WHO releases target regimen profiles for long-acting injectables for TB

The World Health Organization (WHO) has published Target regimen profiles for long-acting injectables for tuberculosis prevention and treatment . Tuberculosis (TB) prevention and treatment still depend on daily oral regimens taken over months, and sustaining adherence over such periods is difficult for many people. Long-acting injectables (LAIs) could significantly lighten the burden for people taking TB medicines and the health system that delivers them. They have already changed the management of other conditions, most visibly HIV, and several LAI candidates for TB are now entering or approaching clinical development.

“Long-acting injectables 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,” said Dr Tereza Kasaeva, Director of the WHO Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections.

The target regimen profiles (TRPs) set out, early in development, what a new LAI regimen for TB preventive treatment or for the treatment of TB disease would have to achieve to be useful in practice. They are intended for the pharmaceutical industry, academia, research institutions, product development partners, TB-affected communities, civil society organizations and donors. For each characteristic they define a minimal requirement, which a product must meet to be worth pursuing, and an optimal requirement, the most desirable yet realistically achievable target.

The profile for TB preventive treatment aims at a full course given as a single injection at one encounter. The profile for TB disease aims at a regimen of no more than four months, given in three or fewer dosing encounters. Both call for injections given by a trained health worker at the lowest feasible level of the health system, small injection volumes, no cold chain, and efficacy and safety at least as good as those of current oral regimens. The document also sets out the trade-offs between characteristics, and addresses trial design, overall treatment burden, scalability, equitable access, transparent pricing and cost.

A Scientific TRP Development Group was convened by WHO to develop these profiles. The Group included trialists, pharmacologists, regulators, national TB programme officers, people with lived experience of TB and civil society representatives. They were informed by a landscape analysis, a public consultation in April and May 2026, and community and provider surveys, focus group discussions and a multicountry discrete choice experiment.

Work on better oral regimens should continue in parallel, for people who would prefer not to receive injections, and implementation should preserve patient choice.