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May 4, 2026Pharmaceuticals3 citationsOpen Access

From Algorithms to Assets: A Comprehensive Review of AI’s Role in Preclinical Drug Discovery and the Hurdles to Clinical Translation

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MCMengqi CaiTLTiancai Liu

Key Points

  • The review explores the role of AI in enhancing preclinical drug discovery and identifies hurdles for clinical translation.
  • Reviewed literature from 2020 to 2026 on AI methods in drug discovery.
  • Discussed applications such as drug-target interaction prediction and virtual screening.
  • Critically analyzed challenges like data quality and regulatory adaptation.
  • Identified AI methods show promise in predicting drug interactions and minimizing failure rates.
  • Translational hurdles highlighted pose significant obstacles to clinical adoption of AI-driven drug discovery.
  • Future directions include multimodal AI and closed-loop automation as solutions for improving drug development processes.

Abstract

The integration of artificial intelligence (AI) and big data is poised to significantly augment drug research and development, offering the potential to address persistent challenges such as lengthy timelines and high failure rates. This review provides a critical overview of AI applications across the preclinical drug discovery pipeline (the 2020–2026 literature), covering drug–target interaction prediction, structure prediction, de novo design, virtual screening, drug repurposing, and ADMET forecasting. Beyond surveying technical developments, we critically discuss key translational hurdles, including data quality, model interpretability, patient heterogeneity, and regulatory adaptation, and provide structured summaries of representative models. We conclude by outlining future directions, such as multimodal AI, digital twins, and closed-loop automation, that aim to bridge the gap between computational prediction and clinical application. This review aims to inform researchers and accelerate the delivery of safe and effective therapies.

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Cite This Study

Cai et al. (2026) studied this question.

synapsesocial.com/papers/69f837793ed186a739981a64https://doi.org/10.3390/ph19050696
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