SYNB-1618 is under clinical development by Synlogic 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 SYNB-1618’s likelihood of approval (LoA) and phase transition for Phenylketonuria (PKU) took place on 24 Aug 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 SYNB-1618 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

SYNB-1618 overview

SYNB-1618 is under development for the treatment of phenylketonuria (PKU). SYNB1618 is derived from a safe strain of bacteria called Escherichia coli Nissle. The therapeutic candidate is administered through oral route as a lyophilized formulation. It is a genetically modified organism (GMO) designed from natural probiotic bacteria that are engineered using Synlogic’s proprietary synthetic biology and microbiome platform to treat disease.

Synlogic overview

Synlogic, formerly TMC Therapeutics, is a clinical stage drug development company that develops novel class of living medicines for the treatment of rare and genetic metabolic diseases. The company’s pipeline includes SYNB1618 to treat the Phenylketonuria. It also produces drugs based on its proprietary synthetic biology and microbiome platform for the treatment of diseases, including liver disease, inflammatory and immune disorders, and cancer. The company’s synthetic biotics are designed to make therapeutic effects throughout the body from an initial stage in the microbiome. The company works in partnership with pharmaceutical and biotechnology companies for novel drug development in major disease areas. Synlogic is headquartered in Cambridge, Massachusetts, the US.

Quick View SYNB-1618 LOA Data

Report Segments
  • Innovator
Drug Name
  • SYNB-1618
Administration Pathway
  • Oral
Therapeutic Areas
  • Metabolic Disorders
Key Developers
  • Sponsor Company: Synlogic
  • Originator: Synlogic
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.