crotalidae immune f(ab')2 (equine)
Trade name: Anavip
Animal productapprovedOrphan Drug FDA
Approved
May 6, 2015
Clinical trial activity
2 trials · 3 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
2
Phase 3
1
Phase 4
0
Earliest trial started Jan 1, 2005 (NCT00868309)
Timeline
2000s
- Jan 29, 2004
Orphan Drug Designation
- Jan 1, 2005
Instituto Bioclon — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2008
Instituto Bioclon — Earliest Phase 3 Sponsor(trial)
2010s
- May 6, 2015
Instituto Bioclon — Earliest FDA Approval
- May 6, 2015
Instituto Bioclon — NDA Organization
- May 6, 2015
Rare Disease Therapeutics — NDA Secondary Org
Indications
Approved for
Mechanism of action
- crotalid venomImmunity, passive
crotalid venom immunity, passive
Approval history
- approvedMay 6, 2015
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- anavip
- anavip
- crotalidae immune f(ab')2 (equine)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00636116 | Phase 3 | May 1, 2008 | Instituto Bioclon, National Autonomous University of Mexico, University of Arizona |
| NCT00868309 | Phase 2 | Jan 1, 2005 | Instituto Bioclon, University of Arizona |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Instituto Bioclon | For profit | 2 | 2 | 2 | 2005 |
| University of Arizona | Academic/Hospital | 2 | 0 | 2 | 2005 |
| National Autonomous University of Mexico | Academic/Hospital | 1 | 0 | 1 | 2008 |
3 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Instituto Bioclon | For profit | NDA | May 6, 2015 |
| Rare Disease Therapeutics | For profit | NDA2 | May 6, 2015 |