Drug Profile


Alternative Names: GF-001001-00; M-512101; M5120; T-3912

Latest Information Update: 20 Feb 2017

Price : $50

At a glance

  • Originator Toyama Chemical
  • Developer Cipher Pharmaceuticals; Ferrer; Maruho; Medimetriks Pharmaceuticals
  • Class Antibacterials; Cyclopropanes; Pyridines; Quinolones; Small molecules
  • Mechanism of Action DNA topoisomerase inhibitors
  • 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 No

Highest Development Phases

  • Registered Acne vulgaris; Skin and soft tissue infections
  • Preregistration Impetigo

Most Recent Events

  • 16 Feb 2017 Maruho plans a open label, randomised trial for Acne vulgaris (Combination therapy, In adolescents, In adults) in Japan (UMIN000024874)
  • 31 Aug 2016 FDA assigns PDUFA action date of 22/06/2017 for ozenoxacin for Impetigo
  • 31 Aug 2016 US FDA accepts NDA for ozenoxacin for Impetigo for review
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