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Pivotal phase IIb/III trial of low-dose naltrexone for Crohn's disease

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Pivotal phase IIb/III trial of low-dose naltrexone for Crohn's disease

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 22 Jun 2023

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At a glance

  • Drugs Naltrexone (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Biostax

    • Most Recent Events

    • 26 Mar 2018 According to an Immune Therapeutics media release, IMUN/Cytocom expects to submit final protocols for this pivotal rollover trial based on the meeting with the FDA shortly
    • 26 Mar 2018 According to an Immune Therapeutics media release, the company will also filing with the FDA an Investigational New Drug (IND) application to Lodonal in pediatric patients age 2 to 11 in the treatment of mild to severe Crohns disease.
    • 26 Mar 2018 According to an Immune Therapeutics media release, the company announced that it has received minutes from the Type C meeting held on January 16, 2018, between Immune Therapeutics on behalf of Cytocom, the license holder, and the US Food and Drug Administration (FDA).

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