Emapalumab
As of the edition of 20 October 2026, Emapalumab is an antibody: marketed, first approved in 2018 (US); acts on IFNG; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Antibody
- Brand name
- Gamifant
- First approved
- 20 November 2018 (US)
- Approvals on record
- 6 in 1 region
- Holder of the most recent approval
- Swedish Orphan Biovitrum
- Registered trials
- 19, 2 stopped early
- Disease areas
- Blood and lymph; Immune system; Bones, joints and muscles; Cancer; Skin and connective tissue; Digestive system
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 Swedish Orphan Biovitrum. 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.
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 Emapalumab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IFNG | Interferon gamma | P01579 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 11 | 1 | 9 | 1 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Swedish Orphan Biovitrum | Acquired holder and Lead sponsor of trials | 2011 to now |