By Clinical Research News Team 

December 16, 2025 | As psychedelic and dissociative-based medications pick up more interest, they may enter mainstream psychiatry in the coming years. According to Hans Eriksson, M.D., Ph.D., chief medical officer (CMO) for precision psychiatry company HMNC Brain Health, “We’re in the second golden era of neuropsychopharmacology.”  

Though ketamine and psilocybin are highlighted for their potential, their mechanisms—and side effects—still require further investigation. Clinical trials reveal nuances in dosing, metabolism, and patient response that challenge early assumptions about how psychedelic-related therapies work. 

One example is HMNC’s oral ketamine formulation, KET01, which has undergone a multicenter phase 2 study across Germany, Poland, and the Czech Republic. Unlike intravenous ketamine or Spravato (esketamine), KET01 releases slowly through the gut, delaying peak concentration in the bloodstream for seven hours. In the trial, this dosing strategy produced antidepressant effects without the dissociation or cardiovascular side effects typically associated with ketamine therapy. A antidepressant signal emerged within hours of the initial dose, and clear separation from placebo appeared by day four, an unusually rapid response for an oral medication. Although the placebo group temporarily improved at the three-week mark, the early signal was strong enough to justify further development. 

HMNC is also working on reviving earlier scientific leads that were stalled for logistical reasons. The company is currently looking into correcting disturbances in the stress resilience system. Drugs that target hormonal pathways of the hypothalamic-pituitary-adrenal (HPA) axis showed promise about two decades ago but never advanced due to cumbersome diagnostic requirements. HMNC’s phase 2 trial of nelivaptan, a vasopressin blocker licensed developed by Sanofi, revisits this potential therapy with more sophisticated trial design and genetic patient-selection tools. In a 338-patient study, pairing the drug with the company’s genetic selection tool yielded encouraging efficacy signals. 

These trials also address another obstacle: how to scale treatments that traditionally require intensive oversight. While companies like Compass Pathways focuses on psilocybin-based therapy paired with psychological support while HMNC aims to develop personalized therapies using predictive patient selection tools, a strategy that could dramatically expand accessibility. 

To read the full story written by Deborah Borfitz, head over to Bio-It World News.