Forty years of trauma drug testing in rodents has produced no new approved trauma medicine

Researchers at Pebble Biotechnology Laboratories have released the Pebble Trauma Atlas, an interactive resource that maps every drug studied in small-rodent models of physical trauma between 1980 and 2020 and follows each one through to its regulatory outcome in humans. Across 5,033 published studies and 333 distinct drugs, not one new trauma medicine reached approval as a result of that preclinical work.

Of the 333 drugs, 291 went on to be tested in at least one human clinical trial, almost all for conditions other than trauma. Only two drugs (tranexamic acid and recombinant human bone morphogenetic protein-2) and one device (autologous keratinocytes) are approved to treat a trauma indication, and all three were approved before they appeared in the trauma literature analysed here.

The atlas extends a systematic review by the same group, published September 2026 in PLOS ONE. That peer-reviewed analysis covered 1,257 studies of acute injury in small animal models published between 1990 and 2010. Only 3 drugs achieved first-in-class regulatory approval for the indication tested, but in an exploratory analysis, 86 per cent of the drugs that met any definition of translational success were later subject to major safety concerns.

The atlas is published as regulators reconsider the role of animal testing in drug development. In 2025 the US Food and Drug Administration set out a roadmap to reduce animal testing in preclinical safety studies, the National Institutes of Health announced that it would no longer create funding opportunities for projects focused solely on animal testing, and the FDA Modernization Act 3.0 advanced a formal route to qualify non-animal, new approach methods.

"For years we have challenged whether small animal models are of any use in trauma, and many in the scientific community have argued that they are. We performed this analysis so that the data can answer the question, rather than dogma, and the message is clear. If the same models have not produced a single new approved trauma drug in 40 years, the next 40 years are unlikely to be any different, unless we stop using these models," said Professor James Fildes, Chief Scientist of Pebble Biotechnology Laboratories.

"This is not an argument against studying trauma. It is an argument for being clear about which methods predict human outcomes, at exactly the moment regulators are asking the same question," said Dr Tim Entwistle, lead author of the study.

The atlas is open to anyone at https://atlas.pebble.bio. The systematic review is open access in PLOS ONE at https://doi.org/10.1371/journal.pone.0358773, and the atlas dataset is available at https://osf.io/h7g45.