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First-in-class small molecule drugs in 2018
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Lei WANG1, 2, Zheng-yu JIANG1, 2, Qi-dong YOU1, 2, *
Acta Pharmaceutica Sinica | 2019, 54(7) : 1145 - 1156
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Acta Pharmaceutica Sinica | 2019, 54(7): 1145-1156
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First-in-class small molecule drugs in 2018
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Lei WANG1, 2, Zheng-yu JIANG1, 2, Qi-dong YOU1, 2, *
Affiliations
  • 1. Jiangsu Key Laboratory of Drug Design and Optimization, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
  • 2. Department of Medicinal Chemistry, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
Published: 2019-07-12 doi: 10.16438/j.0513-4870.2019-0356
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In 2018, FDA approved 59 kinds of new drugs in all, breaking the record of 53 set in 1993. There were 34 types of small molecule drugs, which accounted for 64% of the whole new drugs. Of these 34 new small molecule drugs, 9 first-in-class ones marked a milestone for the subsequent drug discovery and development. These include Glasdegib, the world's first small molecule inhibitor targeting Smo through Hedgehog signaling pathway; Ivosidenib, the first small molecule inhibitor targeting mutant IDH1; Tecovirimat, the first small molecule drug for anti-variola virus therapy through targeting p37; Baloxavir marboxil, the first anti-flu drug targeting cap-dependent endonuclease; Elagolix sodium, the first small molecule inhibitor in treating endometriosis by targeting GnRH-R, etc. The research and development of first-in-class drugs is always full of obstacles and challenges. However, once they were successfully recognized as the "heavy bomb" drugs, they would become huge benefits. This article chose the representative first-in-class small molecule drugs that were approved in 2018 as examples to analyze their development processes in an attempt to provide guidance for the research and development of more first-in-class drugs.

first-in-class drug  /  small-molecule drug  /  drug development
Lei WANG, Zheng-yu JIANG, Qi-dong YOU. First-in-class small molecule drugs in 2018[J]. Acta Pharmaceutica Sinica, 2019 , 54 (7) : 1145 -1156 . DOI: 10.16438/j.0513-4870.2019-0356
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Article Info
doi: 10.16438/j.0513-4870.2019-0356
  • Receive Date：2019-05-07
  • Online Date：2026-01-26
  • Published：2019-07-12
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  • Received：2019-05-07
  • Revised：2019-05-29
Affiliations
    1. Jiangsu Key Laboratory of Drug Design and Optimization, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
    2. Department of Medicinal Chemistry, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
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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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