Rho(D) Immune Globulin Intravenous (Human)
Trade name: WinRho
Approved
Apr 10, 1968
Rho(D) immune globulin (RhIG) is a medication used to prevent RhD isoimmunization in mothers who are RhD negative and to treat idiopathic thrombocytopenic purpura (ITP) in people who are Rh positive. RhIG is commonly referred to as 'anti-D'. It is often given both during and following pregnancy. It may also be used when RhD-negative people are given RhD-positive blood. It is given by injection into muscle or a vein. A single dose lasts 12 weeks. It is made from human blood plasma. — Wikipedia
Clinical trial activity
8 trials · 15 clinical orgs · 4 marketing orgs
Earliest trial started May 1, 2004 (NCT02246842)
Timeline
1960s
- Apr 10, 1968
Earliest FDA Approval
1970s
1990s
- Apr 2, 1996
Kamada, Ltd. — NDA Secondary Org
- Apr 23, 1998
Kedrion SpA — NDA Secondary Org
2000s
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
- Feb 12, 2004
CSL Behring — NDA Secondary Org
2010s
- Jan 1, 2019
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- RhodopsinImmunity, passive
RHO immunity, passive
Approval history
- approvedApr 10, 1968
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaRho(D) immune globulin ↗
- NCATS48W7181FLP ↗
Also known as
- anti-d
- anti-d
- anti-d
- anti-d antibody
- anti-d immunoglobulin
- anti-d immunoglobulin
- anti-d immunoglobulins
- human anti-d immunoglobulin
- human anti-d immunoglobulin
- human rho(d) immune globulin
- igg, rho (d)
- immunoglobulin human anti-rh
- rh0(d) immune globulin intravenous (human)
- rho(d) antibody
- rho (d) immune globulin,human
- rho d immune globulin human
- rho(d) immune globulin human
- rho(d) immune globulin (human)
- rho(d) immune globulin (human)
- rho(d) immune globulin im human
- rho(d) immune globulin intravenous (human)
- rhogam
- winrho
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05245734 | Phase 3 | Feb 8, 2022 | Biopharma Plasma LLC, Government of Ukraine, Ivano-Frankivsk National Medical University |
| NCT03939637 | Phase 3 | May 2, 2019 | Baylor University, Harvard University, University of California, San Francisco |
| NCT01763658 | Phase 2/Phase 3 (Phase 3) | Mar 1, 2013 | Ain Shams University |
| NCT01443247 | N/A | Sep 1, 2010 | Postgraduate Institute of Medical Education and Research |
| NCT00952575 | Phase 2 | Aug 1, 2009 | Laboratoire français de Fractionnement et de Biotechnologies, Parexel |
| NCT00239733 | Phase 4 | Mar 1, 2005 | Cornell University, National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT00128882 | Phase 2 | Nov 1, 2004 | Aarhus University |
| NCT02246842 | Phase 1 | May 1, 2004 | Bio Products Laboratory, Radcliffe Cardiology |
Organizations
Research & Development (15)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Aarhus University | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Baylor University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Biopharma Plasma LLC | For profit | 1 | 1 | 1 | 2022 |
| Bio Products Laboratory | For profit | 1 | 1 | 1 | 2004 |
| Cornell University | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Government of Ukraine | Government | 1 | 0 | 1 | 2022 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Ivano-Frankivsk National Medical University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Laboratoire français de Fractionnement et de Biotechnologies | For profit | 1 | 1 | 1 | 2009 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2005 |
| Parexel | For profit | 1 | 0 | 1 | 2009 |
| Postgraduate Institute of Medical Education and Research | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Radcliffe Cardiology | Academic/Hospital | 1 | 0 | 1 | 2004 |
| University of California, San Francisco | Academic/Hospital | 1 | 0 | 1 | 2019 |
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| CSL Behring | For profit | NDA2 | Feb 12, 2004 |
| Grifols | For profit | NDA2 | Jun 11, 1971 |
| Grifols | For profit | NDA | Jun 11, 1971 |
| Kamada, Ltd. | For profit | NDA2 | Apr 2, 1996 |
| Kedrion SpA | For profit | NDA2 | Apr 23, 1998 |