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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: 08 Aug 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

  • 06 Aug 2024 Clene plans a Type C meeting with the US FDA to discuss an accelerated approval regulatory pathway in the third quarter of 2024
  • 16 Jul 2024 Clene Nanomedicine plans interaction with FDA to receive feedback on the potential path to submission of a new drug application (NDA) for CNM-Au8 in third quarter of 2024
  • 11 Jul 2024 Clene Nanomedicine plans to submit a briefing book by July 13 to the USFDA in advance of a granted Type C interaction

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