Pinealon
Khavinson BioregulatorAlso known as: EDR peptide · Glutamylaspartylarginine · T-33 peptide · Pinealon cytogen
Preliminary Human
Pinealon sits in the most evidence-poor tier ClearBatch covers — a plausible-sounding Khavinson-designed tripeptide backed by roughly three decades of output from a single St. Petersburg research network, with no independent Western replication, no registered clinical trial, and no regulatory approval outside Russia's dietary-supplement framework. Human evidence is limited to small open-label Russian studies (strongest: n=72 TBI case series, no placebo), and the same network's Trofimova 2015 paper reported prooxidant activity and CD34+ hematopoietic suppression — a countersignal vendor marketing omits.
Countersignal from inside the same research network
Trofimova 2015 — a paper from the same Khavinson network that produced essentially every Pinealon study — reported prooxidant activity and CD34+ hematopoietic cell suppression with Pinealon. This directly contradicts the "antioxidant" positioning in consumer marketing and is rarely mentioned by vendors.
Research use only. Not approved for human consumption in any jurisdiction listed here unless the Regulatory Status table below explicitly states otherwise.
Evidence Tier
Preliminary Human
Human Studies
6
FDA Status
Not Nominated
WADA Status
Prohibited (S0)
Mol. Weight
418.4 Da
Last Reviewed
Apr 19, 2026
Claimed benefits by evidence tier
Column header colour matches the tier
Preliminary Human3
- Cognitive improvement in traumatic brain injury / cerebrasthenia
- Reduction of "borderline mental disorders" / stress resilience in occupational settings
- "Geroprotector" effect in polymorbid elderly (countersignal paper)
Animal Only6
- Neuroprotection against oxidative and excitotoxic stress
- Improvement of learning and memory in animal aging models
- Alzheimer-relevant neuroprotection (dendritic spine preservation)
- Huntington's disease neuroprotection
- Telomere lengthening / geroprotection
- Irisin / "exercise mimetic" effect
Unsupported3
- Circadian rhythm / sleep / "pineal function restoration"
- "Anti-Alzheimer's," "reverses aging," "treats Parkinson's / MS / encephalopathy"
- Oral bioavailability enabling at-home "nootropic" effects
Regulatory watch
FDA PCAC review of Epitalon (Khavinson-family sibling tetrapeptide, AEDG) — scheduled before the end of February 2027. Epitalon was in 503A Category 2 and is being removed after nomination withdrawal.
Although this review is about Epitalon and not Pinealon directly, its outcome is the nearest regulatory signal for the Khavinson short-peptide bioregulator class. A recommendation on Epitalon may set precedent for how the FDA characterizes Pinealon and related Khavinson cytogens if any are nominated in the future.
Broader compounded-peptide environment: FDA public docket FDA-2025-N-6895 (open through July 22, 2026) collects comment on BPC-157, KPV, TB-500, MOTs-C, and related peptides ahead of the July 23–24, 2026 PCAC meeting.
Pinealon is NOT on this agenda, but the meeting is expected to shape the FDA's overall stance on short peptide bioregulators sold as research chemicals — indirectly relevant to how Pinealon will be treated if it is ever nominated.
Expected 2026-07-24 · Docket FDA-2025-N-6895 · Source
Vendors selling Pinealon
Found 5 vendors currently offering Pinealon in their catalog.
🇪🇺Particle Peptides
Slovakia
COA Coverage
25/25
100%
✓ HPLC✓ MS✓ Endo✓ Ster✓ Metals
Verified Peptides
COA Coverage
138/138
100%
✓ HPLC✓ MS✓ Endo✓ Ster— Metals
🇺🇸Soma Chems
USA
COA Coverage
60/64
94%
✓ HPLC✓ MS✓ Endo— Ster— Metals
🇺🇸BioLongevityLabs
USA
COA Coverage
43/89
48%
✓ HPLC✓ MS✓ Endo✓ Ster— Metals
🇺🇸Core Peptides
USA
COA Coverage
18/103
17%
✓ HPLC✓ MS— Endo— Ster— Metals
All Pinealon products
Every Pinealon product across 5 verified vendors — sorted by vendor trust tier, then by COA purity (quantified reports beat unquantified), then by most recent COA date.
| Vendor | Product | Size | COA Date | Purity | Lab | COA |
|---|---|---|---|---|---|---|
| Particle Peptides Recommended | Pinealon 10mg | 10mg | 2025-07-29 | 96.35% | LiquilabsTier 3 — Limited | View |
| Soma Chems Trusted | Pinealon | — | 2026-02-13 | 99.76% | Freedom Diagnostics TestingTier 4 — Unverifiable | View |
| Verified Peptides Trusted | Pinealon Peptide Purity | — | 2025-11-13 | — | Janoshik AnalyticalTier 1 — Established | View |
| BioLongevityLabs Unrated | Pinealon (20mg) | 20mg | — | — | — | — |
| Core Peptides Unrated | Pinealon (20mg) | 20mg | — | — | — | — |
About this peptide
Plain English
Pinealon is a very short synthetic peptide — just three amino acids glued together — designed by Russian researcher Vladimir Khavinson and his group in St. Petersburg. It is one of a larger family of "short peptide bioregulators" they developed and marketed in Russia as dietary supplements. The theory behind it is that the peptide is small enough to slip inside cells and even the cell nucleus and influence which genes turn on, particularly in the brain. Most of the actual research behind these claims has been done in rats, mice, and cells in a dish. There is very little independent, Western-replicated human data, and Pinealon is not approved as a medicine in the United States, Canada, the United Kingdom, the EU, or Australia.
Technical
Pinealon is the tripeptide Glu-Asp-Arg (EDR), one of several "cytogen" short peptides generated by the Khavinson laboratory by fragmenting bovine/porcine brain cortex extracts (Cortexin) and synthesizing the proposed active sequence. The literature proposes a non-receptor mechanism: EDR is thought to enter cells and nuclei directly (shown in HeLa cells with FITC-labeled peptide), bind preferentially to d(CCTGCC)/d(CCAGC)/CNG and CAG-containing motifs in the major groove of dsDNA, and modulate transcription of genes relevant to antioxidant defense (SOD2, GPX1), apoptosis (CASP3, p53), PPAR signaling (PPARA, PPARG), and monoamine synthesis (TPH1). Virtually all functional evidence is from the Khavinson group and collaborators, published mostly in Russian journals (Bull. Exp. Biol. Med., Adv. Gerontol.) with limited peer-reviewed international replication. Human data are limited to small open-label studies from the same institute network.
Mechanism of action
Cell and nuclear penetration
FITC-labeled Pinealon labels cytoplasm, nucleus, and nucleolus in HeLa cells, implying passive or semi-active translocation without a receptor. The proposed nuclear access is the foundation for all downstream DNA-binding claims.
Proposed direct DNA binding
Molecular modeling and fluorescence quenching suggest preferential binding to d(CCTGCC)2, d(CCAGC)2, and CNG/CAG-containing oligonucleotides. Binding specificity in vivo has not been independently validated.
Reactive oxygen species suppression
Reduces ROS accumulation in rat cerebellar granule cells, PC12 cells, and human neutrophils under ouabain, H2O2, or homocysteine stress in vitro.
Delayed ERK1/2 activation
Extends the lag phase of MAPK/ERK activation under oxidative stress in rat cell culture; proposed as part of the neuroprotective signaling story.
Antioxidant enzyme induction (SOD2, GPX1)
Raises SOD2 and GPX1 activity in hypoxia-sensitive rat brain toward levels observed in hypoxia-resistant rats.
Caspase-3 / p53 modulation
Reduces caspase-3 activity in aged rat brain after hypoxic hypoxia and alters p53-related apoptotic signaling. Reduced apoptotic clearance of damaged cells is a theoretical long-term safety concern not evaluated in any long-duration study.
PPARA / PPARG transcriptional binding (in silico)
Proposed binding motifs identified in PPARA and PPARG promoters through in silico scanning only — no functional ChIP or reporter-assay validation published.
TPH1 / serotonin synthesis
Increases serotonin expression in rat brain cortex cultures; one predicted TPH1 promoter binding site.
Every mechanistic claim above derives from the Khavinson research network (St. Petersburg Institute of Bioregulation and Gerontology and direct collaborators). There is no independent replication in Western labs of the proposed sequence-specific DNA-binding mechanism, and the idea that a naked, charged tripeptide efficiently crosses plasma and nuclear membranes to exert transcriptional effects is not a mainstream pharmacological model. Most of the downstream gene-regulation claims (PPARA, PPARG, TPH1 binding) come from in silico promoter scanning rather than functional ChIP or reporter assays. Treat the mechanism as "proposed by one research school" rather than "established."
Key studies
Independence warning: most efficacy evidence for this peptide originates from a single research group or single clinical group. Replication by independent groups is limited.
Pinealon Increases Cell Viability by Suppression of Free Radical Levels and Activating Proliferative Processes (2011)
Khavinson V.Kh., Lin'kova N.S., Tarnovskaia S.I., Umnov R.S., Elashkina E.V., Durnova A.O. · Rejuvenation Research 14(5):535–541
- Participants
- Rat cerebellar granule cells, human neutrophils, PC12 pheochromocytoma cells (all cell culture)
- Methodology
- Induced oxidative stress with ouabain, homocysteine, H2O2, or zymosan; measured ROS, propidium-iodide necrosis, and ERK1/2 phosphorylation timing with vs without Pinealon.
- Result
- Dose-dependent reduction of ROS and necrosis; delayed ERK1/2 activation.
Honest read
In vitro only. Single research group. No independent cell-biology replication in the 15 years since. ROS quenching in a dish is mechanistically plausible for any charged small molecule and is a low-bar assay. Relevance to human cognition is unestablished.
Pinealon protects the rat offspring from prenatal hyperhomocysteinemia (2012)
Arutjunyan A.V., Kozina L.S., Stvolinskiy S.L., Bulygina Y.V., Mashkina A.P., Khavinson V.Kh. · Int J Clin Exp Med 5(2):179–185
- Participants
- Pregnant Wistar rats loaded with methionine to induce hyperhomocysteinemia; 3 groups, 6 families each, 23 pups per behavioral arm
- Methodology
- 10 µg/kg i.p. Pinealon to pregnant dams; Morris water maze in 45-day-old pups; flow cytometry ROS/PI on cerebellar granule cells from 10-day-old pups.
- Result
- Pinealon-treated pups had normal body weight, better spatial navigation, fewer necrotic neurons, and lower ROS vs methionine-only pups. Plasma homocysteine unchanged.
Honest read
Small animal study with non-blinded outcome measurement and small sample (~23/arm for behavior, n=4–5 for chemistry). Affiliation: D.O. Ott Institute + Khavinson's own Institute of Bioregulation and Gerontology — not an independent group. Model is disease-specific (prenatal hyperhomocysteinemia), not a generalizable aging model. The Int J Clin Exp Med is a low-impact, frequently-criticized venue.
Penetration of short fluorescence-labeled peptides into the nucleus in HeLa cells and specific interaction of the peptides with deoxyribooligonucleotides and DNA in vitro (2011)
Fedoreyeva L.I., Kireev I.I., Khavinson V.Kh., Vanyushin B.F. · Biochemistry (Moscow) 76(11):1210–1219
- Participants
- HeLa cell cultures; in vitro FAM-labeled oligonucleotides for Stern-Volmer quenching
- Methodology
- FITC-labeled Pinealon, Epithalon, Testagen incubated with HeLa cells; fluorescence imaging of cytoplasm/nucleus/nucleolus; Stern-Volmer quenching with FAM-labeled oligonucleotides.
- Result
- All three peptides found in nuclei; Pinealon quenched CAG- and CNG-containing sequences preferentially.
Honest read
FITC-peptide localization is notoriously artifact-prone — fluorophore alone can drive cellular uptake, and fixation-induced redistribution is a known issue in the broader cell-penetrating-peptide literature (see Wikipedia/CPP). The study does not address whether unlabeled EDR penetrates comparably, nor whether the binding is strong/specific enough to matter at physiological concentrations. This is the single cited source for most downstream "direct DNA regulator" claims.
Neuroprotective effects of peptide bioregulators in people of various age (2013)
Umnov R.S., Linkova N.S., Khavinson V.Kh. · Adv Gerontol 26:671–678
- Participants
- 72 patients with TBI sequelae and "cerebrasthenia"
- Methodology
- Open-label, no placebo comparator described, subjective memory/headache outcomes plus EEG alpha-index. Oral Pinealon alongside standard therapy.
- Result
- Reported improvement.
Honest read
Russian-language journal, open-label, no randomization, no placebo, no blinded rating, outcome measures self-reported. Authors all affiliated with the institute that developed and profits from Pinealon. This is the strongest "human" evidence currently claimed, and it would not pass a first-pass screen at any systematic review.
Peptide correction of the borderline mental disorders in the truck drivers (2012)
Bashkireva A.S., Artamonova V.G. · Adv Gerontol 25(4):718–728
- Participants
- 150 male truck drivers vs 150 metal craftsmen
- Methodology
- Open-label peptide intervention (Pinealon + Vesugen combination) versus no-intervention comparator.
- Result
- Combined cytogens produced the "best" improvement in psychoemotional state.
Honest read
Confounded — Pinealon was not isolated from Vesugen. Cross-trade comparison is inherently non-equivalent. No placebo. No blinding. Outcomes are questionnaire-based self-report. Reasonable hypothesis-generator, not evidence of efficacy.
Synthetic peptides for correction of molecular-cellular mechanisms of aging in elderly polymorbid patients (2015)
Trofimova S.V., Umnov R.S., Linkova N.S. · Adv Gerontol 28(3):432–439
- Participants
- 32 polymorbid patients aged 41–83
- Methodology
- Compared Pinealon and Vesugen effects on cellular/molecular aging markers.
- Result
- Vesugen outperformed Pinealon on geroprophylactic markers. Notably, Pinealon showed evidence of PROOXIDANT activity by chemiluminescence and suppression of CD34+ hematopoietic cell markers, which the authors described as inhibition of hemopoiesis.
Honest read
This is a significant countersignal to the "Pinealon = antioxidant" narrative in the marketing literature. The same research network reporting this finding should not be glossed over. Needs independent confirmation before drawing conclusions either way.
Neuroprotective Effects of Tripeptides EDR and KED in an In Vivo 5xFAD Model of Alzheimer's Disease (2021)
Khavinson V., Ilina A., Kraskovskaya N., Linkova N., Kolchina N., Mironova E., Erofeev A., Bezprozvanny I. · Pharmaceuticals 14(6):515
- Participants
- 5xFAD-M transgenic mice (Alzheimer's model)
- Methodology
- EDR and KED peptides administered IP; dendritic spine morphology quantified.
- Result
- Both peptides prevented loss of mushroom-shaped dendritic spines.
Honest read
Same research group; MDPI's Pharmaceuticals has a more variable review standard than top neuroscience journals. Dendritic spine preservation is a surrogate endpoint, not cognitive function. No Western replication.
Research timeline
- 2007
Khavinson group files Russian and European patents describing short peptides stimulating CNS neuron regeneration, including EDR/Pinealon (EP 2024388 / WO 2007/139431).
- 2008
Kozina et al., Doklady Biological Sciences 418:419 — first reports of in vivo antihypoxic effects of short peptides including Pinealon in rats.
- 2011
Fedoreyeva et al. show FITC-labeled Pinealon penetrates HeLa cell nuclei and binds specific oligonucleotides. Foundational mechanistic paper.
- 2011
Khavinson et al., Rejuvenation Research — foundational cell-viability / ROS study in rat cerebellar granule cells, PC12, and human neutrophils.
- 2012
Arutjunyan et al., Int J Clin Exp Med — prenatal hyperhomocysteinemia rat pup behavioral study.
- 2012
Bashkireva & Artamonova — first occupational human intervention study; Pinealon combined with Vesugen in 150 truck drivers.
- 2013
Umnov, Linkova, Khavinson TBI/cerebrasthenia case series (n=72) — still the largest human Pinealon report in the literature.
- 2014
Mendzheritskii et al., Adv Gerontol — hypoxic hypoxia in aged rats; caspase-3 modulation reported.
- 2015
Trofimova et al. polymorbidity/organic brain syndrome case series — COUNTERSIGNAL: prooxidant activity and CD34+ hematopoietic suppression observed with Pinealon.
- 2017
Kraskovskaya et al. — dendritic spine preservation in 5xFAD Alzheimer mouse model.
- 2019
Georgievna et al. — 2-macaque preliminary report in a Moscow University anthropology bulletin (not well-indexed in Western databases).
- 2020
Khavinson et al. mechanistic review in Molecules — most-cited recent synthesis.
- 2021
Khavinson et al., Pharmaceuticals 14:515 — 5xFAD Alzheimer's mouse neuroprotection with EDR and KED tripeptides.
- 2024
Vladimir Khavinson dies. Research program continues under collaborators (Linkova, Trofimova, Popugaeva, Kraskovskaya); future trajectory and independence of the Pinealon literature is uncertain.
- 2026
ClearBatch verification pass (April 2026): no registered Phase I/II/III trial identified for Pinealon in ClinicalTrials.gov or the EU Clinical Trials Register, and no FDA 503A nomination has ever been submitted.
What we don't know
- Pharmacokinetics — no published human PK data. Oral bioavailability, plasma half-life, brain penetration, and metabolism of intact EDR vs hydrolysis to free amino acids are all uncharacterized.
- Whether oral EDR survives the gut — tripeptides are cleaved by brush-border peptidases, and there is no evidence that orally-administered Pinealon reaches the brain intact at physiologically meaningful concentrations in humans.
- Specificity of DNA binding in vivo — in-silico promoter-motif matches (CCTGCC, CCAGC) are extremely short and occur many thousands of times across the genome; evidence of genuine functional selectivity is absent.
- Human efficacy for any claimed indication — no RCT, no systematic review, no replication outside Russia.
- Dose-response in humans — the 10 mg/capsule oral dose used commercially is picked by analogy, not clinical titration.
- Long-term safety — no trials exceeding a few weeks in duration with formal adverse-event tracking.
- Drug interactions — not formally studied.
- Reproductive and developmental safety in humans — not studied; rat prenatal data is the only signal, and the vendor literature warns against use in pregnancy/breastfeeding.
- Purity and identity of commercial material — whether vendor-sold Pinealon is actually the intended L-Glu-L-Asp-L-Arg sequence rather than diastereomers, cyclic products, or truncation products is rarely independently verified.
- Cross-precedent: the FDA PCAC review of Epitalon (Khavinson-family sibling peptide) scheduled for February 2027 may set precedent for how the FDA characterizes short Khavinson peptide bioregulators generally.
Regulatory status
| Jurisdiction | Status | Details | Last Verified | Source |
|---|---|---|---|---|
| United States (FDA) | Not Nominated | Pinealon was NEVER nominated to the FDA 503A bulks list and does not appear in any category (1, 2, or 3) of the Bulk Drug Substances Nominated for Use in Compounding Under Section 503A as of April 15, 2026. It is also not an FDA-approved drug: no NDA or IND is on file, and there is no USP/NF monograph. Consequently, Pinealon has no lawful pathway into US traditional compounding. For cross-reference, Epitalon (the Khavinson-family sibling peptide) was on the Category 2 list and is being removed after nomination withdrawal, with PCAC review scheduled before the end of February 2027 — that meeting's outcome may set precedent for how the FDA characterizes Khavinson-family short peptide bioregulators generally. Additionally, the DoD Operation Supplement Safety program's general prohibition on unapproved drugs and peptide hormones (DoDI 6130.06) applies to service members even though Pinealon is not specifically named in the OPSS prohibited-ingredients database. | 2026-04-19 | |
| Canada (Health Canada) | Not Authorized | No Natural Product Number (NPN) identified for Pinealon in the Health Canada Licensed Natural Health Products Database. No Drug Identification Number (DIN) as a drug. Not listed in the Natural Health Products Ingredients Database as an approved medicinal ingredient. There is no legal Canadian route for Pinealon as a prescription medicine, compounded preparation, or regulated natural health product. | 2026-04-19 | |
| United Kingdom (MHRA) | Not Authorized | No MHRA marketing authorization identified. Not in the MHRA approved medicines register. Unapproved peptide products are treated as unlicensed medicines in the UK and cannot be legally supplied to the public. | 2026-04-19 | |
| European Union (EMA) | Not Authorized | No EMA central marketing authorization identified. No CHMP opinion on record. Not on the EMA list of authorized centralized products. Sold in some EU countries as a Russian-imported dietary supplement with contested legal status. | 2026-04-19 | |
| Australia (TGA) | Not Authorized | Not included in the Australian Register of Therapeutic Goods (ARTG). The TGA's April 2026 public safety notice on unapproved peptides warns that imported or compounded peptides without ARTG entry are illegal and have been associated with anaphylaxis, systemic inflammatory response syndrome, hospitalization, and infection events. Pinealon is captured under this class-level warning. | 2026-04-19 | |
| WADA | Prohibited (S0) | Not specifically named on the 2026 WADA Prohibited List. Falls under S0 (Non-Approved Substances) by default — the catch-all for any pharmacological substance with no current approval by any governmental regulatory health authority for human therapeutic use. Prohibited at all times (in-competition and out-of-competition) with no Therapeutic Use Exemption available. This framing distinguishes Pinealon from BPC-157 (specifically named S0) and tesamorelin (specifically named under S2.1.2): Pinealon is captured by regulatory default rather than by name. | 2026-04-19 |
Safety profile
Reported side effects
- Vendor and Russian dietary-supplement literature describes Pinealon as well-tolerated; no peer-reviewed pharmacovigilance data exists
- Injection-site reactions (theoretical, class risk for any injectable peptide)
- Fatigue, lightheadedness (anecdotal, secondary sources)
- GI upset (anecdotal, secondary sources)
- Flu-like symptoms (anecdotal, secondary sources)
- Allergic reactions (theoretical, class risk for any injectable peptide)
Theoretical concerns
Prooxidant activity and CD34+ hematopoietic cell suppression
Trofimova 2015 — from inside the Khavinson network itself — reported prooxidant chemiluminescence activity and suppression of CD34+ hematopoietic cell markers with Pinealon in polymorbid elderly patients. This directly contradicts the "pure antioxidant" marketing narrative. It is a concrete biomarker finding, not a theoretical extrapolation, and should be independently confirmed before broad use.
Severity: documented
Theoretical tumorigenic risk from caspase-3 / p53 suppression
Reported suppression of caspase-3 and p53 could in principle reduce normal apoptotic clearance of damaged or transformed cells. This theoretical concern has not been evaluated in long-term animal or human studies and remains speculative.
Severity: theoretical
Class-level risks of unapproved injectable peptides
The TGA has documented anaphylaxis, systemic inflammatory response syndrome, systemic hypersensitivity, infection, local tissue damage, and musculoskeletal events (plantar fasciitis, Achilles tendinitis) associated with unapproved compounded/imported peptides as a class. Pinealon is captured by these class-level risks even though no Pinealon-specific adverse-event series has been published.
Severity: possible
Purity and counterion uncertainty in research-grade material
Research-grade Pinealon is typically shipped as an acetate or TFA salt with limited independent analytical verification. Residual TFA above ~0.5% can be cytotoxic in cell assays and can confound "antioxidant" readouts. COAs lacking peptide-content % distinct from chromatographic purity %, counterion identity, ESI-MS confirmation, and chiral/stereochemistry verification have not actually demonstrated what is in the vial.
Severity: possible
Contraindications
- Pregnancy (per Garmonia vendor labeling; no human reproductive data)
- Breastfeeding (per Garmonia vendor labeling; no lactation data)
- Under age 18 (per Garmonia vendor labeling)
- Individual hypersensitivity to the product
Interactions
- No formal drug-interaction studies in humans have been conducted. Absence of known interactions should not be interpreted as absence of interactions.
Dosing observed in the literature
These are doses observed in published research (animal models, cell culture, and small open-label Russian human studies) and on a Russian dietary-supplement label. They are not dosing recommendations. Pinealon is not approved for human therapeutic use in the United States, Canada, the United Kingdom, the European Union, or Australia. No human pharmacokinetic data exists to support dose extrapolation. Content is for research reference only and is not medical advice.
| Route | Range | Context | Source |
|---|---|---|---|
| intraperitoneal | 10 µg/kg/day × 5 days (pregnant rats) | Prenatal hyperhomocysteinemia rat model; given to pregnant dams before methionine loading. | PMC3342713 |
| intraperitoneal | 400 µg/kg/day (5xFAD mice, 2–4 months of age) | Alzheimer's mouse model dendritic-spine preservation study. | Source |
| oral | 10 mg/capsule, 1–2 capsules 2–3×/day × 30 days; cycle every 3–6 months | Russian dietary-supplement labeling for the commercial "Pinealon cytogen" capsule (Garmonia Ltd / NPCRIZ). This is the manufacturer schedule, not a clinical dosing recommendation. | Source |
| oral | Oral administration alongside standard therapy; exact dose not standardized in English-language abstract | Umnov/Linkova/Khavinson 2013 TBI case series (n=72). | PMID:24738258 |
| other | 10^-8 to 10^-6 M (cell culture concentrations) | Cerebellar granule cells and HeLa cells, in vitro. | PMID:21978084 |
Stability & handling
- Lyophilized shelf life
- Typically labeled 2–3 years at −20°C sealed and desiccated; 0–4°C acceptable for weeks
- Lyophilized storage
- Freeze at −20°C or below, sealed and desiccated; protect from light and moisture
- Reconstitution diluents
- Sterile physiological saline or bacteriostatic water (research use), Sterile water or PBS (cell culture)
- Reconstituted (refrigerated)
- Short (days to ~2 weeks) refrigerated at 2–8°C
- Reconstituted (room temp)
- Not recommended for extended periods — stability not characterized
- OK to refreeze
- No
- Light sensitive
- Yes — protect from light
EDR has a small MW (~418) and is prone to hygroscopic mass gain; keep desiccated. Do not refreeze thawed reconstituted solution — repeated freeze/thaw cycles increase hydrolysis and adsorption loss. If long-term frozen storage is needed, divide reconstituted solution into single-use aliquots at reconstitution time and thaw each aliquot only once. No peer-reviewed stability characterization (e.g., forced degradation studies with mass spec) of Pinealon specifically has been identified in the primary literature; the values above are vendor-derived.
Frequently asked questions
Is Pinealon legal to buy in the US?
As a research chemical sold with "not for human consumption" labeling, vendors operate in a gray zone — the FDA has sent warning letters to other vendors selling "research" peptides that are actually intended for human use. Pinealon is not an FDA-approved drug, is not on the 503A list (not even nominated), cannot be legally compounded for human use in the US, and has no lawful pharmacy channel. Personal import for human consumption is not lawful.
Can my doctor prescribe Pinealon?
No. Because it is not FDA-approved and not on the 503A list, no US pharmacy can lawfully compound it, and no physician can lawfully prescribe it within the US compounding framework. Some clinics nevertheless do.
Is it banned by WADA?
It is not named on the 2026 Prohibited List but falls under the catch-all category S0 — Non-Approved Substances, prohibited at all times for competing athletes, because no governmental regulator has approved it for human therapeutic use. This is the same default-capture that applies to any unapproved peptide and is distinct from BPC-157 (specifically named under S0) and tesamorelin (specifically named under S2.1.2).
Does the oral capsule actually work after swallowing?
Unknown. No published human pharmacokinetic study demonstrates that oral EDR survives gastrointestinal peptidases and reaches the bloodstream or brain intact. The commercial Russian capsules (Garmonia / NPCRIZ) are sold on the strength of in-house, mostly open-label, Russian-language reports.
Pinealon vs Epitalon — what's the difference?
Both come from the Khavinson program. Epitalon (Ala-Glu-Asp-Gly, AEDG) is a tetrapeptide associated with claimed pineal/telomerase effects and has a larger (still mostly single-group) literature. Pinealon (EDR) is a tripeptide positioned as the neuroprotective cousin. They are NOT the same peptide and should not be conflated. Epitalon has been in FDA 503A discussions; Pinealon has not.
What's the best human evidence for Pinealon?
Honestly, nothing that would satisfy a Western regulator. The strongest pieces are the Umnov/Linkova/Khavinson 2013 TBI case series (n=72, open-label, no placebo) and the Bashkireva/Artamonova truck-driver study (which used Pinealon and Vesugen combined, not Pinealon alone). Both are from the Khavinson institute network and were published in Russian-language gerontology journals.
Is it safe?
No regulator has evaluated it. The single-group Russian literature describes it as well-tolerated in small samples, but a 2015 paper from the same network (Trofimova et al.) reported prooxidant chemiluminescence activity and suppression of CD34+ hematopoietic cell markers. Long-term safety is unstudied, and the same class of unapproved compounded/imported peptides has been associated with anaphylaxis, SIRS, hospitalization, and infection per the TGA.
Why does so much of the marketing copy sound impressive?
Because the Khavinson group published a very large number of papers over four decades, mostly in Russian journals and mostly in-house. Vendors quote the sheer volume and use phrases from those papers. Volume of publication is not the same as independent replication or regulatory acceptance — a distinction that is easy to lose on vendor pages.
Is it the same as "Cortexin"?
No. Cortexin is the original animal-derived polypeptide mixture from bovine/porcine cerebral cortex used as a prescription neuroprotective drug in Russia. Pinealon is a single synthetic tripeptide (EDR) that was identified as a fragment of Cortexin and is marketed separately. Conflating them is a common marketing-copy error.
What should I look for on a Pinealon COA?
A Pinealon COA should report four things, separately: (1) peptide content (%) distinct from HPLC purity (%) — stated vial masses often represent salt weight, not peptide content; (2) counterion identity (acetate vs TFA) and % by mass — residual TFA above ~0.5% can be cytotoxic; (3) ESI-MS confirmation of the 418-Da molecular ion; (4) chiral/stereochemistry verification (chiral HPLC or NMR) — charged tripeptides with Glu and Asp side chains are prone to aspartimide formation yielding β-Asp and D-Asp impurities. Endotoxin (LAL) testing is also relevant for any injectable-intended peptide. A COA that reports only "HPLC purity ≥98%" without the above has not actually demonstrated what is in the vial. ClearBatch's vendor pages show which of these signals are published per batch.
Last researched: Apr 19, 2026