Preloaded Autoinjector | Prostamax | 3ml Pen | 20mg

The prostamax pen is a preloaded 3ml research autoinjector holding the tetrapeptide Lys-Glu-Asp-Pro in solution at 20/3 mg/ml, giving 20mg of total peptide. This sequence ends in an Asp-Pro bond, the most acid-labile linkage in ordinary peptide chemistry, and hydrolysing it converts the molecule into a different Khavinson peptide.

Specification Table

What Changes When The Prostamax Pen Ships KEDP In Solution?

The clock starts on one bond in particular. Aspartyl-proline is the linkage that Piszkiewicz, Landon and Smith identified in 1970 as cleaving anomalously fast under acid and heat, and it has been a known nuisance in protein sequencing ever since. This tetrapeptide carries that bond between residues 3 and 4, at the C-terminal end of the chain.

What comes out of that hydrolysis is the interesting part. Cleaving Asp3-Pro4 releases free proline, 115.13 g/mol, and leaves Lys-Glu-Asp behind at 390.4 g/mol. Lys-Glu-Asp is not a nameless fragment. It is KED, the sequence sold separately as Vesugen. An over-aged solution of this tetrapeptide does not simply lose potency; it converts, molecule by molecule, into a different Khavinson bioregulator with its own product page and its own claimed tissue specificity.

The pH dependence turns that into a compounding problem rather than a static one. The molecule has three carboxylates, on Glu2, Asp3 and the free C-terminus, against two amines, the lysine side chain and the free N-terminus. Net charge is about -1 at pH 7.4 with a calculated isoelectric point near 4.0. Dissolve the free acid in unbuffered water and the resulting solution is itself acidic, which is exactly the condition that accelerates Asp-Pro hydrolysis. Without a buffer the peptide creates the environment that degrades it.

Proline also removes the escape route that most aspartates have. Succinimide formation, the ring closure that produces iso-aspartate at Asp-Gly sites, needs a backbone amide hydrogen on the following residue. Proline has no backbone N-H, so no succinimide can form here. That means no iso-Asp rearrangement and no mass-silent isomer to chase, but it also means the Asp-Pro route is direct hydrolysis with nothing competing for the same intermediate.

What is absent from this sequence is as informative as what is present. There is no methionine, tryptophan, tyrosine, cysteine, histidine, asparagine or glutamine. No oxidation chemistry, no deamidation, no disulfide scrambling and no aromatic photochemistry. Diketopiperazine formation from the free N-terminus is possible in principle, releasing the Asp-Pro dipeptide at 230.2 g/mol, but cyclisation is fastest when residue 2 is proline or glycine, and here it is glutamate, so this is expected to be a slow route. Nobody has measured it.

The molecule is under 500 daltons and very hydrophilic with no aromatic residue, so aggregation is not expected. Being anionic, adsorption to negatively charged glass should be low, which is one place where this peptide suits a glass cartridge better than the cationic peptides dominating this catalogue.

What Is Prostamax, And How Firm Is The Identity?

Prostamax is the St Petersburg Institute of Bioregulation and Gerontology name for the synthetic tetrapeptide H-Lys-Glu-Asp-Pro-OH, one of the short peptides the Khavinson group describes as tissue-specific bioregulators. The sequence is confirmed rather than assumed: Dzhokhadze and colleagues put Lys-Glu-Asp-Pro in the title of a 2012 paper indexed at PMID 23221144 that names the peptide Prostamax, and a PubMed search on the name retrieves five further papers from Khavinson-affiliated groups.

The identity below the sequence is thinner. No PubChem compound record was traced under the trade name, the sequence or the systematic name in preparing this page. The molecular formula C20H33N5O9 and the mass of 487.5 g/mol are calculated from the residues rather than taken from a registry, and vendor CAS numbers could not be matched to ChemIDplus, DSSTox or the FDA global substance registry.

For a compound with no registry entry, that makes the certificate of analysis the only identity document. Mass spectrometry against the calculated 487.228 monoisotopic mass, and amino acid analysis or sequencing to confirm the residue order, are what turn a name on a label into a known molecule. Background on this family of compounds sits in the bioregulator research overview.

Prostamax Solution Stability And The Vesugen Problem

No prostamax solution stability study exists. PubMed returns six records for the name and not one concerns stability, formulation, pharmacokinetics or toxicology. Everything on this page about aqueous behaviour is mechanistic inference from the Asp-Pro literature applied to a sequence that has never been put on a stability programme.

That absence matters more here than it would for an inert sequence, because the predicted degradation product is a marketed compound in its own right. A cartridge that has drifted acidic over months contains an unknown mixture of the tetrapeptide and Lys-Glu-Asp, and a total-peptide assay by mass or by nitrogen content will not distinguish them.

The practical version of the question is short. What is the buffer, what is the pH, and has anyone measured the KED fraction at release. Without those, prostamax solution stability in a specific cartridge is a hypothesis. General handling principles are set out in the peptide storage and stability notes.

Concentration And Increment Arithmetic For The Prostamax Pen

At 20mg in 3 ml the concentration is 20/3 mg/ml, and dividing that by the calculated 487.5 g/mol gives a molar concentration of 20 x 0.684 mM. Per increment, 0.01 ml delivers 20/300 mg and 0.1 ml delivers 20/30 mg.

A worked example makes the scale readable. A 20 mg fill gives 6.67 mg/ml, which is 13.7 mM, with 67 micrograms in 0.01 ml and 0.67 mg in 0.1 ml.

Now set that against the only quantitative concentration in the published record. Zakutskii and colleagues in 2006 applied this peptide to organotypic explant cultures at 0.05 ng/ml, which for a 487.5 g/mol molecule is 1.0 x 10-10 molar, about 0.1 nanomolar. Reaching 0.1 nanomolar from a 13.7 mM fill requires a dilution of roughly 1.3 x 10^8 fold, so a 20 mg cartridge is around 130 million times more concentrated than the only effective concentration anyone has published. The lymphocyte chromatin papers state no concentration at all. The dilution calculator handles a series of that length; the point is that the device format changes nothing about it.

Does Prostamax Come In A Pen, And What Does The Format Suit?

Does prostamax come in a pen: yes, as a preloaded 3ml research device, and the format suits some of this compound’s problems better than others. Fixing concentration at fill removes reconstitution error, and for a peptide whose published effective concentration sits eight orders of magnitude below the cartridge, removing one source of variance at the top of a long dilution series is worth having. The general argument is set out in the pen versus vial article and across the preloaded autoinjector range.

The prostamax pen vs vial comparison turns on the Asp-Pro bond rather than on convenience. A lyophilized cake is not hydrolysing, because hydrolysis needs water. A solution is, at a rate nobody has measured, in a formulation whose pH is not published. The lyophilized vial presentation is the option that keeps the peptide out of water until the moment of use, and the nasal spray format is a third presentation with its own handling profile.

Where that question resolves in favour of the pen is repeated equivalent draws from one lot over a defined and recorded interval. Where it does not is any protocol assuming the contents are the same in month four as they were at fill.

Prostamax Pen Storage, And What Cold Cannot Fix

Prostamax pen storage is 2-8°C, protected from light, without freezing. Cold slows hydrolysis in the ordinary way, and freezing a cartridge risks concentration gradients and damage to the glass.

Light protection is precautionary rather than mechanistic for this molecule. With no tryptophan, tyrosine or histidine there is no chromophore above about 220 nm and no direct photolysis pathway, which is a genuine difference from the copper and tyrosine-containing compounds elsewhere in this range.

What cold storage cannot fix is formulation pH. If the solution is unbuffered and acidic, refrigeration slows the Asp-Pro cleavage without removing the driver, and the peptide continues to generate the conditions for its own hydrolysis. Record the fill date and the date of first actuation, and treat elapsed time in solution as an experimental variable rather than a footnote.

What The Product Record Does Not State

Solution pH is the first and largest gap, for the reason given above. A near-neutral buffered formulation and an unbuffered one are different products for this sequence, and only one of them is defensible.

The excipient system is unpublished, which is the same question in a different form: buffering species, ionic strength and whether anything is present to hold pH against the peptide’s own acidity.

Salt form is unpublished. Vendors state acetate; the Khavinson papers specify none; and free acid, acetate and trifluoroacetate give different peptide content for the same nominal 20mg.

Fill date and any release data on the Lys-Glu-Asp fraction are unpublished, and for a compound with no stability literature at all that fraction is the one number that would say something real about a given cartridge. Request all four against the certificate of analysis.

Verifying The Device And Confirming The Contents

Begin with the detection wavelength, because it disqualifies a common certificate format. This peptide has no tryptophan, tyrosine or histidine and therefore no absorbance above roughly 220 nm. A purity figure reported by HPLC at 254 nm or 280 nm is not measuring this molecule at all. Purity assays therefore need detection at 210 to 220 nm, or mass spectrometry instead.

The mass evidence is unusually clean here. The intact peptide is 487.5 g/mol average and 487.228 monoisotopic. Hydrolysis of the Asp-Pro bond produces a peak at 390.4 for Lys-Glu-Asp and free proline at 115.13. Those are well-separated masses rather than a fractional shift, so a single mass spectrum of a stored cartridge answers the main stability question directly. A diketopiperazine route would show the Asp-Pro dipeptide near 230.2, which is equally visible.

Inspect the solution against a white background before each draw and check for haze or particulate. Let the prostamax pen reach ambient temperature before actuating, since a cold solution is more viscous and viscosity changes delivered volume in a spring-driven mechanism. Verify delivered mass gravimetrically once per device against a tared vessel.

What The Literature Actually Reports

Six PubMed records, no clinical trial, and no in vivo animal dosing study. That is the entire file.

The proposed mechanism is nuclear. The Khavinson group argues that short bioregulator peptides enter the nucleus and bind DNA or histones, changing chromatin condensation and gene expression. Khavinson, Lezhava and Malinin in 2004 reported that this peptide, alongside Epithalon and Livagen, decondensed pericentromeric heterochromatin of chromosome 1 and activated ribosomal genes in lymphocytes from donors aged 75 to 88. Meskhi 2004 reported chromatin melting endotherms shifted by 2.9 and 1.0 degrees. Dzhokhadze 2012 reported the same deheterochromatinisation in lymphocytes from donors aged 75 to 86. No receptor or binding partner has been identified, and whether a tetrapeptide reaches the nucleus at meaningful concentrations in a living animal is not established.

The animal evidence is one explant paper. Zakutskii 2006 applied Cardiogen, Bronchogen, this peptide and Pancragen to organotypic explant cultures of heart, lung, prostate and pancreas from rats aged 3 weeks and 18 months, reporting that each stimulated growth of its own tissue explant at 0.05 ng/ml.

One finding deserves direct quotation of its numbers. Dzhokhadze 2012 recorded sister-chromatid exchange frequency rising from 5.9 plus or minus 0.2 per cell to 12.0 plus or minus 0.28 per cell in elderly lymphocytes. The authors present that as evidence of chromatin decondensation. Sister-chromatid exchange is also a standard genotoxicity endpoint, and no mutagenicity study exists to settle which reading is right.

What has not been studied covers most of what a buyer might assume. There is no human trial of any design, no pharmacokinetic or toxicology data, no injectable route studied in humans or animals, and no replication outside Khavinson-affiliated groups, the Tbilisi authors included. The group’s own 2021 systematic review in Molecules names Vesugen, Pinealon, Epitalon, Bronchogen, Cardiogen, Testagen, Vilon and Thymogen. It does not name this peptide.

Safety And Regulatory Position

No approval exists anywhere. There is no FDA, EMA, PMDA, TGA or Health Canada authorisation, no new drug application, no international non-proprietary name and no pharmacopoeial monograph. The Russian product of the same name is sold as a supplement rather than a registered medicine, and that status was not verified in preparing this page.

The compound is not named on the FDA Category 2 bulk-substance page for substances presenting significant safety risks, and no import alert was located. It has not been located in the FDA 503A bulk-substance categories. WADA lists no entry under this name, although S0, the clause for non-approved pharmacological substances, would reach it in a sporting context.

On safety the position is an absence of data rather than a record of tolerability. No toxicology, mutagenicity or immunogenicity study exists, no adverse findings have been reported as such, and the one genotoxicity-relevant measurement in the file is the doubled sister-chromatid exchange described above. This is a laboratory research supply, and administration to humans or animals is not among the uses it is offered for.

What Is Prostamax 20mg Claimed to Do?

KEDP is the prostate peptide bioregulator in Khavinson’s organ-mapping scheme, and every claim attached to it follows from that assignment. Published reports from the originating institute describe changes in prostate tissue architecture in ageing rats, reduced inflammatory markers in models of chronic prostatitis, and improved functional scores in small unblinded human series. The endpoints are mostly histological or symptom-based, and the studies come from a single research programme.

Read the prostate health vocabulary around Prostamax 20mg with that origin in mind. Prostate health is a marketing category rather than a measurable endpoint, and prostate function in these studies means histology scored by the investigators. Benign prostatic hyperplasia, usually abbreviated BPH, is a well-defined clinical condition with approved treatments, and this research peptide is not one of them. That literature belongs to alpha blockers and 5-alpha reductase inhibitors, which have registrational trials, labels and decades of prescribing data. No regulator anywhere has approved KEDP for any indication, so nothing on this page describes a treatment for BPH or for anything else.

Reported effects on prostate function in the rodent work are group-level histology, not measurements in an individual animal followed over time. Prostamax 20mg is a research preparation, and the honest position is that the prostate function claims rest on a small in-house literature with no independent replication and no pharmacokinetic data in any species.

How Is This Peptide Made and What Should the CoA Show?

By solid-phase peptide synthesis, the same Fmoc chemistry used for essentially every short research peptide sold today. The chain is built one residue at a time on a resin bead, then cleaved, then purified by reversed-phase HPLC. The relevant consequence for a purchaser is what that process leaves behind: deletion sequences missing one residue, capped failure sequences, residual scavengers from the cleavage cocktail, and a counter-ion, usually trifluoroacetate, from the purification.

Those residues are what a CoA is for. A useful certificate states purity by HPLC with the gradient described, identity by accurate mass, water content, and the counter-ion with its percentage. Two CoAs quoting the same purity figure are not equivalent if one used a shallow gradient capable of resolving a Lys-Glu-Asp deletion from the intact tetrapeptide and the other used a fast generic run that would not. Glutamic acid at position two and aspartic acid at position three differ by a single carbon, and a synthesis error swapping them changes the mass by fourteen daltons, which a routine identity check will see only if it is looking.

Ask for the lot-specific CoA rather than a representative one, and ask which document matches the format. For a vial of lyophilized powder the certificate describes a solid. For this device it should describe the solution, including concentration and fill date. Both formats are used across research peptides in this catalogue, and the certificates are not interchangeable.

Where Does Prostamax Sit Beside Other Research Peptides?

Beside compounds it has very little in common with. Catalogue pages routinely list KEDP next to BPC-157 and GHK-Cu, and the three are unrelated. BPC-157 is a fifteen-residue fragment of a gastric protein with a large rodent literature on tendon, ligament and gut injury. The other is a copper-binding tripeptide from human plasma with a long history in cosmetic and wound-healing research and a structural rationale for its metal complex. Neither is a Khavinson bioregulator.

What the three do share is regulatory position, which is none. None is approved anywhere, all are sold for laboratory research, and all attract peptide therapy marketing that describes protocols the published literature does not contain. Where a vial is reconstituted with bacteriostatic water and this pen is not, the storage and stability questions differ, but the evidentiary questions are identical across the group.

Published Literature

The list below was checked against PubMed listings or Crossref records before publication, and no reference was added that the underlying research file did not contain.

1. Dzhokhadze TA, Buadze TZh, Gaiozishvili MN, et al. Deheterochromatinization of the chromatin in old age induced by oligopeptide bioregulator (Lys-Glu-Asp-Pro). Georgian Med News. 2012;(212):76-82. PMID: 23221144
2. Khavinson VKh, Lezhava TA, Malinin VV. Effects of short peptides on lymphocyte chromatin in senile subjects. Bull Exp Biol Med. 2004;137(1):78-81. DOI: 10.1023/b:bebm.0000024393.40560.05. PMID: 15085253
3. Meskhi T, Khachidze D, Barbakadze Sh, et al. The influence of the peptide bioregulator prostamax on heterochromatin of human lymphocytes in situ. Biofizika. 2004;49(6):1091-1093. PMID: 15612551
4. Zakutskii AN, Chalisova NI, Ryzhak GA, et al. The tissue-specific effect of synthetic peptides-biologic regulators in organotypic tissues culture in young and old rats. Adv Gerontol. 2006;19:93-96. PMID: 17152728
5. Kiladze M, Gorgoshidze M, Monaselidze J, et al. Microcalorimetric study of human blood lymphocytes culture at presence of copper, cadmium and prostamax. Georgian Med News. 2009;(168):104-107. PMID: 19359734
6. Piszkiewicz D, Landon M, Smith EL. Anomalous cleavage of aspartyl-proline peptide bonds during amino acid sequence determinations. Biochem Biophys Res Commun. 1970;40(5):1173-1178. DOI: 10.1016/0006-291X(70)90918-6
7. Khavinson VK, Popovich IG, Linkova NS. Peptide regulation of gene expression: a systematic review. Molecules. 2021;26(22):7053. DOI: 10.3390/molecules26227053. PMID: 34834147

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