Drug Profile


Alternative Names: Kymerase; P3A; SYN 004; Synthetic Bacillus licheniformis isoenzyme - Synthetic Biologics

Latest Information Update: 07 Mar 2017

Price : $50

At a glance

  • Originator Ipsat Therapies
  • Developer Synthetic Biologics
  • Class Aminohydrolases; Anti-infectives
  • Mechanism of Action Beta lactamase stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Clostridium infections; Diarrhoea

Most Recent Events

  • 02 Mar 2017 Synthetic Biologics plans to initiate phase III clinical trials for the prevention of C. difficile infections and antibiotic-associated diarrhoea, in the first half of 2018
  • 02 Mar 2017 Updated efficacy data from a phase IIb trial in Clostridium infections (Prevention) released by Synthetic Biologics
  • 05 Jan 2017 Top-line safety and efficacy data from phase-IIb trial in Clostridium infections (Prevention) released by Synthetic Biologics
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