Field Notes · Evidence audit · Regulation
Pinealon's human evidence is five Russian-language reports and a patent. The one FDA drug listing under its name registers a different peptide.
Pinealon is the tripeptide Glu-Asp-Arg from the St. Petersburg group of Vladimir Khavinson. A PubMed search on November 7, 2026 found five reports of it in people, all in one Russian journal and read here as abstracts; none describes a placebo group, and the only one that states a dose used 100-microgram oral capsules. ClinicalTrials.gov lists no study. The single entry in FDA's drug listing directory named Pinealon Acetate records a 14-residue HLA-B fragment as its active ingredient, and a listing is not an approval.
The molecule
Three amino acids, one laboratory, one patent family
Pinealon is glutamyl-aspartyl-arginine, written H-Glu-Asp-Arg-OH, with a molecular weight of 418.40 without its acetate counter-ion.[10] It belongs to the family of short "peptide bioregulators", also called cytogens, studied by Vladimir Khavinson's group in St. Petersburg; its 2011 cell-culture paper in Rejuvenation Research lists the Saint Petersburg Institute of Bioregulation and Gerontology as Khavinson's affiliation.[12] The same group patented it. A Russian patent with a priority date of May 30, 2006 claims the tripeptide for stimulating neuron regeneration at 0.01 to 100 micrograms per kilogram once a day, and a US patent in the same family, published September 3, 2013, names Khavinson and three colleagues as inventors.[10][11] Google Patents shows the US patent assigned from SIA Peptides to Garmonia Ltd and then, in 2019, to Peptidpro LLC, and lists its status as expired for non-payment of fees, a status Google labels an assumption rather than a legal conclusion.[10]
The human record
Five reports, one journal, no placebo described
PubMed returned 22 records for pinealon on November 7, 2026; a wider search for the name or the sequence returned 47, most of them unrelated proteins that happen to contain the same three-amino-acid motif.[1][2] Five records describe people receiving pinealon, and every one is a Russian-language article in Advances in Gerontology published between 2012 and 2016. pepmg read their English abstracts, not the full Russian texts.
Locomotive crews, 2012. Workers "used preparation during two weeks (1 capsule containing 100 mkg of Pinealon 2 times a day)", and the authors report improved biological-age and adaptation indicators. The abstract gives no number of workers and describes no comparison group.[3]
Truck drivers, 2012. PubMed tags this one a clinical trial. Its abstract mostly describes a survey of 150 male truck drivers against 150 metal craftsmen, then states that "the application of bioregulating peptides" restored adaptive potential and reduced the risk of borderline mental disorders (p < 0.001 to 0.05), with the best effect from combining pinealon with vesugen. It does not say how many people took the peptides, at what dose or by what route.[4]
Organic brain syndrome, 2015. Thirty-two people aged 41 to 83 received pinealon and Vesugen , and the abstract reports on each, saying vesugen had the "more visible" effect. Its own breakdown, 18 men and 12 women, adds up to 30. The authors report a significant anabolic effect and slower aging by biological-age indicators, and in the same abstract report prooxidant activity and a fall in CD34-positive blood stem-cell markers that they call "significant inhibition of hemopoiesis". They still recommend both peptides for geriatric use.[5]
Comparison of anti-aging methods, 2016. In 110 people, the authors compared dry carbon dioxide baths, hyperbaric oxygen, massage and the vesugen-pinealon pair, and report the most pronounced effect on biological-age indicators when the two peptides, named in the abstract as Vezugen and Pinealon, were used together; massage and the peptides were the safest of the methods.[6]
Work ability, 2015. The abstract names no specific peptide and no sample size; PubMed's subject indexing lists pinealon among its substances, and it argues for adding "small peptides" to the preventive nutrition of workers exposed to occupational hazards.[7]
Read together, three of the five abstracts name a second peptide, vesugen, given with or alongside pinealon, the outcomes are mostly composite "biological age", questionnaire and work-ability scores, and none of the abstracts mentions randomization to placebo or blinding.[3][4][5][6][7] ClinicalTrials.gov returned no study for pinealon, for pinealon as an intervention, or for "Glu-Asp-Arg" on November 7, 2026.[16]
The citation trail
A 72-patient claim that leads back to a review and a patent
A 2020 English-language review in Molecules by Khavinson and colleagues is the fullest summary of the human claims that pepmg found. It states that "oral administration of Pinealon in addition to standard therapy in 72 patients with traumatic brain injury consequences and cerebrasthenia led to improved memory, reduced duration and intensity of headaches", citing a 2013 review by the same group, and that brain-injury patients made fewer errors on a correction test, citing an Israeli patent that names Khavinson and three colleagues as inventors.[8][9] The review declares: "Authors declare no conflict of interest."[8] pepmg found no primary report of the 72-patient study in PubMed on November 7, 2026.[1]
The US member of that patent family has the clinical example in full. It describes 25 patients aged 31 to 60 with head injuries sustained one to ten years earlier, "randomly subdivided into 2 groups"; the peptide group received intramuscular injections once a day for 10 days at 5.0 mg, 10 micrograms or 1 microgram depending on injury severity, and the tables compare them with patients "after treatment with commonly used medications".[10] The patent's tables report correction-test errors falling from 12.6 before treatment to 6.4 after the peptide, against 9.7 after the usual medications, and do not give the size of each group.[10] A patent filing is not peer-reviewed, and these figures are reported with their source and population.
The claim has since travelled. A January 2026 review in an American Academy of Orthopaedic Surgeons journal says studies have explored pinealon for "enhancing cognitive function, improving sleep, and promoting resilience to oxidative stress", and its single citation for that sentence is the 2012 truck-driver paper.[15] That paper's abstract does not mention sleep.[4] The same review says there is "a current lack of clinical trials".[15]
The laboratory work
Cells, rat pups and mice
The non-human work is also mostly from the same network. In cultured cerebellar neurons, neutrophils and PC12 cells, pinealon showed dose-dependent restriction of reactive oxygen species and reduced necrotic cell death.[12] Given to pregnant rats fed excess methionine, it was reported to improve the offspring's spatial learning.[13] In a 2021 study of an Alzheimer's mouse model, the EDR and KED peptides prevented dendritic spine loss; the abstract states a dose only for KED, and an erratum to the paper was published in 2025.[14] These are animal and cell results, not evidence of an effect in a person.
Regulatory status
No approval, no compounding nomination, and a listing for a different molecule
A Drugs@FDA search through openFDA on November 7, 2026 returned no match for pinealon.[17] Pinealon appears in none of the three categories of FDA's 503A bulk drug substance nominations list, updated May 14, 2026, which pepmg read page by page.[22] It is not among the six peptides covered by the HHS enforcement-discretion policy announced in the Federal Register on October 30, 2026; the notice itself refers to an Appendix A, and the six names are taken from pepmg's November 2 note.[23][24] pepmg did not check the 503B list.
The National Drug Code directory does return one entry. Darmerica LLC lists NDC 71052-677, generic name Pinealon Acetate, marketing category BULK INGREDIENT, powder in 1 g and 5 g containers, with marketing dates entered as April 27, 2021 to December 31, 2030.[17] FDA's page on the directory says assignment of an NDC number "does not in any way denote FDA approval of the product" and that inclusion "does not indicate that FDA has verified the information provided"; labelers submit the content themselves.[21]
The record's registered active ingredient is "PEPTIDE B27PD" at 1 g/g.[17] FDA's Global Substance Registration System defines that as a 14-residue protein sequence, ALNEDLSSWTAADT, also named "amino acids 125-138 of HLA-B" and OPTIQUEL.[19] It is a fragment of a human immune-system molecule that a Munich group gave by mouth to uveitis patients in an open trial in the 1990s.[20] It is not Glu-Asp-Arg. The mismatch is not unique to this entry: the same ingredient name is attached to ten listings from four labelers, under generic names including KPV, FGL, PE 22-28, P21 and Pinealon.[18] In these records, then, the ingredient field does not identify the product. pepmg reports what the database says and makes no claim about what any container holds.
The market
Forty vendors, sold in milligrams
pepmg's price index generated November 6, 2026 shows pinealon at 40 vendors in 58 listings. Of the 56 single-compound listings, 16 are 10 mg and 17 are 20 mg, the smallest listed size is 5 mg, and seven state no size; two further listings are nasal-spray blends.[25] For scale, the only human study that states a dose used capsules holding 100 micrograms, so the smallest vial on the index holds as much peptide as fifty of them.[3][25] That is arithmetic about quantities, not a dose recommendation. Of the five human reports, only the locomotive abstract states a route, and it is oral; the only injected use in people that pepmg found is the patent's 25 patients, and none of the sources tested a nasal spray.[10]
Questions people are asking
Has pinealon been tested in people?
Only in five small Russian reports from 2012 to 2016, all in Advances in Gerontology. None of their abstracts describes a placebo group, three of the five abstracts also name the peptide vesugen, and ClinicalTrials.gov lists no study.[1][4][5][16]
What dose did the human studies use?
One abstract states it: 100-microgram oral capsules twice a day for two weeks in locomotive crews. The inventors' US patent describes 10 days of intramuscular injections at 1 microgram, 10 micrograms or 5.0 mg in 25 head-injury patients. Reported with source and population; not a recommendation.[3][10]
Is it FDA approved?
No approval was found in Drugs@FDA, it is in none of the three categories of FDA's 503A nominations list, and it is not among the six peptides in the October 30, 2026 HHS policy.[17][22][24]
Source ledger
Documents used
- PubMed search: pinealon (22 records)National Library of Medicine, PubMed · Searched Nov. 7, 2026
- PubMed search: pinealon, "Glu-Asp-Arg" or "EDR peptide" in title or abstract (47 records, most of them unrelated uses of the amino-acid motif)National Library of Medicine, PubMed · Searched Nov. 7, 2026
- Analysis of some parameters of biological age and adaptation possibilities of workers of locomotive brigades (Russian; English abstract)Advances in Gerontology (Nazimko et al.), PubMed · 2012; read Nov. 7, 2026
- The peptide correction of neurotic disorders among professional truck-drivers (Russian; English abstract)Advances in Gerontology (Bashkireva and Artamonova), PubMed · 2012; read Nov. 7, 2026
- Effect of synthetic peptides on aging of patients with chronic polymorbidity and organic brain syndrome of the central nervous system in remission (Russian; English abstract)Advances in Gerontology (Meshchaninov et al.), PubMed · 2015; read Nov. 7, 2026
- Comparative analysis of different methods of geroprotective (Russian; English abstract)Advances in Gerontology (Myakotnykh et al.), PubMed · 2016; read Nov. 7, 2026
- Assessment of work ability index in evaluation of small peptides geroprotective effect (Russian; English abstract; MeSH-indexed to pinealon)Advances in Gerontology (Bashkireva and Kachan), PubMed · 2015; read Nov. 7, 2026
- EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease (full text, including reference list and conflict statement)Molecules (Khavinson et al.), PubMed Central · Dec. 31, 2020; read Nov. 7, 2026
- Neuroprotective effects of peptides bioregulators in people of various age (review; Russian; English abstract)Advances in Gerontology (Umnov, Lin'kova and Khavinson), PubMed · 2013; read Nov. 7, 2026
- US 8,524,674 B2: Method of improving the conditioned reflex habit, the muscle tonus, or the motion coordination of a patient after suffering trauma to the brain cortex (full text, Example 8, Tables 4 and 5, assignment record)Google Patents (inventors Khavinson, Grigoriev, Malinin and Ryzhak) · Published Sept. 3, 2013; read Nov. 7, 2026
- RU 2301678 C1: peptide stimulating regeneration of central nervous system neurons, pharmaceutical composition and method of its use (machine translation)Google Patents · Priority May 30, 2006; read Nov. 7, 2026
- Pinealon increases cell viability by suppression of free radical levels and activating proliferative processes (abstract)Rejuvenation Research (Khavinson et al.), PubMed · October 2011; read Nov. 7, 2026
- Pinealon protects the rat offspring from prenatal hyperhomocysteinemia (abstract)International Journal of Clinical and Experimental Medicine (Arutjunyan et al.), PubMed · 2012; read Nov. 7, 2026
- Neuroprotective Effects of Tripeptides-Epigenetic Regulators in Mouse Model of Alzheimer's Disease (abstract; erratum published 2025)Pharmaceuticals (Khavinson et al.), PubMed · May 27, 2021; read Nov. 7, 2026
- Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions (full text, pinealon section and reference 44)JAAOS Global Research and Reviews (Rahman, Lee and Seeds), PubMed Central · Jan. 2, 2026; read Nov. 7, 2026
- ClinicalTrials.gov searches for pinealon (0 studies), pinealon as an intervention (0) and "Glu-Asp-Arg" (0)U.S. National Library of Medicine, ClinicalTrials.gov · Searched Nov. 7, 2026
- National Drug Code directory API, generic or brand name pinealon (1 bulk-ingredient record, NDC 71052-677, Darmerica LLC); Drugs@FDA API returned no matchU.S. Food and Drug Administration, openFDA · Queried Nov. 7, 2026 (data last updated Nov. 6, 2026)
- National Drug Code directory API, active ingredient "PEPTIDE B27PD" (10 records from 4 labelers)U.S. Food and Drug Administration, openFDA · Queried Nov. 7, 2026
- Global Substance Registration System record for PEPTIDE B27PD (UNII D99LD4BK0S; sequence ALNEDLSSWTAADT; also named amino acids 125-138 of HLA-B, and OPTIQUEL)FDA and NCATS, GSRS · Read Nov. 7, 2026
- Molecular mimicry as a therapeutic approach for an autoimmune disease: oral treatment of uveitis-patients with an MHC-peptide crossreactive with autoantigen, first results (abstract)Immunology Letters (Thurau et al.), PubMed · June 1, 1997; read Nov. 7, 2026
- National Drug Code Directory (states that assignment of an NDC number does not denote FDA approval and that inclusion does not indicate FDA has verified the information)U.S. Food and Drug Administration · Content current as of March 4, 2026; read Nov. 7, 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (categories 1 to 3)U.S. Food and Drug Administration · Updated May 14, 2026; read Nov. 7, 2026
- Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Doc. 2026-22192)U.S. Department of Health and Human Services, Federal Register · Published Oct. 30, 2026; read Nov. 7, 2026
- pepmg Field Note on the HHS enforcement-discretion policy, naming the six covered peptidespepmg · Published Nov. 2, 2026
- pepmg price index, Pinealon listingspepmg · Index generated Nov. 6, 2026