The looming crisis of bedaquiline-resistant tuberculosis and a promising way forward.

Drug-resistant tuberculosis is entering a new and dangerous phase. Bedaquiline and other newer drugs have transformed drug-resistant tuberculosis treatment, yet resistance to these agents is now being reported across high-burden settings. In some regions, baseline bedaquiline resistance is substantial, treatment outcomes for extensively drug-resistant tuberculosis remain poor and mortality is unacceptably high. At the same time, the tuberculosis drug pipeline is stronger than it has been in decades, with several promising investigational compounds advancing to late-stage trials. However, regulatory approval remains years away, leaving people with few or no effective treatment options to wait-and often die-while drugs with potential benefit remain inaccessible. Here, we argue that the central barrier to addressing complex drug-resistant tuberculosis is not scientific, but moral and organisational. Drawing on lessons from earlier pre-approval access programmes for bedaquiline and delamanid, we propose the establishment of compassionate-use support platforms (CUSPs): coordinated, global mechanisms to facilitate equitable access to investigational tuberculosis drugs before formal approval. Well designed CUSPs could balance urgency with safety, share responsibility across stakeholders, strengthen diagnostic and pharmacovigilance capacity, and ensure that people with the most difficult-to-treat tuberculosis are not excluded from scientific progress.