First Wave BioPharma, Inc., a clinical-stage biopharmaceutical company, engages in the research and development of targeted and non-systemic therapies for the treatment of patients with gastrointestinal diseases.

Its product candidates include niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties; and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients.

The company develops FW-COV, which is in Phase II clinical trials for the treatment of severe acute respiratory syndrome coronavirus 2 gastrointestinal infections; FW-UP, which is in Phase II clinical trials for the treatment ulcerative proctitis and ulcerative proctosigmoiditis; FW-ICI-AC for immune checkpoint inhibitor-associated colitis and diarrhea in advanced stage oncology patients; and FW-UC, which is in Phase Ib/IIa clinical trials for the treatment of ulcerative proctitis and ulcerative proctosigmoiditis.

It also develops FW-CD, which has completed Phase I clinical trials for Crohn's disease; and adrulipase, an oral, non-systemic, and biologic capsule for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis.

The company was formerly known as AzurRx BioPharma, Inc. and changed its name to First Wave BioPharma, Inc. in September 2021.

First Wave BioPharma, Inc. was incorporated in 2014 and is headquartered in Boca Raton, Florida.