FW-424 (niclosamide)

FW-424 is a gut-restricted, small molecule formulation of niclosamide developed by First Wave Bio (later acquired by AzurRx BioPharma, which became Entero Therapeutics). It can be formulated for either oral or rectal administration and is being developed primarily for the treatment of ulcerative colitis and other inflammatory bowel diseases. The drug works through multiple mechanisms including reducing levels of pro-inflammatory cytokines, killing pathogenic lamina propria T cells, and blocking pathogenic Wnt signaling to promote mucosal healing. It targets the metabolism of disease-causing Th17 cells. FW-424 has low oral bioavailability and is gut-restricted, which reduces the potential for systemic side effects including unwanted immunosuppression. The drug demonstrated potent therapeutic activity in preclinical animal models of IBD, equal to or surpassing competitor compounds. Clinical trials showed benefits for patients with mild-to-moderate ulcerative colitis in Phase 1b/2a studies[1][5][6][7][9].

Other names

FW-420FW420FW 420FW-1022FW1022FW 1022FW-CDFW-COVFW-ICI-ACFW-UCFW-UPmicronized niclosamideMetaWave