FDA will not endorse bipolar II psilocybin scale-up without controlled comparator data.

The US drug regulator (FDA) is very unlikely to approve expanding psilocybin treatment for bipolar II disorder based on the current small, loosely structured studies. Bipolar II involves mood swings that can tip into dangerous highs (called mania), and the FDA needs head-to-head comparison studies before it will sign off. Without that evidence, people with bipolar II won't get access through official medical channels anytime soon.

The open-label feasibility protocol cannot support efficacy or safety claims in a mood-cycling population with mania risk.