Onset
Not established; same-course reports are anecdotal or drawn from a small clinical description.
Protocol / Research Dosing Guide
Pinealon Dosage Guide: Oral Trial Evidence, Reconstitution and Safety
An evidence-organized Pinealon reference that keeps the small published Russian oral study separate from the subcutaneous vial titrations circulated in research communities.
Last reviewed September 16, 202617 minute readResearch information only
Level 3 — Limited published human reportNo Western randomized controlled trialNot FDA approved
Pinealon Quick Start
Pinealon is a three-amino-acid peptide (Glu-Asp-Arg) developed by Vladimir Khavinson's group at the St. Petersburg Institute of Bioregulation and Gerontology. Animal work reports neuroprotective and antioxidant activity in neuron cultures and in offspring of rats with experimental hyperhomocysteinemia. The only human report identified is a small, Russian-language clinical description involving patients with consequences of traumatic brain injury and cerebrasthenia. No Western randomized controlled trial of Pinealon has been published, and the subcutaneous vial schedule sold to research communities has not itself been tested.
Why researchers care
Brain aging, oxidative stress resistance, memory and cerebrasthenia research
Class
Synthetic tripeptide bioregulator, Glu-Asp-Arg (EDR peptide)
Route reported
Oral capsule in the published report; subcutaneous injection in community protocols
Cycle length
10–20 day course reported, repeated 2–3 times per year
Regulatory status
Not FDA approved for any human use
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Pinealon Dosing Protocol and Schedule
The supplied source describes a common 20 mg subcutaneous vial reconstituted with 3.0 mL bacteriostatic water, with a community titration of 1.0–2.0 mg once daily for 10–20 days, and a separate oral pattern of a single 20 mg capsule daily for the same 10–20 day window. It states that oral bioavailability of the peptide has not been precisely quantified in published work.
| Phase or study | Amount | Frequency / evidence |
|---|---|---|
| Oral (reported pattern) | 20 mg once daily | Reported in Khavinson-group literature |
| Subcutaneous, Days 1–5 | 1.0 mg once daily | Community reported |
| Subcutaneous, Days 6–14 | 1.5 mg once daily | Community reported |
| Subcutaneous, Days 15–20 | 2.0 mg once daily | Community reported |
| Cycle length | 10–20 days, extendable to 28 days in some sources | Mixed community and reported |
| Off period | 2–3 months between cycles | Community reported, matches reported oral spacing |
The oral capsule pattern is the route described in the small published clinical report. The subcutaneous milligram figures and their titration steps are a community construction built around a commercial 20 mg vial; no injectable dose-finding study was identified.
Pinealon Supplies Needed
Neutral research-material planning only. This does not establish an appropriate amount or route.
Research planning item
Exact labeled research vial (commonly 10 mg or 20 mg)
Research planning item
Bacteriostatic water at a measured volume
Research planning item
U-100 insulin syringes
Research planning item
Alcohol prep swabs
Research planning item
Sharps container
Research planning item
Refrigeration for the prepared vial
Research planning item
Written concentration label with the preparation date
Pinealon Reconstitution Calculator
Vial-format concentration math
Concentration
5 mg/mL
Draw volume
0.2 mL
U-100 units
20
Mathematical draws
10
Arithmetic only. The entered amount is not a recommendation and does not establish suitability.
Best Time to Take Pinealon: Morning or Night?
Morning or evening?
Morning or early afternoon is the community pattern; no study compared times of day.
Daily or spaced?
Once daily is both the reported oral pattern and the community injectable pattern.
With food?
Not established for either route.
Missed amount?
No validated replacement procedure exists for either route.
Pinealon Route Comparison
| Format | What is reported | Evidence limit |
|---|---|---|
| Oral capsule | 20 mg once daily in the published clinical description | The only route with a published human report |
| Subcutaneous | 1.0–2.0 mg once daily in community titrations | No published human injection study |
| Route conversion | Not established | Oral and subcutaneous exposure are not interchangeable |
Routes and amounts are not interchangeable unless a verified study explicitly establishes a conversion.
Pinealon Half-Life and Dosing Frequency
| Measure | Finding | Evidence limit |
|---|---|---|
| Human plasma half-life | Not established | No human PK study was identified |
| Oral bioavailability | Not precisely quantified in published work | PEPT2 transport is proposed but not measured for Pinealon |
| Animal distribution | Not established as a published figure for Pinealon specifically | Related bioregulator mechanism work only |
| Frequency logic | Once daily is a reported convention | Not derived from pharmacokinetics |
Pinealon Dosage Chart
| Route | Amount | Frequency | Source | Human validation |
|---|---|---|---|---|
| Oral | 20 mg | Once daily | Reported clinical description | No |
| Subcutaneous | 1.0 mg | Once daily | Community report | No |
| Subcutaneous | 1.5 mg | Once daily | Community report | No |
| Subcutaneous | 2.0 mg | Once daily | Community report | No |
Published study values describe those studies. Community-reported values are not validated dosing recommendations.
Pinealon Reconstitution Guide
Concentration: 5 mg/mL
| Entered amount | Volume | U-100 units |
|---|---|---|
| 1 mg | 0.2 mL | 20 units |
| 2 mg | 0.4 mL | 40 units |
| 3 mg | 0.6 mL | 60 units |
- 1.Confirm the exact quantity printed on the vial.
- 2.Choose and record the bacteriostatic water volume; 20 mg into 3.0 mL gives about 6.67 mg/mL.
- 3.Clean the stopper with an alcohol swab.
- 4.Add the liquid slowly down the vial wall.
- 5.Swirl gently until clear; never shake.
- 6.Inspect for cloudiness, color or particles and discard anything that is not clear.
- 7.Label the vial with the concentration and the preparation date.
- 8.Refrigerate the prepared vial and use only the calculated concentration for arithmetic.
Reconstitution does not establish identity, purity, sterility, stability, or an appropriate amount.
How Pinealon Works
Structure
Pinealon is a synthetic tripeptide, Glu-Asp-Arg, one of the short peptide bioregulators from the Khavinson group.
Pinealon Human Trials and FDA Status
Current status · verified September 16, 2026
Not FDA approved for any human use
- A published animal study reported that Pinealon improved spatial learning and reduced oxidative markers in the offspring of rats with experimental hyperhomocysteinemia.
- A published in vitro and in vivo review describes EDR peptide effects on gene expression tied to Alzheimer's disease pathogenesis in animal and cell models.
- A small Russian-language clinical report describes oral Pinealon use in adult patients with consequences of traumatic brain injury and cerebrasthenia; sample size and controls are not detailed to Western trial-registry standards in the source reviewed.
- No published randomized controlled human trial of Pinealon was identified, and no injectable human study was identified.
Who Should Avoid Pinealon?
This is an evidence-gap and precaution list, not an approved prescribing label.
Pregnancy or breastfeeding
No human safety data
Children or adolescents
No established protocol
Active cancer or history of malignancy
Effects of gene-expression-modulating peptides in this setting are not characterized
Known ingredient sensitivity
No characterized allergy profile
Concurrent neurologic or psychiatric medicines
No interaction studies
Long-term or repeated use
No long-term human safety data
Pinealon Side Effects, Risks and Safety
Injection-site redness or irritationAnecdotal
Important limitation: No controlled incidence data for the subcutaneous route.
HeadacheAnecdotal
Important limitation: No controlled incidence data.
Sleep or mood changesAnecdotal
Important limitation: Causality is not established.
Allergic responseUnknown
Important limitation: No characterized safety dataset.
Drug interactionsUnknown
Important limitation: No interaction studies.
Long-term effectsUnknown
Important limitation: No extended follow-up beyond the small reported course.
Pinealon Timeline and Monitoring
Course length
10–20 days is the reported and community-echoed window, extendable to 28 days in some sources.
Rest interval
2–3 months between courses is reported, matching the oral pattern described in the source.
Monitoring
No validated Pinealon monitoring schedule or stopping rule exists.
Pinealon Benefits and Results: What the Evidence Shows
| Claim | Evidence level | What research shows | Important limitation |
|---|---|---|---|
| Memory support in TBI-related cerebrasthenia | Limited human report | Small Russian clinical description | Not replicated in a Western trial |
| Oxidative stress resistance | Animal and cell culture | Rat and neuron-culture studies | Not measured in humans |
| General cognitive or focus claims | Not established | Community and vendor claims | No controlled human data |
| Neuroprotection in Alzheimer's-model systems | Preclinical | Mouse and cell-culture gene-expression work | Human relevance not established |
Pinealon Storage and Handling
Lyophilized powder
Freezer storage is the commonly reported condition for unreconstituted research vials; follow the exact product label.
Prepared vial
Refrigerate at 2–8 °C; no validated Pinealon-specific stability duration was identified for the reconstituted solution.
Oral capsules
Follow the manufacturer label; no independent stability study was identified.
Appearance
A clear, colorless solution is expected; cloudiness or particles mean discard.
Pinealon Troubleshooting
Solution appears cloudy
Discard and do not inject; appearance cannot confirm sterility.
Calculated units look wrong
Recheck vial quantity, diluent volume, target amount and U-100 conversion.
Oral and injectable amounts conflict
No validated route conversion exists between the reported 20 mg oral dose and any injectable amount.
Unexpected symptoms occur
No Pinealon safety protocol exists; seek licensed clinical review.
A scheduled dose is missed
No validated missed-dose procedure exists.
Pinealon Comparisons
| Compound | Class or mechanism | Evidence | FDA status |
|---|---|---|---|
| Pinealon | EDR tripeptide bioregulator | Small published human report, animal studies | Not FDA approved |
| Epitalon | AEDG tetrapeptide bioregulator | Small Russian trials on aging biomarkers | Not FDA approved |
| Semax | ACTH(4–7) analogue | Larger published Russian clinical literature | Not FDA approved |
| Selank | Tuftsin analogue anxiolytic | Published Russian anxiolytic trials | Not FDA approved |
Pinealon Frequently Asked Questions
What is Pinealon?
A synthetic three-amino-acid peptide, Glu-Asp-Arg, developed by the Khavinson group and studied mainly for brain aging and oxidative stress resistance.
Is Pinealon FDA approved?
No. It has no FDA-approved human use.
Is there a human trial?
A small Russian-language clinical report describes oral use in patients with traumatic brain injury consequences and cerebrasthenia. No Western randomized controlled trial was identified.
Is the subcutaneous schedule validated?
No. The vial titration is a community construction, not a tested injectable protocol.
What is its half-life?
Not established in the sources reviewed.
Is oral bioavailability known?
No. Researchers propose a PEPT2 transport mechanism, but exact human bioavailability has not been quantified.
Can animal findings be applied directly to humans?
No. Animal and cell-culture results describe biological plausibility, not confirmed human effects or doses.
Is there a validated rest period?
The reported 2–3 month spacing between courses reflects the oral literature pattern; it has not been independently validated for the injectable route.
What does the calculator do?
It converts entered vial and liquid values into concentration and U-100 volume math only.
Is long-term safety known?
No. No extended human safety dataset was identified.
Are Pinealon and other bioregulator peptides interchangeable?
No. Each short peptide bioregulator (Epitalon, Semax, Selank, Pinealon) has a distinct sequence and separate evidence base.
Sources and Research
Coverage source
1. Pinealon protocol coverage source
Community schedule, reconstitution math, and quick-start categories; not primary evidence.
Open direct sourceAnimal research
2. Pinealon protects the rat offspring from prenatal hyperhomocysteinemia
Animal study reporting improved spatial learning and reduced oxidative stress markers in offspring of treated rat dams.
Open direct sourceLaboratory and review
3. EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease
Review of Pinealon (EDR peptide) gene-expression and neuroprotection findings in animal and cell-culture systems.
Open direct sourceMissing information flagged for review
- Western randomized controlled human trial: Not established
- Validated subcutaneous human dose: Not established
- Human pharmacokinetics and half-life: Not established
- Quantified oral bioavailability: Not established
- Validated cycle and rest period for the injectable route: Not established
- Long-term human safety data: Not established
- Drug interaction data: Not established