Drugs / Raxibacumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RAXIBACUMAB | — | 2018-01-11 | fda.gov ↗ |
| Approved | US (FDA) | RAXIBACUMAB | — | 2012-12-14 | fda.gov ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02016963 | Jan → May 2008 | inhalational anthrax | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00639678 | Mar → Jul 2008 | — | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02339155 | Feb 2015 → Jan 2017 | bacterial infectious disease | Emergent BioSolutions | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Raxibacumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02016963 ↗ |
| Known as | Abthrax | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108638 ↗ |
| Modality | Monoclonal antibody | “Raxibacumab is a human IgG1lambda monoclonal antibody directed against protective antigen, a component of the anthrax toxin.” PMID 19587338 ↗ Jul 2009 |
| Route | Intravenous | “Safety studies were conducted with intravenous raxibacumab (40 mg per kilogram) in 333 healthy human volunteers.” PMID 19587338 ↗ Jul 2009 |