cytomegalovirus immune globulin intravenous (human)
Trade name: cytogam
BiologicalapprovedOrphan Drug FDA
Approved
Apr 17, 1990
Clinical trial activity
8 trials · 14 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
2
Phase 3
2
Phase 4
4
Earliest trial started Jan 1, 2000 (NCT00214240)
Timeline
1980s
- Aug 3, 1987
Orphan Drug Designation
1990s
- Apr 1, 1990
MedImmune — First NDA Organization
- Apr 1, 1990
MedImmune — NDA Organization
- Apr 17, 1990
Earliest FDA Approval
- Apr 17, 1990
Kamada, Ltd. — NDA Secondary Org
2000s
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
2020s
- Jan 1, 2025
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
- CytomegalovirusImmunity, passive
Cytomegalovirus immunity, passive
Approval history
- approvedApr 17, 1990
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- NCATS129L90A25N ↗
Also known as
- cmv hyperimmune globulin
- cmvig
- cmv-immune globulin
- cytogam
- cytogam
- cytomegalovirus immune globulin intravenous (human)
- cytomegalovirus-specific hyperimmune globulin
- cytotect
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06958796 | Phase 4 | Nov 15, 2025 | Harvard University, Kamada, Ltd., The University of Texas, Dallas |
| NCT07096453 | Phase 1/Phase 2 (Phase 2) | Oct 2, 2025 | University of Minnesota |
| NCT07009548 | Phase 4 | Jun 26, 2025 | Kamada, Ltd., University of Pittsburgh |
| NCT01376778 | Phase 3 | Apr 1, 2012 | Brown University, George Washington University, National Institutes of Health (NIH) |
| NCT01509404 | Phase 4 | Nov 1, 2011 | CSL Behring, University of South Carolina |
| NCT00784979 | Phase 4 | Jan 1, 2002 | CSL Behring, Lifelink Healthcare Institute, University of South Florida |
| NCT00137748 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2001 | University of Rochester |
| NCT00214240 | N/A | Jan 1, 2000 | University of Wisconsin |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| CSL Behring | For profit | 2 | 0 | 1 | 2002 |
| Kamada, Ltd. | For profit | 2 | 0 | 1 | 2025 |
| Brown University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| George Washington University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Lifelink Healthcare Institute | Academic/Hospital | 1 | 0 | 1 | 2002 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2012 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of Minnesota | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Pittsburgh | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Rochester | Academic/Hospital | 1 | 1 | 1 | 2001 |
| University of South Carolina | Academic/Hospital | 1 | 1 | 1 | 2011 |
| University of South Florida | Academic/Hospital | 1 | 1 | 1 | 2002 |
| University of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2000 |
14 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Kamada, Ltd. | For profit | NDA2 | Apr 17, 1990 |
| MedImmune | For profit | NDA | Apr 1, 1990 |