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CNM Au 8

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Drug Profile

CNM Au 8

Alternative Names: Clean-surfaced gold nanocrystals; CNM-Au8; Gold nanocrystal suspension; Nanocrystalline gold

Latest Information Update: 13 Dec 2024

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At a glance

  • Originator Clene Nanomedicine
  • Class Antiparkinsonians; Eye disorder therapies; Heavy metals
  • Mechanism of Action Energy metabolism stimulants; Immunomodulators
  • Orphan Drug Status

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

    Yes - Amyotrophic lateral sclerosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Amyotrophic lateral sclerosis
  • Phase II/III Multiple sclerosis
  • Phase II Optic nerve disorders; Parkinson's disease
  • Preclinical Rett syndrome

Most Recent Events

  • 10 Dec 2024 Clene Nanomedicine plans to meet with the US FDA to file an NDA for Amyotrophic lateral sclerosis under the accelerated approval pathway mid 2025
  • 13 Nov 2024 Clene Nanomedicine met with the US FDA to file an NDA for Amyotrophic lateral sclerosis under the accelerated approval pathway
  • 18 Sep 2024 Efficacy and adverse event data from the phase II/III VISIONARY-MS long term extension (VISIONARY-MS LTE) trial in multiple sclerosis presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2024)

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