Efbemalenograstim alfa
As of the edition of 20 October 2026, Efbemalenograstim alfa is a protein: marketed, first approved in 2023 (US); acts on CSF3R; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Protein
- Brand name
- Ryzneuta
- First approved
- 16 November 2023 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Fisiopharma; 2 holders in all
- Registered trials
- 12, 0 stopped early
- Disease areas
- Blood and lymph; Cancer; Skin and connective tissue; Hormones; Digestive system; Lungs and airways
US protection
US protection ends in 2035.
US protection ends in 2035, 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 Evive Biotechnology. 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 product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Efbemalenograstim alfa.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CSF3R | Granulocyte colony-stimulating factor receptor | Q99062 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 7 | 3 | 2 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Evive Biotechnology | Originator | 2023 to now |
| Fisiopharma | Applicant | 2024 to now |