Nitazoxanide is under clinical development by Romark Laboratories LC and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Nitazoxanide’s likelihood of approval (LoA) and phase transition for Enterovirus Infections took place on 21 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 21 Dec 2022 increased Nitazoxanide’s LoA and PTSR for Rhinovirus Infections.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Nitazoxanide Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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

Quick View Nitazoxanide LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Nitazoxanide
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Infectious Disease
Key Developers
Highest Development Stage
  • Marketed

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.