After more than two decades of preclinical and clinical studies, on August 27, 2019, the US Food and Drug Administration (FDA) approved the adenosine A_2A receptor antagonist Nourianz® (istradefylline) developed by Kyowa Hakko Kirin Inc., Japan, as an add-on treatment to levodopa in Parkinson’s disease (PD) with “OFF” episodes. This milestone achievement is the culmination of the decade-long clinical studies of the effects of istradefylline in more than 4000 PD patients. Istradefylline is the first non-dopaminergic drug approved by FDA for PD in the last two decades. This approval also provides some important lessons to be remembered, namely, concerning disease-specific adenosine signaling and targeting subpopulation of PD patients. Importantly, this approval paves the way to foster entirely novel therapeutic opportunities for adenosine A_2A receptor antagonists, such as neuroprotection or reversal of mood and cognitive deficits in PD and other neuropsychiatric diseases.

中文翻译：

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迟来的美国 FDA 批准腺苷 A2A 受体拮抗剂 istradefylline 用于治疗帕金森病。

经过二十多年的临床前和临床研究，2019年8月27日，美国食品药品监督管理局（FDA）批准了腺苷A _2A受体拮抗剂 Nourianz® (istradefylline) 由日本协和发酵麒麟公司开发，作为左旋多巴治疗帕金森氏病 (PD) “关闭”发作的附加疗法。这一里程碑式的成就是对伊曲茶碱对 4000 多名 PD 患者影响的长达十年的临床研究的高潮。Istradefylline 是过去二十年来 FDA 批准的第一种用于 PD 的非多巴胺能药物。该批准还提供了一些需要记住的重要教训，即关于疾病特异性腺苷信号传导和靶向 PD 患者亚群。重要的是，这一批准为促进腺苷 A _{2A 的}全新治疗机会铺平了道路 受体拮抗剂，例如神经保护或逆转 PD 和其他神经精神疾病中的情绪和认知缺陷。