digoxin immune fab (ovine)
Trade name: DigiFab
Animal productapprovedOrphan Drug FDA
Approved
Apr 22, 1986
Digoxin immune fab or digoxin-specific antibody is an antidote for overdose of digoxin. It is made from immunoglobulin fragments from sheep that have already been immunized with a digoxin derivative, digoxindicarboxymethoxylamine (DDMA). Its brand names include Digibind (GlaxoSmithKline) and DigiFab. — Wikipedia
Clinical trial activity
5 trials · 8 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
3
Phase 3
0
Phase 4
2
Earliest trial started Feb 1, 2004 (NCT00158743)
Timeline
1980s
- Nov 1, 1984
Orphan Drug Designation
- Apr 22, 1986
Wellcome Trust — Earliest FDA Approval
- Apr 22, 1986
Wellcome Trust — NDA Secondary Org
- Apr 22, 1986
Wellcome Trust — NDA Organization
Indications
Approved for
Mechanism of action
- Solute carrier organic anion transporter family member 1A4Immunity, passive
SLCO1A4 immunity, passive
Approval history
- approvedApr 22, 1986
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaDigoxin immune fab ↗
- NCATSYB12NQZ1YN ↗
Also known as
- digibind
- digibind
- digibind
- digidot
- digifab
- digitalis antitoxin
- digoxin antibodies fab fragments
- digoxin immune fab
- digoxin immune fab
- digoxin immune fab (ovine)
- digoxin immune fab (ovine)
- digoxin immune fab, ovine
- digoxin-specific antibody fragments
- fabad
- ovine digoxin immune fab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03810417 | Phase 4 | Sep 30, 2019 | University of Maryland |
| NCT03008616 | Phase 2 | Apr 12, 2017 | Velo Bio, LLC |
| NCT00852787 | Phase 4 | Apr 1, 2009 | National Institute on Aging (NIA), University of Toledo |
| NCT00550576 | Phase 2 | Oct 1, 2007 | Technion University |
| NCT00158743 | Phase 2 | Feb 1, 2004 | BTG, GlaxoSmithKline, Wake Forest University |
Showing 5 of 5 trials
Page 1 / 1
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| BTG | For profit | 1 | 1 | 1 | 2004 |
| GlaxoSmithKline | For profit | 1 | 0 | 1 | 2004 |
| National Institute on Aging (NIA) | Government | 1 | 1 | 1 | 2009 |
| Technion University | Academic/Hospital | 1 | 1 | 1 | 2007 |
| University of Maryland | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of Toledo | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Velo Bio, LLC | For profit | 1 | 1 | 1 | 2017 |
| Wake Forest University | Academic/Hospital | 1 | 0 | 1 | 2004 |
8 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| BTG | For profit | NDA2 | Aug 31, 2001 |
| Wellcome Trust | Academic/Hospital | NDA2 | Apr 22, 1986 |
| Wellcome Trust | Academic/Hospital | NDA | Apr 22, 1986 |