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NGN 101

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Drug Profile

NGN 101

Alternative Names: NGN-101

Latest Information Update: 09 Jan 2024

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At a glance

  • Originator Neurogene Inc
  • Class Gene therapies
  • Mechanism of Action Ceroid-lipofuscinosis neuronal protein 5 replacements; Gene transference
  • Orphan Drug Status

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

    Yes - Neuronal ceroid lipofuscinosis
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Neuronal ceroid lipofuscinosis

Most Recent Events

  • 05 Jan 2024 Neurogene plans a clinical/regulatory strategy meeting with the US FDA to discuss registrational pathway for NGN 101 for Neuronal ceroid lipofuscinosis in second half of 2024
  • 31 Dec 2023 Neurogene in-license four pending patent applications from the University of North Carolina at Chapel Hill for NGN 101 Worldwide
  • 08 Feb 2022 Phase-I/II clinical trials in Neuronal ceroid lipofuscinosis (In children) in USA (Intraventricular) (NCT05228145)

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