Pegfilgrastim
As of the edition of 20 October 2026, Pegfilgrastim is a protein: marketed, first approved in 2002 (US); acts on CSF3R; US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Protein
- Brand name
- Neulasta
- First approved
- 31 January 2002 (US)
- Approvals on record
- 17 in 6 regions
- Holder of the most recent approval
- Cristália Produtos Químicos Farmacêuticos Ltda; 11 holders in all
- Withdrawn from market
- 4 February 2021 (in some regions)
- Registered trials
- 277, 38 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health
US protection
US protection ended in 2022.
The orphan exclusivity ended in 2022 (it covers one use only). The application that gives this date is held by Amgen.
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Pegfilgrastim.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CSF3R | Granulocyte colony-stimulating factor receptor | Q99062 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 9 | 2 | 2 |
| Phase 1 | 55 | 38 | 6 | 8 |
| Phase 2 | 154 | 97 | 25 | 23 |
| Phase 3 | 39 | 19 | 10 | 5 |
| Phase 4 | 11 | 9 | 1 | 0 |
| All trials | 277 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 2002 to now |
| Kyowa Kirin | Applicant and Lead sponsor of trials | 2006 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2015 to now |
| Laboratório Teuto Brasileiro S/A | Applicant | 2023 to now |
| Aché Laboratórios Farmacêuticos | Later holder | 2025 to now |
| Cristália Produtos Químicos Farmacêuticos Ltda | Later holder | 2026 to now |