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3786343 ↗ |
| Known as | BI1482694CL2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3786343 ↗ |
| Known as | HM61713 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02444819 ↗ |
| Known as | Olita | “Olmutinib(Olita®)” NCT03228277 ↗ |
| Known as | Olmutinib dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3786343 ↗ |
| Known as | OLMUTINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3786343 ↗ |
| Action | Inhibit | “Epidermal growth factor receptor erbB1 inhibitor” CHEMBL3786343 ↗ |
| Modality | Small molecule | — CHEMBL3786343 ↗ |
| Route | Oral | “after oral administration” NCT01588145 ↗ |
| Target | EGFR | “Epidermal growth factor receptor erbB1 inhibitor” CHEMBL3786343 ↗ |