Ovagen

Overview

Ovagen is a marketing name for the synthetic tripeptide Glu-Asp-Leu (EDL) — one of the "short peptide bioregulators" associated with Vladimir Khavinson and the St. Petersburg Institute of Bioregulation and Gerontology. It is sold as a research reagent and promoted for liver ("hepatoprotection"), gastrointestinal-mucosal and immune "support," via a proposed peptide–DNA / gene-expression mechanism rather than classical cell-surface receptor signalling.

The chemistry is well-defined and independently verifiable: PubChem CID 444128 confirms the molecular formula C15H25N3O8, a molecular weight of 375.37 g/mol, and the EDL amino-acid sequence. The biological and clinical evidence is not at the same level. The mechanistic claims are best read as [Hypothesis], and the efficacy claims rest on limited, older, largely Russian preclinical material [Animal]/[In vitro] with no verifiable randomized controlled trials and no credible human efficacy data located in this review.

Ovagen is not approved by the FDA or EMA for any use.

Chemistry and structure

Values above are drawn from PubChem CID 444128, whose IUPAC name confirms the EDL sequence, and from a PUG-REST synonym query (synonyms include Glutamyl-aspartyl-leucine and CHEBI:137252). No CAS registry number is present in that record. A vendor-cited CAS value ("9046-70-2") is not the CAS for this peptide — it is the registered CAS number for ovine follicle-stimulating hormone (the unrelated veterinary "Ovagen"), so it appears misassigned via the naming collision and is not reported here as this compound's CAS.

Mechanism of action

• Nuclear entry and gene-expression modulation in liver and GI tissue — Ovagen is proposed to enter cells and the nucleus and modulate gene expression / DNA structure (the "peptide bioregulator" model), rather than acting on cell-surface receptors. [Hypothesis] (Core Khavinson-school framework; described in vendor and institute material, not established by independent mechanistic studies specific to EDL)
• Modulation of hepatocyte / GI-mucosal gene expression — proposed effects relevant to detoxification, protein synthesis and barrier integrity in aging/stress models. [In vitro] (Reported in cell-culture-level descriptions; primary peer-reviewed sources for EDL specifically were not verifiable)
• Hepatoprotective / anti-fibrotic and GI-mucosa protective effects — asserted mainly in vendor summaries citing animal-model work (rodents/livestock). [Animal] (Not independently confirmed against primary literature in this review)

Research and evidence

Human evidence. No verifiable human efficacy data was found. Some vendor pages assert a "1 human study, 0 RCTs" figure, and others cite "22 studies," but no citable peer-reviewed human trial of Ovagen/EDL could be located or confirmed against a primary source, so no human claim should be relied upon. In short: no well-established human clinical trials. Human dosing, pharmacokinetics (half-life, oral vs injectable bioavailability) and safety profile are not established in verifiable sources.

Status and regulation

Ovagen (the EDL peptide) is not FDA- or EMA-approved for any therapeutic — or, for this peptide, veterinary — indication. It is marketed and sold as a "research chemical"/reagent, not as a licensed medicine. In Russia, Khavinson-school peptide preparations have historically been distributed as supplements ("Cytamins"/"Cytogens"-type) rather than as EMA/FDA-registered drugs; a specific formal Russian marketing authorisation for the synthetic EDL "Ovagen" was not verified here. It should be treated as an unapproved investigational substance: it becomes an unauthorised medicine the moment it is intended for human use. "No specific prohibition" is not affirmative permission for human use.

WADA status: no source was found asserting Ovagen/EDL is on the WADA Prohibited List or assigning a specific class code (e.g. S0/S2), so no class code is stated here. WADA sport-prohibition is a separate axis from legality.

Safety

• Human safety profile is not established in verifiable sources — no toxicology, pharmacokinetics, or adverse-event data of adequate quality were found.
• The biological effects reported are preclinical and derive from animal and cell-culture descriptions (largely secondary/marketing material), which do not establish safety in humans.
• Material sold as a research reagent is not a quality-controlled medicine and may vary in identity, purity, and sterility; vendor "99% purity" claims are unverified.
• No human dosing has been established; any human use is experimental and unsupervised by design.

Legal status

Ovagen's regulatory classification is a research reagent ("research use only") — it is not approved for human use in the US or EU. "No specific ban" is not affirmative permission: a compound becomes an unauthorised medicine the moment it is intended for human use, regardless of how it is labeled at point of sale. Regulatory status differs by country and can change. This is not legal advice — verify the status in your own jurisdiction. (Dated 2026-07-08.)

How it compares

• Epitalon — another Khavinson "short peptide bioregulator" (a synthetic tetrapeptide, AEDG) marketed for longevity. Like Ovagen, it rests on a proposed peptide–gene-expression mechanism and on older, largely single-lineage preclinical evidence with limited independent replication.
• Thymalin — a calf-thymus peptide preparation from the same research school, framed as an immunomodulator. It shares Ovagen's pattern of limited, older, mostly-Russian evidence; Ovagen, by contrast, is a single defined synthetic tripeptide.

Common misconceptions

• "Ovagen is a proven liver-protective drug." The hepatoprotective claims are preclinical and largely from vendor/secondary material [Animal]/[In vitro]; there is no well-established human trial. It is not a proven human therapy.
• "Its CAS number is 9046-70-2." That value is actually the CAS registry number for ovine follicle-stimulating hormone — the unrelated veterinary "Ovagen" — not for the EDL peptide; it is misassigned via the naming collision. PubChem CID 444128 has no CAS registered, so the CAS is reported here as Not established.
• "There are 22 studies, including a human study." These vendor-cited figures could not be traced to citable PubMed records; no human trial of Ovagen/EDL was verified.
• "It reactivates genes by entering the nucleus." Nuclear entry and gene-expression modulation is a hypothesis-level claim from the developers' school [Hypothesis], not independently verified in the reviewed sources.
• "Not banned means legal to take." No specific ban is not affirmative permission; Ovagen is a research reagent and becomes an unauthorised medicine the moment it is intended for human use.
• "All products called 'Ovagen' are the same thing." No — "Ovagen" is also an unrelated ovine-FSH veterinary reproductive product, a different substance from the EDL peptide described here.

Russian research

Much of Ovagen's evidence base comes from Russian peptide-bioregulator research — specifically the school of V.Kh. Khavinson at the St. Petersburg Institute of Bioregulation and Gerontology, with the in-vivo animal work carried out together with I.I. Zamorskii's group at Bukovinian State Medical University (Chernivtsi). It is surfaced here for completeness and framed honestly: the verifiable primary literature on the actual Ovagen tripeptide (EDL, Glu-Asp-Leu) is small, preclinical, single-lineage, and — importantly — about the kidney, not the liver.

What the verifiable EDL studies actually show (all renal):

• [Animal] EDL produced a nephroprotective effect in two rat models of acute kidney injury — gentamicin-induced (toxic) nephropathy and ischemia/reperfusion — with the authors framing this as justification for further study of EDL's nephroprotective potential. Zamorskii II, Shchudrova TS, Lin'kova NS, Nichik TE, Khavinson VKh. Nephroprotective Effect of EDL Peptide at Acute Injury of Kidneys of Different Genesis. Bulletin of Experimental Biology and Medicine. 2017;163(3):389-393. PMID 28744634; DOI 10.1007/s10517-017-3811-1.

• [Animal] In rats with cisplatin-induced acute renal failure, EDL (one of four tested treatments) was reported to improve diuresis, creatinine and glomerular filtration rate and to reduce urinary protein excretion versus untreated controls. Zamorskii II, Shchudrova TS, Lin'kova NS, Nichik TE, Khavinson VKh. Peptides Restore Functional State of the Kidneys During Cisplatin-Induced Acute Renal Failure. Bulletin of Experimental Biology and Medicine. 2015;159(6):736-739. PMID 26515176; DOI 10.1007/s10517-015-3062-y.

• [In vitro] In primary renal cell cultures aged in vitro, EDL (designated peptide "T-35") was reported to modulate expression of signaling and cell-renewal markers — here specifically Ki-67, p53, MMP-14 and IL-8. Khavinson VKh, Lin'kova NS, Polyakova VO, Durnova AO, Nichik TE, Kvetnoi IM. Peptides Regulate Expression of Signaling Molecules in Kidney Cell Cultures during In Vitro Aging. Bulletin of Experimental Biology and Medicine. 2014;157(2):261-264. PMID 24958378; DOI 10.1007/s10517-014-2540-y.

• [In vitro] In young and aged renal cell cultures, EDL (and the peptide AED) were reported to increase cell proliferation and decrease expression of the aging markers p16, p21 and p53 while increasing SIRT-6. This Russian-language report is the primary source behind the widely-repeated vendor "p16/p21/p53/SIRT-6" claim — and it is a renal cell study, not a liver one. No DOI was located (Russian journal); the PMID is verifiable. Khavinson VKh, Tarnovskaia SI, Lin'kova NS, et al. [Tripeptides slow down aging process in renal cell culture]. Advances in Gerontology. 2014;27(4):651-656. [Russian] PMID 25946838.

• [Animal] In old rats, peptides including EDL were reported to increase diuresis (1.2–1.4x), reduce urinary protein and stimulate antioxidant enzyme activity without nephrotoxicity, with the authors framing EDL and related peptides as candidate nephroprotective agents in kidney aging. Russian-language; PMID verifiable. Zamorskii II, Shchudrova TS, Zeleniuk VG, Linkova NS, Nichik TE, Khavinson VK. [The influence of peptides on the morphofunctional state of old rats kidneys]. Advances in Gerontology. 2018;31(4):498-504. [Russian] PMID 30607912.

What could NOT be verified (stated here rather than cited): No verifiable EDL-specific primary study on the liver, gastrointestinal mucosa or immune function was located — so Ovagen's marketed identity as a "liver/GI bioregulator" is not supported by the locatable primary EDL literature, which is renal. The mechanism claim that "EDL enters the nucleus and binds the ctcc DNA sequence" could not be verified for EDL: the DNA-binding and nuclear-penetration papers (Fedoreyeva/Khavinson, Biochemistry (Moscow) 2011 PMID 22117547 and 2013 PMID 23581987) tested AEDL/Bronchogen (Ala-Glu-Asp-Leu, a tetrapeptide), Epitalon, Pinealon and Testagen — not the EDL tripeptide — and reported CNG/CAG/CTG preferences, not CTCC binding. AEDL and EDL are different molecules, so AEDL's DNA-binding and bronchial results should not be attributed to EDL. Likewise, the vendor "liver explant proliferation +24%" figure traces to a tetrapeptide effect on chick-embryo liver explants, not the EDL tripeptide. Vendor efficacy figures ("22 studies", "1 human study", "99% purity") and the PEPT1/PEPT2 transporter-uptake mechanism could not be traced to citable primary EDL sources. Russian-language sources describe EDL as a kidney/nephroprotective peptide, but no independently verifiable EDL primary study on liver, GI or immune function was found.

Quality bottom line: This is a modest, self-consistent but non-replicated preclinical kidney dataset. All five studies come from a single research network (recurring authors Khavinson, Lin'kova, Nichik, Zamorskii, Kvetnoi) rather than independent replication; the reports are short (typically ~4–6 pages) in Bulletin of Experimental Biology and Medicine and Advances in Gerontology, with sample sizes and blinding/randomisation details not evident from the abstracts, and two are Russian-language with PMID-only verification. No human trial of EDL/Ovagen was located. A specific Russian marketing authorisation (регистрационное удостоверение) for synthetic EDL "Ovagen" as a registered medicine could not be verified — and in any case, being studied by a Russian institute or sold as a supplement is a regulatory/commercial fact, not proof of efficacy. Outside Russia, EDL/Ovagen is sold only as a research-use-only reagent and is not FDA- or EMA-approved.