Trial Profile

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

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 29 May 2023

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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

22 May 2023 Status changed from recruiting to discontinued, according to a RedHill Biopharma media release.
28 Apr 2023 According to a RedHill Biopharma media release, In August 2022, the European Commission granted Orphan Drug Designation to RHB-204, which is in an ongoing U.S. Phase 3 study, for the treatment of nontuberculous mycobacteria (NTM) disease, providing 10 years of post-approval EU market exclusivity.
25 Nov 2020 Status changed from planning to recruiting, according to a RedHill Biopharma media release.

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