Nitazoxanide CR 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 CR’s likelihood of approval (LoA) and phase transition for Rhinovirus Infections took place on 21 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Nitazoxanide CR overview

Nitazoxanide is under development for the treatment of Coronavirus disease 2019 (COVID-19), influenza A and B infections, respiratory syncytial virus (RSV) infections, enterovirus and rhinovirus infections. The drug candidate is an oral controlled release formulated as capsule, tablet and powder as controlled release formulation. It is a small molecule 5-nitrothiazole compound with antiparasitic, antibacterial and antiviral activity.

It was also under development for the treatment of chronic hepatitis B.

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 CR LOA Data

Report Segments
  • Innovator
Drug Name
  • Nitazoxanide CR
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
Key Developers
Highest Development Stage
  • Phase III

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.