No FDA approval of any psychedelic beyond esketamine within 12 months; MDMA NDA path requires additional data.

Right now, the only psychedelic-like drug the FDA (the US drug regulator) has fully approved is esketamine, a nasal spray for depression. No other psychedelic will join it in the next 12 months. The company behind MDMA-assisted therapy has to do more research before regulators will consider approving it. This matters because FDA approval is what lets doctors prescribe a drug and insurance companies pay for it.

The agency won't move on hype. Ibogaine framing is preclinical/analogue-focused. Esketamine remains the only cleared novel agent; real approvals need clean Phase 3 packages.