EDP-305 is under clinical development by Enanta Pharmaceuticals 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 EDP-305’s likelihood of approval (LoA) and phase transition for Non-Alcoholic Steatohepatitis (NASH) took place on 05 Oct 2021, 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 EDP-305 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

EDP-305 overview

EDP-305 is under development for the treatment of non-alcoholic steatohepatitis (NASH). The drug candidate is a steroidal non-carboxylic acid, modified with additional non-steroidal binding element to enhance potency. It is administered through oral route formulated as tablet and suspension. The drug candidate acts by targeting farnesoid X-activated receptor. It was under development for the treatment of non-alcoholic fatty liver disease (NAFLD) and primary biliary cirrhosis.

Enanta Pharmaceuticals overview

Enanta Pharmaceuticals (Enanta) is a biotechnology company. It discovers and develops small molecule drugs for the treatment of viral infections and liver diseases. The company’s lead product candidate includes EDP-305, a farnesoid X receptor (FXR) agonist intended for the treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). Enanta also develops EDP-938, a potent N-protein inhibitor for the respiratory syncytial virus; and programs to discover and develop chemical entities for the treatment of the hepatitis B virus. The company also develops and markets protease inhibitor compounds for the treatment of the hepatitis C virus through collaborative development and license agreement with AbbVie. Enanta is headquartered in Watertown, Massachusetts, the US

Quick View EDP-305 LOA Data

Report Segments
  • Innovator
Drug Name
  • EDP-305
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
Key Developers
Highest Development Stage
  • Phase II

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.