WHO Releases Target Regimen Profiles for Long-Acting Injectable TB Medicines

On 28 October 2026, the World Health Organization (WHO) published Target Regimen Profiles (TRPs) for long-acting injectables (LAIs) for tuberculosis prevention and treatment. TB prevention and treatment still depend on daily oral regimens taken over months, and sustaining adherence over such long periods is difficult for many people. LAIs could significantly lighten that burden, shifting it from people taking TB medicines to the health systems that deliver them. The approach has already changed the management of other conditions, most visibly HIV, and several LAI candidates for TB are now entering or approaching clinical development.

The profiles 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. 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, while 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 addresses trial design, overall treatment burden, scalability, equitable access, transparent pricing and cost. Dr Tereza Kasaeva, Director of the WHO Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, said long-acting injectables could make TB prevention and treatment much simpler, and that the profiles tell developers early what a new regimen must achieve without trading away efficacy, safety or patient choice.

The profiles were developed by a Scientific TRP Development Group convened by WHO, including trialists, pharmacologists, regulators, national TB programme officers, people with lived experience of TB and civil society representatives, informed by a landscape analysis, a public consultation in April and May 2026, community and provider surveys, focus group discussions and a multicountry discrete choice experiment. WHO emphasizes that work on better oral regimens should continue in parallel, and that implementation should preserve patient choice.

For pharmaceutical manufacturers and procurement partners, the TRPs are an early, authoritative signal of the product characteristics WHO expects the next generation of TB medicines to meet. Developers weighing pipeline investments can benchmark candidates against the minimal and optimal requirements, while bulk buyers and tuberculosis programme suppliers should note the explicit attention to scalable manufacture, equitable access and transparent pricing, all of which will shape how future LAI regimens are tendered and supplied to high-burden countries.

Source: WHO, WHO releases target regimen profiles for long-acting injectables for TB, https://www.who.int/news/item/28-10-2026-who-releases-target-regimen-profiles-for-long-acting-injectables-for-tb