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: 07 Nov 2017

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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 infections; Diarrhoea

Most Recent Events

  • 01 Nov 2017 Synthetic Biologics holds a Type-B multidisciplinary meeting with the US FDA for drug development plan and regulatory pathway for marketing approval of ribaxamase before November 2017
  • 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 the first quarter of 2018
  • 04 Oct 2017 Efficacy data from a phase IIb trial in Clostridium infections presented at the IDWeek 2017
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