Eculizumab
As of the edition of 20 October 2026, Eculizumab is an antibody: marketed, first approved in 2007 (US); acts on C5; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Antibody
- Brand name
- Soliris
- First approved
- 16 March 2007 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 3 holders in all
- Registered trials
- 95, 16 stopped early
- Disease areas
- Blood and lymph; Immune system; Pregnancy and women's health; Urinary and reproductive; Nervous system; Cancer
US protection
US protection ends in 2032.
The orphan exclusivity ends in 2032 (it covers one use only). The application that gives this date is held by AstraZeneca.
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.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| C5 | Complement C5 | P01031 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 4 | 1 | 0 |
| Phase 1 | 6 | 5 | 0 | 1 |
| Phase 2 | 41 | 23 | 3 | 11 |
| Phase 3 | 34 | 26 | 4 | 4 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 95 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 2007 to now |