WHO releases target regimen profiles for long-acting injectable tuberculosis treatments

On October 28, 2026, the World Health Organization released target regimen profiles for long-acting injectable tuberculosis treatments. Aiming to replace difficult multi-month daily oral pills, the profiles set parameters for drug developers: preventive treatment should be a single injection, while active disease treatment should require four months or less across three or fewer visits. Guided by Dr Tereza Kasaeva, WHO stresses that oral drug research must continue to safeguard patient choice.

Context and purpose of long-acting injectables

• ▪The World Health Organization published Target Regimen Profiles to guide the clinical development of long-acting injectable regimens for tuberculosis prevention and treatment.
• ▪Several long-acting injectable drug candidates for tuberculosis are entering or approaching clinical development as potential alternatives to multi-month daily oral regimens.
• ▪The World Health Organization's Target Regimen Profiles are intended to inform pharmaceutical companies, academia, research institutions, product development partners, affected communities, civil society, and donors early in product development.
• ▪Long-acting injectables have transformed condition management in human immunodeficiency virus (HIV) care, prompting similar applications for tuberculosis.

Target specifications for tuberculosis injection regimens

• ▪The World Health Organization document specifies requirements for administration by trained health workers at the lowest feasible health system level, small injection volumes, transparent pricing, equitable access, and trial design trade-offs.
• ▪The target regimen profile for active tuberculosis disease specifies a maximum regimen duration of four months delivered across three or fewer dosing encounters.
• ▪The World Health Organization defined minimal requirements as baseline criteria products must meet to be worth pursuing, and optimal requirements as desirable yet realistically achievable target specifications.
• ▪The World Health Organization's target regimen profiles require long-acting injectable tuberculosis treatments to match or exceed current oral regimens in efficacy and safety without requiring a cold chain.
• ▪The World Health Organization target regimen profile for tuberculosis preventive treatment aims for a full treatment course administered as a single injection during one clinical encounter.

Development process of the target regimen profiles

• ▪Development of the World Health Organization target regimen profiles was informed by a public consultation conducted in April and May 2026 alongside community surveys, focus groups, and a discrete choice experiment.
• ▪The World Health Organization convened a Scientific Target Regimen Profile Development Group including trialists, pharmacologists, regulators, national tuberculosis programme officers, civil society representatives, and individuals with lived tuberculosis experience.