Alemtuzumab
As of the edition of 20 October 2026, Alemtuzumab is an antibody: marketed, first approved in 2001 (US); acts on CD52; US protection ended in 2013.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Antibody
- Brand name
- Campath
- First approved
- 7 May 2001 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Withdrawn from market
- 8 August 2012 (in some regions)
- Registered trials
- 291, 73 stopped early
- Disease areas
- Blood and lymph; Immune system; Cancer; Inherited and neonatal; Nervous system; Heart and blood vessels
US protection
US protection ended in 2013.
US protection ended in 2013, 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 Sanofi. 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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
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 Alemtuzumab.
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 |
|---|---|---|
| CD52 | CAMPATH-1 antigen | P31358 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 33 | 16 | 2 | 10 |
| Phase 1 | 39 | 19 | 4 | 14 |
| Phase 2 | 186 | 98 | 30 | 45 |
| Phase 3 | 19 | 16 | 0 | 1 |
| Phase 4 | 14 | 10 | 0 | 3 |
| All trials | 291 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 2001 to now |