[Psychiatric drug development on the verge of its Rubicon]

Recent reports from the psychiatric drug development space have been feeding the expectation of novel pharmacotherapies reaching the clinic over the next couple of years. In this context, advancement of novel compounds such as esketamine, KarXT, MDMA, daridorexant and psilocybine following decades of stagnation, is undoubtedly promising. However, complacency on the side of drug developers and psychiatrist should be considered premature.

Discussion of literature, examples and backgrounds of drug development in psychiatry.

After all, compared to neurology and oncology, psychiatry is lagging behind in terms of potential new drugs targeting truly novel mechanisms of action to treat psychiatric disorders. The current situation is conceptually related to 1) lacking an understanding of the pathophysiology of psychiatric disorders, 2) limited pharmacological characterization of novel drugs, 3) equating phenomenological diagnostic categories to diseases with a biological basis, and 4) the pharmaceutical industry aiming to introduce ‘blockbuster drugs’ to the market.

Altogether, psychiatric drug development is currently undergoing something of a renaissance, but relevant stakeholders seem unable to address the shortcomings and pitfalls of the current approach, risking psychiatric drug development to fall even further behind. Improving drug development in psychiatry is only possible if clinicians, researchers, drug developers and regulators join forces in a concerted effort to address these issues.