Clesacostat tromethamine, what is the likelihood that the drug will be approved?

Clesacostat tromethamine is under clinical development by Pfizer 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 Clesacostat tromethamine’s likelihood of approval (LoA) and phase transition for Non Alcoholic Fatty Liver Disease (NAFLD) took place on 16 Aug 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Clesacostat tromethamine LoA and PTSR Report.

Clesacostat tromethamine overview

Clesacostat (PF-05221304) is under development for the treatment of  non alcoholic fatty liver disease (NAFLD). The therapeutic candidate is administered orally as a tablet. The drug candidate is a new molecular entity (NME) and targets acetyl-coenzyme A carboxylase enzyme. It was also under development for nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Pfizer overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

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