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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: 28 Aug 2025

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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

  • 14 Aug 2025 Clene Nanomedicine plans an ALS Survival Data Type C Meeting with the US FDA in the third quarter of 2025
  • 14 Aug 2025 Clene Nanomedicine plans to file an NDA for Amyotrophic lateral sclerosis under the accelerated approval pathway by the end of 2025
  • 14 Aug 2025 Clene plans to discuss the entire VISIONARY-MS trial including recently presented data at an end-of-Phase II Type B MS Program Meeting with the US FDA in the third quarter of 2025

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