PSIL-002 — Safety, Research, Risks & Legal Status

Not medical advice. PSIL-002 is discussed here for informational and harm-reduction purposes only. We do not endorse use, and any dosing context is informational, not a protocol.

Also known as	Psilera-002; proprietary internal designation (no public development code or brand name identified)
Category	Research Chemical
Developer	Psilera, Inc. (Florida, USA)
Scaffold	Halogenated DMT derivative; exact structure proprietary and patent-pending
Development stage	Preclinical only as of August 2022; no human trials initiated
Primary assay	Mouse head-twitch response (HTR) negative at 0.5-100 mg/kg; psilacetin used as positive control
Receptor target	5-HT1 receptor modulator (subtype not publicly specified)
Pipeline position	Earlier-stage than PSIL-006, Psilera's current lead candidate
US legal status	PSIL-002 is an unapproved investigational compound with no FDA authorization for human use. Its parent scaffold is N,N-dimethyltryptamine (DMT), a Schedule I controlled substance under the Controlled Substances Act. PSIL-002, as a DMT derivative, very likely falls within the scope of the Federal Analogue Act (21 U.S.C. § 813), which treats structural analogs of Schedule I substances as Schedule I themselves when intended for human consumption. Psilera, Inc. holds DEA Schedule I researcher registration authorizing laboratory research on DMT, psilocybin, and psilocin; this authorization covers internal preclinical work only and does not render the compound legal for general possession, sale, or human use. Patent-pending status means the structure is not publicly disclosed. Not a dietary supplement. Not approved in any jurisdiction.

What is PSIL-002?

PSIL-002 is a proprietary halogenated derivative of N,N-dimethyltryptamine (DMT) developed by Psilera, Inc. (Florida) as a purportedly non-hallucinogenic neuroplastogenic agent. The exact chemical structure has not been publicly disclosed. The compound is designed to retain potential antidepressant and neuroplasticity-promoting effects while eliminating the hallucinogenic activity associated with classical tryptamines. As of August 2022, development is preclinical only; no human trials have been initiated. Psilera's more advanced pipeline candidate as of the same period is PSIL-006.

How it works

PSIL-002 is described by its developer as a serotonin 5-HT1 receptor modulator - specifically a serotonergic agonist at one or more 5-HT1 receptor subtypes. The precise subtype selectivity (5-HT1A, 5-HT1B, 5-HT1D, or others) has not been specified in public sources. The hallucinogenic effects of classical psychedelics are primarily mediated through 5-HT2A agonism; by contrast, PSIL-002's proposed mechanism bypasses 5-HT2A engagement. The structural modifications relative to DMT (described as halogenation at undisclosed positions) are believed to account for the altered receptor binding profile. Whether neuroplastogenesis is driven by receptor agonism directly, downstream BDNF/TrkB signaling, or other mechanisms has not been characterized in published work. All mechanistic claims rest on a single preclinical mouse study with no independent replication as of available public data.

Background & history

Psilera, Inc. was founded with a focus on developing next-generation neurotherapeutics based on psychedelic scaffolds. The company obtained DEA Schedule I researcher registration prior to 2021, authorizing work on DMT, psilocybin, and psilocin. PSIL-002 was publicly described as a halogenated DMT derivative intended to produce antidepressant and anxiolytic effects without hallucination. In vivo mouse behavioral data were reported circa August 2022, showing absence of head-twitch response at all tested doses (0.5-100 mg/kg), with psilacetin (4-AcO-DMT) used as a positive hallucinogenic control. These findings were announced via press release and covered by psychedelic industry media. As of the most recent available information, PSIL-002 has not advanced to human trials, and Psilera's pipeline appears to prioritize PSIL-006 as its lead candidate.

What the research says

All published evidence is preclinical and originates from a single in vivo mouse study conducted by Psilera. The study assessed hallucinogenic liability using the head-twitch response (HTR) assay across a broad dose range (0.5-100 mg/kg). No HTR was observed at any dose, and the compound was reported as well-tolerated with a behavioral signal consistent with antidepressant, anxiolytic, and anti-addictive activity. No pharmacokinetic data, receptor binding assays, cardiovascular safety data, or independent replications have been published. There are no active ClinicalTrials.gov entries for PSIL-002. No peer-reviewed publications specifically characterizing PSIL-002 pharmacology were identified in public literature as of available data. The broader rationale for non-hallucinogenic tryptamines as neuroplastogens draws on a growing body of preclinical work with other compounds (tabernanthalog, TBG, and related scaffolds), but this context does not constitute evidence for PSIL-002 specifically. The reliability of all PSIL-002 claims is low pending independent replication and human data.

Reported effects

Absence of hallucinogenic effects (head-twitch response) in mouse behavioral assay across all tested doses - preclinical only
Reported antidepressant-like behavioral signal in mouse models - preclinical only, no human data
Reported anxiolytic-like behavioral signal in mouse models - preclinical only
Reported anti-addictive signal in mouse behavioral paradigms (particularly alcohol-related models) - preclinical only
Neuroplastogenesis is the proposed mechanistic basis for therapeutic effects - not yet demonstrated independently in PSIL-002-specific published work
No human pharmacological effects documented

Dosing & administration (informational)

Mouse study doses ranged from 0.5 to 100 mg/kg (intraperitoneal or equivalent route not fully specified in public summaries). These figures are reported for informational context only and cannot be translated to human dosing - species differences, route, bioavailability, and complete absence of human PK data make any extrapolation inappropriate. No human dosing protocol exists. Consult a licensed clinician and qualified research team for any therapeutic or investigational use questions; this entry does not constitute dosing guidance.

This is general research/context information, not medical advice or a recommended protocol.

Safety & side effects

No human safety data exist; all tolerability observations come from a single preclinical mouse study
No cardiovascular safety characterization has been published for PSIL-002 specifically
Class-level concern: serotonin agonists can carry proarrhythmic or serotonin syndrome-related risk; whether this applies to PSIL-002 is unknown
No adverse events were reported in preclinical mouse work, though rodent models have significant limitations in predicting human toxicity
Halogenated tryptamine derivatives are chemically novel; metabolic fate, off-target binding, and long-term toxicity are entirely uncharacterized
Federal Analogue Act classification means human consumption outside an authorized research context carries serious legal risk
Structure is undisclosed; any material sold commercially as PSIL-002 cannot be verified as the authentic compound

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Who should avoid it

Human consumption outside authorized DEA-registered research - likely Schedule I analog under federal law
Concurrent use with serotonergic agents (MAOIs, SSRIs, SNRIs) - theoretical serotonin syndrome risk extrapolated from drug class
Use by individuals with personal or family history of psychosis or bipolar disorder - class-level precaution, no PSIL-002-specific data
Purchasing from commercial research chemical vendors - structure is undisclosed and proprietary; purity and identity of any commercial product cannot be verified
Any use during pregnancy or lactation - no safety data in any population
Assuming preclinical mouse data predicts human efficacy or safety - the evidence base is extremely thin

How it is commonly combined

No stacking data exist. PSIL-002 has not been studied in combination with any agent in published literature. Theoretical combinations with other neuroplastogens (ketamine, other tryptamines) or antidepressants carry unknown interaction risk. No protocols or rationales should be inferred from this entry.

Legal & regulatory. PSIL-002 is an unapproved investigational compound with no FDA authorization for human use. Its parent scaffold is N,N-dimethyltryptamine (DMT), a Schedule I controlled substance under the Controlled Substances Act. PSIL-002, as a DMT derivative, very likely falls within the scope of the Federal Analogue Act (21 U.S.C. § 813), which treats structural analogs of Schedule I substances as Schedule I themselves when intended for human consumption. Psilera, Inc. holds DEA Schedule I researcher registration authorizing laboratory research on DMT, psilocybin, and psilocin; this authorization covers internal preclinical work only and does not render the compound legal for general possession, sale, or human use. Patent-pending status means the structure is not publicly disclosed. Not a dietary supplement. Not approved in any jurisdiction.

Quality & harm reduction

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Frequently asked questions

Is PSIL-002 truly non-hallucinogenic?

In one preclinical mouse study, PSIL-002 did not produce head-twitch response - a standard behavioral proxy for hallucinogenic activity in rodents - at any dose tested (0.5-100 mg/kg). This is promising preliminary data, but rodent HTR does not perfectly predict subjective human psychedelic experience. No human data exist to confirm or refute this claim.

Has PSIL-002 been tested in humans?

No. As of available public information through August 2022, PSIL-002 is preclinical only. No human pharmacokinetic, safety, or efficacy data have been published, and no ClinicalTrials.gov entries for PSIL-002 were identified.

What dose should I use?

No human dosing protocol exists for PSIL-002, and this entry does not provide one. Mouse study doses (0.5-100 mg/kg) cannot be extrapolated to humans without human PK, safety, and dose-finding data. Consult a licensed clinician and a DEA-authorized research program for any clinical interest.

Is PSIL-002 legal to possess?

Almost certainly not for general possession in the United States. The parent scaffold is DMT (Schedule I), and PSIL-002 as a structural analog very likely falls under the Federal Analogue Act when intended for human consumption. Psilera operates under DEA Schedule I researcher authorization, which applies only to their licensed program. Possession outside an authorized research context carries serious federal legal risk.

How does PSIL-002 differ from classical psychedelics like psilocybin?

Classical psychedelics such as psilocybin primarily produce subjective effects via 5-HT2A agonism. PSIL-002 is designed to act at 5-HT1 receptors rather than 5-HT2A, theoretically preserving neuroplasticity and therapeutic signals while avoiding hallucinogenic activity. Whether this translates to a meaningfully different human experience or therapeutic profile remains untested in clinical populations.

Where can I find published studies on PSIL-002?

No peer-reviewed journal articles specifically characterizing PSIL-002 pharmacology were identified in publicly available databases as of available data. The primary public record consists of a Psilera press release (circa August 2022) and coverage by Psychedelic Alpha. Broader context can be found by searching PubMed for 'DMT neuroplasticity antidepressant' or 'non-hallucinogenic psychedelic neuroplastogen'.

References & further reading

PubMed: DMT neuroplasticity antidepressant (search term)
PubMed: non-hallucinogenic psychedelic neuroplastogen tabernanthalog (search term)
PubMed: serotonin 5-HT1A agonist antidepressant mechanism (search term)
PubMed: psychedelic cardiovascular safety serotonin agonist (search term)
ClinicalTrials.gov: psilocybin OR psilocin OR DMT mood disorder (search filter - no PSIL-002 specific trials identified)