Schedule I in US; FDA rejected Lykos NDA August 2024; Transcend/Otsuka methylone analog in Phase 3
Context behind the headlines.
A living reference layer for the recurring compounds, companies, concepts, and regulators shaping the psychedelic story.
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The entities and institutions most likely to recur across the reporting.
Schedule I in US; approved in Australia for TRD and PTSD; extensive Phase 2/3 trials globally
Seeking Phase 3 redesign following FDA Complete Response Letter (August 2024)
Active regulator for multiple psychedelic INDs; midomafetamine NDA reviewed in June 2024 and later rejected via Complete Response Letter
Active nonprofit research and policy organization; MDMA-assisted therapy remains investigational and MAPS continues public education and program context
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Phase 3 COMP360 for TRD underway; FDA accepted IND application for PTSD in January 2026
Phase 3 PARADIGM program underway for HLP003/CYB003 in major depressive disorder
Seeking Phase 3 redesign following FDA Complete Response Letter (August 2024)
Active nonprofit research and policy organization; MDMA-assisted therapy remains investigational and MAPS continues public education and program context
Deceased; enduring and contested figure in psilocybin history
Deceased; enduring figure in psilocybin history and in debates over colonial extractivism
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Companies
Phase 3 COMP360 for TRD underway; FDA accepted IND application for PTSD in January 2026
Phase 3 PARADIGM program underway for HLP003/CYB003 in major depressive disorder
Seeking Phase 3 redesign following FDA Complete Response Letter (August 2024)
Active nonprofit research and policy organization; MDMA-assisted therapy remains investigational and MAPS continues public education and program context
Compounds
Schedule I in US; legal in Mexico; active research for OUD and TBI; DoD interest
Schedule I in US; FDA rejected Lykos NDA August 2024; Transcend/Otsuka methylone analog in Phase 3
Schedule I in US; approved in Australia for TRD and PTSD; extensive Phase 2/3 trials globally
Concepts
No approved treatment in US; Phase 3 redesign underway at Lykos
Active research area; psilocybin showing signal but mixed Phase 2/3 results
Regulators
Active regulator for multiple psychedelic INDs; midomafetamine NDA reviewed in June 2024 and later rejected via Complete Response Letter
People
Deceased; enduring figure in psilocybin history and in debates over colonial extractivism
Deceased; enduring and contested figure in psilocybin history
Deceased; enduring influence through Be Here Now, archival talks, and later spiritual-teaching work
Deceased; enduring counterculture symbol and reference point in psychedelic history