| Abstract | The major hurdles on the development path of CNS therapeutics include an inherent complexity of the CNS, highly restricted drug access to CNS targets by the blood–brain barrier (BBB), paucity of translational preclinical disease models, safety risks, and lack of clinical biomarkers to aid in patient selection and early assessment of efficacy in clinical trials. Drug development for CNS is therefore highly complex and risky – more expensive and lengthy than for any other indication. The CNS drugs have one of the highest pipeline attrition rates and longest development times (114 months); clinical trial failures tend to occur later in the clinical development, making the cost of developing a CNS drug among the highest of any therapeutic indication. |
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