Product Description
Pegfilgrastim is a covalent conjugant of filgrastim (a recombinant human granulocyte colony-stimulating factor) and monomethoxypolyethylene glycol. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/12010086/)
Mechanisms of Action: G-CSF
Novel Mechanism: No
Modality: Coagulation Factor
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela | Vietnam
Approved Indications: Febrile Neutropenia | Neutropenia | Oncology Unspecified | Hematopoietic Stem Cell Transplant | Stem Cell Transplant
Known Adverse Events: Pain Unspecified
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additonal Commercial Interests: None
Clinical Description
![Map of Global Clinical Trials for Pegfilgrastim](https://pryzm-maps.s3.us-west-2.amazonaws.com/758current_maps.png)
Countries in Clinic: Australia, China, France, Japan, New Zealand, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Neutropenia
Phase 2: Breast Cancer|Hepatitis B, Chronic|Intestinal Diseases|Lymphoma|Multiple Myeloma
Phase 1: Febrile Neutropenia|Hematopoietic Stem Cell Transplant
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
BREASTIMMU02 | P2 |
Recruiting |
Breast Cancer |
2025-01-01 |
|
jRCT2011210029 | P2 |
Completed |
Multiple Myeloma|Lymphoma |
2022-10-31 |
|
ACTRN12620000657921 | P1 |
Completed |
Neutropenia |
2021-02-08 |
|
2006-7041-83/hah | P2 |
Not yet recruiting |
Intestinal Diseases|Hepatitis B, Chronic |
None |