WHO issues new guidance to accelerate development of long-acting tuberculosis therapies
Long-acting injectables (LAIs) could offer an alternative by reducing the frequency of doses and the need for repeated medication administration.
SWITZERLAND – The World Health Organization (WHO) has published new development targets for long-acting injectable medicines for tuberculosis (TB) prevention and treatment, aiming to reduce the burden of prolonged oral treatment and improve patient adherence.
Most TB prevention and treatment programmes rely on daily oral medicines taken over several months.
Maintaining adherence throughout treatment remains difficult for many patients and places additional demands on healthcare services.
Long-acting injectables (LAIs) could offer an alternative by reducing the frequency of doses and the need for repeated medication administration.
LAIs have already changed treatment delivery in other therapeutic areas, particularly HIV.
Several candidates for TB prevention and treatment are also entering or approaching clinical development, creating a need for clear product development standards.
“Long-acting injectables could make TB prevention and treatment much simpler for the people who need them,” said Dr Tereza Kasaeva, Director of WHO’s Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections.
She explained that the new profiles would help developers identify the performance requirements for future products while maintaining efficacy, safety and patient choice.
WHO defines development requirements
The target regimen profiles (TRPs) outline the minimum and optimal characteristics that developers should consider when designing LAI regimens for TB preventive treatment and active TB disease.
They are intended to guide pharmaceutical companies, academic institutions, research organisations, product development partners, civil society groups, TB-affected communities and donors.
The profile for TB prevention targets a complete course delivered through a single injection during one healthcare encounter.
For active TB disease, WHO recommends a regimen lasting no more than four months, with three or fewer dosing encounters.
Both profiles specify that trained healthcare workers should administer the injections at the lowest feasible level of the health system.
They also prioritise small injection volumes, products that do not require cold-chain storage, and safety and efficacy comparable to existing oral regimens.
The profiles address additional development considerations, including clinical trial design, treatment burden, scalability, equitable access, transparent pricing and affordability.
These requirements are intended to help developers balance clinical performance with the practical demands of delivering TB medicines across different healthcare settings.
Industry and research implications
WHO convened a Scientific TRP Development Group comprising clinical trial specialists, pharmacologists, regulators, national TB programme representatives, people with lived experience of TB and civil society organisations.
The group drew on a landscape analysis, a public consultation conducted in April and May 2026, and surveys involving patients and healthcare providers.
It also considered focus group discussions and a multicountry discrete choice experiment to incorporate preferences and practical considerations into the profiles.
For pharmaceutical developers, the guidance provides a framework for prioritising formulation design, dosing frequency, clinical performance and delivery requirements during early-stage research.
It also highlights the importance of developing products that can be administered without complex storage infrastructure, particularly in resource-constrained settings.
WHO emphasised that research into improved oral TB regimens should continue alongside injectable development.
This would preserve treatment options for patients who prefer oral medicines and ensure that future programmes maintain individual choice.
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