Ravulizumab
As of the edition of 20 October 2026, Ravulizumab is an antibody: marketed, first approved in 2018 (US); acts on C5; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Antibody
- Brand name
- Ultomiris
- First approved
- 21 December 2018 (US)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 2 holders in all
- Registered trials
- 49, 8 stopped early
- Disease areas
- Blood and lymph; Immune system; Nervous system; Pregnancy and women's health; Urinary and reproductive; Cancer
US protection
US protection ends in 2030.
US protection ends in 2030, 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 AstraZeneca. 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.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| C5 | Complement C5 | P01031 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 1 | 7 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 5 | 2 | 1 | 2 |
| Phase 3 | 26 | 11 | 8 | 6 |
| Phase 4 | 5 | 1 | 3 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 2014 to now |