Human imaging studies are providing new insights into nose-to-brain (N2B) drug delivery, helping researchers move beyond theoretical pathways toward direct evidence of central nervous system exposure. This article explores how first-in-human PET imaging has demonstrated transport of intranasally administered molecules to multiple brain regions, why reproducibility remains a critical development challenge, and how integrated device-formulation approaches are helping shape the next generation of N2B delivery strategies.
How Can Human Imaging Improve Confidence in Nose-to-Brain Drug Development?
Nose-to-brain (N2B) drug delivery has long attracted interest as a non-invasive approach for delivering therapies to the central nervous system (CNS). Yet as the field advances beyond proof of concept, developers face a critical challenge: understanding how reliably therapies reach their intended targets and how delivery performance influences clinical outcomes.
Recent advances in human imaging are helping to reshape this discussion. New research approaches provide unprecedented visibility into drug delivery after nasal administration, offering insights that could strengthen development strategies and increase confidence in N2B programmes. Rather than relying solely on indirect measures, researchers can increasingly explore the relationship between administration, delivery, and CNS exposure more directly.
At the same time, N2B development remains inherently complex. Delivery outcomes may be influenced by formulation characteristics, device design, administration technique, and patient-specific factors. As a result, reproducibility has become a growing focus for developers seeking to reduce uncertainty and better interpret clinical findings.
This shift is driving a more integrated approach to development, one that considers formulation, delivery technology, human factors, and performance evaluation as interconnected elements of a broader strategy. Increasingly, success depends not only on the therapeutic itself, but also on how effectively the delivery system supports consistent administration under real-world conditions.
In this article, we explore how emerging human evidence is influencing the future of N2B drug development, why reproducibility matters, and how purpose-designed delivery platforms may help advance the next generation of CNS therapies.