> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/filgrastim-942bf0d3-0bf1-4bf8-9e38-81a6c277d728
> Record changed: 2026-10-13

# Filgrastim

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

Drug type

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

First approval year

1991

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

## Development status

**First approval year**

1991

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

## Names and chemistry

**Drug type**

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

**Drug name**

Filgrastim

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

### Brand names (38)

- accofil
- Accofil
- biograstim
- Biograstim
- filgrastim hexal
- Filgrastim hexal
- filgrastim ratiopharm
- Filgrastim ratiopharm
- gran 300
- Gran 300
- gran injection 150
- Gran injection 150
- granix
- Granix
- grastofil
- Grastofil
- neupogen
- Neupogen
- neupogen 30
- Neupogen 30
- neupogen 48
- Neupogen 48
- nivestim
- Nivestim
- nivestym

And 13 more, listed on the interactive page.

### Other names (148)

- colony stimulating factor human clone 1034 n l methionyl
- COLONY-STIMULATING FACTOR (HUMAN CLONE 1034), N-L-METHIONYL-
- ep 2006
- EP-2006
- ep2006
- Ep2006
- EP2006
- filgrastim
- Filgrastim
- FILGRASTIM
- Filgrastim (Eurofarma)
- FILGRASTIM (NEUPOGEN)
- FILGRASTIM (R-METHUG-CSF)
- FILGRASTIM \[EMA EPAR\]
- filgrastim \[INN\]
- FILGRASTIM \[JAN\]
- FILGRASTIM \[MART.\]
- FILGRASTIM \[PURPLE BOOK CDER\]
- FILGRASTIM \[USAN\]
- FILGRASTIM \[USP MONOGRAPH\]
- FILGRASTIM \[VANDF\]
- Filgrastim \[WHO-DD\]
- filgrastim aafi
- Filgrastim aafi
- Filgrastim aafi \[WHO-DD\]

And 123 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L03AA02

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

**CAS registry numbers**

- 121181-53-1

**ChEMBL ID**

CHEMBL1201567

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201567)

**FDA ingredient codes (UNII)**

- PVI5M0M1GW

### RxNorm IDs (RxCUI) (2)

- 68442
- 2057198

## Regulatory information

### United States

**Applicant**

AMGEN

**Approval date**

20 Feb 1991

**Application number**

BLA103353

### European Union

**Status**

Authorised

**Status date**

15 Sept 2008

**Authorisation date**

15 Sept 2008

**Approved indications**

Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

**Product number**

EMEA/H/C/000827

**Authorisation holder**

Teva GmbH

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

Yes

**Generic medicines**

0

**Biosimilar medicines**

7

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Cancer
- Hematopoietic Stem Cell Transplantation

European medicines record

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

### Other regulatory facts

**Patents**

0

**Designations**

4

**Earliest recorded loss of exclusivity**

29 Feb 2024

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

filgrastim

**Type**

Peptide

**Drug name stem**

\-stim

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral

### Mechanisms of action

- **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 (183)

- **Condition**  
Hematopoietic Stem Cell Transplantation

**Highest recorded phase**  
4

**Subject identifier**  
D018380
- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000094

**Subject identifier**  
D015456
- **Condition**  
Leukemia, Lymphocytic, Chronic, B-Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000095

**Subject identifier**  
D015451
- **Condition**  
Lymphoma, Follicular

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000096

**Subject identifier**  
D008224
- **Condition**  
Sarcoma, Ewing

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000174

**Subject identifier**  
D012512
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Hodgkin Disease

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000183

**Subject identifier**  
D006689
- **Condition**  
Lymphoma, B-Cell, Marginal Zone

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000191

**Subject identifier**  
D018442
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000196

**Subject identifier**  
D011471
- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Neoplasms, Plasma Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000200

**Subject identifier**  
D054219
- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000209

**Subject identifier**  
D015456
- **Condition**  
Lymphoma, T-Cell, Peripheral

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000211

**Subject identifier**  
D016411
- **Condition**  
Leukemia, Erythroblastic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000218

**Subject identifier**  
D004915
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000220

**Subject identifier**  
D054198
- **Condition**  
Leukemia, Monocytic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000221

**Subject identifier**  
D007948
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Leukemia, Myelomonocytic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000223

**Subject identifier**  
D015479
- **Condition**  
Leukemia, Promyelocytic, Acute

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000224

**Subject identifier**  
D015473
- **Condition**  
Pheochromocytoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000239

**Subject identifier**  
D010673
- **Condition**  
Burkitt Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000309

**Subject identifier**  
D002051
- **Condition**  
Carcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000313

**Subject identifier**  
D002277
- **Condition**  
Glioma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000326

**Subject identifier**  
D005910
- **Condition**  
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000339

**Subject identifier**  
D015464

And 158 more, listed on the interactive page.

### Open Targets indications (298)

- **Condition identifier**  
EFO\_0000183

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000198
- **Condition identifier**  
EFO\_0000200

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000211

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000220

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000222

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000384

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0000389

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000407

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000544
- **Condition identifier**  
EFO\_0000544

**Highest recorded phase**  
4
- **Condition identifier**  
EFO\_0000545
- **Condition identifier**  
EFO\_0000565

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000574

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000612
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000621

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000681

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000691

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000702

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000712

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000764
- **Condition identifier**  
EFO\_0000768

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001065

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001378

**Highest recorded phase**  
3

And 273 more, listed on the interactive page.

### Reported adverse events (31)

- **Event**  
acute myeloid leukaemia

**Reports**  
62

**Reporting signal score**

97.333
- **Event**  
aortitis

**Reports**  
28

**Reporting signal score**

95.3846
- **Event**  
application site bruise

**Reports**  
204

**Reporting signal score**

693.756
- **Event**  
application site discomfort

**Reports**  
274

**Reporting signal score**

896.75
- **Event**  
application site haemorrhage

**Reports**  
1,049

**Reporting signal score**  
3,705.05
- **Event**  
application site pain

**Reports**  
792

**Reporting signal score**  
1,774.71
- **Event**  
bone pain

**Reports**  
1,761

**Reporting signal score**  
2,767.47
- **Event**  
device adhesion issue

**Reports**  
5,341

**Reporting signal score**  
19,860.9
- **Event**  
device electrical finding

**Reports**  
168

**Reporting signal score**

606.663
- **Event**  
device physical property issue

**Reports**  
596

**Reporting signal score**  
1,800.67
- **Event**  
device power source issue

**Reports**  
333

**Reporting signal score**  
1,117.3
- **Event**  
device use error

**Reports**  
4,867

**Reporting signal score**  
16,314.6
- **Event**  
disease recurrence

**Reports**  
114

**Reporting signal score**

152.446
- **Event**  
febrile neutropenia

**Reports**  
2,326

**Reporting signal score**  
3,293.91
- **Event**  
heart rate abnormal

**Reports**  
43

**Reporting signal score**

97.6987
- **Event**  
immune reconstitution inflammatory syndrome

**Reports**  
62

**Reporting signal score**

114.545
- **Event**  
leukopenia

**Reports**  
138

**Reporting signal score**

98.9335
- **Event**  
mucosal inflammation

**Reports**  
135

**Reporting signal score**

166.433
- **Event**  
neutropenia

**Reports**  
1,733

**Reporting signal score**

920.845
- **Event**  
neutrophil count decreased

**Reports**  
161

**Reporting signal score**

184.025
- **Event**  
occupational exposure to product

**Reports**  
756

**Reporting signal score**  
1,939.97
- **Event**  
pancytopenia

**Reports**  
161

**Reporting signal score**

139.174
- **Event**  
pyrexia

**Reports**  
629

**Reporting signal score**

424.276
- **Event**  
splenomegaly

**Reports**  
72

**Reporting signal score**

117.386
- **Event**  
staphylococcal bacteraemia

**Reports**  
103

**Reporting signal score**

298.696

And 6 more, listed on the interactive page.

### Trial references (840)

- NCT00000899  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000899)
- NCT00002126  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002126)
- NCT00002255  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002255)
- NCT00001335  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001335)
- NCT00002634  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002634)
- NCT00002740  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002740)
- NCT00003093  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003093)
- NCT00003119  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003119)
- NCT00003141  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003141)
- NCT00003203  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003203)
- NCT00003846  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003846)
- NCT00003926  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003926)
- NCT00004188  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004188)
- NCT00005835  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005835)
- NCT00005978  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005978)
- NCT00017225  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00017225)
- NCT00017368  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00017368)
- NCT00024193  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00024193)
- NCT00025649  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00025649)
- NCT00030719  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00030719)
- NCT00040872  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00040872)
- NCT00053950  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00053950)
- NCT00070200  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00070200)
- NCT00075634  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00075634)
- NCT00083135  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00083135)

And 815 more, listed on the interactive page.

## Dosing

**Dose**

5 mcg/kg

**Route**

Subcutaneous

**How often**

Once daily

### Conditions of use

- Administer for at least 4 days before leukapheresis and until last leukapheresis

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences

- **Component**  
Sequence

**Type**  
Protein

**Sequence**  
MTPLGPASSLPQSFLLKCLEQVRKIQGDGAALQEKLCATYKLCHPEELVLLGHSLGIPWAPLSSCPSQALQLAGCLSQLHSGLFLYQGLLQALEGISPELGPTLDTLQLDVADFATTIWQQMEELGMAPALQPTQGAMPAFASAFQRRAGGVLVASHLQSFLEVSYRVLRHLAQP

## National Drug Codes

- 0069-0291
- 0069-0292
- 0069-0293
- 0069-0294
- 55513-209
- 55513-530
- 55513-546
- 55513-924
- 61314-318
- 61314-326
- 63459-910
- 63459-912
- 63459-918
- 63459-920
- 69097-429
- 69097-430
- 69448-008
- 69448-009
- 72374-101
- 72374-102
- 70121-1568
- 70121-1569
- 70121-1570
- 70121-1571

## Related records

### Trials (934)

- 131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
- 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
- 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
- A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
- A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
- A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
- A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
- A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients
- A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer.
- A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
- A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
- A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
- A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
- A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies
- A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
- 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 Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
- A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions
- A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
- A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

### Approved for (3)

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

### In development for (173)

- Acute basophilic leukemia Phase 3
- Acute erythroid leukemia Phase 3
- Acute leukemia of ambiguous lineage Phase 3
- Acute lymphoblastic leukemia Phase 3
- Acute megakaryoblastic leukemia Phase 3
- Acute monocytic leukemia Phase 3
- Acute myeloblastic leukemia without maturation Phase 3
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 3
- Acute myelomonocytic leukemia M4 Phase 3
- [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Phase 3
- Acute promyelocytic leukemia Phase 1
- Adrenal cortex carcinoma Phase 3
- Adrenal gland pheochromocytoma Phase 3
- Adult T-cell leukemia/lymphoma Phase 3
- AL amyloidosis Phase 3
- Alcoholic hepatitis Phase 3
- [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 1
- [Amyotrophic lateral sclerosis](https://trialight.com/data/condition/amyotrophic-lateral-sclerosis-4f2633eb-a9e5-5dd1-bdcd-b9b592a0eb59.md) Phase 2
- Anaplastic ependymoma Phase 3
- Anaplastic large cell lymphoma Phase 2

### Other linked conditions (1)

- Glycogen storage disease II

### 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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