TABLE 1

Recent and ongoing clinical trials of new and emerging therapies for NTM

AgentCompanyMechanism of actionTarget populationPhaseClinicalTrials.gov identifierStatus
ALISInsmed Inc.Inhaled amikacinTreatment refractory MACIIINCT02344004Completed
ALISInsmed Inc.Inhaled amikacinTreatment naïve MACIIINCT04677569Recruiting
ALISInsmed Inc.Inhaled amikacinTreatment refractory M.abscessusIINCT03038178Completed
BedaquilineJanssen Pharmaceutical K.K.Inhibition of energy metabolismTreatment refractory MACII/IIINCT04630145Recruiting
ClofazimineInhibition of DNA replicationMACIINCT02968212Recruiting
OmadacyclineParatek Pharmaceuticals Inc.Inhibition of protein synthesis (tetracycline)M.abscessusIINCT04922554Recruiting
LinezolidSiam Pharmaceutical Ltd.Inhibition of protein synthesisNTM pulmonary diseaseIVNCT03220074Recruiting
Inhaled nitric oxideMycobacterial killingNTM pulmonary diseaseNCT03748992Completed
Inhaled nitric oxideMallinckrodt PharmaceuticalsMycobacterial killingNTM pulmonary diseaseNCT03473314Completed
Inhaled nitric oxideMallinckrodt PharmaceuticalsMycobacterial killingNTM pulmonary diseaseNCT03331445Terminated
Inhaled nitric oxideBeyond Air Inc.Mycobacterial killingM.abscessusIINCT03208764Completed
Inhaled nitric oxideBeyond Air Inc.Mycobacterial killingTreatment refractory NTMNCT04685720Recruiting
IFN-γ/GM-CSFImmunomodulationMAC pulmonary diseaseINCT00111397Completed
GM-CSFSavara Inc.ImmunomodulationTreatment refractory NTMIINCT03421743Completed
GM-CSFSavara Inc.ImmunomodulationCystic fibrosis NTM infectionIINCT03597347Terminated
IL-7RevimmuneImmunomodulationTreatment refractory NTMIINCT04154826Recruiting
i.v. GalliumDisruption of iron metabolismCystic fibrosis NTM infectionIbNCT04294043Recruiting

ALIS: amikacin liposome inhalation suspension; MAC: Mycobacterium avium complex; IFN-γ: interferon gamma; GM-CSF: granulocyte–macrophage colony-stimulating factor; IL: interleukin.