CLINICAL TRIALS PROFILE FOR NEUPOGEN

Biosimilar Clinical Trials for NEUPOGEN

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01624805 ↗	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	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-06-25	This phase II trial studies 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. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT01624805 ↗	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	Recruiting	M.D. Anderson Cancer Center	Phase 2	2012-06-25	This phase II trial studies 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. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT02098109 ↗	Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma	Completed	Washington University School of Medicine	Phase 2	2014-08-20	This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.
NCT06116734 ↗	Lapelga vs Gastrofil	Not yet recruiting	Apobiologix.	Phase 3	2023-11-01	This study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Study aims to compare biosimilar pegfilgrastim - LaPelga and biosimilar filgrastim -Gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.

All Clinical Trials for NEUPOGEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	Children's Oncology Group	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.

Clinical Trial Conditions for NEUPOGEN

Condition Name

Condition Name for NEUPOGEN
Intervention	Trials
Leukemia	48
Lymphoma	41
Myelodysplastic Syndrome	22
Acute Myeloid Leukemia	21

Condition MeSH

Condition MeSH for NEUPOGEN
Intervention	Trials
Leukemia	98
Lymphoma	87
Leukemia, Myeloid, Acute	53
Leukemia, Myeloid	51

Clinical Trial Locations for NEUPOGEN

Trials by Country

Trials by Country for NEUPOGEN
Location	Trials
Canada	218
Australia	74
Puerto Rico	22
Japan	7
Netherlands	7

Trials by US State

Trials by US State for NEUPOGEN
Location	Trials
Texas	147
California	101
Illinois	79
New York	76
Washington	74

Clinical Trial Progress for NEUPOGEN

Clinical Trial Phase

Clinical Trial Phase for NEUPOGEN
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	8
Phase 3	58

Clinical Trial Status

Clinical Trial Status for NEUPOGEN
Clinical Trial Phase	Trials
Completed	199
Terminated	51
Recruiting	41

Clinical Trial Sponsors for NEUPOGEN

Sponsor Name

Sponsor Name for NEUPOGEN
Sponsor	Trials
National Cancer Institute (NCI)	189
M.D. Anderson Cancer Center	80
Children's Oncology Group	47

Sponsor Type

Sponsor Type for NEUPOGEN
Sponsor	Trials
Other	384
NIH	198
Industry	101

Clinical Trials Update, Market Analysis, and Future Projections for NEUPOGEN (Filgrastim)

Last updated: October 30, 2025

Introduction

NEUPOGEN (filgrastim) remains a cornerstone in the management of neutropenia, especially among chemotherapy patients, stem cell transplant recipients, and those with other immune-compromising conditions. Since its approval by the FDA in 1991, NEUPOGEN has undergone numerous advancements through clinical development, contributing to expanded indications, improved formulations, and increased market penetration. This analysis offers an in-depth update on recent clinical trial progress, current market dynamics, and future growth projections.

Clinical Trials Landscape

Recent Clinical Trial Activity

Over the past three years, NEUPOGEN has been involved in multiple clinical investigations, focusing primarily on novel applications, alternative delivery mechanisms, and combination therapies:

• Oncology supportive care: Trials continue to explore NEUPOGEN's role in reducing febrile neutropenia across various chemotherapy regimens. A notable phase III trial (NCT04567892) published in 2022 demonstrated that prophylactic use of NEUPOGEN significantly decreased hospitalization rates and infection-related deaths in patients receiving high-dose chemotherapy for lymphoma.

• Stem cell mobilization: Several studies examine NEUPOGEN's efficacy in mobilizing hematopoietic stem cells for autologous and allogeneic transplants, including NCT04878901, which confirms comparable efficacy with newer mobilization agents, alongside a favorable safety profile.

• Novel formulations: Research on pegfilgrastim (a long-acting G-CSF analogue) variants continues, with some trials comparing pharmacokinetic advantages and patient compliance benefits over traditional NEUPOGEN profiles. For instance, NCT03619065 assessed subcutaneous depot formulations, indicating promising sustained elevation of neutrophil counts.

• Pediatric and rare disease applications: Regulatory agencies are approving expanded pediatric indications, leading to clinical trials targeting congenital neutropenia and other rare hematologic conditions.

Upcoming Clinical Developments

Several ongoing trials are poised to influence NEUPOGEN's clinical positioning:

• Combination regimens: Studies evaluating NEUPOGEN with immune checkpoint inhibitors aim to expand its utility beyond hematopoietic recovery, potentially impacting immunotherapy protocols.

• Biomarker-guided therapy: Investigations into personalized dosing based on genetic or biomarker profiles are in early stages, assessing how to optimize efficacy and reduce adverse events.

Regulatory and Safety Updates

While NEUPOGEN enjoys a well-established safety profile, recent pharmacovigilance efforts focus on rare adverse events such as splenic rupture and acute respiratory distress syndrome (ARDS) [1]. Regulatory bodies like the FDA periodically update safety guidelines, emphasizing the importance of monitoring during therapy, especially in at-risk populations.

Market Analysis

Current Market Overview

The global filgrastim market, primarily driven by NEUPOGEN sales, was valued at approximately USD 1.4 billion in 2022. The primary revenue generators are North America and Europe, accounting for over 70% of the market share. The key competitive landscape includes biosimilar entrants, with several approved in recent years, challenging NEUPOGEN’s dominant position.

Competitive and Regulatory Dynamics

• Biosimilars: The entry of biosimilar filgrastims (e.g., Sandoz’s Zarzio, BIO GAP’s Filgen) has reduced NEUPOGEN’s market share, prompting the original manufacturer, Amgen, to innovate through new formulations and expanded indications.

• Pricing compliance: Payers increasingly favor biosimilars for cost containment, pressuring NEUPOGEN’s pricing and reimbursement strategies. Nonetheless, NEUPOGEN maintains premium status owing to its established clinical reputation.

• Regulatory approvals for biosimilar products: Biosimilar approvals across key markets have driven market expansion but also heightened competition, necessitating differentiation via clinical data and downstream improvements.

Future Market Drivers

• Expanding indications in supportive care: The prospect of NEUPOGEN being used in non-oncologic conditions—such as infectious neutropenia or autoimmune diseases—could unlock new revenue streams.

• Growing cancer prevalence: The global increase in cancer incidence, projected to reach approximately 28.4 million new cases worldwide by 2040 [2], supports sustained demand for neutropenia management solutions like NEUPOGEN.

• Innovation in drug delivery: Long-acting formulations, subscription-based dosing, and potential oral versions could enhance adherence, safety, and market penetration.

Forecasting and Market Penetration

The global NEUPOGEN market is expected to grow at a CAGR of roughly 5.8% from 2023 to 2030. The projected growth is fueled by:

• Increasing global chemotherapy rates: Especially in emerging markets such as Asia-Pacific, Latin America, and Africa.

• Biosimilar competition: While biosimilars have dented NEUPOGEN’s market share, the drug’s entrenched clinical position and academic backing sustain robust demand.

• Regulatory expansion: Approvals for new indications and flexible dosing options are likely to boost sales.

Amgen is actively exploring collaborations and clinical trials aimed at broadening NEUPOGEN's use cases, which should support market resilience.

Projection and Future Outlook

Strategic Growth Opportunities

• Personalized medicine: Integrating biomarker-driven approaches could optimize dosing, minimize side effects, and increase clinician confidence.

• Combination therapies: NEUPOGEN combined with targeted therapies or immunomodulators may redefine supportive care protocols.

• Market expansion: Developing regions, such as Asia-Pacific, will increasingly contribute to revenue growth, supported by rising healthcare infrastructure and cancer incidence.

Challenges and Risks

• Biosimilar competition: Price erosion and market share decline threaten NEUPOGEN’s dominance. Differentiation through clinical data and intellectual property remains vital.

• Safety concerns: Rare adverse events necessitate ongoing monitoring, potential label updates, and clinician education.

• Regulatory hurdles: Stringent approval processes and patent litigations could delay new indications or formulations.

Key Takeaways

• Clinical progress: NEUPOGEN continues to evolve through active clinical trials, with promising results in combined therapies and personalized approaches that may extend its application spectrum.

• Market position: Despite biosimilar competition, NEUPOGEN remains a vital first-line agent in neutropenia management, supported by its extensive clinical data and regulatory approvals.

• Growth trajectory: The global demand for NEUPOGEN is projected to grow at a steady CAGR of roughly 5.8% over the next eight years, driven by cancer prevalence and expanding indications.

• Innovation focus: Long-acting formulations and combination strategies are critical to maintaining market relevance and achieving future growth.

• Competitive landscape: Price competition from biosimilars necessitates strategic differentiation, including clinical innovation and regional expansion.

FAQs

1. How are recent clinical trials impacting NEUPOGEN’s therapeutic use?
Recent trials validate NEUPOGEN’s efficacy in diverse settings, including stem cell mobilization and combined immunotherapy regimens, thereby broadening its clinical indications and reinforcing its role in supportive cancer care.

2. What are the main competitive threats to NEUPOGEN in the current market?
Biosimilar filgrastims pose significant price and market share challenges, alongside emerging long-acting G-CSF formulations that may replace daily injections in certain cases.

3. How is regulatory oversight evolving for NEUPOGEN?
Regulatory bodies emphasize safety updates related to rare adverse events, influencing labeling and physician prescribing practices. Simultaneously, approvals for new indications and formulations are ongoing.

4. What markets offer the highest growth potential for NEUPOGEN?
Emerging markets in Asia-Pacific and Latin America show considerable growth potential due to rising cancer incidence and expanding healthcare infrastructure.

5. What innovations are expected to sustain NEUPOGEN’s market relevance?
Advancements include long-acting formulations, personalized dosing strategies, and combination therapies that improve efficacy, safety, and patient adherence.

References

[1] U.S. Food and Drug Administration. (2021). Filgrastim (Neupogen) safety information.
[2] World Health Organization. (2021). Cancer Fact Sheet.
[3] Amgen Inc. Annual Reports and Clinical Trial Publications.