muromonab cd3

Trade name: Orthoclone OKT3

mAbapproved

Approved

Jun 1, 1986

Muromonab-CD3 is an immunosuppressant medication given to reduce acute rejection in people with organ transplants. It is a monoclonal antibody targeted at the CD3 receptor, a membrane protein on the surface of T cells. It is the first monoclonal antibody to be approved for clinical use in humans. — Wikipedia

Clinical trial activity

27 trials · 31 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 31, 1980

Timeline

1980s

Jan 1, 1980
Earliest Phase 1 Sponsor
Jun 1, 1986
Earliest FDA Approval

1990s

Sep 14, 1992
Centocor — First NDA Organization
Sep 14, 1992
Centocor — NDA Secondary Org
Sep 14, 1992
Centocor — NDA Organization
Jan 1, 1994
Earliest Phase 2 Sponsor(trial)
Jan 1, 1999
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Kidney Diseases (approved 1986)

Studied for

Mechanism of action

T-cell surface glycoprotein CD3 epsilon chainACTIVATOR
CD3E activator
- T-cell surface glycoprotein CD3 epsilon chain (CD3E) ↗
T-cell surface glycoprotein CD3 epsilon chainINHIBITOR
CD3E inhibitor
- T-cell surface glycoprotein CD3 epsilon chain (CD3E) ↗
T cell surface glycoprotein CD3INHIBITOR
T cell surface glycoprotein CD3 inhibitor
Epsilon is binding site
- T-cell surface glycoprotein CD3 epsilon chain

Approval history

approvedJun 1, 1986

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Yes

Topical

Black box warning

Sources

Also known as

anti-cd3
hokt3
hokt3
j&j (ortho)clone okt3
muromonab
muromonab cd3
muromonab-cd3
muromonab-cd3
muromonab-cd3
muromonab-cd3
muromonab-cd3
muromonab-cd3
okt3
okt-3
okt-3
orthoclone okt3
orthoclone okt3
orthoclone okt3

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT03368339	Phase 2	Dec 10, 2017	Realm Therapeutics
NCT01205087	Phase 2	Sep 1, 2010	Hebrew University, Therapix Biosciences Ltd.
NCT01287195	Phase 1/Phase 2 (Phase 2)	Apr 7, 2009	Harvard University
NCT00824135	Phase 1	Jan 1, 2009	Genzyme, St. Jude Children's Hospital
NCT00619372	Phase 1	Jan 1, 2008	Hebrew University
NCT00566696	Phase 2	Dec 1, 2007	St. Jude Children's Hospital
NCT01423500	Phase 3	Jan 1, 2007	Akdeniz University, Azienda Ospedaliera San Gerardo di Monza, Istanbul University, Poznan University, St. Anna Kinderkrebsforschung, Tel Aviv University, University of Bratislava, University of Copenhagen, Utrecht University
NCT00450983	Phase 2	Dec 1, 2006	National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), University of Washington
NCT00143559	Phase 2	Aug 1, 2005	St. Jude Children's Hospital
NCT00091611	Phase 1	Sep 1, 2004	National Cancer Institute (NCI), National Institutes of Health (NIH)
NCT00145587	N/A	Jul 1, 2004	St. Jude Children's Hospital
NCT00145626	Phase 2	May 1, 2004	Assisi Foundation, St. Jude Children's Hospital
NCT00080353	Phase 2	Mar 1, 2004	National Cancer Institute (NCI)
NCT00202917	Phase 1/Phase 2 (Phase 2)	Feb 1, 2004	University of Tuebingen
NCT01423747	Phase 3	Jul 1, 2003	International BFM Study Group, Medical University of Vienna, St. Anna Kinderkrebsforschung, University of Kiel
NCT00145613	Phase 2	Jun 1, 2003	St. Jude Children's Hospital
NCT00152139	Phase 3	May 1, 2002	St. Jude Children's Hospital
NCT00027443	N/A	Aug 1, 2001	Mayo Clinic
NCT00004482	Phase 2	Dec 1, 1999	Mayo Clinic
NCT00000936	Phase 3	Nov 1, 1999	National Institute of Allergy and Infectious Diseases (NIAID)

Showing 20 of 27 trials

Page 1 / 2

Organizations

Research & Development (31)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Cancer Institute (NCI)	Government	8	3	2	1994
St. Jude Children's Hospital	Academic/Hospital	7	7	4	2002
Hebrew University	Academic/Hospital	2	2	2	2008
Mayo Clinic	Academic/Hospital	2	2	2	1999
National Institute of Allergy and Infectious Diseases (NIAID)	Government	2	1	2	1999
St. Anna Kinderkrebsforschung	Academic/Hospital	2	2	1	2003
Wayne State University	Academic/Hospital	2	2	1	1997
Akdeniz University	Academic/Hospital	1	0	1	2007
Assisi Foundation	Academic/Hospital	1	0	1	2004
Azienda Ospedaliera San Gerardo di Monza	Academic/Hospital	1	0	1	2007
Genzyme	For profit	1	0	1	2009
Harvard University	Academic/Hospital	1	1	1	2009
International BFM Study Group	Academic/Hospital	1	0	1	2003
Istanbul University	Academic/Hospital	1	0	1	2007
Johnson and Johnson	For profit	1	1	1	1980
Medical University of Vienna	Academic/Hospital	1	0	1	2003
National Institutes of Health (NIH)	Government	1	0	1	2004
Poznan University	Academic/Hospital	1	0	1	2007
Realm Therapeutics	For profit	1	1	1	2017
St. Vincent Medical Center - Los Angeles	Academic/Hospital	1	1	1	1991

31 organizations

Page 1 / 2

Marketing (2)

Organization	Org type	Relationship	Date
Centocor	For profit	NDA2	Sep 14, 1992
Centocor	For profit	NDA	Sep 14, 1992