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Peer-reviewedCC BY-NCJournal of Enzyme Inhibition and Medicinal Chemistry

A comprehensive review of small molecule drugs approved by the FDA in 2025: advance and prospect

  • Yi‐Ru Bai1,2
  • Ruifang Li1
  • Xinhui Zhang1
  • Dong‐Jie Seng3
  • Ying Xu3
  • Sai‐Yang Zhang4
  • Shuo Yuan3,2
4 affiliations
  1. 1College of Biological Engineering, Henan University of Technology
  2. 2School of Chemistry and Chemical Engineering, Henan University of Technology
  3. 3Children’s Hospital Affiliated to Zhengzhou University, Henan Children’s Hospital, Zhengzhou Children’s Hospital
  4. 4Department of Pharmacology, School of Basic Medical Sciences, Zhengzhou University
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Abstract

In 2025, the FDA approved 46 drug marketing applications, 31 of which were small molecule drugs. Despite the advancements in biotechnologies such as antibody drugs, RNA-based treatments, and antibody-drug conjugates, small molecule drugs remain dominant in new drug discovery. With progress in computer-aided drug design and scaffold-based drug design etc, modern drug discovery has stepped into a phase of rapid development. The marketed drugs in the same field often share similar structures and biological activities, while development of me-too drugs can notably enhance potency and streamline the development process. Comprehending the development process of newly launched drugs helps to identify mainstream technologies and provides structural scaffolds and inspirations for future research. This review comprehensively summarises the development progress of new drugs approved in 2025, including molecular design, structural modification, structure-activity relationship, and enhancement of drug-like properties to offer valuable insights to pharmaceutical chemists and bring inspiration for future research.

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Cite

BibTeXRIS
BibTeX
@article{bai2026comprehensive,
  title = {{A comprehensive review of small molecule drugs approved by the FDA in 2025: advance and prospect}},
  author = {Yi‐Ru Bai and Ruifang Li and Xinhui Zhang and Dong‐Jie Seng and Ying Xu and Sai‐Yang Zhang and Shuo Yuan},
  journal = {Journal of Enzyme Inhibition and Medicinal Chemistry},
  year = {2026},
  month = jul,
  doi = {10.1080/14756366.2026.2704735},
  url = {https://doi.org/10.1080/14756366.2026.2704735},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - A comprehensive review of small molecule drugs approved by the FDA in 2025: advance and prospect
AU  - Yi‐Ru Bai
AU  - Ruifang Li
AU  - Xinhui Zhang
AU  - Dong‐Jie Seng
AU  - Ying Xu
AU  - Sai‐Yang Zhang
AU  - Shuo Yuan
PY  - 2026
DA  - 2026/07/20
JO  - Journal of Enzyme Inhibition and Medicinal Chemistry
DO  - 10.1080/14756366.2026.2704735
UR  - https://doi.org/10.1080/14756366.2026.2704735
AB  - In 2025, the FDA approved 46 drug marketing applications, 31 of which were small molecule drugs. Despite the advancements in biotechnologies such as antibody drugs, RNA-based treatments, and antibody-drug conjugates, small molecule drugs remain dominant in new drug discovery. With progress in computer-aided drug design and scaffold-based drug design etc, modern drug discovery has stepped into a phase of rapid development. The marketed drugs in the same field often share similar structures and biological activities, while development of me-too drugs can notably enhance potency and streamline the development process. Comprehending the development process of newly launched drugs helps to identify mainstream technologies and provides structural scaffolds and inspirations for future research. This review comprehensively summarises the development progress of new drugs approved in 2025, including molecular design, structural modification, structure-activity relationship, and enhancement of drug-like properties to offer valuable insights to pharmaceutical chemists and bring inspiration for future research.
SN  - 1475-6366
SN  - 1475-6374
ER  -