{"format":"citation-manifest/v1","page":"https://semaxlabs.com/monograph","claim_count":60,"claims":[{"id":"clm-001","text":"Semax is the heptapeptide Met-Glu-His-Phe-Pro-Gly-Pro (MEHFPGP), CAS 80714-61-0, PubChem CID 9811102, molecular formula C37H51N9O10S, molecular weight 813.9 g/mol.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/9811102","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"clm-002","text":"Semax is built from the ACTH(4-7) fragment Met-Glu-His-Phe with the tripeptide Pro-Gly-Pro attached at the C terminus. It is therefore described in the literature both as an ACTH(4-10) analogue (positions 8, 9 and 10 of natural ACTH replaced by Pro-Gly-Pro) and as ACTH(4-7)PGP. Both names denote the same molecule.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/9811102","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"clm-003","text":"Semax is devoid of the hormonal activity of the parent ACTH molecule, as stated in the indexed literature.","source_url":"https://europepmc.org/article/MED/16996699","grade":"review","grade_label":"Review or guideline"},{"id":"clm-010","text":"There is no FDA-approved drug product containing semax. A query of the openFDA Drugs@FDA endpoint for semax as an active ingredient returns no matches.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-011","text":"FDA lists semax on its page of bulk drug substances that may present significant safety risks when used in compounding. FDA's entry reads, verbatim: \"Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.\"","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-012","text":"In the FDA briefing document for the July 23 to 24, 2026 Pharmacy Compounding Advisory Committee meeting, FDA proposed that semax not be added to the 503A Bulks List. The document states, verbatim, as points 13 and 14: \"FDA is proposing that Semax (free base) NOT be included on the 503A Bulks List.\" and \"FDA is proposing that Semax acetate NOT be included on the 503A Bulks List.\"","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-013","text":"Both semax nominations to the 503A Bulks List were withdrawn by the parties that submitted them, and FDA elected to bring the substance to the advisory committee anyway. The briefing document states, verbatim: \"This nomination was withdrawn by the nominator (FDA-2015-N-3534-0485/ FDA-2015-N-3534-0487). However, FDA is electing to proceed with the presentation of Semax-related bulk drug substances (Semax (free base) and Semax acetate) to the PCAC.\" A parallel footnote records the same for docket FDA-2015-N-3534-0484.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-014","text":"FDA evaluates a nominated bulk drug substance against four criteria set out in its February 19, 2019 final rule (84 FR 4696): \"(1) The physical and chemical characterization of the substance; (2) Any safety issues raised by the use of the substance in compounded drug products; (3) The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and (4) Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.\" FDA applies these as a balancing test.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-015","text":"The July 2026 briefing document is an agenda and points-to-consider document. It links out to separate FDA review documents rather than containing FDA's substantive evaluation of semax, so the specific reasoning behind the semax proposal is not stated inside it.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-016","text":"FDA's briefing document notes that a PCAC recommendation is not a final agency decision: \"The FDA does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting.\"","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-017","text":"Inclusion on the 503A Bulks List would not make a substance FDA approved. The list governs which bulk substances a compounding pharmacist may use; it sits inside the section 503A exemptions from new drug approval, adequate-directions labeling, and CGMP requirements.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-020","text":"A Europe PMC search for semax in the title or abstract returns 206 records.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"},{"id":"clm-021","text":"Of those 206 records, 83 are flagged by Europe PMC as Russian-language, 120 as English, 1 as Ukrainian, and 2 carry no language flag. Russian-language records are 40.3 percent of the set.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"},{"id":"clm-022","text":"Fifty of the 206 records carry the PubMed publication type English Abstract, the tag applied to a non-English article indexed with an English-language abstract only.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"},{"id":"clm-023","text":"Across all 206 records, 3 carry the PubMed publication type Clinical Trial, 2 carry Controlled Clinical Trial, and exactly 1 carries Randomized Controlled Trial.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"},{"id":"clm-024","text":"The single semax record carrying the Randomized Controlled Trial tag is not a stroke trial. It is a 27-patient study of motor neuron disease published in Russian in 2007 in Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova.","source_url":"https://europepmc.org/article/MED/18379501","grade":"human-rct","grade_label":"Human RCT"},{"id":"clm-025","text":"The semax literature is not evenly distributed in time: 18 of the 206 records are from the 1990s, 91 from the 2000s, 62 from the 2010s and 35 from the 2020s. Its publishing peak was the 2000s.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"},{"id":"clm-026","text":"A small number of the 206 records are false positives that use the string semax for something other than the peptide. One indexed paper on respiratory acoustic thoracic imaging uses semax as the name of a statistical variable (maximum squared residual error).","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"},{"id":"clm-030","text":"A search of ClinicalTrials.gov returns zero registered studies mentioning semax.","source_url":"https://clinicaltrials.gov/search?term=semax","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-031","text":"No published human pharmacokinetic study of semax was found. A Europe PMC search for semax together with pharmacokinetic in the title or abstract returns zero records.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22%20AND%20TITLE_ABS%3A%22pharmacokinetic%22","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-032","text":"No double-blind semax study, no meta-analysis of semax, no systematic review of semax and no Cochrane review of semax was found in Europe PMC.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22%20AND%20TITLE_ABS%3A%22double-blind%22","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-033","text":"No dedicated human safety or toxicity study of semax was found. Searching semax together with toxicity, adverse or safety returns 10 records, all of which are chemistry, in vitro or animal work or narrative reviews rather than human safety studies.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22%20AND%20%28TITLE_ABS%3A%22toxicity%22%20OR%20TITLE_ABS%3A%22safety%22%29","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-040","text":"Peer-reviewed papers indexed in PubMed describe semax as a Russian drug in clinical use. A 2000 paper in Vestnik oftalmologii is titled \"Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease\"; a 2001 paper in the same journal calls it \"a new Russian neuropeptide\"; a 2001 paper in Brain Research calls it \"a novel Russian compound\"; and a 2020 paper in Genes states that semax \"has been used successfully in the treatment of patients with severe impairment of cerebral blood circulation\".","source_url":"https://europepmc.org/article/MED/10741256","grade":"review","grade_label":"Review or guideline"},{"id":"clm-041","text":"This site does not state that semax holds a Russian marketing authorisation, because that could not be confirmed against the Russian state register during this pack's production. The register's search interface could not be queried programmatically.","source_url":"https://grls.rosminzdrav.ru/Default.aspx","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-042","text":"A 1997 Russian review by the group that developed the peptide describes 15 years of design and study and states that semax \"is one of the rare analogues of regulatory peptides which underwent all stages from fundamental investigations to practical usage\".","source_url":"https://europepmc.org/article/MED/9173745","grade":"review","grade_label":"Review or guideline"},{"id":"clm-050","text":"In a 1997 Russian study of acute hemispheric ischemic stroke, 30 patients received semax and were compared with a control group of 80 patients treated with conventional therapy. The report describes faster regression of general cerebral and focal disorders. The study was not randomized and not blinded.","source_url":"https://europepmc.org/article/MED/11517472","grade":"human-obs","grade_label":"Human observational"},{"id":"clm-051","text":"In a 2018 Russian study, 110 patients recovering from ischemic stroke were assessed in early and late rehabilitation groups, each split into semax and non-semax subgroups. The regimen was 6000 micrograms per day for 10 days, repeated after a 20 day interval. Plasma BDNF rose in the semax subgroups and Barthel index improvement was faster.","source_url":"https://europepmc.org/article/MED/29798983","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-052","text":"A 2005 Russian report examined 187 patients with cerebrovascular insufficiency and described clinical improvement and reduced risk of stroke and transient ischemic attacks with semax. It is indexed as an Evaluation Study, not a randomized trial.","source_url":"https://europepmc.org/article/MED/15792140","grade":"human-obs","grade_label":"Human observational"},{"id":"clm-053","text":"A 2018 placebo-controlled resting-state fMRI study in 24 healthy volunteers (14 semax, 10 placebo) found a larger rostral subcomponent of the default mode network in the semax group. It measured brain network topography, not any clinical outcome.","source_url":"https://europepmc.org/article/MED/30225715","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-054","text":"A 2020 placebo-controlled resting-state fMRI study assessed semax and selank in 52 healthy participants, reporting differences in functional connectivity involving the right amygdala and temporal regions.","source_url":"https://europepmc.org/article/MED/32342318","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-055","text":"A 2002 report in Bulletin of Experimental Biology and Medicine described ulcer healing at day 14 in 89.5 percent of patients given intranasal semax alongside conventional antiulcer drugs versus 30.8 percent of controls, and its own authors concluded that clinical studies of the antiulcer activity of semax are needed.","source_url":"https://europepmc.org/article/MED/12459874","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-056","text":"A 1999 Russian report followed 73 patients with posthypoxic encephalopathy and noted that after semax injection some EEG recordings showed episodes of paroxysmal activity, leading the authors to advise that the first dose be given with brain bioelectric activity monitoring.","source_url":"https://europepmc.org/article/MED/10199046","grade":"human-obs","grade_label":"Human observational"},{"id":"clm-057","text":"A 2000 Russian study in optic nerve disease compared intranasal semax drops, endonasal electrophoresis of semax, and a control group, reporting a favourable effect on the rate of recovery. It is indexed as a Controlled Clinical Trial.","source_url":"https://europepmc.org/article/MED/10741256","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-058","text":"A 2013 Russian study of 114 patients with non-proliferative diabetic retinopathy compared endonasal electrophoresis of semax, intranasal instillation of semax, and standard therapy, and reported the most durable visual improvement in the electrophoresis group.","source_url":"https://europepmc.org/article/MED/24437205","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-059","text":"A 2015 Russian study in psoriasis with metabolic syndrome gave 60 patients intranasal semax in addition to conventional therapy and compared them with 58 patients on conventional therapy alone, reporting improved lipid fractions in the semax group.","source_url":"https://europepmc.org/article/MED/27051926","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-060","text":"A 2022 Russian study of 60 patients with optic neuropathy of vascular origin used endonasal electrophoresis of 0.1 percent semax as one component of a four-part physiotherapy package, alongside transcranial magnetic electrical stimulation, an oxybaric chamber and acupuncture.","source_url":"https://europepmc.org/article/MED/36083821","grade":"human-trial","grade_label":"Human trial"},{"id":"clm-061","text":"The claim that semax treats attention-deficit hyperactivity disorder traces to a 2007 paper in Medical Hypotheses, a journal for the presentation of untested ideas. The paper proposes semax as a candidate for ADHD and Rett syndrome; it reports no trial of its own and no patients.","source_url":"https://europepmc.org/article/MED/16996699","grade":"review","grade_label":"Review or guideline"},{"id":"clm-070","text":"In rats, a single 50 microgram per kilogram dose of semax produced a maximal 1.4-fold rise in hippocampal BDNF protein, a 1.6-fold rise in trkB tyrosine phosphorylation, a 3-fold rise in exon III BDNF mRNA and a 2-fold rise in trkB mRNA, alongside more conditioned avoidance reactions.","source_url":"https://europepmc.org/article/MED/16996037","grade":"animal","grade_label":"Animal"},{"id":"clm-071","text":"Semax binds specifically to cell membranes isolated from rat basal forebrain and raises BDNF protein there after intranasal application, which is the binding evidence underpinning the BDNF mechanism story.","source_url":"https://europepmc.org/article/MED/16635254","grade":"animal","grade_label":"Animal"},{"id":"clm-072","text":"In rats given semax for one hour, nerve growth factor and BDNF gene expression changed rapidly in vivo, extending to the whole animal an effect first seen in glial cell cultures.","source_url":"https://europepmc.org/article/MED/17353092","grade":"animal","grade_label":"Animal"},{"id":"clm-073","text":"In a rat transient middle cerebral artery occlusion stroke model, RNA sequencing found 394 differentially expressed genes at 24 hours in semax-treated animals versus saline, with suppression of inflammation-related genes and activation of neurotransmission-related genes, the reverse of the pattern ischemia-reperfusion produced on its own.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7350263/","grade":"animal","grade_label":"Animal"},{"id":"clm-074","text":"A 2024 rat study of the penumbra-associated frontal cortex after experimental stroke found 3774 genes differentially expressed by ischemia, with semax and a related ACTH peptide shifting 1539 and 2066 genes respectively toward the uninjured profile.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11673339/","grade":"animal","grade_label":"Animal"},{"id":"clm-075","text":"In rats with incomplete global ischemia, semax prevented the rise in cerebral cortex nitric oxide and restored neurological function, while glycine did not.","source_url":"https://europepmc.org/article/MED/11245825","grade":"animal","grade_label":"Animal"},{"id":"clm-076","text":"In cultured rat pheochromocytoma cells exposed to hydrogen peroxide, semax dose-dependently reduced the number of cells damaged by oxidative stress.","source_url":"https://europepmc.org/article/MED/12802399","grade":"in-vitro","grade_label":"In vitro"},{"id":"clm-077","text":"In female mice with spinal cord injury, semax acted on the mu opioid receptor gene Oprm1 to promote deubiquitination and improved functional recovery. This 2025 study was published in the British Journal of Pharmacology.","source_url":"https://europepmc.org/article/MED/40692165","grade":"animal","grade_label":"Animal"},{"id":"clm-078","text":"In transgenic APPswe/PS1dE9/Blg mice modelling Alzheimer's disease, semax and a derivative were assessed on behaviour and amyloidosis using open field, novel object recognition and Barnes maze tests.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12755871/","grade":"animal","grade_label":"Animal"},{"id":"clm-080","text":"Semax is administered intranasally in the published literature, as drops or spray of a 0.1 percent or 1 percent solution, and by endonasal electrophoresis in the ophthalmology studies.","source_url":"https://europepmc.org/article/MED/12459874","grade":"review","grade_label":"Review or guideline"},{"id":"clm-081","text":"Published human semax regimens are not consistent with one another. Reported figures include 6000 micrograms per day for 10 days in stroke rehabilitation, a 1 percent solution given as 2 to 4 drops three times daily for 10 days for peptic ulcer, and 0.015 to 0.050 milligrams per kilogram in the developer group's review. There is no established or licensed human dose.","source_url":"https://europepmc.org/article/MED/29798983","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-082","text":"Semax nasal drop products sold to consumers carry no verified quality standard. FDA states that compounded drugs containing semax may pose a risk for immunogenicity due to the potential for aggregation and peptide-related impurities.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-100","text":"This monograph renders a study-results table of 26 rows, of which 13 are human, 8 are animal, 1 is in vitro and 4 are documented absences of evidence.","source_url":"https://semaxlabs.com","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"clm-101","text":"This site's reference list contains 30 numbered citations, of which 100.0 percent are peer-reviewed or government sources.","source_url":"https://semaxlabs.com","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"clm-102","text":"Of the 13 human study rows rendered in this monograph, 10 are drawn from Russian-language publications and 3 from English-language publications.","source_url":"https://semaxlabs.com","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"clm-090","text":"A 2022 peer-reviewed review of peptide biopharmaceutical development in Russia states that 14 peptide products are registered in the Russian Federation and lists semax among them, classified as a nootropic drug.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9030433/","grade":"review","grade_label":"Review or guideline"},{"id":"clm-091","text":"The same 2022 review states that semax was synthesized at the Institute of Molecular Genetics of the Russian Academy of Sciences under the guidance of academicians I. P. Ashmarin and N. F. Myasoedov, and that \"The Semax peptide is used to treat ischemic stroke due to its nootropic, neuroprotective, and immunomodulatory effects.\"","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9030433/","grade":"review","grade_label":"Review or guideline"},{"id":"clm-092","text":"The same 2022 review asserts that \"An important pharmacodynamic property of Semax is its low toxicity and safety\" and that semax does not depress the central nervous system or negatively affect cardiovascular parameters. This site reports that as a claim made in a Russian-authored review, set against the fact that no dedicated human safety or toxicity study of semax could be located.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9030433/","grade":"review","grade_label":"Review or guideline"},{"id":"clm-093","text":"A Belgian government laboratory analysing two suspicious preparations seized in 2017 and 2018 found they contained selank and semax, wrote that these research peptides \"have not completed any clinical trials\", and reported that they are freely available online \"either as lyophilized powder for injection purposes or are present in nasal sprays\".","source_url":"https://europepmc.org/article/MED/31667971","grade":"review","grade_label":"Review or guideline"},{"id":"clm-094","text":"A 2025 review co-authored by the Polish Anti-Doping Agency and the anti-doping research centre at the University of Lausanne places semax in its table of substances with unclear anti-doping status and lists tetracosactide, a substance prohibited under WADA class S2, as its structurally or biologically similar comparator. Selank appears in the same table with no comparator listed.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12492343/","grade":"review","grade_label":"Review or guideline"},{"id":"clm-095","text":"In human serum, semax inhibited enkephalin-degrading enzymes with an IC50 of 10 micromolar and selank with an IC50 of 20 micromolar, both far more potent than puromycin. This is the one direct head-to-head measurement of the two peptides in human material.","source_url":"https://europepmc.org/article/MED/11443939","grade":"in-vitro","grade_label":"In vitro"},{"id":"clm-096","text":"In rats with 6-hydroxydopamine-induced parkinsonism, neither semax nor selank affected motor activity or passive defensive behaviour; selank alone reduced anxiety in that model.","source_url":"https://europepmc.org/article/MED/28702721","grade":"animal","grade_label":"Animal"},{"id":"clm-097","text":"Run through the identical Europe PMC method, semax has roughly three times the published literature of selank (206 records versus 68) and a similar share of Russian-language work (40.3 percent versus 42.6 percent), yet semax carries fewer records tagged Randomized Controlled Trial in absolute terms: 1 against selank's 2.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22semax%22","grade":"analytical","grade_label":"Analytical study"}]}