Nitazoxanide is under clinical development by Romark Laboratories LC and currently in Phase III for Enterovirus Infections. According to GlobalData, Phase III drugs for Enterovirus Infections have a 40% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nitazoxanide’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.

Nitazoxanide overview

Nitazoxanide (Alinia) is a salicylamide derivative, acts as an anti-parasitic or antiprotozoal agent. It is formulated as film coated tablets and suspension for oral route of administration. Alinia oral Suspension (patients 1 year of age and older) is indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Alinia tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

It was under development for the treatment of hepatitis B as second line therapy and middle east respiratory syndrome (MERS). It was also under development for diarrhea caused by enteric viruses like adenovirus, norovirus or rotavirus, Enterovirus, Rhinovirus, hepatitis B, hepatitis C, Crohn's disease, Clostridium infections, and acute intestinal amoebiasis.

Romark Laboratories LC overview

Romark Laboratories LC (Romark Laboratories) is a pharmaceutical company that discovers, develops and commercializes small molecules for the treatment of infectious diseases and cancers. It develops Nitazoxanide, an oral suspension and tablets used for the treatment of intestinal parasitic infections. Its pipeline product include NT-300, which is used in COVID-19 clinical trials. Romark Laboratories’ pipeline products are used for the treatment of various indications such as anti-infective, antiviral, influenza and RSV. The company operates through its manufacturing facility located in Belgium and Puerto Rico. Romark Laboratories is headquartered in Tampa, Florida, the US

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

GlobalData

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.