vaccinia immunoglobulin
VaccineapprovedOrphan Drug FDA
Approved
May 2, 2005
Clinical trial activity
1 trials · 1 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
0
Phase 3
0
Phase 4
0
Earliest trial started Dec 6, 2000 (NCT00006630)
Timeline
2000s
- Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
- Jun 18, 2004
Orphan Drug Designation
- Feb 24, 2005
Cangene — First NDA Organization
- Feb 24, 2005
Cangene — NDA Organization
- May 2, 2005
Earliest FDA Approval
- May 2, 2005
Emergent BioSolutions — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Vaccinia virusANTAGONIST
Vaccinia virus antagonist
Approval history
- approvedAcceleratedMay 2, 2005
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- NCATS7UB4J759TD ↗
- ChEMBLCHEMBL2108699 ↗
Also known as
- vaccinia immune globulin
- vaccinia immune globulin
- vaccinia immune globulin intravenous (human)
- vaccinia immune human globulin
- vaccinia immunoglobulin
- vigiv
- vigiv
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00006630 | Phase 1 | Dec 6, 2000 | National Institute of Allergy and Infectious Diseases (NIAID) |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2000 |
1 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cangene | For profit | NDA | Feb 24, 2005 |
| Emergent BioSolutions | For profit | NDA2 | May 2, 2005 |