- FDA achieves first-year goals under 2025 roadmap to reduce animal testing
- Agency advances alternatives such as AI models, in vitro systems, and computational tools
- New guidance supports reducing nonhuman primate and horseshoe crab testing
- Searchable database launched to clarify acceptable alternative methods
- Efforts aim to improve drug safety prediction while lowering development costs
The U.S. Food and Drug Administration (FDA) has announced it has met its initial goals under its 2025 roadmap to reduce animal testing in preclinical drug development, marking a year of progress toward more human-relevant scientific approaches.
The roadmap, introduced in April 2025, outlines a structured transition away from traditional animal testing where validated alternatives exist. According to the agency, the initiative is designed to improve the accuracy of drug safety predictions while also reducing development timelines and costs.
Advancing alternatives to animal models
The FDA has expanded the use of new approach methodologies (NAMs), including advanced in vitro systems, computational modeling, and human-derived platforms. These tools are intended to better reflect human biology, addressing longstanding limitations of animal models.
Historically, more than 90% of drugs that pass animal testing fail in human trials, often due to safety or efficacy issues. The FDA’s strategy aims to close this gap by prioritizing methods that more accurately predict human outcomes.
Key milestones in year one
Over the past year, the agency has implemented several initiatives aligned with its roadmap, including:
- Draft guidance to reduce or eliminate nonhuman primate testing in monoclonal antibody development
- Updated recommendations to transition away from horseshoe crab-derived endotoxin testing
- Expanded guidance on “weight-of-evidence” approaches incorporating non-animal data
- Qualification of its first AI-based drug development tool for regulatory use
- Launch of a public database identifying where alternative methods are acceptable
The FDA is also working to reduce animal testing requirements for drugs with established safety records in other countries.
Building infrastructure for long-term change
To support continued progress, the agency has introduced new infrastructure, including a permanent pathway for qualifying innovative drug development tools, enhanced cross-center scientific collaboration, and a formal partnership with the National Institutes of Health.
The FDA is also coordinating with international regulators to align global standards around alternative testing methods.
Implications for drug development
The transition toward non-animal testing approaches is expected to improve the efficiency and reliability of drug development while expanding access to new therapies. At the same time, it represents a significant shift in regulatory science, reducing reliance on animal models across the industry.
The FDA said it will continue working with stakeholders across government, academia, and industry to further advance these efforts and modernize preclinical research.
Information sourced from the U.S. Food and Drug Administration.
