obiltoxaximab
Trade name: anthim
mAbapprovedOrphan Drug FDAFast Track FDA
Approved
Mar 18, 2016
Obiltoxaximab, sold under the brand name Anthim among others, is a monoclonal antibody medication designed for the treatment of exposure to Bacillus anthracis spores. — Wikipedia
Clinical trial activity
8 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
7
Phase 2
0
Phase 3
0
Phase 4
1
Earliest trial started Oct 1, 2005 (NCT00138411)
Timeline
2000s
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
- Jun 9, 2006
Orphan Drug Designation
2010s
- Mar 18, 2016
Elusys Therapeutics — Earliest FDA Approval
- Mar 18, 2016
Elusys Therapeutics — Marketing Organization
- Mar 18, 2016
Elusys Therapeutics — NDA Organization
Indications
Approved for
Mechanism of action
- Protective antigenBINDING AGENT
pagA binding agent
- Anthrax lethal factorINHIBITOR
lef inhibitor
Approval history
- approvedFast trackMar 18, 2016
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaObiltoxaximab ↗
- NCATS29Z5DNL48C ↗
- ChEMBLCHEMBL3544926 ↗
Also known as
- anthim
- anthim
- anthim
- anthim
- eti-204
- eti-204
- eti-204
- eti-204
- obiltoxaximab
- obiltoxaximab
- obiltoxaximab
- obiltoxaximab
- obiltoxaximab
- obiltoxaximab
- obiltoxaximab
- obiltoxaximab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03088111 | Phase 4 | Dec 31, 2023 | APCER Life Sciences, Centers for Disease Control and Prevention (CDC), Elusys Therapeutics |
| NCT01952444 | Phase 1 | Oct 1, 2013 | Davita Clinical Research, Elusys Therapeutics, IQVIA |
| NCT01932242 | Phase 1 | Jul 1, 2013 | Elusys Therapeutics, IQVIA |
| NCT01929226 | Phase 1 | Jul 1, 2013 | Covance, Elusys Therapeutics |
| NCT01932437 | Phase 1 | Jul 1, 2013 | Elusys Therapeutics |
| NCT01453907 | Phase 1 | Oct 1, 2011 | Elusys Therapeutics, IQVIA |
| NCT00829582 | Phase 1 | Feb 1, 2009 | Elusys Therapeutics |
| NCT00138411 | Phase 1 | Oct 1, 2005 | National Institute of Allergy and Infectious Diseases (NIAID) |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Elusys Therapeutics | For profit | 7 | 7 | 2 | 2009 |
| IQVIA | For profit | 3 | 0 | 1 | 2011 |
| APCER Life Sciences | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Centers for Disease Control and Prevention (CDC) | Government | 1 | 0 | 1 | 2023 |
| Covance | For profit | 1 | 0 | 1 | 2013 |
| Davita Clinical Research | For profit | 1 | 0 | 1 | 2013 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2005 |
7 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Elusys Therapeutics | For profit | MKTG | Mar 18, 2016 |
| Elusys Therapeutics | For profit | NDA | Mar 18, 2016 |