Prostamax

Dosing from the Literature

Published for prostate symptoms: no dose from a peer-reviewed study; two patents report 0.01–100 µg/kg injected into muscle daily in 54 men and rectal suppositories daily in 16 men, each for 10–40 days (patent WO 02/066497, 2002; patent RU 2640931, 2018). Not published: any trial of it in a journal, randomised or not.

The rows record what the two patents and one published animal study state, by source. The 2002 patent’s human dose spans a ten-thousand-fold range, 0.01 to 100 µg/kg, and it reports no result for any single dose inside that range (patent WO 02/066497, 2002); the 2018 patent prints its suppository dose in two units a thousandfold apart (patent RU 2640931, 2018). These are stated regimens, not recommendations.

What It Is

Prostamax is a synthetic peptide of four amino acids: lysine, glutamic acid, aspartic acid and proline, written Lys-Glu-Asp-Pro or KEDP, formula C₂₀H₃₃N₅O₉, 487.5 g/mol, monoisotopic mass 487.23 (PubChem CID 9848296). Its 2002 patent gives the free peptide a molecular weight of 487.51, describes making it by solution-phase synthesis as the acetate salt — a white, odourless, amorphous powder at 98.56% peptide content by HPLC — and dissolving it in 0.9% saline at 10 µg/mL for injection (patent WO 02/066497, 2002). The Khavinson group’s 2022 review lists it among its ultrashort peptides as “Prostomax (KEDP)”, with the activity “regulation of prostatic functions”, and cites the European patent as the source for that activity rather than any study (Khavinson et al., 2022).

It comes from the Russian short-peptide programme. Vladimir Khavinson, Vladimir Malinin and Evgeny Grigoriev, of the St Petersburg Institute of Bioregulation and Gerontology, filed the Russian patent on January 25, 2001; it published as RU 2177802 C1 on January 10, 2002, as the international application WO 02/066497 on August 29, 2002, and was granted in Europe as EP 1353939 B1 on August 25, 2004 (patent WO 02/066497, 2002). The 2002 patent set out to replace an extract with a single synthetic molecule: it names Prostatilen as its prototype and lists that extract’s drawbacks as a complicated manufacturing technology, a small output of active substance, variable physico-chemical properties and possible allergic reactions (patent WO 02/066497, 2002).

Prostatilen is a different product, and a registered one. It is a complex of peptides of up to 10 kDa extracted from the prostate of cattle, created in 1992 and later also marketed as Samprost and Vitaprost (Khavinson, 2020). The Russian drug reference RLS lists Prostatilen as rectal suppositories (3, 30 and 50 mg across its package listings; its description, approved in February 2020, is of the 30 mg suppository), an intramuscular solution of 5 mg/1.5 mL and a 5 mg lyophilizate, with “prostate extract” as the active substance and JSC Cytomed as the manufacturer (RLS, Prostatilen, read October 4, 2026); the Vidal drug reference lists its current Russian registrations as 3 mg suppositories, the solution and the lyophilizate (Vidal, searched October 5, 2026). RLS returns no entry for Простамакс (Prostamax) under trade names, active substances or supplements (RLS, searched October 4, 2026), and the developing institute’s own supplement ranges, the Cytogens and the Cytomaxes, list a prostate product called Libidon, described as a peptide complex, with no Prostamax on the pages read (St Petersburg Institute of Bioregulation and Gerontology, read October 4, 2026).

Two development records exist, both for rectal suppositories. A 2011 conference paper from the St Petersburg Chemical-Pharmaceutical Academy and the company GEROPHARM describes Prostamax as a synthetic peptide compound developed by GEROPHARM, names the substance as the tetrapeptide Lys-Glu-Asp-Pro, repeats the 2002 patent’s claims for it, and reports work then under way on the composition and technology of rectal suppositories based on it (Flisyuk et al., 2011). A Russian patent filed on March 23, 2017 by the company ZAO Pharm-Holding, with T. V. Yudaeva and S. V. Vlasenkova as inventors, and published on January 12, 2018, claims rectal suppositories holding 0.3–1.0 mg of the tetrapeptide with dimethyl sulfoxide in a suppository base; it names the injected peptide of the 2002 patent as the closest earlier version and reports stability tests, rabbit tests and one patient series (patent RU 2640931, 2018). No marketed Prostamax medicine, in Russia or elsewhere, turned up for this page (RLS and Vidal, searched October 4–5, 2026).

What is published on the compound itself is small. PubMed returns six records for “prostamax” (October 4, 2026): four studies of human lymphocytes exposed to it in a dish, one study of rat tissue explants, and one paper on peptide motifs in rodent proteins whose abstract names no peptide. Europe PMC returns the same six, plus the patent family (searched October 4, 2026). A separate caution for anyone searching: a capsule supplement sold in Ukraine under the name Prostamax contains 320 mg of saw-palmetto (Serenoa repens) fruit extract per capsule and no peptide at all (searches, October 4, 2026), and RLS lists a Russian capsule supplement spelled Простомакс (Prostomax), described as a source of vitamin E, with no peptide named (RLS, read October 5, 2026).

Who Khavinson was, and what his record supports →

Mechanism of Action

Every finding below is from tissue in a dish, cells taken from donors, animals or a computer model. None was measured inside a person, and most of the work comes from the developers or from papers co-authored by the Tbilisi State University geneticist T. A. Lezhava, who has published with them (Khavinson et al., 2004; Dzhokhadze et al., 2012).

• Tissue-specific growth of explants — In organotypic culture of explants from the heart, lungs, prostate and pancreas of young (3-week-old) and old (18-month-old) rats, four synthetic peptides each stimulated growth in their matching tissue at an effective concentration of 0.05 ng/mL; prostamax was the one tested in prostate explants (Zakutskii et al., 2006). The 2002 patent reports the same kind of result in urinary-bladder explants from 10–11-day chicken embryos: at 20 ng/mL the explant area index rose 23% above control on day 3, out of concentrations from 2 to 400 ng/mL (patent WO 02/066497, 2002).
• Chromatin decondensation in old donors’ lymphocytes — In leukocytes from people aged 75–88, five short peptides including Prostamax activated ribosome genes and decondensed densely packed chromatin fibrils; Epithalon, Livagen and Prostamax also decondensed the pericentromeric structural chromatin of chromosome 1 (Khavinson et al., 2004). In cells from donors aged 75–86, Prostamax raised sister chromatid exchanges to 12.0 ± 0.28 per cell from 5.9 ± 0.2 in untreated cells and silver-positive nucleolar organiser regions to 2.5 per cell from 0.95, and reduced the frequency of large pericentromeric heterochromatin segments on chromosomes 1 and 9; the authors read this as repressed genes being released (Dzhokhadze et al., 2012).
• Heat of chromatin melting (physical measurement) — By differential scanning calorimetry on human lymphocytes, Prostamax redistributed heat between two melting steps and shifted both to lower temperatures, by 2.9 °C and 1.0 °C; the authors suppose a partial relaxation of the 30-nm chromatin fibre within the 10-nm filament (Meskhi et al., 2004). A companion microcalorimetry paper names Prostamax in its title alongside copper and cadmium ions, but its abstract reports results for the two metal ions only (Kiladze et al., 2009).
• Binding to DNA (in a tube) — The Khavinson group proposes a direct interaction between short peptides and DNA as the way they act (Khavinson, 2020). In a study of amino acids, peptides and proteins against double-stranded DNA, the short peptides KE, AEDG and KEDP changed the melting temperature and the stability of the double helix (Solovyev et al., 2015).
• Getting into cells (computer models only) — In the group’s docking calculations across 26 ultrashort peptides, KEDP ranked 22nd of 26 at the LAT1 amino-acid transporter and last at LAT2, but second at the intestinal di- and tripeptide transporter PEPT1, where the authors call KEDP a stronger predicted inhibitor than the known comparators. The paper contradicts its own LAT2 table: its discussion and conclusions list KEDP among the most effective LAT2 ligands and assume LAT2 carries it into cells (Khavinson et al., 2023). Their 2022 review notes that LAT1 is only moderately expressed in the prostate and that KEDP does not bind it strongly, so LAT1 cannot explain a prostate-specific effect (Khavinson et al., 2022). Docking predicts a fit; it does not measure uptake.
• What happens in the body: not measured — No published study reports a blood level, a half-life, a metabolite or prostate uptake of Prostamax, in animals or people (PubMed and Europe PMC, searched October 4, 2026), and neither patent reports one (patent WO 02/066497, 2002; patent RU 2640931, 2018).

What the Research Shows

The published work is in rat tissue (prostate explants among it), flies and donor cells; the prostate-disease results in animals and patients are in two patents (patent WO 02/066497, 2002; patent RU 2640931, 2018). The patient series are in the next section.

• Rat prostatitis (patent, 2002) — In a study of 41 male rats, 33 were given bacterial prostatitis by instilling E. coli through the urethra and 8 were left uninfected; 11 of the infected rats received ten daily injections under the skin of 0.1 µg, started 45 days after infection. At the end their mean score on the patent’s 5-point histological scale was 1.81 ± 0.09, against 2.36 ± 0.12 in 11 infected rats given saline injections and 2.91 ± 0.15 in 11 left untreated (marked P < 0.05 against both), and zinc in prostate tissue fell with the inflammation score. The text says the peptide brought “positive dynamics” in 7 of the 11, while its table counts 7 of 11 still with prostatitis in both the peptide and the saline groups (8 of 11 untreated), and each rat was scored only once, from tissue taken at the end (patent WO 02/066497, 2002). The only other prostate-disease model is the rabbit study in the 2018 patent (next point). Neither is peer reviewed.
• Rabbit prostate enlargement (second patent, 2018) — In 42 male rabbits, prostate enlargement was induced with 30 days of sulpiride injections into the abdomen, then castration and testosterone; groups of 6 then received a placebo suppository or one of six suppository formulations of the peptide at 0.5 mg/kg. On day 21, daily urine output was 16.8–21.1 with the three formulations the patent selected and 1.1 with placebo, against 34.7–36.1 in every group at the start; the text calls this a return almost to healthy starting values, though in its table the three groups kept 48–60% of their starting output. The example is headed as a rat model, but its text describes rabbits (patent RU 2640931, 2018).
• Old rats, oxidation markers (patent, 2002) — In 18 male rats aged 24 months, given 0.1 µg per injection under the skin over 10 days or saline, liver diene conjugates were 44.76 ± 2.48 against 53.19 ± 2.16 in the saline group and liver glutathione peroxidase 798.0 ± 29.1 against 701.4 ± 17.1 (both P < 0.05); serum Schiff’s bases were 17.40 ± 1.54 against 25.20 ± 1.74, not marked significant. Each was measured once, after the rats were killed (patent WO 02/066497, 2002).
• Toxicity tests (patents, 2002 and 2018) — Single intramuscular doses of 1 to 5 mg/kg killed none of 65 mice (a 78-mouse study with a saline group of 13) within 72 hours or 14 days. Daily intramuscular doses of 1 µg/kg, 0.3 mg/kg and 3 mg/kg for 90 days in a study of 48 rats with a saline group, and of 1 µg/kg, 0.1 mg/kg and 1 mg/kg for 6 months in a study of 56 rats, left no pathological changes in blood counts, blood chemistry or organs, as the patent reports it (patent WO 02/066497, 2002). The 2018 patent reports no deaths among 60 male rabbits in six groups of 10, one given a placebo suppository, after single rectal doses it states as 5 mg/kg, and no changes in blood cells, clotting time or blood chemistry after 30 rectal doses (patent RU 2640931, 2018). No peer-reviewed toxicology study of the peptide was found (PubMed, searched October 4, 2026).
• Fruit flies (2008) — Added to larval food at 0.00001% of the medium’s weight, Prostamax raised median survival in two inbred lines — in one, from 26.3 to 40.8 days in females and from 20.8 to 28.4 days in males — and lowered it in a third line, from 28.2 to 21.1 days in females; the authors conclude that the effect of these peptides depends on sex and on the line’s genotype (Mylnikov et al., 2008). The third author was from the developing institute.
• Sequence motifs in long-lived rodents (2017) — A paper from the group reports motifs of short, epigenetically active peptides in proteins of the long-lived naked mole rat, some of them not found in proteins of the Norway rat and the house mouse (Khavinson et al., 2017). PubMed indexes Prostamax among that paper’s substances; its abstract names no individual peptide, and it measures nothing in a prostate.

Human Data

Published and peer-reviewed: nothing in which Prostamax was given to a person (PubMed and Europe PMC, searched October 4, 2026). Registered: nothing — ClinicalTrials.gov holds no record for Prostamax, KEDP or Prostatilen (searched October 4, 2026). What exists is three patient series inside two patents, and four studies on cells taken from donors (patent WO 02/066497, 2002; patent RU 2640931, 2018).

• 35 men with chronic prostatitis (patent, 2002) — Men aged 23–45 were given 0.01–100 µg/kg into muscle once a day for 10–40 days, against a comparison group of 14 treated by conventional methods. The patent reports pain gone in 64.0% and reduced in 32.7%, no change in 3.3%, sexual function fully recovered in 44.4% of those with a disturbance and improved in 41.8%, libido normalised in 37.1%, frequent urination stopped in 87.5% and difficult urination in 80.7%; mean urine-flow rate 23.5 ± 2.4 mL/s after against 17.3 ± 1.2 before (not marked significant), and time to the maximum flow rate 1.5 ± 0.1 against 3.6 ± 0.2 (the one change marked P < 0.05 against before treatment) (patent WO 02/066497, 2002). It gives no results for the comparison group, no randomisation, blinding or placebo, and no dose-by-dose figures. Two of its percentages — 32.7% and 41.8% — are not possible shares of 35 men or of any smaller group, however they were rounded (32.7% of 35 is 11.4 men), so these figures are at odds with the patient numbers the patent gives.
• 19 men with prostate adenoma (patent, 2002) — Men aged 51–67 with stage I–II adenoma received the same regimen, against 17 treated conventionally. Daytime urinations fell to 6.3 ± 0.1 from 8.4 ± 0.5 and night-time to 2.6 ± 0.1 from 3.1 ± 0.1, mean flow rate rose to 17.5 ± 1.6 mL/s from 11.3 ± 1.2 (the daytime count and the mean flow marked P < 0.05 against before treatment, the night-time count not), and 37.3% reported an increase in libido (patent WO 02/066497, 2002). Again, no figures for the comparison group and no blinding, and 37.3% is not a possible share of 19 men (7 of 19 is 36.8%).
• 16 men with prostate adenoma (second patent, 2018) — A Russian patent filed in 2017 by the company ZAO Pharm-Holding describes rectal suppositories of the tetrapeptide given once a day for 10–40 days to 16 men aged 50–63 with stage I–II prostate adenoma, against 5 men given other drugs. It reports that the men’s questionnaires showed better urination, that ultrasound found the adenoma about 10–13% smaller in the 4 men on the highest dose and longest course, and that 52% reported more libido; its table gives urination time as 4 ± 0.7 minutes after against 7 ± 1 before, and the urine-stream score as 4 after against 3 before, on a scale the patent defines with 1 as normal and 5 as the largest change (patent RU 2640931, 2018). It gives no figures for the comparison group and describes no randomisation, blinding or placebo; 52% is not a possible share of 16 men (8 of 16 is 50%); and the dose is 0.3–1.0 mg per suppository in its claims but 0.0003–0.0010 mg in this example.
• Cells from donors, not people dosed — The four published studies on human cells took lymphocytes from donors — people aged 75–88 in one, 75–86 in another, “aging people” in a third, no age given in the fourth’s abstract — and added the peptide in culture (Khavinson et al., 2004; Dzhokhadze et al., 2012; Kiladze et al., 2009; Meskhi et al., 2004). They measure chromosome and chromatin structure. Nobody swallowed or was injected with anything in them.
• The extract has the clinical literature — Prostatilen, the cattle-prostate extract the 2002 patent set out to replace, has been used in Russian urology for decades and keeps generating studies: in 2026, 50 men aged 25–64 with chronic prostatitis and erectile dysfunction were given Prostatilen-AC suppositories (30 + 180 mg) once a day for 10 days, and their mean IIEF-5 score rose from 12.8 ± 5.1 to 17.8 ± 4.3 (p < 0.05), with no control group (Borovets et al., 2026). Each of those suppositories holds 30 mg of the extract and 180 mg of zinc arginyl-glycinate (RLS, Prostatilen AC, read October 5, 2026), so that study tests the extract combined with zinc arginyl-glycinate. It says nothing about the tetrapeptide.

The evidence meter on the Prostamax card reads “Animal only”: it counts published human data on Prostamax itself, for the use on its tag, and there is none (PubMed and Europe PMC, searched October 4, 2026). The 70 patients given it in the two patents are not a peer-reviewed study, and cells taken from donors are laboratory data.

Reconstitution & Storage

No stability or shelf-life data for the powder sold in vials have been published; a 2018 patent reports storage tests of suppository forms, in which two formulations with hydrophilic bases separated and lost about 12–15% of the peptide after 3 months at 30 °C (patent RU 2640931, 2018). The 2002 patent describes its own material as a white, odourless amorphous powder, the acetate salt, 98.56% peptide content by HPLC and 6% moisture, dissolved in 0.9% saline at 10 µg per mL for injection (patent WO 02/066497, 2002). What is sold is mostly lyophilised powder in 20 mg vials; one of the two listings read also names a 20 mg nasal spray and a pre-filled 3 mL pen of the same peptide (listings read October 4, 2026).

• What the listings state — The two research-chemical listings read for this page describe 20 mg of lyophilised powder per vial, 98–99% purity by HPLC with a certificate of analysis, and laboratory research use only. They differ on storage of the powder: one gives −20 °C, the other 2–8 °C or −20 °C; both give 2–8 °C for the solution (listings read October 4, 2026). No study has tested a product bought this way, and no independent analysis of one has been published (PubMed and Europe PMC, searched October 4, 2026).
• Identity — Lys-Glu-Asp-Pro’s molecular weight is 487.5 g/mol and its monoisotopic mass 487.23 (C₂₀H₃₃N₅O₉; PubChem). Its sibling peptides differ at the front: Cortagen’s Ala-Glu-Asp-Pro swaps the first amino acid and weighs 430.4 g/mol, and Crystagen’s Glu-Asp-Pro lacks it and weighs 359.33 g/mol (PubChem, read October 4, 2026). COA Check reads the mass line out of a lab report.
• Sterility — One of the two listings prints the seller’s own test of one lot (sterility “no growth”, endotoxin 0.06 EU/mg) and calls it an in-house result, not an independent third-party test; the other states no sterility result, and no independent test of a sold vial’s sterility has been published (listings read October 4, 2026; PubMed and Europe PMC, searched October 4, 2026). Nothing on this page replaces a third-party lab report.

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Side Effects & Risks

• No peer-reviewed safety data — Nothing published in a journal tests the safety of Prostamax in animals or people (PubMed, searched October 4, 2026).
• What the patents claim — No deaths or visible changes in 65 mice given single intramuscular doses of 1–5 mg/kg (13 more got saline); no pathological changes in a 90-day study of 48 rats (with a saline group) or a 6-month study of 56 rats, dosed daily at three levels; and no side effects mentioned in its two patient series (patent WO 02/066497, 2002). The 2018 patent reports no deaths among rabbits after single rectal doses and no blood, clotting or liver changes after 30 rectal doses, and says nothing about side effects in its 16 patients (patent RU 2640931, 2018). Patents are written by the applicant and are not peer reviewed, and neither describes systematic adverse-event collection in its patients.
• A DNA-damage marker doubled in a dish — In lymphocytes from donors aged 75–86, Prostamax raised sister chromatid exchanges to 12.0 ± 0.28 per cell from 5.9 ± 0.2, which the authors present as chromatin being unpacked (Dzhokhadze et al., 2012). The same measure is used in the opposite direction elsewhere: sister chromatid exchange is a long-standing test for monitoring human genotoxic exposure (Wulf, 1990), and it appears to indicate DNA damage and/or its repair by homologous recombination, although high exchange levels have not been linked to cancer risk (Mourelatos, 2016). No study has tested whether this peptide is genotoxic, and no study has repeated the finding outside the group that reported it (PubMed and Europe PMC, searched October 4, 2026).
• Hormones and the prostate, untested — No peer-reviewed study measured testosterone, dihydrotestosterone, PSA or prostate volume in a person given this peptide (PubMed and Europe PMC, searched October 4, 2026). Neither patent reports a hormone or PSA value; for prostate size, the 2002 patent says ultrasound confirmed a smaller prostate in its prostatitis series, without figures, and the 2018 patent reports an adenoma about 10–13% smaller in 4 of its 16 men (patent WO 02/066497, 2002; patent RU 2640931, 2018). Their claims about libido and sexual function rest on patients’ reports, with no blinding and no comparison figures (patent WO 02/066497, 2002; patent RU 2640931, 2018).
• What a vial contains — A research-chemical label is not proof of contents, and FDA’s letter quotes a seller marketing its Prostamax for prostate disease while labelling it for research use only (FDA warning letter, 2026). The peptide’s monoisotopic mass is 487.23 (PubChem).
• WADA — Prostamax is not named on the 2026 Prohibited List. Section S0 prohibits at all times substances not addressed elsewhere on the List “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…)” (World Anti-Doping Agency, 2026). No approval of Prostamax turned up for this page.

Bloodwork & Monitoring

No monitoring guidance for Prostamax has been published, inside a journal or out. The two patents’ patient series measured these (blood tests, palpation and secretion tests in the 2002 prostatitis series only):

• Routine blood and urine tests — Total blood count, a coagulation panel, biochemical blood tests and urinalysis, before and after the course, in the 2002 prostatitis series; the patent reports no significant deviations from normal values (patent WO 02/066497, 2002). The 2018 series reports no blood tests (patent RU 2640931, 2018).
• Urine flow — Uroflowmetry in the 2002 series: mean and maximum flow rate, time of urination and time to the maximum rate, plus 5-point scores for abdominal straining and the character of the stream (patent WO 02/066497, 2002); in 2018, a questionnaire, the time and frequency of urination and the same kind of 5-point scores (patent RU 2640931, 2018).
• The prostate itself — Ultrasound of the gland in all three series; in the 2002 prostatitis series also palpation through the rectum, leukocytes in prostate secretion, ejaculate and urine, and the share of motile sperm in the ejaculate (patent WO 02/066497, 2002; patent RU 2640931, 2018). No series reports PSA.
• What the published studies measured instead — Chromosome and chromatin measures in cultured cells: sister chromatid exchanges, silver-stained nucleolar organiser regions, C-heterochromatin polymorphism and calorimetric melting curves (Khavinson et al., 2004; Dzhokhadze et al., 2012; Meskhi et al., 2004). None of these is a clinical test.
• Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.

Quick Compare — Prostamax vs Prostatilen

Commonly Stacked With

No published pairing exists. In the 2002 patent’s rat study the peptide was given alone, and its two patient series describe patients who had previously taken conventional drugs, not a combination given with it (patent WO 02/066497, 2002); the 2018 patent’s claimed suppositories, the ones its 16 patients received, dissolve the peptide in dimethyl sulfoxide, and none of its eight formulations adds a second drug (patent RU 2640931, 2018). The chromatin studies tested Prostamax beside Vilon, Epithalon, Livagen and Cortagen, each on its own cells rather than mixed (Khavinson et al., 2004). PubMed and Europe PMC return six records for prostamax and none that tests it with another compound on this site (searched October 4, 2026), so this page carries no stack card.

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Legal Status

Related Compounds

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Next Steps

References

1. National Library of Medicine. PubChem: Prostamax, CID 9848296 (C20H33N5O9; 487.5 g/mol; monoisotopic mass 487.23; synonym 473578-47-1); Cortagen, CID 18439621 (C17H26N4O9; 430.4 g/mol); Glu-Asp-Pro, CID 145455337 (C14H21N3O8; 359.33 g/mol). pubchem.ncbi.nlm.nih.gov. Read October 4, 2026.
2. Khavinson VKh, Malinin VV, Grigoriev EI, inventors; St Petersburg Institute of Bioregulation and Gerontology, assignee. Tetrapeptide regulating prostate functions and its compositions and methods. International application PCT/RU2001/000433, filed October 16, 2001, published as WO 02/066497 A2 on August 29, 2002; granted in Europe as EP 1353939 B1 on August 25, 2004; priority Russian patent RU 2177802 C1, filed January 25, 2001, published January 10, 2002. patents.google.com/patent/WO2002066497A2/en and patents.google.com/patent/EP1353939B1/en. Read October 4, 2026.
3. Yudaeva TV, Vlasenkova SV, inventors; ZAO Pharm-Holding, assignee. Rectal suppositories for the treatment of prostate diseases containing the tetrapeptide lysyl-glutamyl-aspartyl-proline. Russian patent RU 2640931 C1, application RU 2017109789, filed March 23, 2017, published January 12, 2018. patents.google.com/patent/RU2640931C1/en. Read October 5, 2026. (In Russian; Examples 3–6 and Tables 1–3: storage tests, rabbit toxicity, a rabbit prostate-enlargement model and 16 patients with prostate adenoma.)
4. 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. PMID: 15085253. DOI: 10.1023/b:bebm.0000024393.40560.05.
5. Meskhi T, Khachidze D, Barbakadze Sh, Madzhagaladze G, Gorgoshidze M, Monaselidze D, Lezhava T, Tadumadze N. [The influence of the peptide bioregulator prostamax on heterochromatin of human lymphocytes in situ]. Biofizika. 2004;49(6):1091-3. PMID: 15612551. (In Russian.)
6. Zakutskii AN, Chalisova NI, Ryzhak GA, Aniskina AI, Filippov SV, Zeziulin PN. [The tissue-specific effect of synthetic peptides-biologic regulators in organotypic tissues culture in young and old rats]. Adv Gerontol. 2006;19:93-6. PMID: 17152728. (In Russian.)
7. Kiladze M, Gorgoshidze M, Monaselidze J, Jokhadze T, Lezhava T. Microcalorimetric study of human blood lymphocytes culture at presence of copper, cadmium and prostamax. Georgian Med News. 2009;(168):104-7. PMID: 19359734.
8. Dzhokhadze TA, Buadze TZh, Gaiozishvili MN, Baratashvili NA, Lezhava TA. [Deheterochromatinization of the chromatin in old age induced by oligopeptide bioregulator (Lys-Glu-Asp-Pro)]. Georgian Med News. 2012;(212):76-82. PMID: 23221144. (In Russian; English abstract.)
9. Khavinson VK, Kormilets DY, Mar’yanovich AT. Peptides (Epigenetic Regulators) in the Structure of Rodents with a Long and Short Lifespan. Bull Exp Biol Med. 2017;163(5):671-676. PMID: 28948547. DOI: 10.1007/s10517-017-3876-x. (PubMed indexes Prostamax among this paper’s substances; the abstract names no individual peptide.)
10. Solovyev AY, Tarnovskaya SI, Chernova IA, Shataeva LK, Skorik YA. The interaction of amino acids, peptides, and proteins with DNA. Int J Biol Macromol. 2015;78:39-45. PMID: 25841380. DOI: 10.1016/j.ijbiomac.2015.03.054.
11. Khavinson V, Linkova N, Kozhevnikova E, Dyatlova A, Petukhov M. Transport of Biologically Active Ultrashort Peptides Using POT and LAT Carriers. Int J Mol Sci. 2022;23(14):7733. PMID: 35887081. DOI: 10.3390/ijms23147733. (Table: “Prostomax (KEDP) … Regulation of prostatic functions”, cited to the European patent; text: LAT1 is moderately expressed in the prostate, but KEDP does not bind it strongly.)
12. Khavinson VK, Linkova NS, Rudskoy AI, Petukhov MG. Feasibility of Transport of 26 Biologically Active Ultrashort Peptides via LAT and PEPT Family Transporters. Biomolecules. 2023;13(3):552. PMID: 36979488. DOI: 10.3390/biom13030552. (Docking scores: KEDP 22nd of 26 at LAT1, 26th at LAT2, 2nd at PEPT1, 8th at PEPT2; the discussion and conclusions nonetheless list KEDP among the most effective LAT2 ligands.)
13. Mylnikov SV, Oparina TI, Malinin VV. [Effects of peptides on antioxidant status and survival curve parameters in inbred pre-selected lines of Drosophila melanogaster]. Ecological Genetics (Ekologicheskaya Genetika). 2008;6(1). ISSN 1811-0932. cyberleninka.ru/article/n/vliyanie-peptidov-na-antioksidantnyy-status-i-parametry-krivyh-vyzhivaniya-selektiruemyh-inbrednyh-liniy-drosophila-melanogaster. Read October 4, 2026. (In Russian; third author from the St Petersburg Institute of Bioregulation and Gerontology.)
14. Flisyuk EV, Shayakhmetov RR, Nikitina IV. [The relevance of peptide preparations in the therapy of prostate diseases]. Zdorov’e — osnova chelovecheskogo potentsiala. 2011;6(1). ISSN 2076-4618. St Petersburg State Chemical-Pharmaceutical Academy and GEROPHARM. cyberleninka.ru/article/n/aktualnost-primeneniya-peptidnyh-preparatov-v-terapii-zabolevaniy-predstatelnoy-zhelezy. Read October 4, 2026. (In Russian.)
15. Khavinson VKh. Peptide medicines: past, present, future. Klin Med (Mosk). 2020;98(3):165-177. DOI: 10.30629/0023-2149-2020-98-3-165-177. (In Russian; Prostatilen created 1992, registration 92/329/7, later Samprost and Vitaprost; a complex of peptides up to 10 kDa from cattle prostate.)
16. Borovets SY, Rybalov MA, Slesarevskaya MN, Al-Shukri SK. [Effect of prostate-derived complex peptide preparations on erectile function in patients with chronic prostatitis]. Urologiia. 2026;(2):92-98. PMID: 42417303. (In Russian; English abstract.)
17. RLS Encyclopedia of Drugs. Prostatilen® (prostate extract): composition, pharmacodynamics, indications, dosage, manufacturer, storage; package listings of 3, 30 and 50 mg suppositories. rlsnet.ru/drugs/prostatilen-5301 (description approved February 11, 2020). Read October 4, 2026. Prostatilen® AC suppositories, 30 mg + 180 mg (prostate extract 0.03 g and zinc arginyl-glycinate 0.18 g per suppository). rlsnet.ru/drugs/prostatilen-ac-75946. Read October 5, 2026. Prostomaks (Простомакс), capsules: supplement entry, “additional source of vitamin E”. rlsnet.ru/baa/prostomaks-49726. Read October 5, 2026. Searches of the same reference for “Простамакс” in trade names, active substances, supplements and pharmacological groups returned no entry (October 4, 2026). (In Russian.)
18. Vidal drug reference (vidal.ru). Search for “простамакс”: no results. Search for “простатилен”: Prostatilen® 3 mg suppositories (registration ЛП-№(002487)-(РГ-RU) of June 7, 2023), 5 mg lyophilizate and 5 mg/1.5 mL solution, with Prostatilen® AC (30 mg + 180 mg) and Prostatilen® Forte (5 mg) suppositories as separate products. Searched October 5, 2026. (In Russian.)
19. St Petersburg Institute of Bioregulation and Gerontology. Cytogens (synthetic short-peptide supplements) and Cytomaxes (tissue peptide-complex supplements, including Libidon for the prostate). gerontology.ru/cytogens and gerontology.ru/cytomaxs. Read October 4, 2026. (In Russian; no Prostamax product on the pages read.)
20. FDA. Warning letter, reference number 729447, June 17, 2026, to a US seller of research peptides (firm not named here): “Prostamax” and “Gonadorelin” are unapproved new drugs under section 505(a) of the FD&C Act; quoted website claims; “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.” fda.gov, Warning Letters. Read October 4, 2026.
21. FDA. Drugs@FDA through openFDA (api.fda.gov/drug/drugsfda.json): searches for prostamax and Lys-Glu-Asp-Pro, October 4, 2026 (no applications). European Medicines Agency. Medicines data table (ema.europa.eu), searched for prostamax and prostatilen, October 4, 2026 (no entry).
22. US Code of Federal Regulations. 21 CFR 216.23 (bulk drug substances that can be used in compounding under section 503A) and 21 CFR 216.24 (drug products withdrawn or removed from the market). ecfr.gov. Read October 4, 2026.
23. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
24. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. fda.gov/media/94164/download.
25. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances. wada-ama.org.
26. Wulf HC. Monitoring of genotoxic exposure of humans by the sister chromatid exchange test. Methodology and confounding factors. Dan Med Bull. 1990;37(2):132-43. PMID: 2188801.
27. Mourelatos D. Sister chromatid exchange assay as a predictor of tumor chemoresponse. Mutat Res Genet Toxicol Environ Mutagen. 2016;803-804:1-12. PMID: 27265374. DOI: 10.1016/j.mrgentox.2016.03.011.
28. Two research-chemical product listings for Lys-Glu-Asp-Pro, read October 4, 2026 (sellers not named, per this site’s policy): 20 mg lyophilised powder per vial, 98–99% purity by HPLC with a certificate of analysis, prices $54.99 and $79.97, labelled for laboratory research use only. Storage of the powder: −20 °C in one, 2–8 °C or −20 °C in the other; both give 2–8 °C for the solution. The $54.99 listing prints the seller’s own lot certificate (sterility “no growth; conforms”, endotoxin 0.06 EU/mg, “In-house result, not an independent third-party test”) and also names a 20 mg nasal spray and a 20 mg pre-filled 3 mL pen.
29. Searches of October 4–5, 2026: PubMed, “prostamax” (6 records), “Lys-Glu-Asp-Pro” (1), “KEDP peptide” (2), “prostatilen” (30), and searches for toxicology, pharmacokinetics and combination studies of the tetrapeptide (none); Europe PMC, “prostamax” (6) and “Lys-Glu-Asp-Pro” (15, including the patent family); ClinicalTrials.gov, “prostamax”, “KEDP”, “prostatilen”, “Lys-Glu-Asp-Pro” and “peptide bioregulator prostate” (no records of the peptide); FDA warning letters, “prostamax” (1 letter) and “Lys-Glu-Asp-Pro” (none); FDA’s 503A and 503B categories lists and 21 CFR 216 (not listed); WADA’s 2026 Prohibited List (not named); Russia’s state register of medicines, grls.rosminzdrav.ru, queried for “Простамакс” (HTTP 503, server error, on October 4; on October 5 the search page asked for a picture code, so unchecked); Vidal (vidal.ru), “простамакс” (no results, October 5); RLS, “Простомакс” (one supplement entry, capsules, October 5); Google Patents’ list of patents citing RU 2177802 C1, which includes RU 2640931 C1 (October 5); CyberLeninka, “простамакс” (4 articles, 2 of which name the peptide) and “Lys-Glu-Asp-Pro”; and a Ukrainian consumer medicines listing for a capsule supplement sold as ПРОСТАМАКС, 320 mg of Serenoa repens fruit extract per capsule (medcentre.com.ua/medikamenty/prostamaks.html).

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