Pegfilgrastim
Highest phase reached
Approved
Drug type
Protein
First approval year
2002
- First approval year
- 2002
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Pegfilgrastim
- Cegfila (previously pegfilgrastim mundipharma)
- cegfila previously pegfilgrastim mundipharma
- fulphila
- Fulphila
- grasustek
- Grasustek
- neulasta
- Neulasta
- neulasta sureclick
- Neulasta sureclick
- neupopeg
- Neupopeg
- nyvepria
- Nyvepria
- pelgraz
- Pelgraz
- pelmeg
- Pelmeg
- ristempa
- Ristempa
- stimufend
- Stimufend
- udenyca
- Udenyca
- ziextenzo
And 1 more, listed on the interactive page.
- armlupeg
- ARMLUPEG
- b 12019
- B-12019
- b12019
- B12019
- cabazitaxel with peg filgrastim
- cegfila
- Cegfila
- Cegfila [EMA EPAR]
- cegfila ema epar
- chs 1701
- Chs-1701
- CHS-1701
- ennumo
- ENNUMO
- fulphila
- Fulphila
- fylnetra
- Fylnetra
- granulocyte colony stimulating factor pegfilgrastim
- granulocyte colony stimulating factor pegfilgrastim mi
- Granulocyte colony-stimulating factor pegfilgrastim
- GRANULOCYTE COLONY-STIMULATING FACTOR PEGFILGRASTIM [MI]
- hsp 130
And 176 more, listed on the interactive page.
- ATC classification codes
- L03AA13
Sources for recorded values
- CAS registry numbers
- 208265-92-3
- ChEMBL ID
- CHEMBL1201568
- FDA ingredient codes (UNII)
- 3A58010674
- 338036
- 2469333
- Applicant
- AMGEN
- Approval date
- 31 Jan 2002
- Application number
- BLA125031
- Status
- Authorised
- Status date
- 22 Aug 2002
- Authorisation date
- 22 Aug 2002
- Approved indications
- 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).
- Product number
- EMEA/H/C/000420
- Authorisation holder
- Amgen Europe B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 10
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Cancer
- Chemotherapy-Induced Febrile Neutropenia
- Febrile Neutropenia
- Neutropenia
European medicines record
- Patents
- 0
- Designations
- 2
- Earliest recorded loss of exclusivity
- 13 Nov 2022
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- pegfilgrastim
- Type
- Peptide
- Drug name stem
- peg-; -stim
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Agonist
- Action type
- Agonist
- Target
- Granulocyte colony-stimulating factor receptor
- Gene symbol
- CSF3R
- Protein identifier
- Q99062
- Primary target
- Yes
- Mechanism
- Granulocyte colony stimulating factor receptor agonist
- Action type
- Agonist
- Target
- Granulocyte colony-stimulating factor receptor
- Protein identifier
- Q99062
Open Targets mechanisms
- Mechanism
- Granulocyte colony stimulating factor receptor agonist
- Action type
- Agonist
- Target
- Granulocyte colony-stimulating factor receptor
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Glioma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000326
- Subject identifier
- D005910
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Neoplasms, Germ Cell and Embryonal
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000514
- Subject identifier
- D009373
- Condition
- Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Neuroblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Osteosarcoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Sarcoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001642
- Subject identifier
- D019337
And 45 more, listed on the interactive page.
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 4
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001645
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004251
- Highest recorded phase
- 1
- Condition identifier
- EFO_0005537
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006834
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007949
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008528
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008572
- Highest recorded phase
- 3
- Condition identifier
- EFO_0010283
- Condition identifier
- HP_0000789
- Highest recorded phase
- 1
- Condition identifier
- HP_0001297
- Highest recorded phase
- 2
- Condition identifier
- HP_0001394
- Highest recorded phase
- 3
- Condition identifier
- HP_0001395
- Highest recorded phase
- 3
And 134 more, listed on the interactive page.
- Event
- application site bruise
- Reports
- 204
- Reporting signal score
- 693.95
- Event
- application site discomfort
- Reports
- 274
- Reporting signal score
- 897.011
- Event
- application site haemorrhage
- Reports
- 1,049
- Reporting signal score
- 3,706.06
- Event
- application site pain
- Reports
- 792
- Reporting signal score
- 1,775.44
- Event
- bone pain
- Reports
- 1,743
- Reporting signal score
- 2,724.01
- Event
- device adhesion issue
- Reports
- 5,355
- Reporting signal score
- 19,933.1
- Event
- device electrical finding
- Reports
- 169
- Reporting signal score
- 611.43
- Event
- device physical property issue
- Reports
- 599
- Reporting signal score
- 1,813.28
- Event
- device power source issue
- Reports
- 333
- Reporting signal score
- 1,117.62
- Event
- device use error
- Reports
- 4,867
- Reporting signal score
- 16,319.5
- Event
- drug hypersensitivity
- Reports
- 64
- Reporting signal score
- 460.028
- Event
- febrile neutropenia
- Reports
- 2,367
- Reporting signal score
- 3,392.4
- Event
- headache
- Reports
- 330
- Reporting signal score
- 484.609
- Event
- neutropenia
- Reports
- 1,657
- Reporting signal score
- 828.233
- Event
- occupational exposure to product
- Reports
- 756
- Reporting signal score
- 1,940.68
- Event
- unintentional medical device removal
- Reports
- 6,546
- Reporting signal score
- 24,146.9
- Event
- wrong technique in product usage process
- Reports
- 7,895
- Reporting signal score
- 17,370.8
- NCT00003955
- NCT00061984
- NCT00073983
- NCT00101127
- NCT01879085
- NCT05634369
- NCT00006011
- NCT00063999
- NCT00035594
- NCT00364468
- NCT00837265
- NCT01126190
- NCT01328938
- NCT01637493
- NCT01674855
- NCT01724866
- NCT01918241
- NCT01923545
- NCT02589301
- NCT02629289
- NCT02725606
- NCT02953340
- NCT03102606
- NCT03294577
- NCT04227990
And 172 more, listed on the interactive page.
- Dose
- 6 mg
- Route
- Subcutaneous
- How often
- Once per chemotherapy cycle
Conditions of use
- Do not administer between 14 days before and 24 hours after chemotherapy
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- MTPLGPASSLPQSFLLKCLEQVRKIQGDGAALQEKLCATYKLCHPEELVLLGHSLGIPWAPLSSCPSQALQLAGCLSQLHSGLFLYQGLLQALEGISPELGPTLDTLQLDVADFATTIWQQMEELGMAPALQPTQGAMPAFASAFQRRAGGVLVASHLQSFLEVSYRVLRHLAQP
- 0069-0324
- 55513-099
- 55513-190
- 55513-192
- 61314-866
- 65219-371
- 69448-025
- 69448-026
- 69448-027
- 70114-101
- 70114-120
- 70114-130
- 70748-273
- 72603-402
- 83257-005
- 70121-1627
Related records
Trials (377)
- A Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for PEG-G-CSF
- A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
- A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
- A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
- A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
- A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
- A Dose-Escalation Study for Patients With Advanced Cancer
- A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip
- A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects
- A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
- A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients
- A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors
- A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
- A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
- A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof
- 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
- A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors
- A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy
- A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
- A Study for Participants With Advanced Cancer
Approved for (3)
- Cancer
- Neoplasm
- Neutropenia
In development for (66)
- Acute lymphoblastic leukemia Phase 2
- Acute myeloid leukemia Phase 2
- Adrenal cortex carcinoma Phase 3
- Aplastic anemia Phase 2
- Brain cancer Phase 1
- Breast cancer Phase 3
- Breast carcinoma Phase 3
- Breast neoplasm Phase 3
- Central nervous system cancer Phase 1
- Cervical cancer Phase 2
- Classic Hodgkin lymphoma Phase 3
- Colorectal cancer Phase 2
- Coronary artery disorder Phase 1
- Diffuse large B-cell lymphoma Phase 3
- Digestive system neuroendocrine neoplasm Phase 2
- Esophageal cancer Phase 3
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 2
- Follicular lymphoma Phase 1
- Gastric cancer Phase 2
Other linked conditions (1)
Targets (1)
- CSF3R Granulocyte colony stimulating factor receptor agonist