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A Pivotal Phase III Study of RHB-204 for the Treatment of Pulmonary Nontuberculous Mycobacteria (NTM) Infections

Trial Profile

A Pivotal Phase III Study of RHB-204 for the Treatment of Pulmonary Nontuberculous Mycobacteria (NTM) Infections

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 Nov 2019

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At a glance

  • Drugs Clarithromycin/clofazimine/rifabutin (Primary)
  • Indications Nontuberculous mycobacterium infections
  • Focus Registrational; Therapeutic Use
  • Sponsors RedHill Biopharma
  • Most Recent Events

    • 19 Nov 2019 According to a RedHill Biopharma media release, this study is intended to potentially support approval of RHB-204, as a stand-alone, first-line treatment for Mycobacterium avium complex (MAC) disease, the most common cause of pulmonary NTM infections.
    • 19 Nov 2019 According to a RedHill Biopharma media release, RedHill plans to initiate this pivotal Phase 3 study activities with RHB-204 for the treatment of pulmonary NTM infections in the first half of 2020, subject to completion of the ongoing non-clinical program and additional input from the FDA.
    • 26 Sep 2019 According to a RedHill Biopharma media release, the comapny plans to initiate this study in the fourth quarter of 2019.
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