raxibacumab
Approved
Dec 14, 2012
Raxibacumab is a human monoclonal antibody intended for the prophylaxis and treatment of inhaled anthrax. Its efficacy has been proven in rabbits and monkeys. In December 2012 raxibacumab was approved in the United States for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. — Wikipedia
Clinical trial activity
3 trials · 2 clinical orgs · 2 marketing orgs
Earliest trial started Jan 1, 2008 (NCT02016963)
Timeline
2000s
- Nov 12, 2003
Orphan Drug Designation
- Jan 1, 2008
Human Genome Sciences — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2008
Human Genome Sciences — Earliest Phase 3 Sponsor(trial)
2010s
- Dec 14, 2012
Human Genome Sciences — Earliest FDA Approval
- Dec 14, 2012
Human Genome Sciences — Marketing Organization
- Dec 14, 2012
Human Genome Sciences — NDA Organization
- Dec 14, 2012
Emergent BioSolutions — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Protective antigenBINDING AGENT
pagA binding agent
It's a monoclonal antibody that binds free PA, preventing the intracellular entry of anthrax
- Anthrax lethal factorINHIBITOR
lef inhibitor
Approval history
- approvedFast trackDec 14, 2012
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaRaxibacumab ↗
- NCATS794PGL549S ↗
- ChEMBLCHEMBL2108638 ↗
Also known as
- abthrax
- abthrax
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab
- raxibacumab monoclonal antibody, human
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02339155 | Phase 4 | Feb 1, 2015 | GlaxoSmithKline |
| NCT00639678 | Phase 3 | Mar 1, 2008 | GlaxoSmithKline, Human Genome Sciences |
| NCT02016963 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2008 | GlaxoSmithKline, Human Genome Sciences |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 3 | 1 | 2 | 2008 |
| Human Genome Sciences | For profit | 2 | 2 | 1 | 2008 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Emergent BioSolutions | For profit | NDA2 | Dec 14, 2012 |
| Human Genome Sciences | For profit | MKTG | Dec 14, 2012 |
| Human Genome Sciences | For profit | NDA | Dec 14, 2012 |