Translating Brazilian medicinal plants into therapeutic innovation: Preclinical evidence and lessons learned

This review critically examines more than four decades of research and innovation conducted by our research group on bioactive constituents and standardized extracts from Brazilian medicinal plants. It integrates phytochemical and preclinical pharmacological evidence, limited clinical studies and translational experiences, highlighting major scientific achievements and the persistent gap between academic research and the development of innovative phytomedicines in Brazil. In parallel, we analyse the evolution of the Brazilian phytomedicine market and regulatory advances aimed at supporting the development of phytotherapeutic agents based on scientific evidence of efficacy and safety. Despite Brazil's exceptional biodiversity and the extensive experimental data generated over several decades on medicinal plants, the translation of scientific knowledge into registered and innovative phytotherapeutic agents remains limited. This review identifies major structural barriers that continue to hinder progress, including the low engagement of the national pharmaceutical industry in innovation-driven drug development, regulatory and operational challenges related to clinical trials, and the absence of sustained governmental policies to support long-term basic and translational research. Collectively, these factors restrict Brazil's capacity to develop medicines domestically and to strategically capitalize on its biological resources. By critically reflecting on lessons learned from our long-term research and innovation efforts, this article underscores the need for integrated strategies aligning scientific excellence, regulatory frameworks, industrial participation and public policies. Strengthening these connections is essential to transform Brazil's medicinal plant biodiversity into clinically validated, safe and accessible therapeutic products that benefit public health and national innovation.