Anifrolumab
As of the edition of 20 October 2026, Anifrolumab is an antibody: marketed, first approved in 2021 (US); acts on IFNAR1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Antibody
- Brand name
- Saphnelo
- First approved
- 30 July 2021 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- AstraZeneca
- Registered trials
- 39, 0 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Infections; Pregnancy and women's health; Urinary and reproductive; Bones, joints and muscles
US protection
US protection ends in 2033.
US protection ends in 2033, 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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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 Anifrolumab.
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 |
|---|---|---|
| IFNAR1 | Interferon alpha/beta receptor 1 | P17181 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 0 | 7 | 0 |
| Phase 1 | 7 | 5 | 1 | 0 |
| Phase 2 | 10 | 6 | 2 | 0 |
| Phase 3 | 12 | 3 | 9 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator and Lead sponsor of trials | 2009 to now |