Data updated: May 26, 2026
NEUPOGEN (filgrastim)
Trial Activity: Stable 79 active trials
Oncology
Approved 1991-02-20
Neupogen (filgrastim) is a leukocyte growth factor used to manage neutropenia and reduce the risk of infection in various clinical settings. It is primarily indicated for patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy or undergoing bone marrow transplantation, as well as those with acute myeloid leukemia. Additionally, the drug is used to mobilize progenitor cells for collection and to treat patients with chronic hereditary neutropenia or acute exposure to myelosuppressive radiation.
How NEUPOGEN Works
Filgrastim acts as a colony-stimulating factor by binding to specific receptors on the surface of hematopoietic cells. This binding stimulates the production, maturation, and activation of neutrophils within the bone marrow. By regulating neutrophil progenitor proliferation and enhancing functions like phagocytosis, the drug increases the body's ability to fight infections while having minimal impact on other blood cell types.
Development Insights
M.D. Anderson Cancer Center conducting 36 trials (12%)
596 indications explored (Broad Platform)
→ multiple myeloma (25 trials)
→ lymphoma (24 trials)
→ acute myeloid leukemia (23 trials)
6
Indications
--
Phase 3 Trials
2
Priority Reviews
35
Years on Market
Details
- Status
- Prescription
- First Approved
- 1991-02-20
- Patent Cliff
- 2022
- Revenue
- $35M (Q3-2022)
- Routes
- N/A
- Dosage Forms
- SYRINGE, VIAL
NEUPOGEN Approval History
1992
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Original
New Indication
New Form
Label Update
92 FDA actions from 1991 to 2025 · 5 indication expansions
Sep 2007 SUPPL
Label
Nov 2004 SUPPL
Label
Jun 2001 SUPPL
Label
Dec 1995 SUPPL
Efficacy
Dec 1994 SUPPL Priority
Efficacy
Jun 1994 SUPPL
Efficacy
Feb 1991 ORIGINAL Priority
New Drug
What NEUPOGEN Treats
7 indicationsNEUPOGEN is approved for 7 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Myeloid Leukemia
- Neutropenia
- Hematopoietic Syndrome of Acute Radiation Syndrome
- Congenital Neutropenia
- Cyclic Neutropenia
- Idiopathic Neutropenia
Source: FDA Label
NEUPOGEN Biosimilars
4 FDA-approvedThese 4 alternatives require prescriber approval to substitute for NEUPOGEN.
What are biosimilars? Lower-cost alternatives to NEUPOGEN with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
NEUPOGEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
4
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 10 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NEUPOGEN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NEUPOGEN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NEUPOGEN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
286 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07585136 | BDSTEM | Ph 1 | not yet recruiting | Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders |
| NCT04759586 | NCI-2021-01071 NCI-2021-01071, ANHL1931 | Ph 3 | active not recruiting | Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma |
| NCT06528691 | GLOBOTRK NCI-2024-02977 | Ph 2 | recruiting | Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors |
| NCT07012044 | NCI-2025-03946 NCI-2025-03946, PEPN2413 | Ph 1 | recruiting | A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia |
| NCT06738368 | RG1124788 NCI-2024-09417, FHIRB0020869 | Ph 2 | recruiting | Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia |
| NCT02015013 | 140020 14-I-0020 | Ph 2 | recruiting | Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models |
| NCT07257419 | HAPALL NCI-2025-08364 | Ph 1 | recruiting | CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma |
| NCT06926751 | PJ-B-241113 | Ph 2 | recruiting | Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors |
| NCT07428486 | 2025-1676 NCI-2026-01274 | Ph 1 | withdrawn | A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia |
| NCT01920932 results posted | HLHR13 NCI-2013-01123 | Ph 2 | active not recruiting | Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma |
| NCT03182244 results posted | 2215-CL-0303 CTR20170326 | Ph 3 | active not recruiting | A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation |
| NCT04684368 | ACNS2021 NCI-2020-13175, ACNS2021 | Ph 2 | recruiting | A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT |
| NCT01318317 results posted | 09174 NCI-2011-00344, 09174 | Ph 1, Ph 2 | active not recruiting | Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT03907488 results posted | NCI-2019-01960 NCI-2019-01960, S1826 | Ph 3 | active not recruiting | Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma |
| NCT01096368 results posted | ACNS0831 NCI-2011-02029, 10-01676 | Ph 3 | completed | Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma |
| NCT06145282 results posted | 10001635 001635-H | Ph 1, Ph 2 | active not recruiting | Non-myeloablative Haploidentical HCT Study for Patients With Sickle Cell Disease, Including Compromised Organ Function |
| NCT04959175 | 10000359 000359-C | Ph 1, Ph 2 | recruiting | Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies |
| NCT04898894 | SELCLAX NCI-2021-03435 | Ph 1 | active not recruiting | Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia |
| NCT05436418 | 10000613 000613-C | Ph 1, Ph 2 | recruiting | The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation |
| NCT03164057 | AML16 NCI-2017-00928 | Ph 2 | active not recruiting | A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT03077542 results posted | 170069 17-H-0069 | Ph 1, Ph 2 | active not recruiting | Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease |
| NCT03755804 | cHOD17 NCI-2018-02924 | Ph 2 | active not recruiting | Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 |
| NCT02436707 | LY17 | Ph 2 | active not recruiting | Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma |
| NCT01864109 | 13-068 | Ph 2 | active not recruiting | Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma |
| NCT07224100 | RG1125799 NCI-2025-07631, FHIRB0021018 | Ph 2 | recruiting | Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma |
| NCT01857934 results posted | NB2012 NCI-2013-00034 | Ph 2 | completed | Therapy for Children With Advanced Stage Neuroblastoma |
| NCT01624805 | 2012-0334 NCI-2012-01096, 2012-0334 | Ph 2 | recruiting | Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome |
| NCT00792948 results posted | NCI-2009-00800 NCI-2009-00800, S0805 | Ph 2 | active not recruiting | Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT03849651 results posted | HAP2HCT NCI-2019-00338 | Ph 2 | active not recruiting | TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies |
| NCT03220022 results posted | NCI-2017-01240 NCI-2017-01240, AMC-101 | Ph 1 | active not recruiting | Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas |
| NCT03250338 | ARO-013 2017-001600-29 | Ph 3 | completed | Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML |
| NCT01553214 | 120096 12-CC-0096 | Ph 4 | recruiting | Improving White Blood Cell Collection From Healthy Donors |
| NCT06325709 | 10001580 001580-I | Ph 1, Ph 2 | recruiting | Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease |
| NCT02918292 CHAMP results posted | BMT CTN 1502 2U10HL069294-11, 5U24CA076518 | Ph 2 | completed | Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502) |
| NCT05796570 MORE | 22-569 | Ph 2 | recruiting | A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies |
| NCT04375631 | RG1006914 NCI-2020-02616, RG1006914 | Ph 1 | recruiting | CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia |
| NCT03214562 | 2016-0979 NCI-2018-01119, 2016-0979 | Ph 1, Ph 2 | recruiting | Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia |
| NCT07044544 | IRB-300014728 (UAB 2469) Robert Award | Ph 1 | recruiting | Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies |
| NCT07441967 | IIT2025140 | Ph 2 | not yet recruiting | The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation |
| NCT04195633 | RG1005742 NCI-2019-07697, 10343 | Ph 2 | recruiting | Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies |
| NCT05170828 | PRESERVE | Ph 1 | withdrawn | Cryopreserved MMUD BM With PTCy for Hematologic Malignancies |
| NCT04224558 | Pro00051458 | Ph 1, Ph 2 | recruiting | Stem Cell Transplantation in Crohn's Disease |
| NCT03480360 results posted | D17170 NCI-2018-01157 | Ph 3 | active not recruiting | Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression |
| NCT06709495 | 24-591 | Ph 1, Ph 2 | recruiting | Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas |
| NCT06207799 | 2023-0448 NCI-2024-00110 | Ph 2 | recruiting | Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma |
| NCT03467386 | 17423 NCI-2018-00177, 17423 | Ph 1 | suspended | Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia |
| NCT03147612 | 2016-0402 NCI-2018-01186, 2016-0402 | Ph 2 | active not recruiting | Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia |
| NCT06851767 | 10002273 002273-I | Ph 1, Ph 2 | enrolling by invitation | Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy |
| NCT03301350 results posted | 2017-0547 NCI-2017-01705, 2017-0547 | Ph 2 | completed | Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer |
Showing 50 of 286 trials
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEUPOGEN FDA Label Details
Indications & Usage
FDA Label (PDF)NEUPOGEN is indicated for the treatment of Febrile Neutropenia; Acute Myeloid Leukemia; Neutropenia; Hematopoietic Syndrome of Acute Radiation Syndrome; Congenital Neutropenia; Cyclic Neutropenia; Idiopathic Neutropenia.
Pro Intelligence Preview
Deep insights for NEUPOGEN
Revenue Insights
- • Q3-2022: $35M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2022
- • Generic/biosimilar risk
Trial Analysis
- • 292 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment