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Pivotal trial of ELX-02 for the treatment of Alport syndrome with nonsense mutations

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Pivotal trial of ELX-02 for the treatment of Alport syndrome with nonsense mutations

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2024

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At a glance

  • Drugs Exaluren (Primary)
  • Indications Hereditary nephritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Eloxx Pharmaceuticals

    • Most Recent Events

    • 11 Jul 2024 According to an Eloxx Pharmaceuticals media release, company received positive written FDA feedback and guidance from a pre-Investigational New Drug Application (PIND) meeting provides pathway to IND application submission to initiate this trial.
    • 16 Apr 2024 According to an Eloxx Pharmaceuticals media release, The company is looking forward to engaging the FDA on initiating the larger clinical trial to support the potential for regulatory marketing approval of ELX-02 in Alport syndrome with nonsense mutations patient.
    • 16 Apr 2024 According to an Eloxx Pharmaceuticals media release, the company requested a Pre-Investigational New Drug (IND) meeting with U.S. FDA. The purpose of the pre-IND meeting will be to request feedback on the company's planned clinical trial in nonsense mutation Alport syndrome patients.

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