BLASUBCUTANEOUSSYRINGE
Approved
Jan 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
29
Data completeness
4/8 — Partial
NEULASTA (pegfilgrastim) by Amgen. Approved for leukocyte growth factor [epc]. First approved in 2002.
Drug data last refreshed 7h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEULASTA (pegfilgrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) analog administered via subcutaneous injection. It stimulates the production and release of neutrophils to prevent chemotherapy-induced neutropenia and reduce infection risk in cancer patients. The pegylated formulation extends half-life compared to filgrastim, allowing for less frequent dosing.
$42MPart D
LOE ApproachingThis product is entering loss-of-exclusivity phase with intense biosimilar competition, signaling potential contraction of commercial teams and shift toward defensive strategies.
Mechanism of Action
Pharmacologic Class:
Leukocyte Growth Factor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (29)
Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
Started Apr 2025
18 enrolled
Preeclampsia
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
Started Apr 2025
180 enrolled
Healthy Volunteer
Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
Started Mar 2025
18 enrolled
Preeclampsia
Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
Started Nov 2023
100 enrolled
Breast Neoplasms
Study of Plinabulin and Pegfilgrastim in People With Multiple Myeloma Undergoing an Autologous Hematopoietic Stem Cell Transplant (AHCT)
Started Dec 2021
17 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.