Drug intelligence / Profile preview

mirikizumab + LY4395089

Development stage
Phase 2
Lead developer
Eli Lilly
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral, Subcutaneous
01

Overview

mirikizumab + LY4395089 is an investigational combination therapy being developed by Eli Lilly and Company for the treatment of moderately to severely active Crohn's disease. The combination consists of mirikizumab (LY3074828), a humanized IgG4 monoclonal antibody that selectively targets the p19 subunit of interleukin-23 (IL-23), and LY4395089, an oral small-molecule farnesoid X receptor (FXR) agonist. By combining the systemic anti-inflammatory effects of IL-23 inhibition with the localized gut-protective and anti-inflammatory actions of FXR activation, this regimen aims to enhance mucosal healing and clinical remission rates. The combination is currently being evaluated in a Phase 2 clinical trial (NCT07483099) where patients receive intravenous mirikizumab co-administered with oral LY4395089, followed by subcutaneous mirikizumab maintenance therapy.

Other names
LY3074828 + LY4395089LY4395089 + LY3074828LY4395089 + mirikizumabLY4395089 and mirikizumabLY-4395089 and mirikizumabLY 4395089 and mirikizumabmirikizumab and LY4395089
02

Targets

FXR (Farnesoid x-activated receptor)IL23A (Interleukin-23 p19 Subunit)

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