Medical Division, Gedeon Richter Plc., 1103 Budapest, Hungary.
Int J Mol Sci. 2024 May 23;25(11):5682. doi: 10.3390/ijms25115682.
Until the late 1800s, drug development was a chance finding based on observations and repeated trials and errors. Today, drug development must go through many iterations and tests to ensure it is safe, potent, and effective. This process is a long and costly endeavor, with many pitfalls and hurdles. The aim of the present review article is to explore what is needed for a molecule to move from the researcher bench to the patients' bedside, presented from an industry perspective through the development program of cariprazine. Cariprazine is a relatively novel antipsychotic medication, approved for the treatment of schizophrenia, bipolar mania, bipolar depression, and major depression as an add-on. It is a D3-preferring D3-D2 partial agonist with the highest binding to the D3 receptors compared to all other antipsychotics. Based on the example of cariprazine, there are several key factors that are needed for a molecule to move from the researcher bench to the patients' bedside, such as targeting an unmet medical need, having a novel mechanism of action, and a smart implementation of development plans.
直到 19 世纪后期,药物研发还是一种基于观察和反复试验和错误的偶然发现。如今,药物研发必须经过多次迭代和测试,以确保其安全、有效。这个过程是一个漫长而昂贵的努力,有许多陷阱和障碍。本文旨在从行业角度探讨一个分子从研究人员的工作台转移到患者床边所需要的条件,并通过 cariprazine 的开发计划进行说明。Cariprazine 是一种相对较新的抗精神病药物,被批准用于治疗精神分裂症、双相躁狂症、双相抑郁症和作为附加治疗的重度抑郁症。它是一种 D3 偏好的 D3-D2 部分激动剂,与所有其他抗精神病药物相比,与 D3 受体的结合最高。基于 cariprazine 的例子,有几个关键因素是一个分子从研究人员的工作台转移到患者床边所需要的,如针对未满足的医疗需求、具有新颖的作用机制,以及明智的开发计划实施。