Interferon gamma-1b
As of the edition of 20 October 2026, Interferon gamma-1b is a protein: marketed, first approved in 1992 (FR); acts on IFNGR1 and IFNGR2; US protection ended in 2011.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Protein
- Brand name
- Actimmune
- First approved
- 30 September 1992 (FR)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Amgen; 3 holders in all
- Registered trials
- 87, 13 stopped early
- Disease areas
- Infections; Cancer; Lungs and airways; Immune system; Urinary and reproductive; Inherited and neonatal
US protection
US protection ended in 2011.
US protection ended in 2011, 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 Amgen. 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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 6 | 1 | 0 |
| Phase 1 | 14 | 11 | 0 | 2 |
| Phase 2 | 43 | 29 | 2 | 7 |
| Phase 3 | 20 | 12 | 3 | 4 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 87 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 1999 to now |