US regulators have unveiled new guidance and funding initiatives aimed at reducing reliance on animal testing in drug development, including expanded support for human-relevant alternatives.

Food and Drug Administration and National Institutes of Health have announced a coordinated set of initiatives designed to reduce the use of animal testing in drug development, signalling a broader shift in US biomedical research policy.

The move includes draft guidance from the FDA encouraging pharmaceutical companies to adopt non-animal methods for assessing the safety and efficacy of new medicines, alongside expanded funding from the NIH for alternative research models that better replicate human biology. The NIH said it has made more than $150 million available to institutions developing these approaches.

The policy direction builds on a series of changes over the past year aimed at limiting animal use in preclinical research. The FDA previously announced plans to phase out animal testing requirements for monoclonal antibodies, while the NIH has moved away from funding projects that rely exclusively on animal models.

In the latest update, HHS said reducing animal testing has become a priority across its agencies. Officials are positioning the shift as part of a broader effort to improve translational success in drug development by encouraging models that may better predict human outcomes.

The FDA’s draft guidance is intended to help drug developers validate and adopt alternative methods such as computational models, organ-on-chip systems and advanced cell-based assays. Regulators say these tools could eventually complement or replace certain animal studies, particularly in early safety assessment.

The NIH funding push is aimed at accelerating innovation in human-relevant research platforms, supporting academic and translational groups working on next-generation disease models. The goal is to bridge the gap between preclinical findings and clinical outcomes, an area long associated with high attrition rates in drug development.

Taken together, the initiatives reflect growing scientific and regulatory momentum towards what agencies describe as a “modernisation” of preclinical testing frameworks. Industry groups are expected to review the draft guidance before it is finalised, with implementation timelines likely to vary across therapeutic areas.

The shift is particularly significant for biologics and complex modalities, where traditional animal models have shown limitations in predicting human immune and systemic responses.

Overall, the changes suggest a gradual but meaningful restructuring of early-stage drug development pathways in the US, with increased emphasis on human-relevant data generation and regulatory acceptance of alternative testing technologies.