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A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants

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Trial Profile

A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Jan 2026

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At a glance

  • Drugs Mirikizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 27 Oct 2025 According to an Eli Lilly and Company media release, the Omvoh single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or prefilled syringe in early 2026.
  • 27 Oct 2025 According to an Eli Lilly and Company media release, the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC).
  • 24 Jan 2025 Status changed from active, no longer recruiting to completed.

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