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A first-in-human clinical trial of RGX-181

Trial Profile

A first-in-human clinical trial of RGX-181

Planning
Phase of Trial: Phase I

Latest Information Update: 31 Jan 2019

At a glance

  • Drugs RGX-181 (Primary)
  • Indications Neuronal ceroid lipofuscinosis
  • Focus Adverse reactions; First in man
  • Sponsors REGENXBIO
  • Most Recent Events

    • 31 Jan 2019 According to a REGENXBIO media release, the company is looking forward to filing an IND with the FDA for this clinical trial in the second half of 2019 to enable initiation of a first-in-human clinical trial.
    • 12 Sep 2018 New trial record
    • 30 Aug 2018 According to a REGENXBIO media release, the company plans to submit an investigational new drug (IND) application for RGX-181 to the U.S. Food and Drug Administration in 2019 to enable initiation of a global first-in-human clinical trial with clinical centers planned in the United States and Europe.
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