Frequently asked questions about psilocybin’s medical applications
Is psilocybin FDA approved for any indication?
No. Psilocybin is not approved by the FDA for any indication.
Is psilocybin classified as a psychedelic drug?
Yes. Psilocybin determines psychedelic effects when administered at psychedelic doses (e.g., 20-30 mg).
Does psilocybin always cause psychedelic effects?
No. When administered at non-psychedelic, sub-perceptual doses, psilocybin does not have psychedelic effects (e.g., modified release psilocybin (REL-P11) administered orally at 2 mg doses or less).
Is psilocybin at psychedelic doses under development for any indication?
Yes. Psilocybin is under development for MDD and other neuropsychiatric indications by several companies.
How is REL-P11 different from immediate release psilocybin?
REL-P11 is a modified release (MR) formulation of psilocybin. REL-P11 is designed to have a lower Cmax (lower peak serum level) and a longer Tmax (longer time to achieve peak serum level) compared to immediate release (IR) psilocybin. Higher and faster peak levels are associated with stronger psychedelic effects.
Does REL-P11 have psychedelic effects?
REL-P11 was tested in a Phase 1 study in healthy subjects (overweight, obese and normal weight subjects) in single ascending doses of 0.5 mg, 1 mg. 1.5 mg and 2 mg. At these dosages REL-P11 did not produce subjective or objective psychedelic or other measurable psychoactive effects.
Are there preclinical data suggesting that psilocybin has potential therapeutic effects for steatotic liver disease, Type 2 diabetes, obesity and dyslipidemia?
Yes. Compelling preclinical results were presented at specialized conferences and published in peer reviewed journals.
Are there preclinical data suggesting that psilocybin has potential therapeutic effects for visual impairment following occipital stroke?
Yes. Compelling preclinical results were presented at specialized conferences.
What is psilocybin microdosing?
Psilocybin microdosing can be defined as chronic use of low-dose non-psychedelic psilocybin (~ 0.5-3 mg psilocybin generally in the form of ~ 100-600 mg dried mushrooms containing 0.5% psilocybin) daily or weekly, typically a few times a week.
Are there data suggesting that chronic psilocybin use is safe and well tolerated?
There are no controlled studies of chronic psilocybin use and therefore safety and efficacy have not been defined. Psilocybin microdosing is relatively common: ~ 1-4% of the US population has tried psilocybin microdosing, mostly in the form of psilocybin-containing dried mushrooms. No deaths and no organ toxicity have been linked to psilocybin microdosing. Additionally, 1 mg tablets of psilocybin were marketed in the US in the 1960s for several years without reported unexpected adverse events. However, any available safety and tolerability information must be taken with caution because no results of controlled studies of psilocybin microdosing are available.
Is psilocybin a controlled substance?
Yes. Psilocybin is a Schedule I controlled substance. If approved, the psilocybin drug product schedule would be determined by the DEA. According to experts, if approved, the psilocybin drug product will be re-evaluated for scheduling and is likely to be categorized as a Schedule IV drug (Johnson 2018).
Why is there an unmet need for novel safe and effective treatments for steatotic liver disease, Type 2 diabetes, obesity and dyslipidemia?
Metabolic disorders affect over two thirds of the general population. While many treatments are available, no treatment is adequate for all patients. More studies are needed to define the ideal patient profile for modified release psilocybin (REL-P11), PEG-psilocin and the combination Psilo-GLP1 agonist.
Why is there an unmet need for novel safe and effective treatments for visual impairment following occipital stroke?
Visual impairment following occipital stroke is a disabling condition. There are currently no available treatments for this condition.
Psilocybin platform: Is there a pipeline of novel potentially therapeutic molecules free of psychedelic effects?
Yes.
Modified Release Psilocybin (REL-P11)
PEG-psilocin (REL-P22)
Psilocin-carbamate (REL-P33)
Psilo+GLP1 agonist combnation (REL-P44)
Neroplastogens ™ for ALS and other neuropsychiatric disorders
What are neuroplastogens™?
Neuroplastogens™ are molecules that may restore physiological neural plasticity, the structural and functional basis of nervous system networks. Neuroplastogen molecules, in contrast with psychoplastogen molecules, do not cause psychoactive effects, such as dissociative effects or psychedelic effects (Cooper 2023). The term “neuroplastogen” was coined by members the NeuroArbor team as outlined in their 2019 patent applications and was trademarked in the US (2022) and EU (2020). In summary, neuroplastogen™ refers to a proprietary class of molecules designed to restore physiological neural plasticity without psychoactive effects.
The combination of REL-1017 and REL-P11 may offer synergistic effects for neurodegenerative conditions, such as ALS.
Where does NeuroArbor perform its research and development?
NeuroArbor performs its research and development through MGGM Therapeutics, a US corporation. With a focus on the development of Neuroplastogens™, MGGM has been collaborating for over 6 years with University of Padova (Italy), Universita` della Svizzera Italiana (CH), Evotec and Eurofins, among other institutions and research facilities. Current research performed by MGGM and sponsored by NeuroArbor includes in silico, in vitro, in vivo and clinical studies advancing psilocybin related compounds as potential therapeutics.