Muromonab

Overview

Murine monoclonal antibody specific to CD3 T-cell lymphocyte antigens. More specifically it is a purified murine (mouse) monoclonal antibody, directed against the CD3 (T3) receptor on the surface of human T-cells (T-lymphocytes) cultured using the murine ascites method. Muromonab is 93% monomeric immune globulin G type 2a (IgG2a).

Indication

For treatment of organ transplant recipients, prevention of organ rejection

Associated Conditions

Acute Renal Allograft Rejection
Steroid resistant Heart transplant rejection
Steroid resistant hepatic transplant rejection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Oral Administration of Anti-CD3 Monoclonal Antibody in Non-responder Genotype-I Chronic Hepatitis C Subjects	2011/10/25	NCT01459419	Phase 2	UNKNOWN	Inspira Medical AB
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome	2010/09/20	NCT01205087	Phase 2	Completed	Hadassah Medical Organization
Oral OKT3 in Combination With Beta-D-Glucosylceramide	2008/02/21	NCT00619372	Phase 1	UNKNOWN	Hadassah Medical Organization
Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies	2007/12/03	NCT00566696	Phase 2	Completed	St. Jude Children's Research Hospital
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies	2005/09/20	NCT00202917	Phase 1	Completed	University Hospital Tuebingen
Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer	2004/09/13	NCT00091611	Phase 1	Terminated	National Cancer Institute (NCI)
Vaccine Treatment in Combination With IL-2 and Treated Lymphocytes for Advanced Melanoma	2004/03/29	NCT00080353	Phase 2	Completed	National Cancer Institute (NCI)
Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis	2001/12/07	NCT00027443	Not Applicable	Completed	Mayo Clinic
Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis	1999/10/19	NCT00004482	Phase 2	Completed	Mayo Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ORTHOCLONE OKT 3 STERILE SOLUTION IV 1MG/ML	Janssen Inc	02015978	Solution - Intravenous	1 MG / ML	12/31/1987

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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