Also known as: psychedelic drugs, psychedelics
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
The Trump administration is reclassifying medical marijuana from Schedule I to Schedule III and accelerating psychedelic research with a $50 million executive order. The FDA commissioner says marijuana has medical benefits but warns of potency and risks to youth. The DEA says the rescheduling process remains pending.
The Trump administration moved to reclassify marijuana from Schedule I to Schedule III under the Controlled Substances Act. The change is expected to ease research restrictions but will not immediately legalize marijuana.
Trump signed an executive order to speed FDA review of ibogaine and other psychedelic drugs and said the U.S. would dedicate $50 million to ibogaine research. The FDA is also preparing priority vouchers and steps toward the first U.S. human trials, while ibogaine remains linked to serious heart risks.
Studies of psilocybin found lasting shifts in life values in healthy volunteers and reduced fear of death in therapeutic settings. Trials have also reported benefits in cancer patients.
