Ribaxamase - Synthetic Biologics

Drug Profile

Ribaxamase - Synthetic Biologics

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

Latest Information Update: 25 Apr 2018

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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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Clostridium-difficile-infections; Diarrhoea

Most Recent Events

  • 23 Apr 2018 Synthetic Biologics plans to initiate phase III trials for the Clostridium difficile infections (Prevention) in USA in the the second half of 2019
  • 20 Apr 2018 Synthetic Biologics, in collaboration with the US FDA, voluntarily withdrew the Breakthrough Therapy status for Clostridium difficile infections (Prevention) in USA
  • 01 Nov 2017 Synthetic Biologics plans collaborative discussions with the US FDA for drug development plan and regulatory pathway for marketing approval of ribaxamase in 2018
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