Drug intelligence / Profile preview

muromonab-CD3 + omeprazole

Development stage
Discontinued
Lead developer
Johnson & Johnson
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral
01

Overview

muromonab-CD3 + omeprazole is an experimental oral combination regimen investigated for the treatment of moderate-to-severe ulcerative colitis. The regimen consists of muromonab-CD3 (originally marketed as Orthoclone OKT3), a murine monoclonal antibody that targets the CD3 receptor on T lymphocytes, and omeprazole, a proton pump inhibitor. In this clinical application, omeprazole is administered prior to muromonab-CD3 to reduce gastric acidity, thereby protecting the antibody from proteolytic degradation in the stomach and facilitating its delivery to the intestinal immune system. The goal of this approach is to induce mucosal tolerance or modulate local T-cell responses in the gut. Although muromonab-CD3 was the first monoclonal antibody approved by the FDA (for intravenous use in organ transplant rejection), its development as an oral therapy for ulcerative colitis by Brigham and Women's Hospital was terminated when the manufacturer, Johnson & Johnson, discontinued the production of the antibody.

Brand names
Orthoclone OKT3
Other names
Oral OKT3Oral anti-CD3Oral muromonab-CD3
02

Targets

CD3D (T-cell surface glycoprotein CD3 delta chain)CD3G (T cell receptor gamma alternate reading frame protein)ATP4A (Potassium–transporting ATPase alpha chain 1)

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