RHB-204 is a proprietary and innovative investigational drug in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.

RedHill initiated a Phase 3 study to evaluate the efficacy and safety of RHB-204 as a first-line treatment of pulmonary NTM disease caused by Mycobacterium avium complex (MAC) following FDA clearance of its Investigational New Drug (IND) application. 

RHB-204 was granted Qualified Infectious Diseases Product (QIDP) designation, Fast Track designation, and Orphan Drug Designation by the FDA for the treatment of Nontuberculous mycobacteria (NTM) disease.

The QIDP designation was granted under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections that have the potential to pose a serious threat to public health.

About Nontuberculous Mycobacteria (NTM) Disease

Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria, found in the soil as well as natural and engineered water systems.

Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world1. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20172.

Pulmonary manifestations account for 80–90% of all NTM-associated diseases3, and approximately 80% of pulmonary NTM infections are caused by Mycobacterium avium complex (MAC)4.

The most common pulmonary NTM disease symptoms include fever, weight loss, chest pain, and blood in sputum5. NTM infections can lead to recurring cased of bronchitis and pneumonia and can, in some cases, lead to respiratory failure6.

Treatment of NTM infection can be difficult, with no FDA-approved first-line standard-of-care therapy. It requires multiple antibiotics and an extended treatment course due to the risk of development of resistance7. Many patients fail these types of therapies and more than half will have either recurring disease or new infection after completing treatment8. As a result, new and effective antimicrobial agents for NTM are urgently needed, particularly for first-line therapy.






1 Henkle E, et al. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 Annals of the American Thoracic Society. 2015; 12(5):642-7.
2 Foster|Rosenblatt, 2017
3 Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416.
4 Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82
5 Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74.
6 The American Lung Association, 2020.
7 Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241,
8 Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84.