SER-109 is under clinical development by Seres Therapeutics and currently in the Pre-Registration 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 SER-109’s likelihood of approval (LoA) and phase transition for Clostridioides difficile Infections (Clostridium difficile Associated Disease) took place on 27 Oct 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.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their SER-109 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

SER-109 overview

SER-109 is under development for the prevention of recurrent Clostridium difficile infections. The therapeutic candidate is administered orally. It is a multifunctional consortia comprising of purified eubacterial spores, that are encapsulated. The therapeutic candidate is developed based on human microbiome therapeutics technology.

Seres Therapeutics overview

Seres Therapeutics (Seres) is a microbiome therapeutics platform company that develops a novel class of biological drugs. The company creates a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis. The company’s lead development candidate, SER-109 is an oral microbiome therapeutic and bacterial spore ecology. Seres’ SER-287 is an oral therapy for the treatment of ulcerative colitis, an inflammatory bowel disease. Its development programs also include SER-301 and SER-155, which are investigational, oral, rationally designed, fermented microbiome therapeutic. The company utilizes its microbiome therapeutics platform to identify key alterations in the microbiome that are associated with or lead to specific diseases. Seres is headquartered in Cambridge, Massachusetts, the US

Quick View SER-109 LOA Data

Report Segments
  • Innovator
Drug Name
  • SER-109
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
Key Developers
  • Sponsor Company: Seres Therapeutics
  • Originator: Seres Therapeutics
Highest Development Stage
  • Pre-Registration


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.