EDR
Evidence Grade D — Primarily preclinical. 15 published studies, mostly animal models. 0 registered clinical trials.
Pinealon is a synthetic tripeptide from the Khavinson bioregulator programme, proposed to target brain tissue (specifically pineal and cortical regions). No controlled human clinical trials have been conducted and it has no approval from any major regulatory agency. The evidence consists of cell studies and animal experiments from the originating group.
15 published studies: 8 human, 5 animal, 3 in-vitro, 2 reviews
Pinealon has no marketing authorisation from any major regulatory agency. No controlled human clinical trials have been conducted. The evidence base consists of in vitro cell studies and animal experiments published primarily by the originating research group.
As with other Khavinson bioregulator peptides, the proposed mechanisms and the underlying theoretical framework have not been evaluated through conventional Western regulatory processes. Products available through unregulated channels lack pharmaceutical quality assurance.
Research from the Khavinson group proposes that Pinealon may interact with DNA promoter regions related to serotonin synthesis. Molecular docking simulations have been published, but these computational predictions have not been validated experimentally in controlled settings. The proposed mechanisms derive from the Khavinson bioregulation framework.
Research suggests Pinealon has a somewhat stronger evidence base than some other Khavinson peptides, with a structured review published in 2020 and some human clinical data (though studies of 32 and 72 participants lacked double-blind, placebo-controlled designs). Molecular docking simulations suggest possible interactions with DNA regions related to serotonin production. No properly controlled human clinical trials, no pharmacokinetic data, and no independent Western replication exist. Some pro-oxidant activity has been detected, warranting monitoring. Products from unregulated channels lack pharmaceutical quality assurance.
No trials registered on ClinicalTrials.gov for this compound.
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
Selank is approved in Russia for anxiety-related conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies. The key clinical study (62 patients) compared Selank to a benzodiazepine in generalised anxiety disorder and reported comparable effects. Published clinical studies are predominantly Russian and have not undergone Western regulatory review. The evidence base does not meet FDA or EMA approval standards. Its regulatory status is limited to Russia and certain former Soviet states.
Semax is approved in Russia for stroke recovery and cognitive conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies, and the clinical evidence base has not undergone Western regulatory review. Published clinical studies are predominantly Russian. The largest published study (110 stroke patients) reported correlations between treatment and BDNF levels. The evidence does not meet the standards typically required for FDA or EMA approval. Its regulatory status is limited to Russia and certain former Soviet states.
Dihexa has no marketing authorisation. No human clinical trials have been conducted. The foundational research by the originating laboratory faces serious integrity concerns: a key paper (McCoy et al., 2013) received an expression of concern for image manipulation, and a second paper (Benoist et al., 2014) was retracted after institutional investigation found falsified and fabricated data. These integrity issues fundamentally undermine the evidence base for dihexa. Products available through unregulated channels are based on research that has been formally questioned or retracted by the scientific community. This compound carries unique evidence quality concerns beyond the standard limitations of other research compounds.
