Terran Biosciences
Phase I3 active candidates
2 shared indicationsPhase I peer2 overlapping stagessame regulator: US FDA
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Lead program: Phase I
Categories
1 domain / 2 areas / 1 specialization
Arcadia Medicine
Data updated
3 Drug Candidates
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.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 3
- Active programmes
- 3
- Lead stage
- Phase I
- Forecast coverage
- 3 of 3
All tracked candidates active
All tracked programmes active
Multiple active stages
3 active programmes with forecast fields
Latest sourced update
Arcadia Medicine — Pipeline
Jun 26, 2026 - company-website - Arcadia Medicine - AM-1004 (Combination Entactogen-Antidepressant)
Next known catalyst
Phase I topline
Timing not specified - AM-1002 (Non-Racemic MDMA) / AM-1002 — Phase 1 First-in-Human (GAD) - Confidence: 45%
7 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase I2 Preclinical
Development Programmes
3AM-1002 (Non-Racemic MDMA)
Phase I
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
Primary: US (FDA)
Phase IActive
Forecast
Phase I topline
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
Arcadia Medicine — Overview
company-website - Arcadia Medicine - Apr 22, 2024 - Verified
Arcadia Medicine — Team
company-website - Arcadia Medicine - Apr 20, 2024 - Verified
Arcadia reports AM-1002 IND clearance and $9.25M raised from investors
Press release - Arcadia Medicine / GlobeNewswire - Oct 6, 2025 - Verified
Release states Arcadia raised $9.25M from investors including Sam Altman, Fred Ehrsam, and Dylan Field while advancing AM-1002.
AM-1004 (Combination Entactogen-Antidepressant)
Preclinical
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.
Programme Tracker
Major Depressive Disorder (MDD)
Primary: US (FDA)
Pre-clinicalActive
Forecast
Pre-clinical completed
Preclinical/discovery. Arcadia lists AM-1004 for MDD as a short-acting psychoactive-empathogen combination therapy; no IND or clinical trial has been announced as of June 2026.
Milestones
Pre-clinical started
CompletedActual: Oct 6, 2025
Arcadia publicly described AM-1004 as a mildly entactogenic antidepressant designed for self-administration as an alternative to SSRIs/SNRIs.
Why it matters: Adds a differentiated non-session-based MDD programme behind Arcadia’s lead AM-1002 clinical-stage asset.
Watch next: Lead candidate nomination, IND-enabling package, or first formal regulatory guidance for AM-1004.
Recorded Events
Oct 6, 2025: Pre-clinical started
Evidence Links
Arcadia Medicine — Pipeline
company-website - Arcadia Medicine - Jun 26, 2026 - Verified
Current company pipeline lists AM-1002 for GAD, AM-1004 for MDD, and AM-1006 for substance abuse/SUD.
Arcadia Medicine Announces FDA Clearance of IND Application for AM-1002
Press release - GlobeNewswire - Oct 6, 2025 - Verified
Release describes secondary candidates AM-1004 and AM-1006 and confirms the company continues to expand its entactogen pipeline.
AM-1006 (Intranasal Low-Dose Psychoactive)
Preclinical
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.
Programme Tracker
Substance Use Disorders (SUD)
Primary: US (FDA)
Pre-clinicalActive
Forecast
Pre-clinical completed
Preclinical/discovery. Arcadia lists AM-1006 for substance use disorder/substance abuse as a short-acting subperceptual psychoactive drug intended for hour-long therapeutic settings.
Milestones
Pre-clinical started
CompletedActual: Oct 6, 2025
Arcadia publicly described AM-1006 as a short-acting, subperceptual psychoactive compound for use in a traditional hour-long therapeutic setting.
Why it matters: Defines Arcadia’s SUD programme separately from AM-1002 and AM-1004 and clarifies that it remains preclinical.
Watch next: Mechanism disclosure, IND-enabling toxicology, or partner/regulatory update.
Recorded Events
Oct 6, 2025: Pre-clinical started
Evidence Links
Arcadia Medicine — Pipeline
company-website - Arcadia Medicine - Jun 26, 2026 - Verified
Current company pipeline lists AM-1002 for GAD, AM-1004 for MDD, and AM-1006 for substance abuse/SUD.
Arcadia Medicine Announces FDA Clearance of IND Application for AM-1002
Press release - GlobeNewswire - Oct 6, 2025 - Verified
Release describes secondary candidates AM-1004 and AM-1006 and confirms the company continues to expand its entactogen pipeline.
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Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase I
- Website
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