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Orthoclone Okt3 (MUROMONAB-CD3)
Orthoclone Okt3 (MUROMONAB-CD3) is a CD3 blocker immunosuppressant originally developed by ORTHO BIOTECH and currently owned by the same company. It targets the T-cell surface glycoprotein CD3, a key component of the immune system. This drug is used to prevent renal transplant rejection and was FDA approved in 1992. As a proprietary product, its commercial status is patented, and key safety considerations include potential infections and allergic reactions. In plain terms, Orthoclone Okt3 works by blocking a specific protein on immune cells to prevent them from attacking the transplanted kidney.
At a glance
| Generic name | MUROMONAB-CD3 |
|---|---|
| Sponsor | Ortho Biotech |
| Drug class | CD3 Blocker Immunosuppressant |
| Target | T-cell surface glycoprotein CD3 |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1992 |
Approved indications
- Renal transplant rejection
Common side effects
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial (PHASE2)
- Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma (PHASE1,PHASE2)
- Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (PHASE1)
- Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults (PHASE3)
- Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma (PHASE3)
- Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Orthoclone Okt3 CI brief — competitive landscape report
- Orthoclone Okt3 updates RSS · CI watch RSS
- Ortho Biotech portfolio CI