Psilera
Also known as: Psilera Bioscience
Psilera is a Florida-based drug discovery company developing non-hallucinogenic psilocybin derivatives and outpatient-compatible psychedelic medicines. Founded in 2019, the female co-founded company has a proprietary compound library of over 1 million novel compounds. Lead candidate PSIL-006 is a non-hallucinogenic psilocybin derivative targeting behavioral variant frontotemporal dementia (bvFTD), with positive preclinical in vivo efficacy data in humanized tau mouse models. Earlier compounds PSIL-001/002 (DMT derivatives) showed improvements in learning and memory.
Development Programmes
3PSIL-006 (Non-Hallucinogenic Psilocybin Derivative)
PsilocybinNon-hallucinogenic psilocybin derivative for behavioral variant frontotemporal dementia (bvFTD). Positive in vivo tau mouse model data (improved sleep, learning, memory). Late IND-enabling with first-in-human targeted 2026. Hesperos organ-on-a-chip collaboration for advanced preclinical modeling.
Programme Tracker
Neurocognitive Disorders
Late IND-enabling. Company states "poised to advance key assets into the clinic within 12 months" (Jan 2026 CMO appointment PR). Hesperos Human-on-a-Chip collaboration modeling PSIL-006 on patient-derived iPSCs. First-in-human expected 2026.
Milestones
Company milestone
CompletedActual: Jan 15, 2024
Psilera announces bvFTD as lead indication for PSIL-006 — first psychedelic-derived compound specifically targeting frontotemporal dementia.
Why it matters: bvFTD is a rapidly fatal neurodegenerative disease with no approved treatments. Selecting bvFTD as lead indication signals confidence in the tau-model data and differentiates Psilera from the crowded depression/PTSD space.
Efficacy data
CompletedActual: Aug 15, 2024
Positive in vivo results in humanized tau mouse model of FTD: PSIL-006 improved sleep patterns, learning, and memory. Positive MTD/safety readouts confirmed. Non-hallucinogenic profile maintained.
Why it matters: First preclinical efficacy signal for a non-hallucinogenic psilocybin derivative in neurodegeneration. Multi-domain improvement (sleep + cognition) suggests broad neuroprotective mechanism beyond isolated endpoints.
Funding milestone
CompletedActual: Sep 5, 2024
USF Research Foundation invests $200K and publicly endorses PSIL-006 FTD research. Co-founders are USF alumni.
Why it matters: University endorsement and investment validates the science from Psilera's academic origin institution. Provides non-dilutive capital for IND-enabling work.
Company milestone
CompletedActual: Jan 15, 2025
Psilera hosts first FTD Research Summit in Tampa — convening researchers, academics, and patient advocacy groups (including AFTD) to advance FTD treatment strategies.
Why it matters: KOL engagement and AFTD participation builds the clinical and advocacy network needed for a rare disease program. FTD-specific summit positions Psilera as a thought leader in this therapeutic space.
partnership
CompletedActual: Feb 20, 2025
Psilera licenses entire DMT patent portfolio to atai Life Sciences (now AtaiBeckley) — upfront payment plus milestones and royalties. Provides Psilera with royalty stream from atai's DMT depression programs (likely VLS-01 for TRD).
Why it matters: Strategic refocus: monetizes legacy DMT IP to fund PSIL-006 FTD development. Creates passive revenue stream from atai's Phase 2 DMT programs without diluting Psilera equity.
Efficacy data
In progressActual: Jun 9, 2025
Strategic collaboration with Hesperos Inc. to evaluate PSIL-006 on their Human-on-a-Chip platform — using patient-derived iPSCs in multi-organ microfluidic systems to model PSIL-006 efficacy and safety in neurodegeneration-relevant neural tissues.
Why it matters: Organ-on-a-chip technology provides human-relevant preclinical data beyond rodent models. For a rare disease like bvFTD where patient recruitment is inherently limited, advanced in vitro modeling strengthens the IND package and supports FDA engagement.
Company milestone
CompletedActual: Jan 8, 2026
Dr. Magali Haas (MD/PhD) appointed CMO. Former Founder/CEO of Cohen Veterans Bioscience; 10+ years at J&J. Company states "poised to advance key assets into the clinic within the next 12 months."
Why it matters: CMO appointment signals imminent IND filing and Phase 1 planning. Haas's experience at Cohen Veterans Bioscience (a leading military mental health research org) and J&J provides the clinical development leadership needed for the transition from preclinical to clinical stage.
Recorded Events
Jan 8, 2026: Company milestone
Jun 9, 2025: Efficacy data
Feb 20, 2025: partnership
Jan 15, 2025: Company milestone
Sep 5, 2024: Funding milestone
Evidence Links
company-website - Psilera - Verified
patient-advocacy - AFTD - Verified
PSIL-025 (Anxiety Neuroplastogen)
Non-hallucinogenic psilocybin derivative for anxiety. Early preclinical; no public compound details disclosed. Company focus is on PSIL-006 (bvFTD) and the new AUD neuroplastogen.
AUD Neuroplastogen (NIH/NIAAA-funded)
PsilocybinNovel non-hallucinogenic psilocybin derivative targeting serotonergic (5-HT2A) and glutaminergic pathways affected by AUD. $2M NIH/NIAAA SBIR grant (Oct 2025, 3 years). Passed initial preclinical safety/toxicity. PI: Dr. Jackie von Salm (CSO).
Programme Tracker
Alcohol Use Disorder (AUD)
NIH/NIAAA SBIR grant-funded IND-enabling studies. Targeting serotonergic and glutaminergic pathways in AUD. Initial preclinical safety and toxicity assessments passed.
Milestones
Funding milestone
CompletedActual: Oct 3, 2025
Psilera secures $2M NIH/NIAAA SBIR grant (3-year term) to advance novel non-hallucinogenic psilocybin derivative toward IND for alcohol use disorder.
Why it matters: NIH peer-reviewed grant validates the scientific approach and provides 3 years of non-dilutive IND-enabling funding. Expands Psilera's therapeutic scope beyond neurodegeneration into addiction.
Recorded Events
Oct 3, 2025: Funding milestone
Quick Facts
- Type
- Private Biotech
- Founded
- 2019
- Lead Stage
- Pre-clinical
- Website
- Visit