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Chunk #0 — The state of drug discovery in psychiatry

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Translating genome-wide association findings into new therapeutics for psychiatry.
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In psychiatry, conventional drug discovery is at an impasse1. In 2015, three (cariprazine, aripiprazole lauroxil, and brexpiprazole) out of 45 new drugs approved by FDA were related to psychiatry. The mechanisms of action of these drugs are not novel as their pharmacology primarily targets dopamine and serotonin receptors. There still remain significant unmet medical needs and societal costs for psychiatric disorders that necessitate novel therapeutics.2 In disorders where partially effective treatments already exist, drug development has a higher investment risk, because any new drug has to exceed the clinical efficacy of existing treatments, or show equivalent efficacy together with significant improvements in safety and tolerability, as well as competing for market share with established standards of care. This is particularly difficult where there is a lack of novel targets with adequate validation. This has resulted in relatively higher drug discovery and development costs and longer than average cycle time in both clinical trial execution and regulatory agency review. Some companies have paused or de-prioritised their drug discovery and clinical trial efforts in psychiatry3. However, there are many (183) clinical trials