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Life sciences · Journal article
Clinical Pharmacology & Therapeutics · August 28, 2026
A consensus or society position rather than new primary data.
This is a consensus expert review and recommendations document on the development and implementation of long-acting therapeutics (LATs) for pediatric populations. It identifies priority conditions (lower respiratory tract infections, malaria, tuberculosis, HIV, syphilis, childhood cancer, and growth hormone deficiency), synthesizes key clinical pharmacology and safety considerations, and proposes a framework for pediatric LAT development that integrates developmental pharmacology, age-informed dosing, acceptability assessment, and equitable access planning.
Consensus expert review and recommendations from Community of Practice workshop. Pediatric populations across infectious and noninfectious disease areas, with emphasis on lower-resource settings and equity considerations. Intervention: Long-acting therapeutics (LATs) across multiple technology platforms and routes of administration.
Nearly 5 million children under five died in 2023, with infectious diseases continuing to substantially contribute to preventable morbidity and mortality Priority pediatric indications identified for LAT impact: lower respiratory tract infections, malaria, tuberculosis, HIV, syphilis, childhood cancer, and growth hormone deficiency LATs may improve adherence and implementation feasibility by sustaining therapeutic or prophylactic exposure and reducing dosing frequency
Specific formulation platforms, excipient safety data, or route-of-administration comparisons are identified as topics but not comprehensively analyzed with numerical evidence Nearly 5 million children under five died in 2023, with infectious diseases continuing to substantially contribute to preventable morbidity and mortality
Clinicians and researchers developing pediatric therapeutics should consider LAT approaches for priority conditions identified, with careful attention to developmental pharmacology, age- and weight-informed dosing, formulation acceptability, and implementation feasibility in varied resource settings. Regulatory and public health stakeholders should engage early in LAT development planning to ensure evidence generation, product suitability, and equitable access.
Expert consensus review synthesizing evidence and recommendations on long-acting therapeutics development for pediatric populations, addressing clinical pharmacology, safety, and implementation considerations.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians and researchers developing pediatric therapeutics should consider LAT approaches for priority conditions identified, with careful attention to developmental pharmacology, age- and weight-informed dosing, formulation acceptability, and implementation feasibility in varied resource settings. Regulatory and public health stakeholders should engage early in LAT development planning to ensure evidence generation, product suitability, and equitable access.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Children have distinct therapeutic needs arising from age-dependent physiology, disease epidemiology, formulation requirements, dosing considerations, and safety vulnerabilities. Despite substantial reductions in childhood mortality over the past three decades, nearly 5 million children under five died in 2023, with infectious diseases continuing to contribute substantially to preventable morbidity and mortality. Long-acting therapeutics (LATs) may help address selected pediatric health priorities by sustaining therapeutic or prophylactic exposure, reducing dosing frequency, and improving adherence and implementation feasibility. This review synthesizes insights from the pediatric health session of the Community of Practice for Long-acting Therapeutics for Maternal and Paediatric Health workshop. The session considered priority pediatric conditions in which existing or emerging LAT approaches could have clinical or public health impact, including lower respiratory tract infections, malaria, tuberculosis, HIV, and syphilis, as well as selected noninfectious indications such as childhood cancer and growth hormone deficiency. We then examine clinical pharmacology and safety considerations central to pediatric LAT development, including developmental pharmacokinetics, absorption-limited disposition and flip-flop kinetics, pharmacokinetic tailing, dose selection, model-informed development, and injection-site tolerability. The review also discusses long-acting technology platforms with potential pediatric applications, route-of-administration considerations, excipient safety, formulation design, acceptability, and implementation challenges. Finally, we propose recommendations to support pediatric LAT development, including early integration of developmental pharmacology, age- and weight-informed dosing, standardized acceptability assessment, product-attribute frameworks, regulatory engagement, and equitable access planning. Realizing the potential of LATs for children will require coordinated, child-centered, and equity-driven approaches that address evidence generation, formulation suitability, implementation context, and affordability from the outset.
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