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An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012

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Trial Profile

An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 30 Jan 2025

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At a glance

  • Drugs CNM Au8 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Expanded access; Therapeutic Use
  • Sponsors Clene Nanomedicine

    • Most Recent Events

    • 10 Dec 2024 According to a Clene Australia media release, Clene intends to follow the FDAs recommendation to provide data from the ongoing EAPs and believes that it can address the FDAs requests. This additional NfL biomarker collection and analyses to support NDA submission is planned to be completed during second quarter of 2025
    • 09 May 2024 Status changed from planning to recruiting.
    • 22 Feb 2024 According to Clene Nanomedicine media release, the trial is expected to commence enrollment in the first half of 2024.

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