Drugs / DA-7218
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | acute skin infections | 2013-10-23 | “On October 23, 2013, Dong-A ST (President Park Chan-il) announced that it had submitted to the U.S.’s FDA its New Drug Application (NDA) for Tedizolid” donga-st.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02097043 | May 2014 | — | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2013-11-06 | Dong-A ST Co., Ltd. | Regulatory 동아 ST 글로벌 신약 허가/발매 가능성 고조 donga-st.com ↗
동아ST는 (대표이사 사장 박찬일) 지난 2007년 1월 미국 트리어스 테라퓨틱스 (Trius Therapeutics)社에 아웃라이센싱한 수퍼박테리아 항생제 ‘tedizolid’의 미국 FDA NDA (New Drug Application, 신약 허가 신청)가 제출되었다고 23일 밝혔다. |
| 2013-11-06 | Dong-A ST Co., Ltd. | Regulatory Dong-A ST’s new global drug most likely to be approved and marketed soon donga-st.com ↗
On October 23, 2013, Dong-A ST (President Park Chan-il) announced that it had submitted to the U.S.’s FDA its New Drug Application (NDA) for Tedizolid, a super-bacteria antibiotic, which it outlicensed to Trius Therapeutics of the United States in January 2007. |
| 2013-01-16 | Dong-A ST Co., Ltd. | Regulatory 수퍼박테리아 항생제 글로벌 신약 가속화 donga-st.com ↗
동아제약(대표이사 사장 김원배)은 지난 2007년 1월 미국 트리어스 테라퓨틱스社에 아웃라이센싱 한 수퍼박테리아 항생제 ‘테디졸리드 (제품 코드DA-7218)’가 미국 FDA로부터 QIDP (Qualified Infectious Disease Product)로 선정되었다고 9일 밝혔다. |
| 2009-06-19 | Dong-A ST Co., Ltd. | Results “Bright Vision of Dong-A with DA-7218” donga-st.com ↗
Dong-A’s super bacteria-targeting antibiotic successfully completed phase 2 study in the US |
| 2008-02-08 | Dong-A ST Co., Ltd. | Regulatory Dong-A Pharmaceutical Antibiotic Targeting Superbacteria Enters Phase I Clinical Trial donga-st.com ↗
Dong-A Pharmaceutical (President Won-Bae Kim) received USFDA approval to enter phase I clinical trial for its DA-7218 antibiotic targeting superbacteria. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-11-06 | Dong-A ST Co., Ltd. | 동아 ST 글로벌 신약 허가/발매 가능성 고조 donga-st.com ↗ |
| 2013-11-06 | Dong-A ST Co., Ltd. | Dong-A ST’s new global drug most likely to be approved and marketed soon donga-st.com ↗ |
| 2013-01-16 | Dong-A ST Co., Ltd. | 수퍼박테리아 항생제 글로벌 신약 가속화 donga-st.com ↗ |
| 2010-09-09 | Dong-A ST Co., Ltd. | 2010 Dong-A Initiated Phase 3 Program of DA-7218 for Oxazolidinone Antibiotic donga-st.com ↗ |
| 2009-06-19 | Dong-A ST Co., Ltd. | “Bright Vision of Dong-A with DA-7218” donga-st.com ↗ |
| 2008-02-08 | Dong-A ST Co., Ltd. | Dong-A Pharmaceutical Antibiotic Targeting Superbacteria Enters Phase I Clinical Trial donga-st.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DA-7218 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02097043 ↗ |
| Route | Intravenous | “single-dose oral and intravenous administration” PMID 28865799 ↗ Aug 2017 |
| Route | Oral | “single-dose oral and intravenous administration” PMID 28865799 ↗ Aug 2017 |