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First-in-class small molecule drugs in 2025
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Lei WANG1, 2, Qi-dong YOU1, 2, *
Acta Pharmaceutica Sinica | 2026, 61(7) : 2377 - 2387
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Acta Pharmaceutica Sinica | 2026, 61(7): 2377-2387
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First-in-class small molecule drugs in 2025
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Lei WANG1, 2, Qi-dong YOU1, 2, *
Affiliations
  • 1Jiangsu Key Laboratory of Drug Design and Optimization, China Pharmaceutical University, Nanjing 210009, China
  • 2School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
Published: 2026-07-12 doi: 10.16438/j.0513-4870.2026-0070
Outline
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In 2025, innovation in drug development remained stable, with the proportion of first-in-class drugs continuing to increase. The Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) approved a total of 46 new drugs in the past year, including 34 new molecular entities (NMEs) and 12 biologics license applications (BLAs). The number of approvals slightly decreased compared to the previous three years. This year, 31 small molecule drugs were approved, accounting for 67% of the total, among which 13 were first in class small molecule drugs. The treatment areas covered rare diseases, oncology, autoimmune diseases, respiratory diseases, and more. Several first in class small molecule drugs have breakthrough clinical value, such as the world's first non-opioid analgesic drug, NaV1.8 inhibitor suzetrigine, the first approved local TRPM8 receptor agonist acoltremon for dry eye disease, the first targeted mitochondrial inner membrane cardiolipin elamipretide, the first approved selective phosphodiesterase 4B (PDE4B) inhibitor nerandomilast for idiopathic pulmonary fibrosis (IPF), and the first selective oral Menin-MLL inhibitor iftomenib. First in class drugs have significant clinical, academic, and commercial value and have attracted extensive attention from patients, researchers and enterprises. This article briefly analyzes the research background, process and therapeutic applications of three representative first in class small molecule drugs from the perspective of medicinal chemistry, with the aim of providing more research directions and methods for the development of first in class drugs.

first in class drug  /  the development and research of drug  /  small molecule drug  /  medicinal chemistry  /  treatment application
王磊, 尤启冬. 2025年首创性小分子药物研究实例浅析. 药学学报, 2026 , 61 (7) : 2377 -2387 . DOI: 10.16438/j.0513-4870.2026-0070
Lei WANG, Qi-dong YOU. First-in-class small molecule drugs in 2025[J]. Acta Pharmaceutica Sinica, 2026 , 61 (7) : 2377 -2387 . DOI: 10.16438/j.0513-4870.2026-0070
Year 2026 volume 61 Issue 7
477
230
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Article Info
doi: 10.16438/j.0513-4870.2026-0070
  • Receive Date:2026-01-19
  • Online Date:2026-09-21
  • Published:2026-07-12
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History
  • Received:2026-01-19
  • Revised:2026-02-08
Affiliations
    1Jiangsu Key Laboratory of Drug Design and Optimization, China Pharmaceutical University, Nanjing 210009, China
    2School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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