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Drug

Lipegfilgrastim

Established medicine
ClassGranulocyte colony stimulating factor receptor agonistResearchOngoing clinical research
RxNorm1440046ChEMBLCHEMBL4594230ATCL03AA14UNII4AWF0N6QV3
CSF3R
Primary target
1
Regulatory events
Latest activity
beta

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

A Randomized, Phase IIIB, Open-label, Two-arm, Multicenter, comparatiVe Study on Efficacy and Safety of Lipegfilgrastim (Lonquex, TEVA) in Comparison to Pegfilgrastim (Neulasta(R), Amgen) in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia - AVOID Neutropenia

Clinical trial2018-04-24Completed · ClinicalTrials.gov

A Randomized, Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Subcutaneous Administration of Lipegfilgrastim (Doses up to 100 μg/kg) in Healthy Japanese and Caucasian Subjects

Clinical trial2015-05-01Completed · ClinicalTrials.gov

Multicenter, Open-label Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100µg/kg XM22 in 21 Children With Ewing Family of Tumors or Rhabdomyosarcoma

Clinical trial2015-04-01Completed · ClinicalTrials.gov

Approval: Lonquex (EMA)

Regulatory2013-07-25EMA

Profile

Identifiers & mechanism

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

Canonical name
Lipegfilgrastim
RxNorm CUI
1440046
ChEMBL ID
CHEMBL4594230
ATC codes
L03AA14
UNII
4AWF0N6QV3
Primary mechanism
Granulocyte colony stimulating factor receptor agonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Granulocyte colony-stimulating factor receptor
CSF3R · Q99062
AGONISTGranulocyte colony stimulating factor receptor agonist

Regulatory timeline

1 event

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
2013-07-25
Latest approval
2013-07-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-07-25Approval
Approval: Lonquex (EMA)
Indication: Lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated… Show full indication

Lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Evidence ↗

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

Clinical trials

3 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
3
registered trials across all phases
LATEST COMPLETION 2018
1
Late-stage (III+)
3
Completed
PHASE DISTRIBUTIONn = 3
Phase 12Phase 31

Recent completions

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

A Randomized, Phase IIIB, Open-label, Two-arm, Multicenter, comparatiVe Study on Efficacy and Safety of Lipegfilgrastim (Lonquex, TEVA) in Comparison to Pegfilgrastim (Neulasta(R), Amgen) in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia - AVOID Neutropenia

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=1012018

A Randomized, Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Subcutaneous Administration of Lipegfilgrastim (Doses up to 100 μg/kg) in Healthy Japanese and Caucasian Subjects

CompletedPH IMerckle GmbHn=482015

Multicenter, Open-label Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100µg/kg XM22 in 21 Children With Ewing Family of Tumors or Rhabdomyosarcoma

CompletedPH IMerckle GmbHn=212015
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.