Muromonab-cd3
As of the edition of 20 October 2026, Muromonab-cd3 is a drug: marketed, first approved in 1992 (US); acts on CD3E; US protection ended in 2004.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1992
- Kind
- Unknown
- Brand name
- Orthoclone OKT3
- First approved
- 14 September 1992 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Johnson & Johnson
- Registered trials
- 18, 3 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2004.
US protection ended in 2004, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Johnson & Johnson. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CD3E | T-cell surface glycoprotein CD3 epsilon chain | P07766 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 4 | 2 | 0 | 1 |
| Phase 2 | 11 | 7 | 0 | 2 |
| Phase 3 | 2 | 0 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant | 1992 to now |