Drugs / Obiltoxaximab
Obiltoxaximab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nyxthracis (previously Obiltoxaximab SFL) | — | 2020-11-18 | europa.eu ↗ |
| Approved | US (FDA) | ANTHIM | — | 2016-03-18 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT01952444 | Oct 2013 → Apr 2014 | inhalational anthrax | Elusys Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01932437 | Jul 2013 → Jul 2014 | inhalational anthrax | Elusys Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01932242 | Jul 2013 → Apr 2014 | inhalational anthrax | Elusys Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01929226 | Jul → Nov 2013 | inhalational anthrax | Elusys Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01453907 | Oct 2011 → Jun 2012 | anthrax infection | Elusys Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00829582 | Feb → Jul 2009 | — | Elusys Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00138411 | Oct 2005 → Mar 2006 | anthrax infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03088111 | Dec 2023 | inhalational anthrax | Elusys Therapeutics | Unknown | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Obiltoxaximab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03088111 ↗ |
| Known as | Anthim | “Anthim (Obiltoxaximab)” NCT03088111 ↗ |
| Known as | ETI-204 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01453907 ↗ |
| Known as | Nyxthracis (previously obiltoxaximab sfl) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544926 ↗ |
| Modality | Monoclonal antibody | “ETI-204 is a monoclonal antibody (MAb) to protective antigen (PA) from Bacillus anthracis.” NCT00829582 ↗ |
| Route | Intravenous | “single intravenous infusion of 120, 240 or 360 mg of ETI-204” NCT00829582 ↗ |