WHO Sets New Targets for Long-Acting Tuberculosis Injectables

The World Health Organisation has established new target regimen profiles for long-acting injectables intended for the prevention and treatment of tuberculosis. The global health body aims to guide drug developers toward simplified therapies that reduce reliance on extended courses of daily oral medication.

At present, tuberculosis prevention and treatment regimens require patients to consume daily oral medicines over multiple months, creating adherence challenges for many individuals over long durations. Long-acting injectables have previously altered the management of other medical conditions, notably HIV, and several injectable candidates for tuberculosis are currently moving toward clinical development.

Dr Tereza Kasaeva, Director of the World Health Organisation department for HIV, tuberculosis, hepatitis and sexually transmitted infections, noted the importance of establishing these specifications early. "Long-acting injectables (LAIs) could make TB prevention and treatment much simpler for the people who need them. These profiles tell developers, early, what a new regimen must achieve to make that difference in practice, without trading away efficacy, safety or patient choice," Dr Kasaeva said.

According to the newly released framework, the target profile for tuberculosis preventive treatment focuses on delivering a full course as a single injection at one medical encounter. For treatment, the profile outlines a regimen lasting no longer than four months, delivered across three or fewer dosing encounters. Both standards stipulate that injections must be administered by a trained health worker at the lowest feasible level of the health system, require small injection volumes, and operate without a cold chain.

Additionally, the World Health Organisation specified that new injectable formulations must achieve efficacy and safety levels at least equal to current oral regimens. The document details trade-offs among product characteristics and incorporates considerations regarding clinical trial design, treatment burden, scalability, equitable access, cost, and transparent pricing.

The profiles were developed by a dedicated Scientific target regimen profile development group convened by the organisation. The panel comprised trialists, pharmacologists, regulators, national tuberculosis programme officers, civil society representatives, and people with lived experience of tuberculosis. Their recommendations were informed by a landscape analysis, community and healthcare provider surveys, focus group discussions, a multicountry discrete choice experiment, and a public consultation conducted in April and May 2026.