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Clarithromycin/clofazimine/rifabutin - RedHill Biopharma

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Drug Profile

Clarithromycin/clofazimine/rifabutin - RedHill Biopharma

Alternative Names: Clarithromycin/rifabutin/clofazimine; Clofazimine/clarithromycin/rifabutin; Clofazimine/rifabutin/clarithromycin; Myoconda®; RHB 204; RHB-104; Rifabutin/clarithromycin/clofazimine; Rifabutin/clofazimine/clarithromycin

Latest Information Update: 24 Jul 2025

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At a glance

  • Originator Centre for Digestive Diseases
  • Developer RedHill Biopharma
  • Class Anti-inflammatories; Antibacterials; Antihyperglycaemics; Antipsoriatics; Antirheumatics; Aza compounds; Ethers; Macrolides; Phenazines; Piperidines; Rifamycins; Skin disorder therapies; Small molecules; Spiro compounds
  • Mechanism of Action Adenosine triphosphatase inhibitors; P-glycoprotein inhibitors; Phospholipase A2 inhibitors; Protein 50S ribosomal subunit inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Nontuberculous mycobacterium infections; Crohn's disease
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Crohn's disease; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
  • No development reported Psoriasis; Rheumatoid arthritis; Systemic lupus erythematosus; Type 1 diabetes mellitus
  • Discontinued Multiple sclerosis

Most Recent Events

  • 21 Jul 2025 Clarithromycin/clofazimine/rifabutin - RedHill Biopharma is available for licensing as of 21 Jul 2025.
  • 21 Jul 2025 RedHill Biopharma received positive feedback from the USFDA providing guidance on the pathway to approval for the RHB-204 in Crohn's disease
  • 12 Mar 2025 RedHill Biopharma has patent protection for Clarithromycin/clofazimine/rifabutin in USA

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