NIH To End Funding for Animal-Only Studies, Backing Shift to New Approach Methodologies

The U.S. National Institutes of Health (NIH) will no longer fund new grant proposals that rely exclusively on animal testing, according to reporting by Brian Buntz in Drug Discovery & Development. The policy was announced during the FDA & NIH Workshop on Reducing Animal Testing by Dr. Nicole Kleinstreuer, Acting NIH Deputy Director for Program Coordination, Planning and Strategic Initiatives.

“All new NIH funding opportunities moving forward should incorporate language on consideration of NAMs,” Kleinstreuer stated, referring to New Approach Methodologies—alternatives such as AI models, computational simulations, and organ-on-chip technologies. “NIH will no longer seek proposals exclusively for animal models.”

The change follows the FDA’s April 2025 plan to phase out animal testing requirements for monoclonal antibodies and other drugs. Together, the announcements reflect increasing alignment between federal agencies in reducing reliance on animal studies.

See also: FDA Plan to Replace Animal Testing with AI Models and Human-Based Methods in Drug Evaluation Shift

As Buntz notes, the NIH policy does not mandate specific levels of NAM integration. This opens a potential loophole: applicants could still submit animal-heavy proposals, provided they include a nominal NAM component. Nonetheless, the move signals institutional support for modernizing preclinical research strategies.

Kleinstreuer characterized the shift as necessary for public health, stating that current goals "cannot be fulfilled using outdated animal-based models that fail to translate to human outcomes."

Animal advocacy group PETA welcomed the announcement. Senior VP Kathy Guillermo praised NIH’s decision as a "groundbreaking new policy" that could spare millions of animals and move science toward more human-relevant methods.

See also: Beyond Animal Testing: Organ-on-a-Chip Companies Usher in a New Era for Drug Trials

While the policy’s impact will depend on implementation details and how grant reviewers interpret NAM requirements, the NIH has now formally ended funding for animal-only research proposals—placing federally funded biomedical science on a defined path toward animal-alternative models.

Topics: Bioeconomy & Society    Clinical Trials