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Detalimogene voraplasmid - enGene

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Drug Profile

Detalimogene voraplasmid - enGene

Alternative Names: Bladder cancer gene therapy - enGene; DDX® intravesicle gene therapy - enGene; Detalimogene; EG-70

Latest Information Update: 05 Dec 2025

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At a glance

  • Originator enGene
  • Class Antineoplastics; Gene therapies; Immunotherapies
  • Mechanism of Action DDX58 protein inhibitors; Gene transference; Interleukin 12 replacements
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Bladder cancer
  • Research Urogenital cancer

Most Recent Events

  • 03 Dec 2025 Adverse events data from the phase I/II LENGEND trial in Bladder cancer released by enGene
  • 11 Nov 2025 enGene anticipates potential FDA approval for Detalimogene voraplasmid in 2027
  • 11 Nov 2025 enGene plans to engage with the US FDA on a statistical analysis plan to determine which patients should be included in the final efficacy evaluable population in the pivotal LEGEND trial

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