for IgG4-related disease
Sponsor announced submission MAY 28 2026. FDA filing review (~60 days) in progress; PDUFA date estimated as acceptance + 10 months Standard Review. Card updates with confirmed dates when FDA acceptance announcement lands.
IgG4-related disease is a chronic inflammatory condition where the immune system's IgG4 antibodies and other cells infiltrate tissues, often causing damaging scarring. Obexelimab is an investigational antibody designed to simultaneously bind to two proteins on the surface of B cells, which are responsible for producing IgG4 antibodies. By targeting these B cells, the drug may reduce the production of disease-driving antibodies and prevent the painful flare-ups that characterize this disorder.
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
Source: ClinicalTrials.gov