Niclosamide is under clinical development by First Wave BioPharma and currently in Phase II for Proctitis. According to GlobalData, Phase II drugs for Proctitis have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Niclosamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Niclosamide overview

Niclosamide is under development for the treatment of ulcerative colitis, proctitis ulcerative, proctosigmoiditis and checkpoint-induced colitis and crohn's disease. The drug candidate is administered through rectal route as enema and also through oral route as tablet.

First Wave BioPharma overview

First Wave BioPharma, formerly AzurRx BioPharma, is a development-stage biopharmaceutical company that focuses on non-systemic biologics for the treatment of patients with gastrointestinal disorders. The company’s products under development include MS1819 a non-systemic yeast recombinant enzyme intended for the treatment of exocrine pancreatic insufficiency exocrine (EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). MS1819 completed the phase IIa trial in partnership with Mayoly which is a European Pharmaceutical company. Its pre-clinical products include AZX1103 and AZX1101 which is a recombinant beta-lactamases enzyme for the prevention of nosocomial (hospital-acquired) infections and antibiotic-associated diarrhea. The company has operations in France and the US. First Wave BioPharma is headquartered in Brooklyn, New York, the US.

For a complete picture of Niclosamide’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.