Compound hub · Semax
Is Semax legal? Australian, US and Russian status
A name search of Australia's October 2026 Poisons Standard found no entry for Semax; this does not establish its legal status or rule out group headings (F2026L01327, checked 14 October 2026). The ARTG was not searched, while the FDA reports no approved US drug containing Semax and registration in Russia; these are separate regulatory questions, not a decision on any person's legal position (FDA briefing document, July 2026).
Your nose, your gut and your blood treat a molecule the same way in every country: enzymes meet it and go to work. Law does not behave like that. Each country sorts the same seven-amino-acid chain into its own boxes, and some countries have never opened a box for it. The Semax hub gathers the published record on this peptide, and the Semax research guide covers the compound itself.
This page reads the legal records one at a time: the Australian Poisons Standard, the TGA, the US Food and Drug Administration, the Russian register as the FDA cites it, and the World Anti-Doping Agency's List. Each record was read on 14 October 2026. The page reports what each says and where each is silent. It gives no legal advice. The Australian law hub holds the wider framework.
Key facts
| Common name | Semax |
|---|---|
| Sequence | Met-Glu-His-Phe-Pro-Gly-Pro, seven amino acids (FDA briefing document, July 2026) |
| Formula and weight | C37H51N9O10S; 813.93 g/mol; CAS 80714-61-0 (FDA briefing document, July 2026) |
| Records read | 14 October 2026 |
| Australian instrument | Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, F2026L01327, dated 28 September 2026: no match for 'semax' in a text search (read 14 October 2026) |
| TGA advisory | Published 13 April 2026: names BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295 as examples; Semax is not named |
| ARTG search | The ARTG register was not searched for this page (14 October 2026) |
| FDA status | Not a component of any FDA-approved drug; no USP or NF monograph (FDA briefing document, July 2026) |
| FDA advisory committee | Semax listed for the 23 and 24 July 2026 meeting; the FDA meeting page posts no vote result (checked 14 October 2026) |
| Registered medicine | Registered drug in Russia, as cited by the FDA from the Russian State Register of Medicines (FDA briefing document, July 2026); the register was not searched for this page |
| WADA 2026 List | Semax not named in the WADA 2026 Prohibited List (read 14 October 2026); listed with 'unclear' status in Pokrywka et al., Biology of Sport, 2025 |
Is Semax legal or illegal in Australia?
No record read for this page says that Semax is legal or illegal in Australia. A text search of the Poisons Standard (Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, F2026L01327, dated 28 September 2026) found no entry naming Semax (read 14 October 2026). The TGA states that unapproved peptide products have not been evaluated for safety, quality or effectiveness, that a 'research use only' disclaimer does not make supply lawful, and that state and territory laws may add controls (TGA advisory, 13 April 2026). Whether a given act is lawful depends on the act, the person and the jurisdiction.
An absent name is not a permission, and it is not a ban. The Australian law hub explains what 'no individual entry' means, including that group headings can reach substances they do not name. A name search cannot rule those headings out, and this page draws no group-heading conclusion for Semax. The same instrument names corticotrophin and tetracosactide in Schedule 4 (read 14 October 2026). Those entries name other substances, and this page does not say they reach Semax.
The catalogue lists Semax reference material for laboratory work. Research material is not a medicine, and a catalogue label changes none of the records on this page.
Evidence limits
What do these legal records not tell you about Semax?
The records read for this page do not establish any person's legal position on Semax, whether for possession, supply or import. They are a text search of the Poisons Standard, regulator and anti-doping documents, and peer-reviewed papers, all read on 14 October 2026. Four things were not checked: the live ARTG register, the Russian-language State Register of Medicines, state and territory legislation, and the US federal controlled-substance schedules (21 CFR Part 1308). A later Poisons Standard or FDA decision can change the picture. This page reports records and is not legal advice.
Each record answers one question only. A schedule entry classifies a substance. An ARTG entry approves a product. A sport list sets a rule for athletes. An FDA committee vote advises the agency on a compounding list. Mixing them up is the commonest way to misread peptide law.
Is Semax an approved medicine in Australia?
No TGA document read for this page lists Semax as an approved medicine. The TGA calls goods that are not included in the ARTG, the Australian Register of Therapeutic Goods, unapproved peptide products. Its advisory of 13 April 2026 names BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295 as examples and does not name Semax. The ARTG is a live database that was not searched for this page on 14 October 2026, so the page states nothing about any single ARTG entry. Absence from a document is not approval.
The advisory says unapproved peptide products have not been assessed by the TGA for safety, quality or effectiveness, and that how they are made, whether they are sterile and what side effects they may cause are unknown. It lists adverse events the TGA has received for such products as a class, including severe allergic reactions and systemic inflammatory response syndrome. Those reports do not name Semax. The advisory was read on the TGA site on 14 October 2026.
Is Semax legal or available in the United States?
Semax is not an FDA-approved drug, and no US federal record read for this page declares it legal or illegal. The FDA's July 2026 briefing document says no US Pharmacopeia or National Formulary monograph exists for Semax and that Semax is not a component of any FDA-approved drug. The same document says Semax products are widely marketed in the US. It also says that, based on a US Attorney press release, a pharmacy compounded and distributed products containing semax from 25 October 2018 to 1 April 2020, and that it is unclear which form of semax was used.
Compounding is the making of a medicine for one patient from bulk ingredients by a licensed pharmacist or physician. Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) sets the legal conditions, including which bulk ingredients are eligible. The FDA's briefing document says no outsourcing facility, a registered large-scale compounder, has reported compounding drug products containing semax since 2019 (FDA briefing document, July 2026).
The briefing document is a staff paper for an advisory committee, not a ruling on any person or product.
Why is Semax not FDA approved?
The FDA records read for this page do not say why Semax has no FDA approval, and they describe no approval application for it. The July 2026 briefing document asks a different question: whether Semax belongs on the 503A Bulks List, the list of bulk substances that pharmacists may compound with. FDA staff stated that the evaluation criteria weigh against adding Semax. They cited chemistry gaps, too little clinical information to describe its safety, and too little evidence of effectiveness for cerebral ischemia (blocked blood flow to the brain), migraine and trigeminal neuralgia, a facial nerve pain condition (FDA briefing document, July 2026).
On effectiveness, the FDA says only two references were available, with limited design detail, small samples and missing information on some clinical endpoints. On chemistry, it says Semax is a common name and not a United States Adopted Name, that salts and derivatives are sold under that one name, and that endotoxin and impurity data were not identified (FDA briefing document, July 2026). ADHD was nominated as a use but was not evaluated, because the FDA did not find supporting literature (FDA briefing document, July 2026).
What did the FDA advisory committee decide about Semax?
The official record read does not establish the committee's vote on Semax. The FDA meeting page lists Semax free base and Semax acetate for the 23 and 24 July 2026 meeting, evaluated for cerebral ischemia, migraine and trigeminal neuralgia. That page posts no vote result (checked 14 October 2026). The FDA's July 2026 briefing document is background material prepared for the committee. The sources read did not include a final FDA determination on Semax; an advisory committee's recommendation and drug approval are separate records.
The FDA's 503A bulks page, read on 14 October 2026, says a compounder under section 503A may use a bulk substance that has a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list. Appearing on the list is therefore a separate question from drug approval. The Australian law hub sets the same July 2026 meeting beside the other catalogue peptides.
The FDA's meeting page identifies the agenda. It does not supply an official vote record in the material checked on 14 October 2026.
Which countries approve or use Semax?
Russia is the only country named as having registered Semax as a medicine in the sources read for this page. The FDA's July 2026 briefing document states that Semax is a registered drug in Russia and cites the Russian State Register of Medicines. A 2022 review describes Semax as an original Russian peptide drug in the nootropic group (Deigin et al., Pharmaceutics, 2022). The FDA found no Semax monograph in the European, Japanese or International Pharmacopoeias. No source opened for this page lists Semax's legal status country by country, and this page did not search other countries' registers.
The Russian register is the official source for label text. It is in Russian and was not searched for this page, so no label statement is reported here, and the FDA's briefing, which cites the register, quotes none. What studies measured about timing is on the Semax half-life page.
What is in Semax?
Semax is a seven-amino-acid peptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro, the molecular formula C37H51N9O10S and a molecular weight of 813.93 g/mol (FDA briefing document, July 2026; PubChem record 9811102). Its sequence is a synthetic analogue of the ACTH(4-10) fragment, a piece of adrenocorticotropic hormone, a body signal released by the pituitary gland (Deigin et al., Pharmaceutics, 2022). The FDA notes that Semax is sold as a free base or as salts such as the acetate (C39H55N9O12S, 874.0 g/mol), and evaluates each as a different bulk substance.
The FDA warns that product labels naming 'Semax' can describe different derivatives. A certificate of analysis records what a given sample contained. A product name does not.
What is N-acetyl Semax amidate, and what does the law say about it?
N-acetyl Semax amidate is a name for Semax with an acetyl group on the amino end of the chain and an amide on the carboxyl end. A PubMed search on 14 October 2026 for 'N-acetyl semax', 'N-acetyl-semax' or 'Na-Semax' returned no records, so the sources searched did not find a published study under that name. The closest work studied Ac-Semax, acetylated at the amino end only, in test-tube and cell-line experiments, which is laboratory work on a different form, with no replicate count in the abstract, that does not establish a human result (Magrì et al., Journal of Inorganic Biochemistry, 2016).
A text search of the Poisons Standard, the TGA advisory and the WADA 2026 List found no entry for it.
The FDA says it has met multiple salts and derivatives, including different active moieties, sold commercially under the same common name for Semax, and treats them as different substances. Semax compared with Adamax, Dihexa and N-acetyl Semax amidate sets out what is published for each.
Is Semax banned in sport?
Semax is not named in the WADA 2026 Prohibited List, which took effect on 1 January 2026 (read 14 October 2026). A 2025 review by Polish anti-doping scientists placed Semax in a table of substances with 'unclear' status, among those the authors presumed to meet WADA's criteria because of similarity to tetracosactide, a corticotrophin listed in class S2 (Pokrywka et al., *Biology of Sport*, 2025). Sport Integrity Australia's peptides page names other peptides and does not name Semax (read 14 October 2026). The sources read did not include an anti-doping ruling on Semax, and this page makes none.
The WADA 2026 Prohibited List, effective 1 January 2026 and checked 14 October 2026, defines its S0 category as pharmacological substances not addressed by later sections that have no current governmental health-authority approval for human therapeutic use. The FDA reports that Semax is a registered drug in Russia. This page does not decide whether that registration affects how class S0 applies.
Comparison
Seven dated records about Semax, compared by what each says and what each leaves open. All were read on 14 October 2026. This is not legal advice.
| Record | What it says about Semax and what it leaves open |
|---|---|
| Poisons Standard—October 2026 (F2026L01327, dated 28 September 2026) | A text search for 'semax' found no individual entry; the search does not show whether a group heading reaches Semax, and it does not show any person's position. |
| TGA advisory (13 April 2026) | Defines unapproved peptide products as goods not included in the ARTG and does not name Semax among its examples; it gives no ARTG search result for Semax. |
| FDA briefing document (July 2026) | Says Semax has no USP or NF monograph, is not a component of any FDA-approved drug and is a registered drug in Russia; it is a staff paper and not a final FDA decision. |
| FDA advisory committee (23-24 July 2026) | The FDA meeting page lists Semax among the substances evaluated but posts no vote result (checked 14 October 2026); a committee recommendation is not drug approval or a final FDA determination. |
| Russian register, as cited by the FDA | The FDA cites it for Semax's registered-drug status in Russia; the register was not searched for this page, so its label text is not reported. |
| WADA 2026 Prohibited List | Semax is not named in the List, and a 2025 review listed it with 'unclear' status; neither is an anti-doping ruling. |
| Sport Integrity Australia, Peptides explained | Names other peptides and does not name Semax; it does not give the outcome of any individual case. |
FAQ
Is Semax a controlled substance?
No record read for this page describes Semax as a controlled substance. The FDA's July 2026 briefing says it did not identify nonclinical studies showing whether Semax has reinforcing and addictive properties, which is a gap in the record and not a finding either way (FDA briefing document, July 2026). The US federal controlled-substance schedules (21 CFR Part 1308) were not searched for this page, so it makes no statement on US federal scheduling.
Does Semax act like a stimulant, and does it affect dopamine?
In a rodent study, Semax alone did not change tissue or extracellular levels of dopamine and its breakdown products, and it enhanced the dopamine release and movement caused by D-amphetamine, a stimulant; the abstract gives no group sizes and the result does not establish a human result (Eremin et al., Neurochemical Research, 2005). The FDA called that finding concerning, because increased dopamine tone in the striatum is a response typically induced by drugs of abuse such as cocaine (FDA briefing document, July 2026). The records read include no human study of stimulant-like effects. The Semax side effects page covers the recorded safety data.
Can Semax be addictive?
No study read for this page tested whether Semax is addictive, in animals or in people. The FDA says it did not identify nonclinical studies of reinforcing or addictive properties (FDA briefing document, July 2026). In rodents, Semax enhanced amphetamine-induced dopamine release and movement; the abstract gives no group sizes, and this does not establish human addiction or a human result (Eremin et al., Neurochemical Research, 2005). Absence of a study is not evidence of absence of risk.
Has Semax been studied for ADHD?
A PubMed search for 'semax AND ADHD' on 14 October 2026 returned 2 records, and neither reports a trial in people with ADHD. One is a 2007 hypothesis paper that proposed Semax as a candidate for ADHD, as a proposal rather than a trial result (Tsai, Medical Hypotheses, 2007). The other is a 2003 paper on hypoxia and its correction with peptide hormones in animals (Maslova et al., Neuroscience and Behavioral Physiology, 2003). The FDA did not evaluate ADHD because it did not find supporting literature (FDA briefing document, July 2026). A hypothesis is not a trial result.
Does Semax affect hormones?
In rats assessed at 65 days of age after neonatal isolation, with groups of 13, 12 and 11 rats, Semax raised a blunted stress-induced corticosterone release to control values; this does not establish a human result (Volodina et al., Acta Naturae, 2012, full text). The sources read include no human hormone study.
Does Semax affect the heart?
In rats, one study reported that Semax changed heart rate variability at one time of day and not at another; the abstract gives no number of rats and the result does not establish a human result (Arushanian et al., Eksperimental'naia i Klinicheskaia Farmakologiia, 2009). In rats 28 days after induced heart injury, Semax reduced the growth of sympathetic nerve fibres in the ventricular septum and did not change beta-receptor density; the abstract gives no group sizes and the result does not establish a human result (Gavrilova et al., Bulletin of Experimental Biology and Medicine, 2017). The FDA raised a concern about bleeding risk based on reported antithrombotic properties of Semax (FDA briefing document, July 2026). The sources read include no human heart-safety study.
Is there a review or official source on the clinical evidence for Semax?
The most detailed official source read is the FDA's July 2026 briefing document, which reviews the nonclinical, clinical and safety literature for Semax. A PubMed search on 14 October 2026 returned 232 records matching 'semax', and a search combining 'semax' with the systematic-review and meta-analysis filters returned none. A 2022 narrative review covers Semax among Russian peptide drugs (Deigin et al., Pharmaceutics, 2022).
Is Dihexa FDA approved?
No FDA record read for this page lists Dihexa as an approved drug. The FDA meeting page for 23 and 24 July 2026 does not list Dihexa among the substances discussed, and a ClinicalTrials.gov search on 14 October 2026 found no record for it. A PubMed search for 'dihexa' on the same date returned 19 records, none tagged as a clinical trial or randomised controlled trial.
More in this hub
Citations
6 sourcesDeigin VI et al. Pharmaceutics. 2022;14(4):716.
doi:10.3390/pharmaceutics14040716Magrì A et al. Journal of Inorganic Biochemistry. 2016;164:59-69.
doi:10.1016/j.jinorgbio.2016.08.013Pokrywka A et al. Biology of Sport. 2025;42(4):189-201.
doi:10.5114/biolsport.2025.150047Eremin KO et al. Neurochemical Research. 2005;30(12):1493-1500.
doi:10.1007/s11064-005-8826-8Tsai SJ Medical Hypotheses. 2007;68(5):1144-1146.
doi:10.1016/j.mehy.2006.07.017Volodina MA et al. Acta Naturae. 2012;4(1):86-92.
doi:10.32607/20758251-2012-4-1-86-92
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Semax reference material — catalogue listingResearch use only — not for human or animal use.
Read the Semax research guideForm Laboratories supplies research-use-only reference material. This article is an educational summary of published third-party literature. It is not medical advice, not a use instruction, and research material is not for human or animal use.