D tier · weak
The Russian registration is genuine — Gepon is listed as an immunostimulant (ATC L03AX) with a Russian marketing authorisation and a named manufacturer — but essentially the entire clinical literature in any language is authored by the two people who developed and commercialise it, and ClinicalTrials.gov holds a single registration (NCT04627233, Iran, 20 participants planned) that never posted a status update after November 2020 or any results. That is thinner than Semax or Selank, both graded C on Russian-only evidence.
hep-1
HEP-1, marketed in Russia as Gepon, is a synthetic 14-residue peptide corresponding to a sequence within human ezrin, registered in the Russian Federation as an immunomodulator for infections and immunodeficiency states. The registration is real and verifiable, but the supporting clinical evidence is almost entirely Russian and is authored by the peptide's own developers, one of whom operates a commercial company built around it. Outside Russia the compound has produced one registered phase 1 trial that appears never to have reported, and no independent replication.
// we supply this one
available as a research reagent
≥ 98% HPLC · lyophilised powder · batch certificate published. Grade D above is our own and is not adjusted because we stock it.
the explanation
HEP-1, sold in Russia under the name Gepon, is a short lab-made peptide copied from a human protein called ezrin. Russia genuinely licenses it as an immune-system medicine, mainly for infections and for thrush. Almost all the research supporting it was done and written up by the two men who invented it and sell it, and no independent group anywhere has confirmed the results.
regulatory status
Registered medicine in Russia only; unlicensed everywhere else
Gepon is a genuinely registered Russian medicinal product: the Vidal drug reference lists an oral solution with a Russian marketing authorisation number, marketing authorisation holder Aveksima, manufacturer Immafarm, clinical-pharmacological group 'immunostimulating agent' and ATC code L03AX (other immunostimulants), with indications covering correction of weakened immunity in immunodeficiency states, HIV infection, treatment and prevention of opportunistic bacterial, viral and fungal infections, and candidiasis of the skin and mucous membranes. Its developers date the original Russian registration for human use to 2001. It holds no marketing authorisation from the MHRA, EMA or FDA, is not a licensed medicinal product in the UK, and is not a lawful dietary-supplement ingredient here; lawful UK supply is as a research reagent only, not for human use. HEP-1 is not named on the WADA Prohibited List but, being unapproved by any regulator outside Russia, would engage class S0 (Non-Approved Substances) for athletes in jurisdictions where it is not an approved therapeutic.
how it works · proposed mechanism
Ezrin is an ERM-family protein that links the actin cytoskeleton to the plasma membrane and participates in immune-cell signalling and receptor clustering. HEP-1 reproduces a 14-residue stretch of ezrin's alpha-helical domain, and its developers propose that this fragment acts extracellularly as an immune signal rather than as a structural mimic. The claimed dual action is dampening of excessive inflammation together with enhancement of adaptive antiviral immunity.
An ezrin fragment, verifiably
The sequence TEKKRRETVEREKE occurs within the alpha-helical domain of human ezrin (UniProt P15311), so the derivation is real and checkable, and the Russian marketing authorisation lists exactly this tetradecapeptide as the active substance. What the fragment does outside the intact protein is the part that is not established. Fragment-derived activity is a common and legitimate starting hypothesis but it needs independent confirmation.
Claimed anti-inflammatory plus adjuvant activity
The developers describe inhibition of inflammatory cytokine signalling alongside amplification of adaptive antiviral immunity, including adjuvant-like enhancement of antibody responses. This bidirectional profile is attractive but unusual, and it is asserted from assays reported by the same group. No independent laboratory has reproduced the combination.
Registered indications are broad and mostly anti-infective
The Russian authorisation covers immunodeficiency states, HIV infection, prevention and treatment of opportunistic bacterial, viral and fungal infections, and mucocutaneous candidiasis. Breadth of registered indication in one jurisdiction is not the same as demonstrated effect; it reflects that country's regulatory practice for immunomodulators, which has historically approved several peptides on evidence that would not satisfy the EMA or MHRA.
The evidence and the commercial interest are the same people
The English-language clinical and mechanistic literature is dominated by two authors: one affiliated to a private company in London that develops ezrin peptides, the other to the Institute of Immunology in Moscow. Their own 2021 review concedes that the COVID findings 'must be replicated in large-scale randomised placebo controlled clinical studies, to be verified'. Single-source evidence with a direct commercial interest is the defining feature of this compound's literature.
what’s reported
evidence shape
7 sourcesThe composition of the cited literature by study type. This describes the shape of the evidence, not its quality — and it does not by itself set the grade.
⚠ the catch
This index grades Semax and Selank at C specifically because their evidence is Russian-language and single-source, and both of those have more published work than HEP-1 does. Here the entire English-language clinical literature is written by the two developers — one at a private London company built on ezrin peptides, the other at the Moscow institute that originated it — and their own review states that the findings 'must be replicated in large-scale randomised placebo controlled clinical studies, to be verified'. The only trial ever registered outside Russia, NCT04627233 in Tehran, planned 20 participants, was last updated in November 2020, still shows a status of unknown, and has posted no results. The Russian registration is genuine, and it is the only hard fact about this compound; nothing about it constitutes independent evidence of effect.
key published findings
- The Russian registration is verifiable: the Vidal drug reference lists Gepon as an oral solution with a Russian marketing authorisation, holder Aveksima, manufacturer Immafarm, therapeutic group 'immunomodulating agent' and ATC code L03AX, with the active substance named as the tetradecapeptide threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamyl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate.
- The sequence TEKKRRETVEREKE genuinely occurs within human ezrin (UniProt P15311), confirming the compound is what it claims to be structurally.
- Computed formula and mass for the free-acid tetradecapeptide (C74H132N26O27, 1818) match the PubChem record for HEP-1/Gepon exactly, and PubChem gives CAS 174641-44-2.
- ClinicalTrials.gov holds exactly one relevant registration: NCT04627233, 'The clinical trial of application of ezrin peptide (HEP-1) for treatment of coronavirus disease (COVID-19) infection', Shahid Beheshti University of Medical Sciences, Tehran, phase 1, 20 participants estimated, status unknown, last update posted 13 November 2020, no results.
- The clinical studies cited by the developers are Russian: 100 children at the Morozov Moscow Children's Hospital (50 allocated to Gepon, 50 control) and 135 adults with acute viral respiratory infection at Moscow Hospital No 1, with randomised subgroups; blinding and placebo control are not documented in the review's description.
- The English-language literature is authored by Rupert D. Holms (Newal R&D Ltd., London) and Ravshan I. Ataullakhanov (Institute of Immunology, Moscow) — the developers — including the 2021 review and a 2007 Arzneimittelforschung report on HEP1 in HIV-infected patients with hepatitis C.
limitations of the evidence
- No independent group has replicated any clinical or immunological finding; the evidence base and the commercial interest are held by the same two people.
- The pivotal clinical studies were conducted and published in Russia, and the review describing them does not document double-blinding or placebo control for the main trials.
- The single non-Russian trial registration has posted no results and has shown no registry activity since November 2020, so it cannot be treated as evidence of anything.
- The registered indications are unusually broad for a single immunomodulator, which is characteristic of the regulatory pathway rather than of demonstrated effect.
- No independent pharmacokinetic characterisation exists, so the half-life, systemic exposure and metabolic fate of a highly charged 14-residue peptide are unknown.
- Because HEP-1 is registered in only one jurisdiction, no EMA, MHRA or FDA assessment report exists to interrogate the underlying data package.
documented safety signals
- No specific safety signal has been documented in the accessible literature, but the reported adverse-event data come from the developers' own studies and cannot be treated as independent; absence of reported harm here largely reflects absence of independent study.
- The registered indications include HIV infection and opportunistic infection in immunocompromised people, a population in which an unverified immunomodulator carries obvious risk if it displaces effective antiretroviral or antifungal therapy.
- An immunomodulator with claimed bidirectional effects on inflammatory and adaptive responses has an inherently uncertain risk profile in autoimmune disease, which no published study addresses.
- Material sold to the research market as HEP-1 is unlicensed and has no pharmacopoeial identity, purity or endotoxin specification, and is not the Russian licensed product.
identity
| full name | HEP-1 (human ezrin peptide one), the synthetic tetradecapeptide TEKKRRETVEREKE marketed in Russia as Gepon |
| category | Other |
| modality | peptide |
| formula | C74H132N26O27 |
| molar mass | 1818 g/mol |
| cas | 174641-44-2 |
| sequence | TEKKRRETVEREKE (14 aa; a sequence found within the alpha-helical domain of human ezrin, UniProt P15311) |
laboratory handling
| storage | Lyophilised powder is stored desiccated at -20 °C and protected from light. Once reconstituted, laboratory practice is refrigeration at 2-8 °C for short-term use, or aliquoting and freezing to avoid repeated freeze-thaw cycles. Handling information only; this material has no approved human use. |
| solubility | Short hydrophilic peptide, readily soluble in sterile or bacteriostatic water and in dilute aqueous buffer. Lot-specific solubility is stated on the certificate of analysis. |
| co-studied with | No human combination data exist outside the developers' own studies, and no independent interaction work has been published; combining an unverified immunomodulator with other immunoactive agents has no evidential basis. |
Handling information describes laboratory practice for a research reagent. It is not a preparation guide for use in humans.
the receipts
7 citedVidal Russian drug reference · 2026 · official
ClinicalTrials.gov, U.S. National Library of Medicine · 2020 · official
World Anti-Doping Agency · 2026 · official
International Journal of Molecular Sciences · 2021 · review
PubChem, National Library of Medicine · 2026 · reference
UniProt Consortium · 2026 · reference
Arzneimittelforschung · 2007 · clinical study
others in Other