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Drug

Pegfilgrastim

Approved · EMA
Late-stage development
Also known as Armlupeg, Fulphila, Fylnetra, Granulocyte colony-stimulating factor pegfilgrastim+13 more

Armlupeg, Fulphila, Fylnetra, Granulocyte colony-stimulating factor pegfilgrastim, Jixinfe, Neulasta, Nyvepria, PEG-G-CSF, PEG-GCSF, Pegfilgrastim (E. coli), Pegylated G-CSF, Pegylated GCSF, Pegylated Granulocyte Colony Stimulating Factor, Stimufend, Udenyca, Ziextenzo, peg-filgrastim.

RxNorm338036UNII3A58010674
33
Active clinical trials
13
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

CHMP positive opinion: Cavoley (EMA)

Regulatory2026-07-24EMA

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)

Clinical trial2026-07-21Results posted · ClinicalTrials.gov

A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Clinical trial2026-07-08Results expected Q3 2027 · ClinicalTrials.gov

A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Clinical trial2026-07-08Results expected Q4 2026 · ClinicalTrials.gov

A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia

Clinical trial2026-07-02Results expected Q1 2028 · ClinicalTrials.gov

A Phase III Clinical Study of the Efficacy and Safety of Polyethylene Glycolized Human Granulocyte Stimulating Factor Injection (PEG-G-CSF) in Preventing Neutropenia After Chemotherapy

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas

Clinical trial2026-06-26Results posted · ClinicalTrials.gov

CHMP positive opinion: Nylaspeg (EMA)

Regulatory2026-06-26EMA

Recall (Class I): PEGFILGRASTIM-CBQV

Regulatory2026-01-16FDA

Approval: Vivlipeg (EMA)

Regulatory2025-08-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pegfilgrastim
Aliases & brands
ArmlupegFulphilaFylnetraGranulocyte colony-stimulating factor pegfilgrastimJixinfeNeulastaNyvepriaPEG-G-CSFPEG-GCSFPegfilgrastim (E. coli)Pegylated G-CSFPegylated GCSFPegylated Granulocyte Colony Stimulating FactorStimufendUdenycaZiextenzopeg-filgrastim
RxNorm CUI
338036
UNII
3A58010674
Regulatory jurisdictions
fdaema

Regulatory timeline

13 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2002-08-22
Latest approval
2025-08-18
Authorities
FDA · EMA
Total events
13
fdaU.S. Food and Drug Administration· 1 event
2026-01-16RecallSafety
Recall (Class I): PEGFILGRASTIM-CBQV
Evidence ↗
emaEuropean Medicines Agency· 12 events
2026-07-24CHMP positive opinion
CHMP positive opinion: Cavoley (EMA)

Indication: Reduction of neutropenia in adults

Evidence ↗
2026-06-26CHMP positive opinion
CHMP positive opinion: Nylaspeg (EMA)

Indication: Reduction of neutropoenia in adults 

Evidence ↗
2025-08-18Approval
Approval: Vivlipeg (EMA)
Indication: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of… Show full indication

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
195
registered trials across all phases
LATEST COMPLETION 2025
33
Active studies
17
Recruiting
51
Late-stage (III+)
125
Completed
37
Discontinued
PHASE DISTRIBUTIONn = 195
Early Phase 11Phase 128Phase 1 / 219Phase 296Phase 2 / 34Phase 336Phase 44Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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 (REaCT-5G)

CompletedPH IVOttawa Hospital Research Instituten=2332023

Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

CompletedPH IVSanofin=212016

G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer

Unknown statusPH IVAnglo Celtic Cooperative Oncology Groupn=8162013

Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)

CompletedPH IVHoffmann-La Rochen=532007

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Active, not recruitingPH IIIAlliance for Clinical Trials in Oncologyn=4202031

Recent completions

Trials that read out recently, adding to the completed evidence base.

Pembrolizumab and aMVAC Chemotherapy as Neoadjuvant Therapy in Non-Urothelial Histology Muscle-Invasive Bladder Cancer: A Pilot Trial

CompletedPH IIUniversity of Washingtonn=172025

A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers

CompletedPH IPharmaEssentian=302025

St. Jude ELIOT: Phase 1 Evaluation of LY2606368, a Molecularly-Targeted CHK1/2 Inhibitor Therapy, in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors

CompletedPH ISt. Jude Children's Research Hospitaln=212025

Phase II Trial of Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies

CompletedPH IIWashington University School of Medicinen=482024

Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma

CompletedPH I/IIMayo Clinicn=1382024

A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma

CompletedPH IIIKey trialUniversity College, Londonn=1,2022024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.