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Phase II trial of clarithromycin/clofazimine/rifabutin [RHB 104] in patients with Crohn's disease secondary to Mycobacterium avium paratuberculosis infection

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Trial Profile

Phase II trial of clarithromycin/clofazimine/rifabutin [RHB 104] in patients with Crohn's disease secondary to Mycobacterium avium paratuberculosis infection

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 10 Nov 2025

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At a glance

Most Recent Events

  • 05 Sep 2025 According to a RedHill Biopharma media release,On July 21, 2025, the Company announced that it had received positive feedback from the FDA, following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Companys potentially groundbreaking RHB-204 Crohn's disease development program.
  • 12 Mar 2025 According to a RedHill Biopharma media release, pending Type C discussions on path to FDA approval with guidance from FDA expected in expected in Q2/25.

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