{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T04:56:35Z","timestamp":1790657795487,"version":"4.1.0"},"reference-count":346,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T00:00:00Z","timestamp":1790467200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["22309103"],"award-info":[{"award-number":["22309103"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"award":["22309103"],"award-info":[{"award-number":["22309103"]}],"id":[{"id":"https:\/\/ror.org\/01h0zpd94","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Natural Science Foundation of Shandong Province","award":["ZR2022MH162"],"award-info":[{"award-number":["ZR2022MH162"]}]},{"name":"Natural Science Foundation of Shandong Province","award":["ZR2022QE202"],"award-info":[{"award-number":["ZR2022QE202"]}]},{"name":"PhD Research Start-up Foundation of Qufu Normal University","award":["614901"],"award-info":[{"award-number":["614901"]}],"id":[{"id":"https:\/\/ror.org\/03ceheh96","id-type":"ROR","asserted-by":"crossref"}]},{"name":"PhD Research Start-up Foundation of Qufu Normal University","award":["615201"],"award-info":[{"award-number":["615201"]}],"id":[{"id":"https:\/\/ror.org\/03ceheh96","id-type":"ROR","asserted-by":"crossref"}]},{"award":["614901"],"award-info":[{"award-number":["614901"]}],"id":[{"id":"https:\/\/ror.org\/03ceheh96","id-type":"ROR","asserted-by":"publisher"}]},{"award":["615201"],"award-info":[{"award-number":["615201"]}],"id":[{"id":"https:\/\/ror.org\/03ceheh96","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>In today\u2019s pharmaceutical sector, innovation is not only the core driver of industry upgrading, but also closely tied to patient health and well-being. A drug\u2019s innovative mechanism of action, physiological effects, chemical structure, and indications collectively reflect both its clinical therapeutic value and the novelty of underlying basic research. This article presents the innovative advances of 31 small-molecule drugs (accounting for 67.4%) approved by the U.S. Food and Drug Administration (FDA) in 2025. These therapeutics span multiple therapeutic areas, including oncology, autoimmune diseases, infectious diseases, cardiovascular disorders, and metabolic conditions, and target a diverse array of molecular targets such as mitogen-activated protein kinase kinases 1 and 2 (MEK1\/2), colony-stimulating factor 1 receptor, protein tyrosine kinase Tec, and Bruton tyrosine kinase, among others. Among these approved small-molecule drugs, 13 are designated as \u201cfirst-in-class\u201d therapies, reflecting the continuous innovation in the field of new drug development. Notably, many of these drugs (e.g., Journavx, Brinsupri, Jascayd, and Kygevvi) have also been granted breakthrough therapy designation, which underscores that they not only feature novel mechanisms of action, but also deliver clinically meaningful efficacy advantages over prior therapeutic options. Notably, in 2025, the FDA approved sunvozertinib, a novel small-molecule drug independently developed by Dizal (Jiangsu, China) Pharmaceutical Co., Ltd., for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, contributing Chinese wisdom and solutions to the transformative evolution of global drug development paradigms. Cross-technology integration, long-acting drug delivery, and precision medicine stand as core industrial trends, enabling innovative drugs to boost therapeutic efficacy, mitigate toxic side effects and refine patients\u2019 medical experience, offering patients expanded regimens for improved survival outcomes. With the development of first-in-class drugs, therapies targeting previously undruggable targets\u2014or those inaccessible via conventional approaches\u2014are entering clinical practice, creating major opportunities for novel, mechanism-based drug discovery. This article comprehensively analyzes the mechanisms of action, synthesis methods, and clinical trials of these drugs chronologically, and delineates emerging trends in novel drug development.<\/jats:p>","DOI":"10.3390\/molecules31193447","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T11:35:59Z","timestamp":1790595359000},"page":"3447","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Small-Molecule Drugs Approved by the FDA in 2025"],"prefix":"10.3390","volume":"31","author":[{"given":"Xiaoyue","family":"Wang","sequence":"first","affiliation":[{"name":"Key Laboratory of Green Natural Products and Pharmaceutical Intermediates in Colleges and Universities of Shandong Province, School of Chemistry and Chemical Engineering, Center for Nanomedicine, Qufu Normal University, Qufu 273165, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"Key Laboratory of Green Natural Products and Pharmaceutical Intermediates in Colleges and Universities of Shandong Province, School of Chemistry and Chemical Engineering, Center for Nanomedicine, Qufu Normal University, Qufu 273165, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui","family":"Luo","sequence":"additional","affiliation":[{"name":"Key Laboratory of Green Natural Products and Pharmaceutical Intermediates in Colleges and Universities of Shandong Province, School of Chemistry and Chemical Engineering, Center for Nanomedicine, Qufu Normal University, Qufu 273165, China"},{"name":"School of Physics and Physical Engineering, Qufu Normal University, Qufu 273165, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donghai","family":"Niu","sequence":"additional","affiliation":[{"name":"Key Laboratory of Green Natural Products and Pharmaceutical Intermediates in Colleges and Universities of Shandong Province, School of Chemistry and Chemical Engineering, Center for Nanomedicine, Qufu Normal University, Qufu 273165, China"},{"name":"School of Chemistry & Chemical Engineering and Environmental Engineering, Weifang University, Weifang 261061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5026-2808","authenticated-orcid":false,"given":"Liyan","family":"Yang","sequence":"additional","affiliation":[{"name":"Key Laboratory of Green Natural Products and Pharmaceutical Intermediates in Colleges and Universities of Shandong Province, School of Chemistry and Chemical Engineering, Center for Nanomedicine, Qufu Normal University, Qufu 273165, China"},{"name":"School of Physics and Physical Engineering, Qufu Normal University, Qufu 273165, China"},{"name":"Beijing National Laboratory for Molecular Sciences, Institute of Chemistry, Chinese Academy of Sciences, Beijing 100190, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3185-0257","authenticated-orcid":false,"given":"Zhonglei","family":"Wang","sequence":"additional","affiliation":[{"name":"Key Laboratory of Green Natural Products and Pharmaceutical Intermediates in Colleges and Universities of Shandong Province, School of Chemistry and Chemical Engineering, Center for Nanomedicine, Qufu Normal University, Qufu 273165, China"},{"name":"Key Laboratory of Bioorganic Phosphorus, School of Pharmaceutical Sciences, Chemistry & Chemical Biology (Ministry of Education), Tsinghua University, Beijing 100084, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1038\/d41573-026-00001-z","article-title":"2025 FDA approvals","volume":"25","author":"Mullard","year":"2026","journal-title":"Nat. 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