Wednesday, July 8, 2026

Drug profile · INN

filgrastim

filgrastim (NIVESTIM) is a granulocyte colony stimulating factor receptor agonist. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L03) L03AA02
US status approved
Patents linked 0
Pipeline programs 36
News articles 0
Drug details — filgrastim
US status
approved
Class
Antineoplastic and immunomodulating agents (L03)
Route
Patents
0
Programs
36
Data quality
0.89

Quick answer

filgrastim (NIVESTIM) is a granulocyte colony stimulating factor receptor agonist. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

Key facts

INN filgrastim
Brand NIVESTIM
Mechanism Granulocyte colony stimulating factor receptor agonist
Target Granulocyte colony-stimulating factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L03)
Formulation VIAL
ATC code L03AA02

Mechanism of action

Granulocyte colony stimulating factor receptor agonist

Primary target: Granulocyte colony-stimulating factor receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. ALL2820 Phase 3 · Telethon Foundation · Adult Philadelphia Chromosome-Positive Acute Lymphoblastic L
  2. CA073-1003 Phase 3 · Celgene · Relapsed/Refractory Follicular Lymphoma
  3. CA244-0008 Phase 3 · Bristol-Myers Squibb Australia · Breast cancer, Triple-negative breast cancer
  4. CA244-0010 Phase 3 · Bristol-Myers Squibb Australia · EGFR-mutated Non-small Cell Lung Cancer
  5. CA2440012 Phase 3 · Bristol-Myers Squibb Australia · Metastatic urothelial cancer
  6. CTX001-111 Phase 3 · Vertex Pharmaceuticals (Australia) · Transfusion-dependent β-thalassemia (TDT)
  7. FEDR-MF-002 Phase 3 · Celgene · Primary myelofibrosis, post-polycythemia vera myelofibrosis
  8. GCT1184-02 Phase 3 · Genmab · Platinum-resistant Ovarian Cancer

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is filgrastim?

filgrastim (NIVESTIM) is a granulocyte colony stimulating factor receptor agonist. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

What is the brand name for filgrastim?

NIVESTIM is a marketed brand name for filgrastim. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of filgrastim?

filgrastim has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.