Evidence Grade D — Primarily preclinical. 15 published studies, mostly animal models. 0 registered clinical trials.
Medically reviewed by a licensed medical professional
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.
Pinealon is also known by these brand and alternate names:
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.
PeptideTrace tracks 0 registered clinical trials for Pinealon sourced from ClinicalTrials.gov.
No trials registered on ClinicalTrials.gov for this compound.
Pinealon is a Khavinson bioregulator tripeptide isolated from Cortexin, named for its reported affinity for pineal and cortical tissue. Its sequence is Glu-Asp-Arg (EDR), with molecular formula C15H26N6O8 and molecular weight 418.41 g/mol (CAS: 175175-23-2; PubChem CID: 10273502). Available as a white lyophilized powder that is water-soluble. Research administration routes include oral and intranasal, as well as subcutaneous injection. Israeli Patent 194346 (2013) was granted for 'Tripeptide Having a Stimulating Effect on the Regeneration of Neurons.' Available as a bioregulator supplement in Russia (GARMONIA Ltd.). Not approved by any Western regulatory agency.
Research suggests Pinealon's small molecular size enables transit across lipid bilayers including nuclear membranes (demonstrated with fluorescence-labeled peptide by Fedoreyeva et al., 2011). Molecular docking simulations suggest binding to nucleotide sequences in the promoter region of the 5-tryptophan hydroxylase gene, potentially enhancing serotonin synthesis. Research suggests modulation of the MAPK/ERK pathway, reduction of caspase-3 activity (decreasing neuronal apoptosis), upregulation of SOD2 and GPX1 antioxidant enzymes, and effects on NMDA receptor subunit gene expression in hippocampus. Under hypoxia conditions, research suggests Pinealon prevents a 3-fold increase in ROS levels. The melatonin connection is partly indirect: the related polypeptide complex Pineamin increased urinary 6-sulfatoxymelatonin excretion by 1.9x in elderly patients with diminished pineal function (N=55).
Khavinson et al. (2011, Rejuvenation Res) showed Pinealon increased cell viability by suppressing free radical levels and activating proliferative processes in vitro. Arutjunyan et al. (2012) demonstrated Pinealon protected rat offspring from prenatal hyperhomocysteinemia with significant reductions in ROS accumulation and necrotic cells. Meshchaninov et al. (2015; N=32) showed that in patients aged 41-83 with chronic polymorbidity, Pinealon demonstrated anabolic effects and improved CNS activity, notably without affecting chromatin condensation degree (nuclear genetic safety). Khavinson et al. (2020, Molecules) reported that oral Pinealon plus standard therapy in 72 patients with TBI consequences/cerebrasthenia improved memory, reduced headache intensity, enhanced performance efficacy, and decreased errors on correction tests. Kraskovskaya et al. (2017) showed EDR peptide (200 ng/mL) restored dendritic spine numbers under amyloid-beta conditions in mouse hippocampal neuron culture.
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.
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This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.
