Drugs / Arbekacin
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02459158 | Sep 2015 → Mar 2017 | bacterial pneumonia | Meiji Seika Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01961830 | Sep → Dec 2013 | — | Meiji Seika Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01907776 | Jul → Dec 2013 | — | Meiji Seika Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01659515 | — | infectious disease | U.S. Army Medical Research and Development Command | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2015-05-29 | Meiji Seika Pharma Co., Ltd. | Regulatory Meiji announces that FDA Grants QIDP and Fast Track Designation to ME1100 meiji.com ↗
FDA additionally granted fast track review of ME1100 under section 505(i) of the Federal Food, Drug and Cosmetic Act. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-05-29 | Meiji Seika Pharma Co., Ltd. | Meiji announces that FDA Grants QIDP and Fast Track Designation to ME1100 meiji.com ↗ |
| 2013-07-26 | Meiji Seika Pharma Co., Ltd. | Meiji Initiates Phase 1 Clinical Trial of Arbekacin Inhalation Solution (ME1100) in the U.S. and Enters into a Licensing Agreement with PARI for a Customized eFlow® Technology Inhalation Device meiji.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arbekacin | “ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL)” NCT01907776 ↗ |
| Known as | ME1100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02459158 ↗ |
| Route | Intravenous | “Intravenous arbekacin in a total daily dose of 5-7 mg/kg” NCT01659515 ↗ |