Long-acting injectables for global health: drug development considerations and applications in malaria and...

Long-acting injectable (LAI) drug formulations represent a transformative modality in modern therapeutics, delivering medications that maintain therapeutic effects over extended periods. While initially developed to improve patient adherence and acceptability for applications such as hormonal contraception and chronic conditions, including psychiatric disorders, their recent success in HIV treatment and prevention has catalyzed a growing interest in their application to global health priorities. While there are effective oral drug regimens available for tuberculosis (TB) treatment and malaria chemoprevention, their dosing regimens challenge patient adherence. By providing sustained pharmacological activity over extended periods, LAIs decouple therapeutic efficacy from patient adherence and simplify drug dosing regimens, enhancing real-world effectiveness. This position paper synthesizes the emerging consensus on the application of LAIs for global health from a multidisciplinary expert workshop convened by Medicines for Malaria Venture (MMV) and the Gates Foundation in Chicago on March 17-19, 2026. Contributions considered compound selection, formulation design, pharmacokinetic and pharmacodynamic requirements, safety and tolerability profiles, toxicology packages for first-in-human studies, regulatory pathways, and the challenges of human dose prediction. Emphasis was placed on the importance of preclinical-to-clinical translation, particularly through the application of pharmacometric tools and model-informed drug development. The workshop highlighted strategic priorities for advancing the LAI field, including coordinated cross-sector approaches, pre-competitive data sharing, and communities of practice to address critical knowledge gaps. These actions aim to realize the potential for expanding LAI technologies to advance global health.