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A randomized clinical trial to demonstrate pharmacokinetic equivalence of FILKRI as compared to Amgen filgrastim (NEUPOGEN) in healthy adults

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Trial Profile

A randomized clinical trial to demonstrate pharmacokinetic equivalence of FILKRI as compared to Amgen filgrastim (NEUPOGEN) in healthy adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Mar 2026

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At a glance

  • Drugs Filgrastim (Primary)
  • Indications Chemotherapy-induced damage; Neutropenia; Radiation injuries
  • Focus Pharmacodynamics; Pharmacokinetics

Most Recent Events

  • 16 Mar 2026 New trial record
  • 17 Feb 2026 According to an Accord Healthcare media release, FILKRI has been approved by USFDA based on 2 randomized studies in healthy adults, with pharmacokinetics (PK)/pharmacodynamics (PD) assessed in one study and safety and immunogenicity evaluated in both, compared with reference product NEUPOGEN.

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