Fexinidazole is under clinical development by Sanofi and currently in the Phase II 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 Fexinidazole’s likelihood of approval (LoA) and phase transition for Chagas Disease (American Trypanosomiasis) took place on 19 Jul 2021, 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.

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

Fexinidazole overview

Fexinidazole is a 2-substituted 5-nitroimidazole derivative that contains a nitro group and is an anti-parasitic agent. It is formulated as tablet for oral route of administration. Fexinidazole is indicated for treatment of both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg.

Fexinidazole is under development for the treatment of human Chagas disease and African trypanosomiasis (sleeping sickness). The drug candidate is administered orally. Fexinidazole is a 2-substituted 5-nitroimidazole (imidazole derivative that contains a nitro group) drug candidate. The drug candidate is an anti-parasitic agent. It was also under development for the treatment of visceral leishmaniasis.

Sanofi overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

Quick View Fexinidazole LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Fexinidazole
Administration Pathway
  • Oral
Therapeutic Areas
  • 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.