LP-410 is an oral rinse formulation intended for the treatment of oral Graft-versus-Host Disease (GvHD), a rare and serious disease. GvHD is a major cause of morbidity and mortality with chronic GvHD being the leading cause of nonmalignant fatality post hematopoietic cell transplantation (HCT).

Lipella has been granted FDA Orphan Drug Designation for LP-410 in the treatment of GvHD and received IND approval for its Phase 2a clinical trial in March 2024. Lipella expects to initiate its Phase 2a clinical trial in GvHD in H1 2025.