Abciximab
As of the edition of 20 October 2026, Abciximab is an antibody: marketed, first approved in 1994 (US); acts on ITGB3; US protection ended in 2006.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1994
- Kind
- Antibody
- Brand name
- Reopro
- First approved
- 22 December 1994 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Johnson & Johnson
- Registered trials
- 29, 7 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Blood and lymph; Hormones; Inherited and neonatal; Nutrition and metabolism
US protection
US protection ended in 2006.
US protection ended in 2006, 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.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Abciximab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ITGB3 | Integrin beta-3 | P05106 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 0 | 0 |
| Phase 2 | 6 | 2 | 0 | 2 |
| Phase 3 | 10 | 5 | 0 | 3 |
| Phase 4 | 10 | 8 | 0 | 2 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 1991 to now |