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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: 27 Feb 2026

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At a glance

  • Originator Clene Nanomedicine
  • Class Antiparkinsonians; Eye disorder therapies; Heavy metals; Neuroprotectants
  • 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

  • 24 Feb 2026 Clene Nanomedicine expects acceptance of FDA for CNM Au 8 in Amyotrophic lateral sclerosis in the second half of 2026
  • 24 Feb 2026 Clene Nanomedicine expects issuance of a Prescription Drug User Fee Act (PDUFA) date for regulatory decision under the accelerated approval pathway in the second half of 2026
  • 24 Feb 2026 Clene Nanomedicine plans a in-person Type C meeting with the US FDA to review its data from ALS disease-specific biomarkers analyses by the end of first quarter of 2026.

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