> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/pegfilgrastim-1d67f09f-a3d2-4dbc-bfb9-efed1a49c050
> Record changed: 2026-10-13

# Pegfilgrastim

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

Drug type

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

First approval year

2002

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

## Development status

**First approval year**

2002

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

## Names and chemistry

**Drug type**

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

**Drug name**

Pegfilgrastim

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

### Brand names (26)

- 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.

### Other names (201)

- 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.

## Identifiers

**ATC classification codes**

- L03AA13

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

**CAS registry numbers**

- 208265-92-3

**ChEMBL ID**

CHEMBL1201568

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201568)

**FDA ingredient codes (UNII)**

- 3A58010674

### RxNorm IDs (RxCUI) (2)

- 338036
- 2469333

## Regulatory information

### United States

**Applicant**

AMGEN

**Approval date**

31 Jan 2002

**Application number**

BLA125031

### European Union

**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

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta)

### Other regulatory facts

**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

### Drug classification

**Pharmacology name**

pegfilgrastim

**Type**

Peptide

**Drug name stem**

peg-; -stim

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral

### Mechanisms of action (2)

- **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

### Investigated indications (70)

- **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.

### Open Targets indications (159)

- **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.

### Reported adverse events (17)

- **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

### Trial references (197)

- NCT00003955  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003955)
- NCT00061984  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00061984)
- NCT00073983  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00073983)
- NCT00101127  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00101127)
- NCT01879085  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01879085)
- NCT05634369  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05634369)
- NCT00006011  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006011)
- NCT00063999  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00063999)
- NCT00035594  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00035594)
- NCT00364468  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00364468)
- NCT00837265  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00837265)
- NCT01126190  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01126190)
- NCT01328938  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01328938)
- NCT01637493  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01637493)
- NCT01674855  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01674855)
- NCT01724866  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01724866)
- NCT01918241  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01918241)
- NCT01923545  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01923545)
- NCT02589301  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02589301)
- NCT02629289  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02629289)
- NCT02725606  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02725606)
- NCT02953340  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02953340)
- NCT03102606  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03102606)
- NCT03294577  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03294577)
- NCT04227990  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04227990)

And 172 more, listed on the interactive page.

## Dosing

**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

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences

- **Component**  
Sequence

**Type**  
Protein

**Sequence**  
MTPLGPASSLPQSFLLKCLEQVRKIQGDGAALQEKLCATYKLCHPEELVLLGHSLGIPWAPLSSCPSQALQLAGCLSQLHSGLFLYQGLLQALEGISPELGPTLDTLQLDVADFATTIWQQMEELGMAPALQPTQGAMPAFASAFQRRAGGVLVASHLQSFLEVSYRVLRHLAQP

## National Drug Codes

- 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](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- Neoplasm
- Neutropenia

### In development for (66)

- Acute lymphoblastic leukemia Phase 2
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 2
- Adrenal cortex carcinoma Phase 3
- Aplastic anemia Phase 2
- Brain cancer Phase 1
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- Breast carcinoma Phase 3
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3
- Central nervous system cancer Phase 1
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 2
- Classic Hodgkin lymphoma Phase 3
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2
- [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 1
- [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 3
- Digestive system neuroendocrine neoplasm Phase 2
- [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) Phase 3
- Exocrine pancreatic carcinoma Phase 2
- [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) Phase 2
- [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) Phase 1
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 2

### Other linked conditions (1)

- [Hematopoietic and lymphoid cell neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-cell-neoplasm-ed3616fa-22fe-5984-94b4-745416e01ef9.md)

### Targets (1)

- [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md) Granulocyte colony stimulating factor receptor agonist

---

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