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Pegfilgrastim

Alternative Names: pegfilgrastim, neulasta, udenyca, fulphila, fylnetra, stimufend
Latest Update: 2024-08-29
Latest Update Note: Clinical Trial Update

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

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

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