Arcadia Medicine
Arcadia Medicine is a San Francisco-based biotech developing safe entactogens for mental health disorders. Their lead candidate AM-1002 is a patented non-racemic MDMA formulation that received FDA IND clearance in October 2025 for Phase 1 trials in generalized anxiety disorder. Backed by investors including Sam Altman and Coinbase co-founder Fred Ehrsam.
Development Programmes
3AM-1002 (Non-Racemic MDMA)
Patented non-racemic (enantiopure) MDMA enriched in one enantiomer. Selectively releases serotonin and oxytocin without significant stimulant properties. Non-neurotoxic, shorter session (2-3 hrs vs 4-6), fewer cardiovascular side effects, wider safe dose range. FDA IND cleared Oct 6, 2025. Phase 1 first-in-human planned.
Programme Tracker
Anxiety Disorders
FDA IND cleared October 6, 2025. Phase 1 first-in-human trial planned. No NCT number posted or first-patient-dosed announcement as of April 2026. Gary Riordan (former FDA primary reviewer) leads regulatory.
Milestones
ip-milestone
CompletedActual: Nov 10, 2022
US Patent Application #20220354822 published for non-racemic MDMA enantiomers. Composition of matter patent covering R-MDMA in enantiomeric excess.
Why it matters: Composition of matter IP provides the strongest possible patent protection for the enantiopure MDMA approach. Differentiates from racemic midomafetamine (Lykos) and positions for regulatory exclusivity.
Funding milestone
CompletedActual: Jun 1, 2023
$9.25M seed round. Investors include Sam Altman (OpenAI CEO), Fred Ehrsam (Coinbase co-founder), Dylan Field (Figma founder), Apollo Projects, Dimensional Fund Advisors, Hydrazine Capital.
Why it matters: High-profile tech investor backing (Altman, Ehrsam, Field) brings visibility and credibility to a pre-clinical psychedelic company. $9.25M provides runway through Phase 1.
regulatory-milestone
CompletedActual: Oct 6, 2025
FDA clears IND application for AM-1002 (patented non-racemic MDMA) for Phase 1 first-in-human study. First MDMA-class IND clearance after FDA's August 2024 Complete Response Letter rejecting Lykos's racemic midomafetamine for PTSD.
Why it matters: FDA willingness to clear a new MDMA-type compound IND after the Lykos CRL signals regulatory openness to differentiated MDMA-class compounds. Non-racemic design addresses the cardiovascular and neurotoxicity concerns that contributed to the Lykos adcom failure. Critical proof point for the entire MDMA-class drug development field.
Recorded Events
Oct 6, 2025: regulatory-milestone
Jun 1, 2023: Funding milestone
Nov 10, 2022: ip-milestone
Evidence Links
company-website - Arcadia Medicine - Verified
company-website - Arcadia Medicine - Verified
AM-1004 (Combination Entactogen-Antidepressant)
Combination psychoactive-empathogen product designed as mildly entactogenic antidepressant for self-administration — intended as SSRI/SNRI alternative without requiring assisted therapy sessions. Fewer negative side effects than psilocybin therapy, shorter time course.
AM-1006 (Intranasal Low-Dose Psychoactive)
Intranasal low-dose psychoactive for substance use disorder. Short-acting, subperceptual design for use in traditional hour-long therapy sessions — not requiring extended multi-hour sessions.
Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase I
- Website
- Visit