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No clinical evidence Comparison Summary# The Evidence Gap in Peptide Psychiatry# A striking pattern in peptide approaches to depression and anxiety is the gap between promising mechanisms and clinical validation: Selank and semax have regulatory approval in Russia and decades of clinical use, but lack Western-standard phase 3 RCTs Rapastinel had the most advanced Western clinical program (FDA Breakthrough Therapy) but failed at the phase 3 stage Nemifitide showed intriguing rapid-onset signals but never achieved a definitive trial NPY has the best-characterized biology as an endogenous anxiolytic but has not been developed as a drug This pattern reflects both the difficulty of antidepressant drug development (high placebo response rates, heterogeneous patient populations) and the specific challenges of peptide therapeutics (BBB penetration, stability, delivery)

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2004 doi: 10.7326/0003-4819-141-6-200409210-00009