Drug Database
FI

filgrastim (Grastofil)

✓ Approved

Apobiologix · CSF3R · Recombinant Proteins

What is filgrastim?

filgrastim is a recombinant proteins developed by Apobiologix. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesGrastofil
CompanyApobiologix
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Apobiologix

Mechanism of Action

Molecular Targets

filgrastim acts on 1 molecular target:

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

filgrastim is developed for 3 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNeutropenia✓ Approved
Surgical and medical proceduresHaematopoietic stem cell mobilisation✓ Approved
Blood and lymphatic system disordersBone marrow disorder✓ Approved

Related Research Articles

PubMedCureus2026-05-15

Pancytopenia and Methemoglobinemia in a Patient With Multiple Myeloma Presenting With Syncope and Dyspnoea: A Diagnostic Challenge.

Abdallah Akram A, Honeini Rawan R, Tamang Pemba P, Abughazal Mahmoud M et al.

Methemoglobinaemia is a rare but important cause of hypoxia that may be overlooked, particularly in patients with complex comorbidities. We present a 76-year-old man with Multiple Myeloma undergoing chemotherapy who presented with recurrent syncope and exertional dyspnoea. Initial investigations revealed pancytopenia and hypoxia. Imaging excluded pulmonary embolism and infection. Arterial blood gas analysis demonstrated elevated methemoglobin levels (10.5%), confirming methemoglobinaemia. The patient was managed with supportive therapy, including oxygen, blood transfusion, and filgrastim, resulting in clinical improvement. This case highlights the importance of considering methemoglobinaemia in patients with unexplained hypoxia, especially when conventional investigations are unremarkable. The coexistence of severe anaemia can further exacerbate tissue hypoxia and complicate diagnosis.

PMID 42137699
Read full article →
PubMedBlood2026-05-12

Biosimilars approved for hematologists: lessons from comparative efficacy studies and comparative analytical assessments.

Herndon Thomas T, Brahme Nina N NN, Ricci M Stacey MS

Biosimilars used in hematology have been at the forefront of biosimilar development since the first US approval in 2015 of a filgrastim product, with over 80 now FDA-licensed. Developers traditionally submitted data from a comparative analytical assessment (CAA) and clinical studies, often including a comparative efficacy study (CES), to support demonstrating their product is "highly similar" to and has "no clinically meaningful differences" from its reference product (RP). However, growing scientific confidence in the analytical comparisons between biosimilars and their RP included in the CAA has prompted FDA and global regulators to reconsider the utility of CES. Recently, FDA published updated recommendations on the need for a CES in biosimilar programs. As approvals for hematologic biosimilars span the entire history of FDA biosimilar development across a breadth of patient ages and diseases, reexamining these programs provides valuable insights into the evolving role of the CES in the past and its role in the future. In this review, we present a historical overview of the development programs for all FDA-approved hematologic biosimilars in the context of an emerging global consensus recognizing the CAA is more sensitive than CES for predicting biosimilarity.

PMID 42117498
Read full article →
PubMedTransfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis2026-04-22

Atraumatic subdural hematoma following filgrastim mobilization in a peripheral blood stem cell donor.

Moraga Richard J RJ, Hazenfield Thomas T, Buzenius Kathryn K, Beckworth Summer S et al.

Filgrastim is widely used for hematopoietic stem cell mobilization and is generally safe in healthy donors. Rare cases of vasculitis and subarachnoid hemorrhage have been reported, but subdural hematoma (SDH) has not, to our knowledge, been described as a nontraumatic event in this setting. A 29-year-old man received filgrastim 10 mcg/kg once daily for 5 days prior to peripheral blood stem cell collection via apheresis. Several hours after apheresis, he developed a sudden headache that progressively worsened and repeatedly woke him from sleep. He presented to the emergency department, where head CT demonstrated an acute left convexity SDH with mass effect. CT angiography and intraoperative inspection showed no aneurysm, arteriovenous malformation, or venous sinus thrombosis. Platelet count and coagulation studies were within normal limits, and there was no history of trauma or anticoagulant use. He subsequently deteriorated clinically, requiring intubation and emergent craniectomy. This case highlights a rare but serious intracranial hemorrhagic event temporally associated with filgrastim administration in a healthy stem cell donor. The absence of alternative etiologies warrants reporting this temporal association.

PMID 42019084
Read full article →
PubMedAnimals : an open access journal from MDPI2026-04-14

Comparison of the Efficacy of Filgrastim and an Inactivated Parapoxvirus ovis Paraimmune Activator in Naturally Infected Cats with Feline Panleukopenia.

Tüfekçi Emre E, Ekinci Gencay G, Kökkaya Serkan S, Toy Muhammed Arif MA et al.

Feline panleukopenia (FPL) is a serious viral disease caused by Feline panleukopenia virus (FPV) that causes leukopenia, lymphopenia, and neutropenia, particularly in young or unvaccinated cats. There is no specific antiviral treatment available for FPL, and treatment protocols generally consist of fluid therapy and supportive care. This study evaluated the clinical and hematological efficacy of filgrastim, a granulocyte colony-stimulating factor (G-CSF) that has shown successful results in treating FPL in various studies, and the paraimmune activator-inactivated Parapoxvirus ovis (iPPVO) in 49 cats naturally infected with FPV. Cats were randomly assigned to four groups: low-dose filgrastim (5 µg/kg, n = 13), high-dose filgrastim (20 µg/kg, n = 14), iPPVO (n = 12), and standard supportive treatment (n = 10). Clinical signs and complete blood counts were assessed on days 0 and 7. By day 7, high-dose filgrastim showed greater increases in white blood cell, lymphocyte, monocyte, and neutrophil counts compared with the other groups (p < 0.05), whereas moderate improvements were observed in the iPPVO group. Leukopenia and lymphopenia resolved faster in the high-dose filgrastim group than in the low-dose filgrastim and standard treatment groups. Clinical recovery, including reduction in vomiting and lethargy, was more pronounced in the high-dose filgrastim and iPPVO groups. Survival rates did not differ significantly among groups (p = 0.615), although the high-dose filgrastim group showed the lowest mortality (42.9%). These findings suggest that high-dose filgrastim may contribute to cytopenias and promote hematological recovery in FPL, while iPPVO may serve as a supportive immunomodulatory therapy. However, it should be noted that the efficacy of filgrastim and/or iPPVO treatments has not been definitively confirmed, likely due to the small sample size and the lack of well-controlled randomized studies.

PMID 41976045
Read full article →
PubMedHaematologica2026-04-09

Cyp7b1-inhibiting azoles enhance hematopoietic stem and progenitor cell mobilization in normal and sickle cell disease mice.

Vu Brandon L BL, Roeder Travis J TJ, Kanaujiya Jitendra K JK, Kimble Amy L AL et al.

Mobilized hematopoietic stem and progenitor cells (HSPCs) are essential for transplantationbased therapies, including curative gene therapies for sickle cell disease (SCD). While granulocyte colony-stimulating factor (G-CSF, filgrastim) remains the standard mobilization agent, many patients respond inadequately, and it can trigger life-threatening vaso-occlusive crises in SCD. The CXCR4 antagonist AMD3100 (plerixafor) is routinely combined with G-CSF for non- SCD settings but is ineffective as a single agent in SCD, underscoring the urgent need for alternative strategies. We previously identified 27-hydroxycholesterol (27HC) as a physiological inducer of HSPC mobilization during pregnancy. Here, we show that exogenous 27HC enhances AMD3100-induced HSPC mobilization in mice, either alone or with G-CSF. Because 27HC is metabolized by the enzyme Cyp7b1, we tested whether pharmacological Cyp7b1 inhibition could mimic this effect. Treatment with clotrimazole, an antifungal and Cyp7b1 inhibitor, significantly enhanced AMD3100-induced HSPC mobilization in wild-type, SCD, and humanized mice. Importantly, intravenous administration of voriconazole, a clinically approved systemic antifungal with Cyp7b1-binding activity, similarly augmented AMD3100-induced HSPC mobilization in wildtype and SCD mice without altering steady-state hematopoiesis. These findings establish Cyp7b1-inhibiting azoles as novel and clinically relevant enhancers of HSPC mobilization, particularly for SCD patients who cannot safely receive G-CSF but require robust HSPC yields for gene therapy.

PMID 41952627
Read full article →
PubMedCureus2026-03-26

Efficacy of the Granulocyte Colony-Stimulating Factor in Sepsis-Associated Immunosuppression: An Open-Label Randomized Controlled Trial.

Reddy K Keerthi KK, Rao Sunil Kumar SK, Saroj Anil Kumar AK, Srivastava Chandradeep C et al.

To determine the efficacy of filgrastim (G-CSF) in reducing the mortality in children with multi-organ failure syndrome (MOFS) persisting for three consecutive days.  Methods: Children aged 1 month to 18 years with two or more organ failures persisting for three days according to Goldstein's criterion were included and randomized to receive either standard of care and filgrastim (G-CSF) at a dose of 4 mcg/kg/day subcutaneously for seven days or standard of care at a 1:1 ratio. The stored blood samples were estimated for TNF-α, A Disintegrin and Metalloproteinase Motifs 13 (ADAMTS13), and soluble Fas ligand (FasL) at the end of the study to confirm the biomarker-based inflammatory phenotypes of sepsis-induced MOFS. Outcomes were 28-day mortality and differences in tumor necrosis factor-alpha (TNF-α) levels, hospital-acquired infection (HAI), and pediatric sequential organ failure assessment score (pSOFA) at seven days of randomization. Of 78 children, 25 (32%), 50 (64.1%), and 3 (3.8%) were discharged, died, and left against medical advice (LAMA), respectively. The two groups were similar except for a higher TLC (14100 [11400-16270]) vs. (17560 [13900-22100]; p=0.02) and male preponderance (18/39 vs. 27/39; p=0.03) in the control group. The intervention group received 2 (2-3) median (IQR) doses of filgrastim (G-CSF) for a 3 (2-3) median (IQR) duration of days. No significant difference was observed between the groups regarding 28-day mortality (26/39 vs. 27/39; 95% CI, p (0.71-1.31, p=0.81), HAI (31/62 vs. 21/53; p=0.27). The pSOFA scores and TNF-α levels at seven days were 8 (6-12) vs. 9 (8-11) (p=0.12) and 81.6 (6.9-237.2) vs. 99.6 (16.2-404.2) (p=0.29), respectively. Subgroup analysis revealed a similar occurrence of mortality in immunoparalysis-associated multi-organ failure (IPMOF) (16/26 vs. 14/21); 95% CI, p (0.60-1.42, p=0.71) at 28 days, and 2 median dose of filgrastim (G-CSF) for 3 median day did not significantly change the TNF-α levels within the intervention group at day seven (56 [32-118] vs. 19 [6.9-118], p=0.77) as compared to day 0. We did not observe any life-threatening/significant sudden deterioration/anaphylaxis after use of filgrastim (G-CSF). Filgrastim (G-CSF) use in immunocompetent children with sepsis-induced MOFS is safe, and a 2-dose of filgrastim (G-CSF) for three days has poor efficacy in the reduction of mortality and did not show significant change in frequency of HAI, TNF-α levels, and pSOFA scores.

PMID 41883885
Read full article →

+2265 more articles available with a free account

Sign up free to view all articles →

Ask about filgrastim