Semax: what the studies show, status and safety
Summary
Semax is a laboratory-made chain of seven amino acids, copied from a fragment of the stress hormone ACTH but without its hormone action. It is a licensed prescription medicine in exactly one country, Russia, where it has been sold as nasal drops since 1994. Nowhere else is it approved. Not a single study of it appears in the international trials register. No safety testing of the kind regulators normally require has ever been published. In May 2026 the US Food and Drug Administration reviewed it and its own scientists advised against letting pharmacies mix it into medicines made up to order.
Key findings at a glance
- Approved in exactly one country. Russia lists two Semax nasal drop products, both prescription only and both on the national list of essential medicines. The current registrations date from 26 March and 18 June 2025 [1], [2], [3].
- Zero registered clinical trials. A query of ClinicalTrials.gov on 6 September 2026 returned a total of 0 studies. Every human study ever run on Semax happened outside the international registers [4].
- 207 papers, almost all preclinical. A PubMed search on the same day returned 207 records, of which only 10 are classed as reviews. The bulk of the literature is animal and cell work [5].
- Nothing is known about what the body does with it, and no safety testing exists. The FDA review found no study in humans of how the peptide is taken up, spread around the body and broken down. That gap covers every route. It records the same gap for the standard animal safety tests: a single dose, repeated doses, damage to genetic material, and effects on fertility and unborn young [1].
- The strongest human study had 24 participants. A placebo-controlled brain scan in healthy adults found a difference in the size of one resting brain network. There was no clinical outcome measured [6].
- The one human pain study was negative. In 16 people with trigeminal neuralgia nothing changed at all. The authors concluded that Semax shows no pain-relieving activity by itself [1], [7].
- An 8 to 5 advisory vote, with no change in the law. An FDA committee voted against the agency's own reviewers in July 2026. The vote is not binding, and Semax remains on the FDA list of bulk substances that may present significant safety risks [8], [9], [10].
What it is
Semax is a synthetic heptapeptide, meaning a short chain of seven amino acid building blocks. Four of them reproduce a fragment of adrenocorticotropic hormone, the pituitary hormone better known as ACTH. The remaining three, proline, glycine and proline again, are not part of the natural hormone at all. They were bolted on deliberately, to slow the enzymes in the body that chop peptides apart [1].
The work began in the Soviet Union. The idea of using regulatory peptides this way came from Ivan Ashmarin at Moscow State University. The molecule itself was made under Nikolai Myasoedov at the Institute of Molecular Genetics [11], [12].
Russian law classes it as a nootropic, a drug meant to act on mental performance. Its product information stresses that it is completely without hormone activity [2], [13].
Quick facts
| Field | Value | Ref |
|---|---|---|
| Name | Semax is a common name, not an international non-proprietary name | [1] |
| Codes | ACTH(4-10) Pro8-Gly9-Pro10, ACTH(4-7)PGP, MEHFPGP | [1] |
| Class | Synthetic ACTH(4-10) analogue; nootropic under Russian law | [1], [2] |
| Structure | 7 amino acids, Met-Glu-His-Phe-Pro-Gly-Pro, all L-form | [1], [14] |
| Formula and mass | C37H51N9O10S, 813.9 g/mol | [14] |
| Half-life | Not published for humans | [1] |
| Route | Intranasal; the only route described in the literature | [1] |
| Status | Prescription medicine in Russia, approved nowhere else | [1], [2], [3] |
| Developer | Institute of Molecular Genetics, Moscow; marketed by Peptogen | [2], [11] |
| ATC code | N06BX, from the Russian classification | [2] |
| CAS registry number | 80714-61-0 | [14] |
| UNII | I5FAL2585H | [14] |
| PubChem CID | 9811102; Wikidata points to the differing record 122178 | [14], [15] |
| InChIKey | AFEHBIGDWIGTEH-AQRCPPRCSA-N | [14] |
| MeSH | C048487 | [15] |
| Wikidata | Q4415058 | [15] |
How it works
Nobody knows. The FDA review puts it plainly: Semax acts through poorly understood mechanisms, and no molecular target has been identified [1]. Everything below is a hypothesis drawn from animals or cell cultures.
- Nerve growth factors. Semax may raise levels of two proteins that help nerve cells survive and grow, BDNF and NGF. In rats both the messenger RNA and the protein rose within hours of a single dose. This is the most reproduced preclinical finding, and it has never been demonstrated in a person [16], [17], [18].
- A binding site, but not a receptor. Radioactively labelled Semax attached to membranes from rat forebrain in a specific and reversible way. The authors suspected membrane-bound enzymes rather than a classical receptor, and no receptor has been identified since [16].
- Serotonin, and a dopamine caveat. A serotonin blocker cancelled the pain effect seen in rats, which points at the serotonin system. In mice the peptide also increased amphetamine-driven dopamine release, which the FDA calls concerning because that pattern is the signature of drugs of abuse [1].
- Gene activity after a stroke. In rats with a blocked brain artery, Semax shifted the activity of large numbers of genes, mostly immune and blood-vessel genes. The authors state the underlying mechanism remains unclear [19].
- Copper chemistry. In test tubes and cell cultures, Semax grabs copper ions. That shuts down the damaging chemistry copper drives on amyloid-beta, the protein linked to Alzheimer's disease [20].
One difference matters for how Semax is classified. Its parent hormone ACTH tells the adrenal glands to make steroids. In side-by-side laboratory comparisons, ACTH fragments did exactly that while Semax did not [13].
What the trials found
Semax has never been tested the way modern medicines are tested. There is no registered trial, no randomised double-blind placebo-controlled study with a clinical main outcome, and no independent replication of any clinical claim [1], [4].
PubMed and ClinicalTrials.gov, both queried on 6 September 2026. A large literature and an empty trials register: the research exists, the registered clinical evidence does not. Sources [4], [5].
Stroke and cerebrovascular disease
Observational, unregistered The Russian stroke literature is the largest body of human work, and it is uniformly favourable and uniformly weak. A 1997 study compared 30 patients given Semax on top of intensive care with 80 patients on conventional treatment. It was neither randomised nor blinded, the groups were unequal, and the abstract reports no effect sizes [21].
Observational, unregistered A 2005 report followed 187 patients with reduced blood flow to the brain in an open study with no described control group [22].
A 2018 study of 110 patients in rehabilitation is the most detailed of the set. It compared people who began rehabilitation early, 89 ± 9 days after the stroke, with people who began late, at 214 ± 22 days. Each group was split by whether Semax was given as well. It found higher blood levels of BDNF in the Semax groups, and those levels moved together with the Barthel index, a score of how well someone manages everyday tasks. Those are correlations, not proof of cause, and again there was no placebo and no registration [23].
The FDA did not assess any of this work. Its rules require a certified translation for foreign-language material, and none was supplied. The entire Russian stroke literature therefore fell outside the review, on a formal point rather than a scientific one [1].
Pain
Open, uncontrolled One 1996 study covered 37 adults with three different pain conditions. Among 16 people with classic trigeminal neuralgia, a stabbing pain in the facial nerve, nothing changed: not the character of the pain, not the sensory thresholds, not the nerve responses measured. Among 12 people with migraine the headache ended in 4 of them, 90 to 120 minutes after it was given, and merely eased in the other 8. The group's total pain score fell from 78 to 32 percent. The remaining 9 had dental plexalgia, a nerve pain in the jaw. The pain went away in 6 and eased in 3, but the attacks came just as often and lasted just as long. The authors' own conclusion was that Semax does not exhibit pain-relieving activity by itself [1], [7].
Healthy volunteers
Placebo-controlled imaging The two brain-scan studies are the only human work with a placebo group. The first, in 2018, scanned 24 healthy adults, 11 men and 13 women, average age 43.9 ± 9.5 years; 14 received Semax and 10 placebo. The front part of one resting brain network, the default mode network, came out larger in the Semax group than in the placebo group [6]. The second, in 2020, scanned 52 healthy people comparing Semax, Selank and placebo [24]. Both measured brain images rather than anything a person would notice, and neither was registered. The FDA also notes that the Semax participants in the two studies may well be the same people [1].
Unregistered The developers' own group reported in 1996 that a single intranasal administration stimulated working memory and attention in 19 healthy men. The full text was not obtainable, the sample was small and male only, and the paper sits in a journal that PubMed does not index [1], [25].
Animal work
Animal data Rats were given a stroke by a light-triggered clot in a brain vessel. After eight days the area of dead brain tissue was around 20 percent smaller than in the animals given plain water instead. The treated animals were also spared the memory loss the water group showed [1]. Similar protective findings recur across many rat studies. The FDA's objection is structural. Nearly all of them use a single fixed dose level, so no dose-response relationship exists, and none measured how much peptide reached the body [1].
Animal data Not everything points one way. In a rat model of Parkinson's disease, neither Semax nor Selank changed motor activity or avoidance learning [26].
In pain models the direction of effect flips with the stimulus and the route. One study found increased sensitivity to heat alongside reduced sensitivity to electric shock [27]. Newer work outside the Russian tradition has reported better recovery after spinal cord injury in mice and less amyloid in an Alzheimer's mouse model [28], [29].
What is still unknown
- How it works in a person. No molecular target, and no human study of the mechanism [1].
- What the body does with it. No pharmacokinetic study in humans exists for any route [1].
- Whether it is safe. None of the standard animal safety studies has been published: a single dose, repeated doses, damage to genetic material, or effects on fertility and unborn young. The one mouse study that touches on cancer was not built to answer that question [1].
- Whether it does anything clinically. No registered trial, and no randomised double-blind study with a clinical main outcome [1], [4].
- What injection does. The compounding proposals covered injection under the skin, a route with neither pharmacokinetic nor safety data behind it [1].
Side effects and safety
The safety picture is unusual, because a licensed product with a nearly empty side-effect list sits on top of an almost entirely empty research file.
- One listed side effect. The Russian product information names mild irritation of the nasal lining with prolonged use, and gives no frequency [2].
- Who must not use it, per the Russian label. People with hypersensitivity to the ingredients, acute psychotic states, conditions involving anxiety or a seizure history. Also women who are pregnant or breastfeeding [2], [13].
- Why pregnancy is excluded. The label gives the reason as an absence of clinical studies, not a demonstrated risk [2].
- One side-effect report in the US database. Through 3 December 2025 the FDA's adverse event reporting system, FAERS, held a single report. A consumer described eye pain and burning after using nasal drops bought online, with hospital treatment and symptoms still present a year later. One report is not a safety record: compounding pharmacies rarely report to the FDA, and Russian reports never reach the database at all [1].
- A possible bleeding risk. Rat studies found increased clot-dissolving activity and smaller clots. The FDA draws a bleeding risk from this, particularly alongside other blood-thinning medicines [1].
- Immunogenicity never tested. Peptides can clump together, and clumps can provoke immune reactions. No aggregation or immunogenicity study exists, which is the specific reason Semax sits on the FDA safety-risk list [1], [10].
- Not well characterised chemically. The FDA classes both the free base and the acetate salt as not well characterised. It found inconsistent naming and no data on impurities, aggregates, endotoxins or microbial contamination [1].
Two things deserve saying plainly. A short side-effect list on a label is not evidence of safety when the underlying toxicology was never done. And the manufacturer's claim that the preparation is practically non-toxic and free of teratogenic or mutagenic effects rests on documents that are not public [1], [2].
Why this page lists no doses
Semax is a licensed prescription medicine in Russia, with official product information and a dosing schedule approved by a regulator. Where a medicine is approved, dosing is a matter for that label and for the prescribing doctor, not for a reference page. Outside Russia the opposite problem applies. There is no approved product, no pharmacopoeia standard, and no published study in people of how the body takes the peptide up and breaks it down. So there is no defensible dose to report. Both reasons point the same way, so this page gives no doses, strengths per drop, treatment lengths or administration instructions.
Development and approval status
From a Moscow laboratory to a US advisory vote
- 1980sDeveloped in MoscowConcept by Ivan Ashmarin, synthesis under Nikolai Myasoedov, refs [11], [12]
- 1994First Russian registration, over the counterHealth Ministry order 294 of 20 December 1994, ref [12]
- 2003The original entry is deletedEvery registration since has been prescription only, ref [12]
- 2011The two strengths run as separate medicinesDifferent indications and different contraindications, refs [2], [3]
- 2025Both products re-registered under new numbering0.1% on 26 March, 1% on 18 June, refs [2], [3]
- May 2026FDA review finds no human pharmacokinetics and no toxicologyReviewers propose not adding it to the compounding list, ref [1]
- July 2026Advisory committee votes 8 to 5 the other wayAdvice only; the law is unchanged, refs [8], [9], [10]
- 1980s the peptide is designed and synthesised in Moscow [11], [12].
- 1994 Russia registers it, at that point without a prescription requirement [12].
- 2003 the original registration is deleted; everything since has been prescription only [12].
- 2011 the two strengths are split into separate registrations with different approved uses [2], [3].
- 2025 both are re-registered under the new numbering, the weaker one in March and the stronger one in June [2], [3].
- 2026 the FDA publishes its review in May, and its advisory committee votes against that review in July [1], [8].
| Market | Status | Since or note |
|---|---|---|
| Russia | Approved | 1994 |
| United States | Unapproved | Safety-risk list |
| European Union | Unapproved | No authorisation |
| Germany | Unapproved | No authorisation |
| United Kingdom | Unapproved | No authorisation |
| Australia | Unregistered | Not scheduled |
| Canada | Unapproved | Register empty |
| Switzerland | Unapproved | No authorisation |
| Japan | Unapproved | No monograph |
The table needs one qualification. Two of the negative findings were checked directly. The Canadian drug register was queried and came back empty, and a full-text search of the Australian Poisons Standard found no mention of Semax [30], [31].
The European, British, Swiss and Australian entries could not be checked against a regulator's own database, because those databases were unreachable on the day. They rest instead on the FDA's worldwide search, which names Russia as the only country with an approval [1].
The two Russian products are not interchangeable. The weaker one carries a broad list of approved uses, from memory problems after brain injury to optic nerve disorders. The stronger one carries exactly one, the acute phase of an ischaemic stroke, the kind caused by a blocked blood vessel, and only as part of combination treatment [2], [3]. Both are on the Russian list of essential medicines [3], [12].
In the United States the substance appears only as a bulk ingredient. openFDA shows a dozen such listings, all of them raw material rather than a finished medicine [32]. That is not an approval.
Since 2019 no registered outsourcing facility, the American term for a large pharmacy that mixes medicines to order for clinics, has reported making anything containing Semax. Wellness clinics and online sellers market it widely all the same [1]. The general legal picture is set out under are peptides legal and FDA-approved peptides.
Not binding. The committee voted to support adding Semax to the compounding list, against the FDA's own scientific reviewers. No FDA primary document with the tally could be found; the numbers come from three agreeing trade and legal reports. Sources [8], [9], [10].
Anti-doping
Semax is not named on the 2026 prohibited list, and its position there is genuinely unresolved rather than clear. The catch-all clause covers only substances with no current approval from any government health authority. The Russian approval is current and held by a health ministry, so on the wording that clause does not bite [33]. The list also bans corticotrophins by name, but Semax lacks the adrenal-stimulating action that defines them [13], [33].
Against that reading stands an assessment from inside the anti-doping system itself. A 2025 review by the Polish anti-doping agency and the University of Lausanne places Semax in its unclear category. It names tetracosactide as the comparable listed substance [34].
The NCAA does not name Semax either, but states in terms that its list is not exhaustive [35]. Detection is not the obstacle: a Belgian reference laboratory built a method for Semax after seizing preparations containing it [36]. Anyone subject to testing needs a binding ruling from their own anti-doping organisation. The wider picture is at peptides banned in sport.
Compared with related peptides
| Peptide | Origin | Status | Strongest human evidence | Anti-doping |
|---|---|---|---|---|
| Semax | ACTH(4-10) fragment plus Pro-Gly-Pro | Prescription medicine in Russia only | Placebo-controlled brain scan, 24 healthy adults, no clinical outcome [6] | Unclear [33], [34] |
| Selank | Tuftsin, an immune peptide | Approved nowhere covered here; on the FDA safety-risk list | Same brain-scan programme, 52 healthy adults [24] | Unclear [34] |
| Adamax | Chemically altered Semax derivative | Approved nowhere | None found | Caught by the catch-all clause [33] |
| Tetracosactide | Synthetic ACTH(1-24), a true corticotrophin | Approved medicine in several markets | Not assessed on this page | Named on the list [33] |
The comparison is really about one question: does the molecule still act like the hormone it came from? Tetracosactide does, and is banned by name. Semax does not, which is why the corticotrophin heading does not obviously cover it [13], [33]. Selank shares only the stabilising Pro-Gly-Pro tail and the same Russian research tradition, not the active core [1].
Adamax and the acetylated derivatives are separate substances, and the changes are not cosmetic. Acetylating the front end measurably alters how the molecule handles copper and zinc [37]. None of the three neighbours has human evidence any stronger than Semax has.
Common misconceptions
- "Semax, Adamax and N-acetyl Semax amidate are the same thing." Three different substances. Only Semax holds the Russian approval, and only Semax escapes the anti-doping catch-all on the wording of the list. Acetylating the molecule changes its metal binding, and openFDA lists N-acetyl Semax as a separate article of trade [32], [33], [37].
- "It is a nootropic, so it is basically a supplement." Nootropic here is not marketing language, it is the Russian regulatory classification. That classification comes with full prescription control, contraindications in pregnancy and in people with a seizure history, and a place on the national essential medicines list [2], [3].
- "It is sold over the counter in Russia." It was, under the original 1994 entry, which was deleted in 2003. Every registration in force today is marked prescription only in the state register [3], [12].
- "The FDA assessed it, so it must be approved in the US." The assessment concluded the opposite. Its reviewers proposed not adding Semax to the compounding list, and it remains on the list of bulk substances that may present significant safety risks. An advisory vote is advice. Adding a substance needs a formal rulemaking procedure, with a published draft and a public consultation, and none has begun [1], [9], [10].
- "Semax and Selank are two versions of the same idea." They are often sold together and share one structural feature. Their active cores, however, come from unrelated molecules: a stress hormone and an immune peptide. The FDA lists them as two separate entries. No study exists on the combination sold in the United States [1], [10].
- "The Russian approval proves it works." It proves a regulator registered it, which is a legal fact rather than an evidence grade. The approval studies of the 1990s are not available as published papers, and no study is in the international register. The accurate description is not that Semax has failed, but that it has never been tested to international standards [1], [4].
Frequently asked questions
Is Semax an approved medicine?
In Russia, yes. Two nasal drop products are entered in the Russian state drug register, both on prescription only, and both on the national list of essential medicines. Everywhere else on this page the answer is no. There is no approval in the United States, the European Union, Germany, the United Kingdom, Australia, Canada, Switzerland or Japan. No major pharmacopoeia carries a quality standard for it.
Is Semax legal to buy in the United States or the European Union?
No medicine containing Semax is licensed in either place, so nothing sold there has been through an approval procedure. American regulators list the raw substance among bulk ingredients that may present significant safety risks in compounding. In the European Union and Germany an unlicensed substance sold for a medical purpose falls under national medicines law. A Russian approval carries no legal weight outside Russia.
What do the human studies of Semax actually show?
Less than the reputation suggests. Not one study of Semax is registered in ClinicalTrials.gov, and none is a randomised, double-blind, placebo-controlled trial with a clinical main outcome. The most carefully built study was a brain-scan experiment in 24 healthy adults that found a difference in one resting brain network, with no clinical result attached. The one published pain study was largely negative, and its own authors concluded the peptide had no pain-relieving action of its own.
How does Semax work?
Nobody knows. The FDA review published in May 2026 says it acts through poorly understood mechanisms and that no molecular target has been identified. The most reproduced laboratory finding is that it raises levels of two nerve growth factors, BDNF and NGF, in rat brain tissue. That work is entirely in animals and cell cultures, and it has never been shown to happen in a person.
Is Semax the same as Selank, Adamax or N-acetyl Semax amidate?
No, they are four different substances. Semax comes from the stress hormone ACTH; Selank comes from an immune peptide called tuftsin. Adamax and N-acetyl Semax amidate are chemically altered derivatives, and the changes measurably alter how the molecule binds copper and zinc. Only Semax itself holds the Russian approval, and only Semax escapes the anti-doping catch-all clause on the wording of the list.
Why does this page not list Semax doses?
Because Semax is a licensed prescription medicine in Russia with official product information behind it, and outside Russia it is not licensed at all. In the first case dosing belongs to the approved label and the prescribing doctor. In the second there is no approved dose to report, and no published study in people of how the body handles the peptide to base one on.
Is Semax banned in sport?
The honest answer is that it is unresolved. Semax is not named on the 2026 prohibited list. The catch-all clause for unapproved substances does not fit on its wording. That clause covers only substances with no current approval from a government health authority, and the Russian approval is current. However, a review by the Polish anti-doping agency and the Lausanne anti-doping research centre places Semax in its unclear category. Anyone subject to testing should get a binding ruling from their national anti-doping organisation.
What are the known side effects of Semax?
The Russian product information lists exactly one, mild irritation of the nasal lining with prolonged use, and gives no frequency for it. That single entry is not a safety record. There is no published safety testing of any kind, nothing on immune reactions, and no study in people of how the body handles the peptide. The FDA also flags a possible bleeding risk from animal work and an unassessed potential for misuse.
Did the FDA approve Semax in 2026?
No. Its advisory committee voted 8 to 5 with one abstention in July 2026, going against the agency's own scientific reviewers. The vote supported adding Semax to a list of bulk substances that pharmacies may compound with. That vote is advice, not law, and it is not a marketing approval either way. Adding a substance to that list needs a formal rulemaking procedure, and as at 6 September 2026 none has happened.
What is still unknown about Semax?
Almost everything a regulator would want to see. Nobody has published a study in people of how the body takes the peptide up and breaks it down, by any route. None of the standard animal safety studies exists either: a single dose, repeated doses, damage to genetic material, effects on fertility and unborn young, or a cancer study built for the purpose. There is also no testing for immune reactions or clumping, no pharmacopoeia quality standard, and no registered clinical trial anywhere in the world.
Sources
- US Food and Drug Administration. Briefing document: evaluation of semax-related bulk drug substances (semax free base and semax acetate) for inclusion on the 503A bulks list. Dated 11 May 2026, prepared for the Pharmacy Compounding Advisory Committee meeting of 23-24 July 2026. https://www.fda.gov/media/193348/download
- Vidal Russia, product information for Semax 0.1% nasal drops; registration ЛП-№(009449)-(РГ-RU) of 26 March 2025, marketing authorisation holder Peptogen, Moscow. Retrieved 6 September 2026. https://www.vidal.ru/drugs/semax__28676
- State Register of Medicines of the Russian Federation (ГРЛС), entry for Semax 1% nasal drops, registration ЛП-№(010596)-(РГ-RU) of 18 June 2025, dispensing status "По рецепту". Mirror consulted on 6 September 2026 because the primary interface is captcha-protected. https://zdravmedinform.ru/grls/reg-lp-010596-rg-ru.html
- ClinicalTrials.gov API v2, query for Semax with total count requested; result 0 studies. Retrieved 6 September 2026. https://clinicaltrials.gov/api/v2/studies?query.term=Semax&countTotal=true
- National Library of Medicine, PubMed E-utilities query "semaxTitle/Abstract"; 207 records, 10 typed as reviews. Retrieved 6 September 2026. https://pubmed.ncbi.nlm.nih.gov/?term=semax%5BTitle%2FAbstract%5D
- Lebedeva IS, Panikratova YR, Sokolov OY et al. (2018). Effects of Semax on the default mode network of the brain. Bulletin of Experimental Biology and Medicine 165(5):653-656. PMID 30225715. DOI 10.1007/s10517-018-4234-3
- Koroleva MV, Meizerov EE, Nezavibat'ko VN et al. (1996). Analgesic action of the new drug semax. Bulletin of Experimental Biology and Medicine 122:1107-1109. Full text not obtainable on 6 September 2026; reported in detail in the FDA review [1].
- Regulatory Focus (Regulatory Affairs Professionals Society). FDA advisory committee backs two more peptides, rejects one for compounding list. 24 July 2026. https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html
- McDermott Will & Schulte. Bulk list bound? PCAC backs majority of peptides in two-day public meeting. 27 July 2026. https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/
- US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Page content current as of 22 April 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- Ashmarin IP, Nezavibat'ko VN, Miasoedov NF et al. (1997). A nootropic adrenocorticotropin analog 4-10-semax: 15 years experience in its design and study. Zhurnal Vysshei Nervnoi Deiatelnosti 47(2):420-430. PMID 9173745. Written by the developers about their own preparation.
- AO Peptogen, manufacturer account of the registration history, including Health Ministry order 294 of 20 December 1994 and government order 2724-r of 26 December 2015 adding Semax to the essential medicines list. Manufacturer source. https://semax.ru/chto_eto/istorija/
- Registry of Medicines of Russia (RLS), Semax entries for both strengths, including the pharmacodynamic statement that the peptide is completely without hormone activity, and the laboratory comparison with ACTH fragments on isolated adrenal cells. Retrieved 6 September 2026. https://www.rlsnet.ru/drugs/semaks-5420
- PubChem, compound CID 9811102 (Semax). Queried through the PUG-REST interface on 6 September 2026. https://pubchem.ncbi.nlm.nih.gov/compound/9811102
- Wikidata, Q4415058 (Semax); references PubChem CID 122178 and a different InChIKey from the record the FDA cites. Retrieved 6 September 2026. https://www.wikidata.org/wiki/Q4415058
- Dolotov OV, Karpenko EA, Seredenina TS et al. (2006). Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain. Journal of Neurochemistry 97(Suppl 1):82-86. PMID 16635254. DOI 10.1111/j.1471-4159.2006.03658.x
- Dolotov OV, Karpenko EA, Inozemtseva LS et al. (2006). Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Research 1117(1):54-60. PMID 16996037. DOI 10.1016/j.brainres.2006.07.108
- Shadrina MI, Dolotov OV, Grivennikov IA et al. (2001). Rapid induction of neurotrophin mRNAs in rat glial cell cultures by Semax, an adrenocorticotropic hormone analog. Neuroscience Letters 308(2):115-118. PMID 11457573. DOI 10.1016/s0304-3940(01)01994-2
- Medvedeva EV, Dmitrieva VG, Povarova OV et al. (2014). The peptide semax affects the expression of genes related to the immune and vascular systems in rat brain focal ischemia: genome-wide transcriptional analysis. BMC Genomics 15:228. PMID 24661604. DOI 10.1186/1471-2164-15-228
- Tomasello MF, Di Rosa MC, Naletova I et al. (2025). Semax, a copper chelator peptide, decreases the Cu(II)-catalyzed ROS production and cytotoxicity of Aβ by metal ion stripping and redox silencing. Bioinorganic Chemistry and Applications 2025:4226220. PMID 40496623. DOI 10.1155/bca/4226220
- Gusev EI, Skvortsova VI, Miasoedov NF et al. (1997). Effectiveness of semax in acute period of hemispheric ischemic stroke. Zhurnal Nevrologii i Psikhiatrii im S S Korsakova 97(6):26-34. PMID 11517472
- Gusev EI, Skvortsova VI, Chukanova EI. (2005). Semax in prevention of disease progress and development of exacerbations in patients with cerebrovascular insufficiency. Zhurnal Nevrologii i Psikhiatrii im S S Korsakova 105(2):35-40. PMID 15792140
- Gusev EI, Martynov MY, Kostenko EV et al. (2018). The efficacy of semax in the treatment of patients at different stages of ischemic stroke. Zhurnal Nevrologii i Psikhiatrii im S S Korsakova 118(3 Vyp 2):61-68. PMID 29798983. DOI 10.17116/jnevro20181183261-68
- Panikratova YR, Lebedeva IS, Sokolov OY et al. (2020). Functional connectomic approach to studying Selank and Semax effects. Doklady Biological Sciences 490(1):9-11. PMID 32342318. DOI 10.1134/S001249662001007X
- Kaplan AYa, Kochetova AG, Nezavibathko VN et al. (1996). Synthetic ACTH analogue Semax displays nootropic-like activity in humans. Neuroscience Research Communications 19(2):115-123. Not indexed in PubMed; full text not obtainable on 6 September 2026.
- Slominsky PA, Shadrina MI, Kolomin TA et al. (2017). Peptides semax and selank affect the behavior of rats with 6-OHDA induced PD-like parkinsonism. Doklady Biological Sciences 474(1):106-109. PMID 28702721. DOI 10.1134/S0012496617030048
- Severyanova LA, Kryukov AA, Plotnikov DV, Dolgintsev ME. (2020). Peptide ACTH(4-7)-PGP: effects on various types of pain and pain-induced behavior in rats after systemic and central administration. Bulletin of Experimental Biology and Medicine 170(2):185-190. PMID 33263853. DOI 10.1007/s10517-020-05029-8
- Liu R, Chen Y, Huang H et al. (2025). Semax peptide targets the μ opioid receptor gene Oprm1 to promote deubiquitination and functional recovery after spinal cord injury in female mice. British Journal of Pharmacology 182(22):5489-5516. PMID 40692165. DOI 10.1111/bph.70122
- Radchenko AI, Kuzubova EV, Apostol AA et al. (2025). The potential of the peptide drug Semax and its derivative for correcting pathological impairments in the animal model of Alzheimer's disease. Acta Naturae 17(4):110-120. PMID 41479572. DOI 10.32607/actanaturae.27808
- Health Canada, Drug Product Database. Queried by brand name and by active ingredient "semax" on 6 September 2026; both returned an empty result. https://health-products.canada.ca/dpd-bdpp/
- Australian Government Department of Health, Poisons Standard 2026. Full text searched for "semax", "corticotropin" and "MET-GLU-HIS" on 6 September 2026; no match. https://www.tga.gov.au/products/poisons-standard-and-scheduling-medicines-and-chemicals
- openFDA, drug/ndc.json queried for "semax" on 6 September 2026: 12 records, all of them bulk ingredient listings, one of them for N-acetyl Semax. Queries of drug/drugsfda.json and drug/label.json returned no matches. https://api.fda.gov/drug/ndc.json
- World Anti-Doping Agency, The 2026 Prohibited List, in force from 1 January 2026. Full text searched on 6 September 2026; Semax does not appear, and the only related entry is section S2.2.2 on corticotrophins. https://www.wada-ama.org/en/prohibited-list
- Pokrywka A, Surała O, Grabowska K et al. (2025). "Brain doping" substances: prohibited or not in sports? Biology of Sport 42(4):189-201. PMID 41048238. DOI 10.5114/biolsport.2025.150047. Semax appears in table 6, the unclear category.
- National Collegiate Athletic Association, banned substances list. Full text searched for "semax" on 6 September 2026; no match. The list states that it is neither complete nor exhaustive. https://www.ncaa.org/sports/2015/6/10/ncaa-banned-substances.aspx
- Vanhee C, Francotte A, Janvier S, Deconinck E. (2020). The occurrence of putative cognitive enhancing research peptides in seized pharmaceutical preparations. Drug Testing and Analysis 12(3):371-381. PMID 31667971. DOI 10.1002/dta.2717
- Naletova I, Nicoletti VG, Milardi D et al. (2016). Influence of the N-terminus acetylation of Semax, a synthetic analog of ACTH(4-10), on copper(II) and zinc(II) coordination and biological properties. Journal of Inorganic Biochemistry 164:8-17. PMID 27586814. DOI 10.1016/j.jinorgbio.2016.08.013
Cite this page
The facts on this page were checked on 6 September 2026, and the registers behind the status table were queried on that same day. The regulatory position could move, because the American compounding question is open and the anti-doping classification is unresolved, so the version and the date matter as much as the text.
myPeptides Research & Editing. (2026). Semax: what the studies show, status and safety. Version 1.0, 6 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/semax
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.
| Version | Date | Change |
|---|---|---|
| 1.0 | 2026-09-06 | Initial publication |
Last verified: 6 September 2026. Next review: on any FDA rulemaking about the compounding list, on a change to the Russian registrations, or on any change in the anti-doping classification.