TheraRadar
Data updated: May 26, 2026

NEULASTA (pegfilgrastim)

Trial Activity: Stable 30 active trials
Oncology Approved 2002-01-31

Ziextenzo is a leukocyte growth factor indicated to decrease the incidence of infection, manifested as febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. The medication is also approved to increase survival in patients who have been acutely exposed to myelosuppressive doses of radiation, a condition known as Hematopoietic Subsyndrome of Acute Radiation Syndrome. Its therapeutic role is centered on supporting the immune system during treatments or events that suppress bone marrow function. It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Source: FDA Label • Amgen • Leukocyte Growth Factor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How NEULASTA Works

This medication acts as a colony-stimulating factor that targets hematopoietic cells within the body. By binding to specific cell surface receptors, the drug stimulates the proliferation, differentiation, and commitment of these cells. This process leads to the functional activation of end cells, which helps restore and maintain essential white blood cell populations. This mechanism is essential for mitigating the effects of myelosuppression caused by chemotherapy or radiation exposure.

Source: FDA Label

Development Insights

M.D. Anderson Cancer Center conducting 9 trials (8%)
258 indications explored (Broad Platform)
→ breast cancer (14 trials)
→ chemotherapy-induced neutropenia (8 trials)
→ neutropenia (7 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
24
Years on Market

Details

Status
Prescription
First Approved
2002-01-31
Revenue
$92M (Q3-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
N/A
Dosage Forms
SYRINGE

Companies

Amgen
Active Ingredient: PEGFILGRASTIM

NEULASTA Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
29 FDA actions from 2002 to 2025 · 2 indication expansions
Aug 2025 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Feb 2021 SUPPL
Label · Labeling
FDA Letter Label
Jan 2021 SUPPL
Label · Labeling
FDA Letter Label

What NEULASTA Treats

2 indications

NEULASTA is approved for 2 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Febrile Neutropenia
  • Acute Radiation Syndrome
Source: FDA Label
Biosimilar for Neulasta

NEULASTA is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.

NEULASTA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

8

Same target(s) AND same indication — head-to-head.

ARMLUPEG
Lupin
2025 2 indic.
RYZNEUTA
EVIVE BIOTECHNOLOGY
2023 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

NYPOZI
TANVEX BIOPHARMA
2024 7 indic.
ROLVEDON
SPECTRUM PHARMS
2022 2 indic.
Unlock 14 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to NEULASTA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ARMLUPEG
PEGFILGRASTIM-UNNE
2 shared
Lupin
Shared indications:
Febrile NeutropeniaAcute Radiation Syndrome
FYLNETRA
PEGFILGRASTIM-PBBK
2 shared
KASHIV BIOSCIENCES LLC
Shared indications:
Febrile NeutropeniaAcute Radiation Syndrome
NYPOZI
FILGRASTIM-TXID
2 shared
TANVEX BIOPHARMA USA INC
Shared indications:
Febrile NeutropeniaAcute Radiation Syndrome
View all 20 similar drugs Pro
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Clinical Trial Registry

112 trials
Trial Sponsor ID Phase Status Title
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
NCT04628767 NCI-2020-09850 NCI-2020-09850, EA8192 Ph 2, Ph 3 recruiting Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
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
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
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
NCT05645718 2022-0312 NCI-2022-10168 Ph 2 recruiting Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia
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
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
NCT03609216 A031701 NCI-2018-01531, U10CA180821 Ph 2 active not recruiting Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
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
NCT07021989 25255 NCI-2025-04294 Ph 2 not yet recruiting ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
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
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
NCT03136146 2016-0211 NCI-2018-01198, 2016-0211 Ph 2 recruiting Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/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
NCT03301350 results posted 2017-0547 NCI-2017-01705, 2017-0547 Ph 2 completed Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
NCT05535166 SJiMB21 NCI-2022-07099, R21CA280187 Ph 2 recruiting Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma
NCT04323956 MC1986 NCI-2020-01855, 19-005387 Ph 1 active not recruiting Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma
NCT03943901 results posted 2019-0138 2019-0138, SMPH\MEDICINE\HEM-ONC Ph 2 active not recruiting Split-Dose R-CHOP for Older Adults With DLBCL
NCT07059611 UPCC 06225 Ph 2 not yet recruiting Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma
NCT06220032 HO170DLBCL HO170 DLBCL-ANTICIPATE 2023-505377-32 Ph 3 recruiting Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
NCT07278856 25404 NCI-2025-08060, 25404 Ph 1 not yet recruiting Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas
NCT01840566 12-117 Ph 1 active not recruiting High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
NCT03571633 BREASTIMMU02 ET17-057 2017-002069-22 Ph 2 active not recruiting Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer
NCT02369458 results posted 201503060 Ph 2 completed Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
NCT02909036 16-875 Ph 1 active not recruiting Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.
NCT05870748 STRO-002-GM3 GOG-3086, ENGOT-OV79 Ph 2, Ph 3 terminated REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
NCT04383743 results posted RG1006206 NCI-2019-08028, 10439 Ph 2 completed Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer
NCT00911183 FRAIL-06 results posted IB-2008-25 IB-FRAIL06, INCA-RECF0892 Ph 2 completed Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial
NCT05011188 21555 NCI-2021-08857 Ph 1, Ph 2 active not recruiting FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer
NCT05032183 results posted 2021-0545 NCI-2021-08859, 2021-0545 Ph 1, Ph 2 terminated Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT07064018 6228 UCI 24-08 Ph 1, Ph 2 recruiting Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
NCT00812669 CTRIAL-IE (ICORG) 07-01 CTRIAL-IE (ICORG) 07-01, 2008-001250-40 Ph 2 completed CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7
NCT01437488 results posted 11D.392 2011-52, JT 2205 Ph 2 completed Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy
NCT04781959 REaCT-5G Ph 4 completed A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
NCT00670358 results posted MC078E MC078E, RV-NHL-PI-0325 Ph 1, Ph 2 completed Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
NCT03102606 Protective-1 results posted BPI-2358-105 phase 3 Ph 3 completed Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
NCT06520176 2024-060 Ph 3 recruiting Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
NCT02073097 results posted CASE3413 Ph 1, Ph 2 completed Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma
NCT04345900 results posted BPI-2358-105 Phase 2 Ph 2 completed Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
NCT00678327 CDR0000593562 CRUK-2007-006064-30, CRUK-07/146 Ph 3 completed Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma
NCT00837265 NEUGR-002 results posted NEUGR-002 Ph 2, Ph 3 completed Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
NCT05283616 CH-CS-003 Ph 3 completed Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
NCT06188676 PMBL-2022 Ph 3 recruiting Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL
NCT02834403 results posted Pro00011685 Ph 1, Ph 2 completed L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
NCT00679029 results posted 0412-07-FB NCI-2009-01693, P30CA036727 Ph 2 terminated Chemotherapy & Bevacizumab for Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-Negative Stage II/III Breast Cancer
NCT02728531 201603149 Ph 1 completed Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma
NCT03197935 IMpassion031 results posted WO39392 2016-004734-22 Ph 3 completed A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
NCT03329378 results posted GCO 17-1585 Ph 2 terminated Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

Showing 50 of 112 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

NEULASTA FDA Label Details

Indications & Usage

FDA Label (PDF)

NEULASTA is indicated for the treatment of Febrile Neutropenia; Acute Radiation Syndrome.

View full patent landscape →
1 patents · 1 families · 35 international docs across 15 countries

Pro Intelligence Preview

Deep insights for NEULASTA

Revenue Insights

  • • Q3-2025: $92M
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • 117 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

FDA Approval: BLA125031 → Label: DailyMed → Trials: ClinicalTrials.gov →

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