Compass正完成两项试验，预计于2026年向美国监管机构递件并以「滚动式」资料提交加速审查，目标在2027年初上市；但仍面临在美国50州层级调整裸盖菇素法律地位与培训足够医护人力等门槛。同时，加拿大Cybin（更名Helus Pharma并赴纳斯达克）与其他以裸盖菇素、MDMA、伊波加因等为基础的「数十种」候选药也在推进。

产业循环上，该领域在2010年代末估值一度升至「数十亿」美元，但2021年随生技下行与安全性疑虑反转：Compass一项高剂量研究中有12名病人出现自杀行为或意念，投资人受惊；2024年FDA也拒绝了MDMA辅助疗法用于PTSD。迄今美国仅有一款相关快速抗忧郁药获批：娇生Spravato（类似氯胺酮的鼻喷剂）。大型机构资金仍偏观望，但支持者（如美国卫生部长Robert F. Kennedy Jr.）与2025年12月18日川普签署放宽大麻限制的行政命令，正推动临床可近性与去污名化的讨论。

A London industry gathering highlights psychedelics’ shift from counterculture to clinic. UK biotech Compass Pathways is advancing synthetic psilocybin for treatment‑resistant depression—patients who didn’t improve on at least two medicines. The protocol is highly structured: a clinic visit, therapist preparation, one pill, then up to about eight hours lying down with curated music and a therapist on standby. Most people start feeling better after one dose; common side effects include headache and nausea.

Compass is finishing two trials and expects to file with US regulators in 2026, aiming to launch in early 2027 via an accelerated, rolling submission. Key hurdles remain: changing psilocybin’s legal status across all 50 US states and training enough healthcare workers. Meanwhile, Canada’s Cybin (rebranding as Helus Pharma with a Nasdaq listing) and “dozens” of other programs are developing drugs based on psilocybin, MDMA, and ibogaine for conditions such as depression, anorexia, and PTSD.

The sector’s boom‑bust arc is stark: late‑2010s valuations climbed into the billions, then reversed in 2021 amid biotech weakness and safety concerns—one high‑dose Compass study saw 12 patients report suicidal behavior or thoughts. Regulators also signaled caution when the FDA rejected MDMA‑assisted therapy for PTSD in 2024. So far, only one related fast‑acting depression drug has US approval: Johnson & Johnson’s Spravato (a ketamine‑like nasal spray). Big institutions remain wary, but political support—plus a Dec. 18, 2025 Trump executive order easing marijuana limits—adds momentum toward mainstream clinical adoption.