Prostamax: what the studies show, status and safety
Summary
Prostamax is a synthetic chain of four amino acids from a St Petersburg institute. Six publications mention it and not one describes a person taking it. Its prostate label traces back to the inventors' own patent, not to a study. In June 2026 the American regulator named it in a warning letter as an unapproved new drug.
Key findings at a glance
- Six publications in total, and not one in a person. PubMed and Europe PMC each return six records, four of them from one Tbilisi group [1]. The trial registry returns nothing at all [2].
- The American regulator named it. On 17 June 2026 the FDA wrote that "Prostamax" and "Gonadorelin" are unapproved new drugs under section 505(a) of the American medicines act [3]. It is the only peptide of its series ever named that way.
- The prostate label rests on the inventors' own patent. Table 2 of the group's 2022 overview reads "Prostomax (KEDP) −13.58 Regulation of prostatic functions" [4]. Its source, reference 177, is their own European patent [5].
- In that same table it fails the authors' own test. They call a score below −15 the sign of likely transport. At −13.58 the peptide misses it, and their discussion says so plainly [4].
- Two calculations, 9.21 units apart. The same carrier scored −13.58 in 2022 and −22.79 in 2023 [4], [6]. In the newer paper the table puts it last of 26 at a second carrier while the text counts it among the best [6].
- No prostate product exists in the series. The institute's catalogue lists seven capsule products and none covers the prostate; that place is held by Libidon, an extract [7].
- Vials hold 20 mg. The patent's efficacy experiments gave an animal 0.1 µg a day [8], [5]. Even its single-administration toxicity test stayed below 0.11 mg in a mouse. That gap shows how far the traded product sits from anything ever tested, and it is not a conversion of any kind.
What it is
Prostamax is a laboratory-made peptide of four amino acids: lysine, glutamic acid, aspartic acid and proline, written Lys-Glu-Asp-Pro or KEDP [9]. It comes from the St Petersburg Institute of Bioregulation and Gerontology, the group around Vladimir Khavinson [5].
It was not isolated from tissue. The patent describes ordinary solution-phase synthesis, purification by chromatography and a white amorphous powder of 98.36 per cent purity [5]. The title of that patent claims a tetrapeptide regulating prostate functions, which is where the organ name on every trade page ultimately comes from.
The words bioregulator, cytogen and ultrashort peptide run through this literature. They are house terms of the same institute, used by no pharmacopoeia and no regulator [4], [7].
Quick facts
| Field | Value | Ref |
|---|---|---|
| Chain | Lys-Glu-Asp-Pro, four amino acids | [9], [5] |
| Formula and mass | C20H33N5O9, 487.5 g/mol | [9] |
| Structure key | InChIKey WUCUNGRTSFLCLI-XUXIUFHCSA-N | [9] |
| Code in the literature | KEDP; also spelled Prostomax in the group's own table | [4] |
| Chemical record | PubChem CID 9848296, findable only under the trade name | [9] |
| Medical subject heading | Supplementary concept UID 67500342, mapped to oligopeptides | [10] |
| Registry number | CAS 473578-47-1, from a single source only | [9] |
| Code with the American regulator | None | [11] |
| Curated chemistry records | No ChEMBL, no DrugBank, no Wikidata entry | [11] |
| Water-loving character | Calculated XLogP −9, polar surface 242 Ų | [9] |
| How long it lasts in the body | No published value, for any route or species | [4] |
| Registered studies in people | None | [2] |
| Approval status | Approved nowhere, for nothing | [3], [11] |
| Sold as | Vials of freeze-dried powder for research use only | [8] |
| Originating group | St Petersburg Institute of Bioregulation and Gerontology | [5] |
How it works
Nobody knows. No target molecule has been identified, no uptake experiment has been published, and no measurement in a living person exists [4].
The group's own account runs as follows. Each step is worth weighing on its own evidence.
- Tissue specificity. In rat explant cultures each peptide of the series was said to stimulate growth in the tissue its name points to [12]. The patent adds a chicken-embryo experiment, described below [5].
- Acting on chromatin. The peptide would reach the cell nucleus and loosen tightly packed DNA [13], [14], [15], [16]. All of that work used donated cells in a dish.
- Touching DNA directly. In a test tube, short peptides carrying both acidic and basic amino acids change the melting temperature of naked DNA. KEDP is one of the three named [17].
- Riding on transport proteins. Computer modelling only, and the two runs disagree, as set out below [4], [6].
- A motif in long-lived animals. Sequence patterns of this peptide family were found in proteins of the naked mole-rat [18]. That is statistics on sequences, not a measurement in a body.
Two things sit awkwardly under all this. With a calculated XLogP of −9 the molecule is extremely water-loving, which argues against it crossing membranes unaided [9]. And the neighbouring Russian preparations for the same organ are extracts of animal tissue, not synthetic peptides; the patent was written expressly to replace one of them [5].
What the studies found
Explant cultures, donated human cells, one rat model, a test tube and a computer: that is the whole record, and none of it describes a person taking the substance [1], [2].
Prostate tissue in a dish
Animal data This is the only reviewed paper that connects the peptide to prostate tissue at all. Explants from heart, lung, prostate and pancreas were cultured with the peptide at 0.05 ng/ml. The rats were aged three weeks or 18 months. Growth was reported as stimulated against untreated explants in every age group [12].
The abstract gives no effect size, no measure of spread and no p-value. It also reports the identical working concentration for four different peptides in four different tissues, which is a strange result to find by measurement.
Bladder tissue from chicken embryos
Animal data The patent describes 45 bladder fragments from chicken embryos aged 10 to 11 days. They were cultured across seven concentrations from 2 to 400 ng/ml. At 20 ng/ml the area index rose by 23 per cent against control on day three, and again after seven days [5].
No value is given for the other six concentrations, including the higher ones. The tissue measured was bladder, not prostate, and the experiment has never been published outside the patent.
The one animal model
Animal data The patent's fourth example describes 41 male rats averaging 230 g. Inflammation of the prostate had been induced with an instillation of E. coli 45 days earlier. Treated animals received 0.1 µg under the skin daily for ten days [5].
The applicants record a change in 7 of 11 animals on a five-point scale they defined themselves, a mean score of 1.81 ± 0.09, and a fall in tissue zinc. There is no p-value, no blinding, no figure for the untreated group and no published version of the work, so none of it can be checked.
Oxidation markers, measured in the wrong organ
Animal data The fifth patent example describes 18 male rats aged 24 months. They received 0.1 µg under the skin daily for ten days. It reports fewer early and late products of fat oxidation, and higher activity of two protective enzymes [5].
Those measurements were taken in liver, brain and serum. Nothing was measured in the prostate, which sits oddly under a claim of tissue specificity.
Human cells in a dish
Cell data The only paper with exact figures for the substance counted sister chromatid exchanges in lymphocytes from donors aged 75 to 86. Under the peptide they reached 12.0 ± 0.28 per cell against 5.9 ± 0.2 in untreated cells, and silver-stained nucleolar organisers 2.5 per cell against 0.95 [13].
That doubling is the page's most delicate number. A rise in sister chromatid exchanges is normally read as a marker of genetic stress; the authors read the same result as loosened chromatin and infer a protective action. Both readings fit the data, and neither has been tested.
Cell data A 2004 paper treated leukocytes from donors aged 75 to 88 with five different peptides. All five activated ribosomal genes. This one loosened the packed region of chromosome 1 but not that of chromosome 9, which Epithalon and Livagen did [14]. Five peptides behaving nearly alike is a poor argument for tissue specificity.
Cell data A calorimetry paper reports that the peptide shifted two chromatin denaturation peaks to lower temperatures, by 2.9 and 1.0 °C [15]. That is a structural observation, not a statement about function.
The paper that adds nothing
Cell data A fourth Tbilisi paper carries the name in its title and studies it alongside copper and cadmium ions. Its abstract reports results for the two metals only [16].
At those low concentrations the metals did not affect the thermal stability of membrane, nuclear and cytoplasmic proteins. No separate result for the peptide appears, so the paper counts towards the total and towards nothing else.
Calculations that contradict each other
Docking scores for KEDP against four transporter structures in the 2023 paper by the originating group. A more negative value means a better calculated fit. PEPT1 is rank 2 of 26 in that table and LAT2 is rank 26 of 26, while the text of the same paper counts the peptide among the best LAT2 ligands. The authors call the PEPT2 figures preliminary. Source [6].
Computer model In 2022 the group docked the peptide against one carrier, LAT1, and got −13.58, rank 21 of 27 [4]. They set their own threshold in the same paper: a score below −15 marks likely transport. The peptide misses it, and their discussion says the peptide does not show high binding ability to LAT1.
Computer model In 2023 the same group ran the same ligand against the same carrier family and got −22.79 for LAT1, rank 22 of 26 [6]. A gap of 9.21 units in one year carries the peptide past the −15 mark the authors had set, although it still sits 22nd of 26 in the new table.
The internal contradiction is sharper still. In that 2023 table the peptide is last of 26 at LAT2, with −11.68. The running text of the same paper lists it among the most effective LAT2 ligands [6]. A docking score is a scoring function, not an affinity and not a measured flow.
What is still unknown
- How the body handles the substance. No absorption figure, no half-life, no excretion data, for any route or species [4].
- Whether any target molecule exists. Nothing has been identified, and no transport experiment of any kind has been run [4], [6].
- Whether anything seen in a dish happens in a living body. Every chromatin result comes from donated cells treated in culture [13], [14].
- Whether the chromatin effect is benign. No standard test for genetic damage exists for this peptide [13].
- What happens with repeated dosing. Only a single-injection experiment in mice has ever been reported [5].
Side effects and safety
No safety profile exists, and that is not a clean bill of health. There is no reviewed toxicology in any species, no pharmacokinetics and no usable entry in any adverse event system [11], [19].
What has actually been observed
- Nothing in the pharmacovigilance system. The American adverse event database holds exactly one record naming the word, and it is a different product. That record covers a prostate food supplement, entered as a concomitant medicine in 2019 with an antibiotic as the suspect drug [19]. It says nothing about the peptide, in either direction.
- The only toxicity figures sit in a patent. Seventy-eight mice weighing 20 to 22 g were split into six groups of 13. Five groups received a single injection into a muscle at 1, 2, 3, 4 and 5 mg/kg and one received saline. None died within 14 days and no change of condition was recorded [5].
- Nothing longer than that single injection. The patent reports no repeated-dosing work at all. Sibling patents of the same institute describe 90-day and six-month experiments [5].
- An open question in the chromatin data. The doubling of sister chromatid exchanges described above would be a warning signal in a standard toxicity test [13]. A substance that measurably changes chromatin structure cannot be called harmless.
Because no reviewed study in people exists, no side effect in people has ever been recorded either [2].
What is missing
- No reviewed toxicology, no no-effect level, and no repeated-dose work in any species [5].
- No data on genetic damage, on reproduction or on the immune system. The second gap is conspicuous for a substance claimed for an organ of the male reproductive tract [13].
- No data on interactions, on pregnancy, on breastfeeding, on children, or on liver and kidney impairment.
- No pharmacopoeia monograph, so traded material cannot be measured against any official standard [11].
The injectable form carries risks of its own, and the American regulator said so directly: injectable products "bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions" [3]. Vials sold for research are made under no pharmaceutical quality system, so sterility, endotoxin content and actual peptide content are unknown [8].
Doses used in studies
The doses below are simply what the cited sources gave, listed so that the results can be understood. They are not advice on how to use anything, and the only figures ever attached to people sit in patent examples rather than in reviewed studies. Those examples are not reproduced on this page.
Every line in the table is a concentration in culture fluid or an amount given to an animal. All but one come from a patent held by the inventors, not one comes from a study in people, and the models cannot be compared with one another.
| Study | Model | Amount | Route | Duration | Ref |
|---|---|---|---|---|---|
| Zakutskii 2006, four tissues | Explants from rats aged 3 weeks and 18 months | 0.05 ng/ml | Added to the culture fluid | Not stated | [12] |
| Patent example 3, bladder explants | 45 fragments from 10- to 11-day chicken embryos | 2 to 400 ng/ml tested, effect at 20 ng/ml | Added to the culture fluid | 2, 3 and 7 days | [5] |
| Patent example 4, animal model | 41 rats, treatment from day 45 | 0.1 µg per animal, not per kilogram | Under the skin | Daily, 10 days | [5] |
| Patent example 5, oxidation markers | 18 male rats, 24 months old | 0.1 µg per animal, not per kilogram | Under the skin | Daily, 10 days | [5] |
| Patent example 2, single-amount toxicity | 78 mice in six groups of 13 | 1 to 5 mg/kg, once | Into a muscle | Single administration | [5] |
A concentration in culture fluid cannot be converted into an amount for a body, and neither can an animal figure. Twenty nanograms per millilitre around a piece of chicken embryo tissue says nothing about levels in anything alive.
The patent also claims protection for everything between 0.01 and 100 µg per kilogram over 10 to 40 days [5]. A span of four orders of magnitude is legal breadth, not dose-finding, and the two examples that illustrate it were never published, registered, randomised or blinded. This page does not reproduce them.
One comparison shows how far the trade has drifted from the documents. Vials sold in the West hold 20 mg of powder [8]. The patent's efficacy experiments gave an animal 0.1 µg a day, and even its toxicity test stayed below 0.11 mg in a 20 to 22 g mouse [5]. A container thus holds orders of magnitude more than any experiment has used. That is a comparison of sizes and nothing else, because no amount for a person exists to compare it with.
Development and approval status
A patent, six papers, no development programme
- 2001Patent filed in RussiaThree inventors from the St Petersburg institute claim the sequence Lys-Glu-Asp-Pro; the document holds every prostate result the substance has
- 2004First papers, on donated human cellsChromatin work in Tbilisi: five peptides behave nearly alike, and a calorimetry paper records shifts of 2.9 and 1.0 degrees
- 2006The only reviewed paper touching prostate tissueRat explants at 0.05 ng/ml, with no effect size, no spread and no p-value reported
- 2012The only paper with exact figuresSister chromatid exchanges 12.0 against 5.9 per cell, a result open to two opposite readings
- 2022Fails its makers own binding testLAT1 score of minus 13.58, rank 21 of 27, above the threshold of minus 15 the same authors set
- 2023A second calculation reverses the firstLAT1 minus 22.79, while the LAT2 table puts the peptide last of 26 and the text calls it one of the best
- 17 June 2026Named in an FDA warning letterAn unapproved new drug under section 505(a); the objected product page is now offline
- 16 September 2026Registers checkedNo approval anywhere, no registered trial, no regulator code, and no supplement version in Russia either
There is no development programme behind Prostamax. No sponsor has filed anything, no phase of testing has begun, and nothing has moved since the patent was filed in 2001 [2], [5].
| Market | Status | Note | Ref |
|---|---|---|---|
| United States | Not approved | No substance code, no label, no listing; named in a warning letter in June 2026 | [3], [11], [19] |
| European Union | Not approved | No authorisation and no trial; the agency's own register could not be read on the day of checking | [20] |
| Germany | Not approved | Neither a licensed medicine nor a listed doping substance; an unlicensed injectable is not lawfully marketable | [20], [21] |
| United Kingdom | Not approved | The register returned only a page shell, so the finding rests on every other register | [20] |
| Australia | Not approved | Absent from the Poisons Standard, which is not permission | [22] |
| Canada | Not approved | The medicines database returns nothing; a control query works | [23] |
| Switzerland | Not approved | No authorisation identified, and no register query was possible | [20] |
| Russia | Not approved | Absent from its own institute's capsule catalogue; the prostate product there is an extract, Libidon | [7] |
Two rows need care. The Australian entry means the substance was never scheduled, not that it may be used [22].
The Russian row is the surprising one. Several peptides of this series are sold there as capsules and this one is not sold at all. What does exist in Russia is Prostatilen, a prescription-free medicine made from bovine prostate extract, which the patent names as the prior art to be replaced [24], [5].
All registers were checked on 16 September 2026. Where a register returned only a page shell, that is recorded as an unverified gap rather than a nil result [20].
Anti-doping
Prostamax is banned at all times, in and out of competition. Category S0 of the 2026 Prohibited List covers "any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use" [25].
The name is not printed on the list, and that is not a gap. Category S2 was checked line by line, including the part on peptides that raise testosterone in men, and the peptide belongs to none of those groups [25]. No hormone value has ever been measured for it.
German anti-doping law works differently. Its annex names banned substances one by one, and this peptide is not among them, so possession is not an offence under that provision [21]. The sporting ban is unaffected. Further detail is in the overview of peptides banned in sport.
Compared with related peptides
Nine of the 27 ultrashort peptides in table 2 of the 2022 overview by the originating group. A more negative value means a better calculated fit; the same authors call a score below minus 15 the sign of likely transport. Prostamax at minus 13.58 is rank 21 of 27 and misses that mark. Source [4].
| Peptide | Relation to Prostamax | What the checks behind this page found |
|---|---|---|
| Prostamax | — | Lys-Glu-Asp-Pro, 487.5 g/mol; scored −13.58 in the group's own 2022 LAT1 table, below the mark they set [9], [4] |
| Livagen | Same series, one amino acid apart | Lys-Glu-Asp-Ala; scored −22.01, and loosened the packed region of chromosome 9 where this peptide did not [4], [14] |
| Cortagen | Same series, lysine swapped for alanine | Ala-Glu-Asp-Pro; scored −12.11, five places further down the same table, and is likewise sold as no product at all [4] |
| Chonluten | Another peptide of the same series | Glu-Asp-Gly; scored −30.30, second only to Vesilut at −34.32, and is a capsule product in Russia [4], [7] |
| Ovagen | Same series, assigned to kidney and liver | Glu-Asp-Leu; scored −28.27, and is one of seven capsule products in the institute's catalogue [4], [7] |
| Cartalax | A tripeptide of the same series | Ala-Glu-Asp; scored −26.65, and is sold in Russia where this one is not [4], [7] |
| Epitalon | The best known peptide of the series | Ala-Glu-Asp-Gly; scored −20.38, and acted on both chromosome regions in the same cell experiment [4], [14] |
The comparison is not about strength. It shows where this peptide sits among its neighbours, and the answer is near the bottom of their own table. Livagen and Epitalon outperformed it in the one head-to-head cell experiment the group ran [14]. And every sibling with a capsule product has something this one lacks: a market in which some authority has looked at it [7].
Common misconceptions
- "Prostamax and Prostatilen are the same thing." They are two different substances. Prostatilen is an extract of bovine prostate tissue, sold in Russia without a prescription [24]. The patent for the tetrapeptide names it as the prior art to be replaced, and a document that distinguishes itself from something is not claiming to be it [5].
- "The prostate label comes from research." It comes from a patent. The row in the group's own overview table is sourced to reference 177, which is their European patent [4], [5]. Two further sequences in that same table carry the identical organ label, so the assignment is not even sharp within their own system [4].
- "It is a Russian supplement like Pinealon or Chonluten." It is not. The institute's catalogue lists seven capsule products and no prostate one; that place is held by Libidon, an extract [7].
- "The capsules sold under this name contain the peptide." They do not. A Russian product of the name is made of cedar oil, cedar resin, castoreum and nettle root juice [26]. An American supplement of a similar name is different again [19].
- "The patient numbers are clinical studies." They are examples in a patent application, written by the applicants to show industrial applicability [5]. There is no publication, no registry entry, no ethics approval, no randomisation and no statistics behind them.
- "The docking papers show it gets into cells." They show nothing of the kind, and they disagree with each other by 9.21 units at the same carrier [4], [6]. No transport experiment has ever been run.
- "There is no chemical record for it." There is: PubChem CID 9848296. The name resolves only under the trade name, so searching for the sequence or the code returns a false blank [9].
Frequently asked questions
Has Prostamax ever been tested in a clinical trial?
No. On 16 September 2026 the ClinicalTrials.gov registry returned nothing for the name, for the code KEDP or for the sequence. No reviewed paper describes anyone taking it. The only patient numbers attached to the substance sit in two examples of a patent held by its inventors, and a patent example is not a study.
What is Prostamax made of?
Four amino acids: lysine, glutamic acid, aspartic acid and proline, written Lys-Glu-Asp-Pro or KEDP. The chemical record gives the formula C20H33N5O9 and a mass of 487.5 g/mol. That makes it a tetrapeptide, made by ordinary peptide synthesis rather than extracted from tissue.
Is Prostamax the same as Prostatilen?
No. Prostatilen, also sold as Samprost, is a Russian medicine made from an extract of bovine prostate tissue, and it is sold there without a prescription. Prostamax is a single synthetic tetrapeptide. The Prostamax patent itself names Prostatilen as the prior art it sets out to replace.
Why did the FDA name Prostamax in a warning letter?
On 17 June 2026 the agency wrote to a Florida seller and called the product an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act. The letter objected to the claims on the seller's website, and it states that a RESEARCH USE ONLY label does not change what the product legally is.
Is Prostamax approved as a medicine anywhere?
No, in no country. There is no authorisation in the United States, the European Union, Germany, the United Kingdom, Australia, Canada, Switzerland or Russia. Unlike several peptides of the same series it is not even sold in Russia as a capsule supplement.
Where does the prostate label on Prostamax come from?
From the inventors' own patent. In the group's 2022 overview table the row reads Prostomax (KEDP), score −13.58, Regulation of prostatic functions, with reference 177. Reference 177 is their European patent, not a study. Two further sequences in the same table carry the identical organ label.
What did the laboratory studies of Prostamax find?
Very little, and almost all of it in a dish. One reviewed paper reports growth stimulation in rat tissue explants at 0.05 ng/ml, without giving effect sizes or p-values. Four papers from one Tbilisi group report chromatin changes in donated human white blood cells. Nobody outside that circle has repeated any of it.
What are the side effects of Prostamax?
Unknown, because nobody has looked. There is no reviewed toxicology in any species and no usable entry in the American adverse event database. The only toxicity figures sit in the inventors' patent and cover a single injection in mice, nothing longer.
Is Prostamax banned in sport?
Yes, at all times, in and out of competition. Category S0 of the 2026 Prohibited List covers any drug-like substance that no health authority has approved for use in people. The name is not printed on the list, and that absence is not a loophole.
Are the capsules sold as Prostamax the same peptide?
No. A Russian capsule product of that name contains cedar oil, cedar resin, castoreum and nettle root juice, and an American supplement of a similar name is a different product again. None of them contains the tetrapeptide.
Sources
- PubMed, NCBI E-utilities, and Europe PMC REST search, retrieved 16 September 2026. The query "prostamax" returns six PubMed records: PMID 28948547, 23221144, 19359734, 17152728, 15612551 and 15085253. Europe PMC returns the identical six. Four of the six come from the same group in Tbilisi, one from the originating institute, and one is a sequence analysis with no experiment on the substance. A seventh paper treats the sequence without using the trade name. The query '"Lys-Glu-Asp-Pro"' returns 15 Europe PMC records, overwhelmingly sequence fragments in unrelated papers. https://pubmed.ncbi.nlm.nih.gov/?term=prostamax
- ClinicalTrials.gov, API v2. Queries on 16 September 2026: "prostamax" total count 0, "KEDP" 0, "prostatilen" 0, and "Lys-Glu-Asp-Pro" 24, all of them on unrelated topics. Control query for a marketed peptide returns 755 studies. No sponsor holds any record on this substance. https://clinicaltrials.gov/api/v2/studies
- US Food and Drug Administration, warning letter to Wholesale Peptide, Brooksville, Florida, MARCS-CMS 729447, 17 June 2026, issued by the Center for Drug Evaluation and Research, Office of Unapproved Drugs and Labeling Compliance. Full text read 16 September 2026. Wording: "Based on our review, 'Prostamax' and 'Gonadorelin' are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a)", and "The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act". Footnote 1 states: "Despite statements on your product labeling marketing your products for, 'RESEARCH USE ONLY' and 'not for human consumption,' evidence obtained from your product labeling, including your website establishes that your products are intended to be drugs for human use." The letter further states that injectable products "bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions". The status was based on claims made on the seller's website, which named benign enlargement of the prostate and inflammation of the prostate; those claims are recorded here only as the object of the agency's objection. The product page named in the letter returned HTTP 404 on 16 September 2026, and no close-out letter was found. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wholesale-peptide-729447-06172026
- Khavinson V, Linkova N, Kozhevnikova E, Dyatlova A, Petukhov M (2022). Transport of biologically active ultrashort peptides using POT and LAT carriers. International Journal of Molecular Sciences 23(14):7733. PMID 35887081. PMCID PMC9323678. DOI 10.3390/ijms23147733. Full text and table 2 read 16 September 2026. The row reads "Prostomax (KEDP) −13.58 Regulation of prostatic functions", carrying the reference number 177, rank 21 of 27, alongside Chonluten (EDG) −30.30, Pinealon (EDR) −30.29, Prostataget (DR) −28.88, Ovagen (EDL) −28.27, Cartalax (AED) −26.65, Livagen (KEDA) −22.01, Epitalon (AEDG) −20.38, Orchiget (AE) −13.03 and Korthagen (AEDP) −12.11. The threshold is the authors' own: "ICM-Score function values of the studied USPs less than −15 may indicate a high probability of highly efficient binding to the LAT1 transporter", with their reference ligands between −19.67 and −15.00. The discussion states: "LAT1 is moderately expressed in the prostate, but KEDP and AE peptides, responsible for prostatic function regulation, do not demonstrate a high binding ability to LAT1." The same organ label is carried by three different sequences in that table. Reference 177 of this paper is the group's own European patent, not a study. No pharmacokinetic data for the substance appears in this or any other publication found.
- Khavinson VKh, Malinin VV, Grigoriev EI. RU2177802C1, "Tetrapeptide regulating the functions of the prostate gland, pharmacological agent based on it and method of its use". Filed 25 January 2001, published 10 January 2002; applicant the St Petersburg Institute of Bioregulation and Gerontology. Russian full text read 16 September 2026 via freepatent.ru and findpatent.ru, claims 1 to 9 and examples 1 to 7. Example 1 gives the synthesis, 98.36 per cent purity by HPLC at 220 nm, acetate counter-ion, a white amorphous odourless powder, 6 per cent moisture and specific rotation −69.2°. Example 2, acute toxicity: 78 male outbred mice of 20 to 22 g in six equal groups of 13, five groups given a single 0.25 ml intramuscular injection at 1, 2, 3, 4 and 5 mg/kg and one given saline, with no deaths and no observed change within 72 hours or by day 14. Example 3: 45 bladder fragments from chicken embryos aged 10 to 11 days, seven concentrations from 2 to 400 ng/ml, area index 23 per cent above control on day 3 at 20 ng/ml and the same effect at 7 days. Example 4: 41 male outbred rats averaging 230 g, prostate inflammation induced 45 days earlier by transurethral instillation of 0.2 ml of enterotoxigenic E. coli K-2935 at 10^9 colony-forming units per ml, treatment 0.1 µg subcutaneously daily for 10 days, reported positive movement of the process in 7 of 11 animals, mean score 1.81 ± 0.09 on a five-point scale defined by the applicants, and falling tissue zinc. Example 5: 18 male rats aged 24 months, 0.1 µg subcutaneously daily for 10 days, with lower diene conjugates in liver and Schiff bases in serum and higher glutathione peroxidase in liver and superoxide dismutase in brain; nothing was measured in the prostate. Claims 7 and 9 assert a range of 0.01 to 100 µg per kilogram, at least once daily for 10 to 40 days, by the parenteral, intranasal, oral or local route. The description names the bovine prostate extract preparation Prostatilen as the prototype the invention is set against, citing difficult preparation, low yield, variable physico-chemical properties and the risk of allergic reactions in extracts. Examples 6 and 7 describe patients; they were written by the applicants, were never published, registered, randomised or blinded, and are not reproduced on this page. A patent office examines novelty, inventive step and industrial applicability, never benefit or safety. The corresponding European patent is EP1353939 / WO2002066497A2, granted 25 August 2004, confirmed bibliographically through khavinson.info and through reference 177 of source 4; its full text could not be retrieved.
- Khavinson V, Linkova N, Dyatlova A, Kantemirova R, Kozlov K et al. (2023). Feasibility of transport of 26 biologically active ultrashort peptides via LAT and PEPT family transporters. Biomolecules 13(3):552. PMID 36979488. PMCID PMC10046148. DOI 10.3390/biom13030552. Full text and tables read 16 September 2026. KEDP scored −22.79 at LAT1 against structure 6IRS, rank 22 of 26; −11.68 at LAT2 against 7B00, rank 26 of 26 and last in the table; −33.42 at PEPT1 against 7PMX, rank 2 of 26; and −6.36 at PEPT2, rank 8 of 26. The authors call the PEPT2 results preliminary because "the data currently available on the PEPT2 transporter structure do not allow a reliable assessment". The running text contradicts the LAT2 table twice, listing KEDP among "the most effective ligands of the LAT2 transporter" and asserting that it "will reversibly bind to LAT2 and be transported into the cell". Docking only, with no experimental transport measurement. The LAT1 figure differs from the 2022 run by 9.21 units for the same ligand.
- St Petersburg Institute of Bioregulation and Gerontology, catalogue page of cytogens, retrieved 16 September 2026. Lists exactly seven capsule products: Vezugen, Pinealon, Kartalax, Kristagen, Ovagen, Khonluten and Vizulingval. No prostate product appears. The prostate preparation of the same catalogue family is Libidon, built on the natural peptide complex A-16 from prostate tissue, an extract rather than the synthetic tetrapeptide; its composition was read from a Russian trade listing, cited only as evidence of what is sold. https://gerontology.ru/cytogens
- Western research-chemical listings for Prostamax, retrieved 16 September 2026. Freeze-dried powder in 20 mg vials at about 80 US dollars, purity stated by the seller as 99 per cent or above by HPLC, sequence and registry number given correctly, marked "supplied for research use only. It is not a drug, food, cosmetic, or dietary supplement" and "not intended to diagnose, treat, cure, or prevent any disease", with storage at 2 to 8 °C after reconstitution and no dosing scheme of any kind. A websearch found the same 20 mg presentation at seven further sellers in the United States and the United Kingdom. Trade records, cited as evidence of what is sold. Not linked.
- PubChem. Compound CID 9848296, Prostamax, C20H33N5O9, 487.5 g/mol, InChIKey WUCUNGRTSFLCLI-XUXIUFHCSA-N, calculated XLogP −9 and topological polar surface area 242 Ų, CAS 473578-47-1 from the synonym list. Retrieved 16 September 2026. The name resolves only under "Prostamax"; queries for "Lys-Glu-Asp-Pro", "KEDP", "Prostomax" and "H-Lys-Glu-Asp-Pro-OH" return not-found, so a sequence search produces a false blank. The registry number rests on this one synonym list alone and was not independently confirmed. https://pubchem.ncbi.nlm.nih.gov/compound/9848296
- National Library of Medicine, MeSH supplementary concept "Prostamax", UID 67500342, registry identifier C500342, heading mapped to oligopeptides, entry terms "H-Lys-Glu-Asp-Pro-OH" and "lysyl-glutamyl-aspartyl-proline". Retrieved through E-utilities 16 September 2026. The record carries no registry number field.
- Curated database and substance register checks, 16 September 2026. FDA Global Substance Registration System, exact-name queries for "Prostamax" and "Lys-Glu-Asp-Pro": zero records each, control query "Semaglutide" returns five; no substance code exists. ChEMBL REST API by InChIKey: total count 0, control query returns one. Wikidata entity search for both the name and the sequence: no item. DrugBank returned HTTP 403, so that finding rests on the absence of a DrugBank link in PubChem and Wikidata. No pharmacopoeia monograph in the United States, European or Japanese pharmacopoeia was identified. https://gsrs.ncats.nih.gov
- Zakutskii AN, Chalisova NI, Ryzhak GA, Aniskina AI, Filippov SV, Zeziulin PN (2006). The tissue-specific effect of synthetic peptides-biologic regulators in organotypic tissues culture in young and old rats. Advances in Gerontology 19:93-96. PMID 17152728. In Russian. Organotypic explant cultures from heart, lung, prostate and pancreas of rats aged 3 weeks and 18 months. Cardiogen, Bronchogen, Prostamax and Pancragen are reported to show a stimulating effect at 0.05 ng/ml in the matching tissue culture against control explants in all age groups. The abstract gives no effect size, no measure of spread and no p-value, and names the identical concentration for four peptides and four tissues. Its closing sentence about clinical use is an extrapolation from explant growth and is not reproduced here. The only reviewed paper connecting the substance to prostate tissue.
- Dzhokhadze TA, Buadze TZh, Gaiozishvili MN, Baratashvili NA, Lezhava TA (2012). Deheterochromatinization of the chromatin in old age induced by oligopeptide bioregulator (Lys-Glu-Asp-Pro). Georgian Medical News (212):76-82. PMID 23221144. In Russian. Lymphocytes from donors aged 75 to 86. Sister chromatid exchanges 12.0 ± 0.28 per cell under the peptide against 5.9 ± 0.2 in intact cells; silver-stained nucleolar organiser regions 2.5 per cell against 0.95; fewer large segments of pericentromeric heterochromatin on chromosomes 1 and 9. The only paper with exact figures for this substance. The authors read the rise in exchanges as decondensation and infer a protective action; a rise in sister chromatid exchanges is conventionally read as a marker of genotoxic stress, and that interpretation of theirs is not adopted here.
- Khavinson VKh, Lezhava TA, Malinin VV (2004). Effects of short peptides on lymphocyte chromatin in senile subjects. Bulletin of Experimental Biology and Medicine 137(1):78-81. PMID 15085253. DOI 10.1023/b:bebm.0000024393.40560.05. Leukocyte cultures from donors aged 75 to 88. Vilon, Epithalon, Livagen, Prostamax and Cortagen all activated ribosomal genes and decondensed tightly packed chromatin fibrils. Differentiating result in the authors' words: "Treatment with Epithalon, Livagen, and Prostamax led to decondensation of chromosome 1 pericentromeric structural chromatin, while Epithalon and Livagen treatment led to changes in chromosome 9 as well." Human cells in culture, not treated people, and no concentrations in the abstract.
- Meskhi T, Khachidze D, Barbakadze Sh, Madzhagaladze G, Gorgoshidze M, Monaselidze D, Lezhava T, Tadumadze N (2004). The influence of the peptide bioregulator prostamax on heterochromatin of human lymphocytes in situ. Biofizika 49(6):1091-1093. PMID 15612551. In Russian. Differential scanning calorimetry of human lymphocyte chromatin, which denatures in two steps at 94.4 °C and 105.1 °C. The peptide redistributed heat between two endotherms and shifted both to lower temperatures, by 2.9 and 1.0 °C. A structural observation, read by the authors as partial relaxation of the 30 nm fibre; no functional claim follows from it.
- Kiladze M, Gorgoshidze M, Monaselidze J, Jokhadze T, Lezhava T (2009). Microcalorimetric study of human blood lymphocytes culture at presence of copper, cadmium and prostamax. Georgian Medical News (168):104-107. PMID 19359734. The abstract reports results for the metal ions only: "Cu(II) and Cd(II) ions at these low concentrations don't influence on the temperature stability of membrane, nuclear and cytoplasm proteins", with copper causing additional heterochromatin condensation and cadmium decondensation. The peptide appears in the title and the stated aim but not in the reported results, so this paper contributes nothing to the substance and is not cited here as evidence of any effect.
- Solovyev AY, Tarnovskaya SI, Chernova IA, Shataeva LK, Skorik YA (2015). The interaction of amino acids, peptides, and proteins with DNA. International Journal of Biological Macromolecules 78:39-45. PMID 25841380. DOI 10.1016/j.ijbiomac.2015.03.054. Melting temperature measurements on isolated double-stranded DNA with docking simulations for single amino acids. Acidic residues weaken and basic residues strengthen the hydrogen bonds between strands, and the paper states: "Short peptides (KE, AEDG, and KEDP) containing a mixture of acidic and basic amino acid residues also affect Tm and the stability of the double helix." No separate numeric value for KEDP appears in the abstract. The only paper on the substance from outside the originating circle, and it measures naked DNA in a tube rather than anything in a cell.
- Khavinson VK, Kormilets DY, Mar'yanovich AT (2017). Peptides (epigenetic regulators) in the structure of rodents with a long and short lifespan. Bulletin of Experimental Biology and Medicine 163(5):671-676. PMID 28948547. DOI 10.1007/s10517-017-3876-x. A sequence analysis finding motifs of short epigenetically active peptides in proteins of the long-lived naked mole-rat, located between lysine and arginine residues, with some absent in rat and mouse proteins. No experiment on this substance; it appears in the search results only because the name occurs in a list of peptides.
- United States register checks, 16 September 2026. openFDA drug label API, searches "prostamax" and openfda.substance_name "PROSTAMAX": not found in both cases. DailyMed web services v2: zero entries, database state 15 September 2026, control query works. openFDA adverse event database, medicinal product "prostamax": exactly one report, safety report 16868019 received 30 September 2019 from the United States and classified as serious. The product named there is "EXTRA MEGA PROSTAMAX", an American prostate food supplement entered as a concomitant medicine alongside twelve other concomitant entries, with ciprofloxacin as the single suspect drug. It is a name collision and carries no information about the tetrapeptide in either direction. Control query returns 66,161 reports. https://api.fda.gov/drug/event.json
- European, British, Swiss and Russian register checks, 16 September 2026. The European Medicines Agency search returned HTTP 401 to an automated request, so the register could not be read; no European public assessment report and no withdrawal document exists. MHRA Products returned byte-identical JavaScript shells of 122,696 characters for both the query and the control, and is therefore not evaluable. Swissmedic returned only its entry page with no usable search. The Russian state medicines register is an ASPX application that returned only its navigation shell for the query "Простамакс". All four are recorded as unverified gaps rather than nil results; the finding of no authorisation rests on every other register checked, on the absence of any registered trial and on the absence of the substance from its own institute's catalogue.
- German Anti-Doping Act, annex to section 2 paragraph 3, published as BGBl. 2023 I No. 67. Full text checked 16 September 2026 for "prostam", "prostat", "tetrapeptid" and "Lys-Glu": no match, while the control entries tesamorelin and ipamorelin appear. Section II of the annex lists erythropoiesis-stimulating agents, chorionic gonadotrophin and luteinising hormone with their releasing factors, corticotrophins, growth hormone with its analogues and fragments, growth hormone releasing factors and secretagogues, and growth factors such as IGF-1, MGF and thymosin beta-4. A prostate tetrapeptide falls under none of these groups and the annex has no catch-all heading for peptides, so possession is not an offence under that provision. Separately, an unlicensed injectable preparation is not lawfully marketable under German medicines law. https://www.gesetze-im-internet.de/antidopg/anlage.html
- Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026, Australia, signed 27 May 2026. Full text checked 16 September 2026 for "PROSTAMAX", "LYS-GLU", "LYSYL" and "PROSTATILEN": no match; control entries pralmorelin and alanylglutamine appear. The Australian medicines register could not be queried programmatically on the day of checking. Unapproved research peptides are handled there much as prescription substances are, so absence from the standard is not permission.
- Health Canada, Drug Product Database API, brand-name query for "prostamax": empty result. Control query returns a record with DIN 02471469. Retrieved 16 September 2026. https://health-products.canada.ca/api/drug/drugproduct/
- RLS, Russian medicines reference, entry for Prostatilen, retrieved 16 September 2026. Active substance "prostate extract", a polypeptide extract from bovine prostate with added glycine; ATC group G04BX; marketing authorisation holder MBNPK Cytomed; forms are rectal suppositories of 3 and 50 mg and a 5 mg lyophilisate or a 5 mg per 1.5 ml solution for intramuscular injection; dispensing status "available without prescription". Cited to separate this licensed extract preparation from the synthetic tetrapeptide. https://www.rlsnet.ru/drugs/prostatilen-5301
- World Anti-Doping Agency. The 2026 Prohibited List, in force from 1 January 2026, section S0 "Non-approved substances". Wording: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times." All substances in the class are specified substances. Full text checked 16 September 2026: the name, the code and the sequence return no match, so the classification follows from the general clause. Section S2 was read in full, including S2.2.1 on peptides that stimulate testosterone in males, which names chorionic gonadotrophin, luteinising hormone, gonadorelin with its agonist analogues and kisspeptin with its analogues; the tetrapeptide belongs to none of those groups, is structurally unrelated to them, and no hormone value has ever been measured for it. https://www.wada-ama.org/en/prohibited-list
- Russian and Baltic trade listings for products sharing the name, retrieved 16 September 2026. A capsule product "Prostamax-2" by Sashera-Med is composed of cedar oil 50 per cent, cedar resin 30 per cent, castoreum 10 per cent and nettle root juice 10 per cent; a further capsule product of a similar name is sold in Lithuania. Neither contains the tetrapeptide. Trade records, cited as evidence of the name collision. Not linked.
Cite this page
The register checks and literature searches behind this page were run on 16 September 2026. For a substance with a record this thin, the date on which those searches came back nearly empty is part of the finding.
myPeptides Research & Editing. (2026). Prostamax: what the studies show, status and safety. Version 1.0, 16 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/prostamax
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.
| Version | Date | Change |
|---|---|---|
| 1.0 | 2026-09-16 | Initial publication |
Last verified: 16 September 2026. Next review: on the appearance of any registered study in people, any independent replication of the laboratory findings, or any change in the regulatory or anti-doping classification.