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# RedHill Bio Fast Track for Antibacterial
- URL: https://www.fdaweb.com/redhill-bio-fast-track-for-antibacterial/
- Published: 2021-01-07T12:00:00.000Z
- Updated: 2026-09-14T16:41:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148400

FDA has granted RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease caused by *Mycobacterium avium* Complex – a rare disease for which there is no FDA-approved first-line therapy. The company recently began a Phase 3 study evaluating the safety and efficacy of RHB-204 at up to 40 sites across the U.S.  

NTM disease is a chronic and debilitating lung disease caused by environmental bacteria found in soil, as well as natural and engineered water systems, the company says. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum. “Pulmonary NTM disease can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure,” it says. There are about an estimated 110,000 pulmonary NTM disease patients in the U.S.  

RedHill Bio describes RHB-204 as a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine. It previously had been granted an FDA Orphan Drug designation and a Qualified Infectious Disease Product designation for the same indication.