Fidaxomicin - Cubist

Drug Profile

Fidaxomicin - Cubist

Alternative Names: Dificid; Dificlir; Difimicin; Lipiarmycin; OPT-80; PAR-101

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Optimer Pharmaceuticals
  • Developer Astellas Pharma; Astellas Pharma Europe Ltd; Cubist Pharmaceuticals; Optimer Pharmaceuticals
  • Class Antibacterials; Glycosides
  • Mechanism of Action DNA-directed RNA polymerase inhibitors
  • Orphan Drug Status

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

    Yes - Clostridium infections
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Clostridium infections
  • Discontinued Methicillin-resistant Staphylococcus aureus infections

Most Recent Events

  • 01 Sep 2016 Astellas completes a phase-III clinical trial in Clostridium infections in Japan (PO) (NCT02179658)
  • 04 Oct 2015 Fidaxomicin licensed to Merck in Taiwan
  • 01 Apr 2015 Optimer Pharmaceuticals completes the phase III DEFLECT-1 trial in Clostridium infections (Prevention) in USA and Canada (NCT01691248)
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