Mitomycin - UroGen Pharma

Drug Profile

Mitomycin - UroGen Pharma

Alternative Names: MITOGEL; Mitomycin 0.18% gel; Mitomycin 0.4% gel; Mitomycin C mixed with TC Gel; Mitomycin C mixed with TC-3 gel; MMC gel; UGN 101; UGN 102; VESIGEL

Latest Information Update: 16 Jul 2018

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At a glance

  • Originator TheraCoat
  • Developer UroGen Pharma
  • Class Antineoplastics; Aziridines; Carbamates; Cytostatic antibiotics; Indoles; Small molecules
  • Mechanism of Action DNA synthesis inhibitors
  • Orphan Drug Status

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

    Yes - Urogenital cancer
  • New Molecular Entity No

Highest Development Phases

  • Phase III Bladder cancer

Most Recent Events

  • 11 Jul 2018 UroGen Pharma plans a phase IIb trial in Bladder cancer (In adults, In the elderly) in USA in the third quarter of 2018 (TC-BC-12; NCT03558503)
  • 30 Jun 2018 UroGen Pharma files an IND application with the US FDA for initiation of a phase IIb trial in bladder cancer (Intravesicular, 1.8%)
  • 21 May 2018 Interim efficacy and adverse events data from the pivotal phase III OYMPUS trial in Bladder cancer presented at the 113th American Urological Association’s annual meeting (AUA-2018)
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