Last modified: 2025-06-07
Abstract
ABSTRACT
Natural products have historically played a crucial role in drug discovery, leading to groundbreaking therapies (Nasim et al., 2022). However, their transition from laboratory discovery to clinical application remains a significant challenge (Fernandez-Moure, 2016). This review explores innovative interdisciplinary strategies to overcome translational barriers in natural product-based drug discovery, integrating metabolomics, genomics, computational tools, and synthetic biology to accelerate drug development (Salem et al., 2020).We highlight case studies of clinically approved natural product-derived drugs, examining key success factors in their translation from bioactive compound identification to regulatory approval (Atanasov et al., 2015). Furthermore, we discuss sustainability challenges, biotechnological advancements for scalable production, and AI-driven methodologies aimed at optimizing clinical trials (Chopra et al., 2023). Regulatory challenges across different jurisdictions, including the FDA (U.S. Food and Drug Administration) (U.S), EMA (European Medicines Agency) (Europe), and CFDA (China Food and Drug Administration) (China), are discussed to provide a global perspective on natural product commercialization (Tresina et al., 2021). The review underscores the need for international collaboration, open-access data sharing, and innovative clinical trial methodologies to enhance efficiency and reduce drug development timelines. Harnessing interdisciplinary strategies and cutting-edge technologies will unlock the full therapeutic potential of natural products, paving the way for sustainable and clinically impactful drug innovations.