Recent and ongoing clinical trials of new and emerging therapies for NTM
Agent | Company | Mechanism of action | Target population | Phase | ClinicalTrials.gov identifier | Status |
ALIS | Insmed Inc. | Inhaled amikacin | Treatment refractory MAC | III | NCT02344004 | Completed |
ALIS | Insmed Inc. | Inhaled amikacin | Treatment naïve MAC | III | NCT04677569 | Recruiting |
ALIS | Insmed Inc. | Inhaled amikacin | Treatment refractory M. abscessus | II | NCT03038178 | Completed |
Bedaquiline | Janssen Pharmaceutical K.K. | Inhibition of energy metabolism | Treatment refractory MAC | II/III | NCT04630145 | Recruiting |
Clofazimine | Inhibition of DNA replication | MAC | II | NCT02968212 | Recruiting | |
Omadacycline | Paratek Pharmaceuticals Inc. | Inhibition of protein synthesis (tetracycline) | M. abscessus | II | NCT04922554 | Recruiting |
Linezolid | Siam Pharmaceutical Ltd. | Inhibition of protein synthesis | NTM pulmonary disease | IV | NCT03220074 | Recruiting |
Inhaled nitric oxide | Mycobacterial killing | NTM pulmonary disease | NCT03748992 | Completed | ||
Inhaled nitric oxide | Mallinckrodt Pharmaceuticals | Mycobacterial killing | NTM pulmonary disease | NCT03473314 | Completed | |
Inhaled nitric oxide | Mallinckrodt Pharmaceuticals | Mycobacterial killing | NTM pulmonary disease | NCT03331445 | Terminated | |
Inhaled nitric oxide | Beyond Air Inc. | Mycobacterial killing | M. abscessus | II | NCT03208764 | Completed |
Inhaled nitric oxide | Beyond Air Inc. | Mycobacterial killing | Treatment refractory NTM | NCT04685720 | Recruiting | |
IFN-γ/GM-CSF | Immunomodulation | MAC pulmonary disease | I | NCT00111397 | Completed | |
GM-CSF | Savara Inc. | Immunomodulation | Treatment refractory NTM | II | NCT03421743 | Completed |
GM-CSF | Savara Inc. | Immunomodulation | Cystic fibrosis NTM infection | II | NCT03597347 | Terminated |
IL-7 | Revimmune | Immunomodulation | Treatment refractory NTM | II | NCT04154826 | Recruiting |
i.v. Gallium | Disruption of iron metabolism | Cystic fibrosis NTM infection | Ib | NCT04294043 | Recruiting |
ALIS: amikacin liposome inhalation suspension; MAC: Mycobacterium avium complex; IFN-γ: interferon gamma; GM-CSF: granulocyte–macrophage colony-stimulating factor; IL: interleukin.