Brain & sleep · Evidence tier B
Semax
Семакс (Russian brand name; Semax 0.1% and Semax 1% nasal drops) · Met-Glu-His-Phe-Pro-Gly-Pro (MEHFPGP) · ACTH(4-7)-Pro-Gly-Pro (ACTH(4-7)PGP) · Semax (heptapeptide) (name on FDA’s compounding lists) · Semax acetate (salt form) · N-Acetyl Semax (vendor name for a modified form, a different molecule)
Semax is a lab-made chain of 7 amino acids: part of the stress hormone ACTH plus a 3-amino-acid tail12. Russia sells it as nose drops for stroke and memory problems34. Its human evidence is small and mostly Russian25.

Quick answers
- What is it?
- A lab-made chain of 7 amino acids. Four come from ACTH, a stress hormone made by the pituitary gland; three were added so the effect lasts longer1. Russia sells it as prescription nose drops34. Its label says it has no hormone activity3.
- Does it work?
- Unproven. FDA staff found too little evidence for brain blood-flow problems, migraine or facial nerve pain2. Russian stroke studies without a placebo reported faster recovery67. A small 1996 study in healthy men reported better work performance but mentions no placebo group28.
- Is it safe?
- Unknown. FDA found no safety data for injections and too little to judge nose drops2. Its Russian label lists only mild nose irritation but rules out use after seizures or with anxiety disorders3. One user reported eye pain and a hospital stay after nose drops2.
What it is
Semax is a lab-made peptide, a chain of 7 amino acids: methionine, glutamic acid, histidine, phenylalanine, proline, glycine and proline (Met-Glu-His-Phe-Pro-Gly-Pro)12. The first four match positions 4 to 7 of ACTH (adrenocorticotropic hormone), the pituitary hormone that tells the adrenal glands to make cortisol1. Its developers started from a natural ACTH fragment, ACTH(4-10), whose effect lasts only 30 to 60 minutes, and replaced its last three amino acids with a proline-glycine-proline tail; they report that semax’s effect lasts 20 to 24 hours1. They also report that it has neither corticotropic (cortisol-releasing) nor melanocyte-stimulating activity, and the Russian label says it has no hormonal activity13. How it works is not settled. In rats, nasal doses of 50 or 250 µg/kg raised BDNF (brain-derived neurotrophic factor), a protein that supports nerve cells, in the basal forebrain within 3 hours, but not in the cerebellum15. In the lab it blocks enzymes in human serum that break down enkephalins, the body’s own opioid-like peptides16. In rodents it raised a serotonin breakdown product in the striatum, a deep brain region, and strongly boosted the dopamine release caused by amphetamine; FDA calls this ‘concerning because increased dopaminergic tone in the striatum is a response typically induced by drugs of abuse such as cocaine’217. It is broken down quickly: in the presence of nerve cells it is cut mainly into two shorter pieces, HFPGP and the Pro-Gly-Pro tail218.
Work on semax began in the late 1970s under N. F. Myasoedov and I. P. Ashmarin, and it was made at the Institute of Molecular Genetics of the Russian Academy of Sciences119. A 0.1% nasal drop came first, and a stronger 1% drop for stroke had been developed by 20011. Both are now registered in Russia to the company Peptogen, under registrations that Vidal dates to 2025 and that replaced older ones34. Much of the human evidence comes from the developers’ circle: Ashmarin co-wrote the 1996 study in healthy men, Myasoedov co-wrote a 1997 stroke study, and a 2013 English-language review of semax and selank was co-written by Myasoedov178. In the US, Wells Pharmacy Network and LDT Health Solutions asked FDA to let pharmacies compound it, then withdrew; FDA reviewed it anyway for its July 2026 advisory meeting2.
Benefits: what the research shows
Nearly all human data come from Russian studies of the nasal drops, often small, published in Russian and without a placebo group25. FDA’s 2026 review set aside the Russian-language stroke papers because full English translations were not available, and it found ‘insufficient evidence’ for cerebral ischemia (poor blood flow to the brain), migraine or trigeminal neuralgia (a facial nerve pain)2. The largest stroke study we could read in full, from 2018, split 110 patients in rehabilitation after ischemic stroke into groups with or without semax, described as random, with no placebo or blinding reported6. The semax groups got 6,000 µg a day for 10 days, twice, 20 days apart. At 1 month, scores on the Barthel index, a 0 to 100 scale of everyday self-care, rose more with semax: 21.6 versus 11.3 points when rehabilitation started early (about 3 months after the stroke) and 14.8 versus 4.1 when it started late (about 7 months). At 5 months, total gains no longer differed in the early group (27.5 versus 25.8 points) but still did in the late group (23.7 versus 18.7). Blood levels of BDNF also rose with semax6. A 1997 study compared 30 acute stroke patients given semax with 80 similar patients on usual care and reported ‘some influence’ on the recovery of movement and other functions7. A 2005 study of 187 people with long-term poor brain blood flow reported less disease progression and fewer strokes, but its English summary gives no figures23. In an open trial in 27 people with motor neuron disease (ALS), semax did not change nerve tests or disease scores, though quality-of-life scores rose24. Other uses rest on even smaller studies. In 32 adults with hard-to-heal peptic ulcers, ulcers had healed by day 14 in 89.5% of those given semax drops on top of standard ulcer drugs versus 30.8% of controls225. Russian eye studies reported benefits in optic nerve disease and in diabetic eye damage, including when semax was driven into the nose lining with a weak electric current2627. For pain, FDA reviewed a 1996 study of one nasal dose with no control group or blinding: 4 of 12 people with migraine said their headache stopped 90 to 120 minutes after the dose, 8 reported weaker relief, and the 16 with typical trigeminal neuralgia had no change2. For focus and memory, the data in healthy people are thin. A 1996 study of 19 healthy men reported EEG (brain-wave) changes like those of nootropic (memory-enhancing) drugs and better work performance for 20 to 24 hours after 0.25 to 1.0 mg, but its summary mentions no placebo group28. A 1997 review by the developers reported better memory and attention in healthy men working under extreme conditions, and no side effects in any patient28. Two placebo-controlled studies, in 24 and 52 healthy volunteers, measured only brain-scan patterns at rest, not thinking or memory2930. No semax trial is registered on ClinicalTrials.gov (searched 7 October 2026)31. Animal data are broader: in rats with induced strokes, nasal semax given twice in the first hour and then daily for 6 more days made the damaged area about 20% smaller at 8 days and protected memory in a learning test232.
Key human studies
| Study | Design | People | Dose and route | Result |
|---|---|---|---|---|
| Gusev et al., Zh Nevrol Psikhiatr Im S S Korsakova 20186PubMed · DOI | Open comparison in stroke rehabilitation; patients were divided into semax and no-semax groups, described as random, with no placebo or blinding reported; Russian-language paper | 110 | Semax 1% nasal drops, 6,000 µg a day for 10 days, repeated after 20 days, added to rehabilitation | At 1 month, Barthel index scores rose 21.6 vs 11.3 points in early rehabilitation (p=0.006) and 14.8 vs 4.1 in late rehabilitation (p<0.001). At 5 months the early groups no longer differed (total gain 27.5 vs 25.8); the late groups still did (23.7 vs 18.7, p=0.044). Blood BDNF rose with semax6. |
| Gusev et al., Zh Nevrol Psikhiatr Im S S Korsakova 19977PubMed | Comparison of acute stroke patients given semax with similar patients on usual care; how patients were assigned is not stated in the English summary; a semax developer is a co-author | 110 | Semax added to intensive care, route not stated in the English summary; daily doses of 12 mg (moderate stroke) or 18 mg (severe stroke) for 5 or 10 days were reported as most effective | In 30 semax patients versus 80 controls, the authors reported ‘some influence’ on the recovery of damaged functions, especially movement; the English summary gives no figures7. |
| Kaplan et al., Neuroscience Research Communications 19968DOI | Study in healthy male volunteers; the abstract mentions no placebo group or randomization; co-written by a semax developer | 19 | Nasal semax, 0.25 to 1.0 mg (about 4 to 16 µg/kg); per FDA, 1 mg daily for 2 days or 0.25 mg once | Reported EEG changes like those of nootropic drugs and better work efficiency in operator tasks for 20 to 24 hours8. FDA notes the paper did not discuss side effects2. |
| Lebedeva et al., Bull Exp Biol Med 201829PubMed · DOI | Placebo-controlled brain-scan study (resting-state fMRI) in healthy volunteers; randomization not stated | 24 | One dose of 1% semax in the nose (14 people; 1.2 mg per FDA) or placebo (10); scans before and 5 and 20 minutes after | The semax group showed a larger front part of the default mode network, a set of brain areas active at rest, than the placebo group. The abstract reports no thinking or memory tests229. |
| Ivanikov et al., Bull Exp Biol Med 200225PubMed · DOI | Controlled comparison in hard-to-heal peptic ulcer: semax plus standard ulcer drugs versus standard drugs alone | 32 | Semax 1%, 2 to 4 drops 3 times a day for 10 days in the nose, plus omeprazole and other ulcer drugs | Ulcers had healed by day 14 in 89.5% of patients given semax versus 30.8% of controls25. FDA notes side effects were not discussed2. |
| Serdiuk et al., Zh Nevrol Psikhiatr Im S S Korsakova 200724PubMed | Open-label trial in sequential groups of patients with motor neuron disease (ALS); no control group described; indexed by PubMed as randomized | 27 | Semax 1% nasal drops, 12 mg a day in two 10-day courses 2 weeks apart | Semax did not change nerve-muscle (EMG) findings or clinical ALS scores; quality-of-life scores improved, mainly emotional state and motivation, most on day 1024. |
Doses studied
Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.
In human studies
Russian labels (nasal drops only). Semax 1% contains 500 µg per drop. For moderate stroke the label lists 2 to 3 drops per nostril 3 to 4 times a day (6,000 to 12,000 µg a day); for severe stroke, 3 to 4 drops per nostril 4 to 5 times a day (12,000 to 20,000 µg a day); courses last 10 days3. Semax 0.1% contains 50 µg per drop. For memory and thinking problems from blood-vessel disease of the brain it lists single doses of 200 to 2,000 µg and 800 to 8,000 µg a day for 10 to 14 days; to prevent mental fatigue, 400 to 900 µg a day for 3 to 5 days; and for children aged 7 and up with minimal brain dysfunction, 200 to 400 µg a day for 30 days4. Studies: 6,000 µg a day in two 10-day courses after stroke6; 12 or 18 mg a day for 5 to 10 days in acute stroke7; 12 mg a day in two 10-day courses in ALS24; 2 to 4 drops of the 1% solution 3 times a day (per nostril, per FDA) for 10 days in peptic ulcer225; 0.25 to 1.0 mg (about 4 to 16 µg/kg) in healthy men8; and single doses listed by FDA as 1.2 mg in brain-scan studies2. FDA found no human data for injection under the skin, and the nasal studies do not describe the devices used2.
In animal studies
As reported. Rats: nasal 50 or 250 µg/kg raised BDNF in the basal forebrain at 3 hours15; nasal 250 µg/kg at 15 minutes and 1 hour after an induced stroke, then daily for 6 more days, shrank the damage2; 100 µg/kg into the abdomen (intraperitoneal) in other stroke studies2; 1 mg/kg a day in the nose for 5 days raised anti-clotting and clot-dissolving activity2. Rodents: 1.5 to 500 µg/kg into the abdomen in pain tests2; 0.15 mg/kg into the abdomen raised a serotonin breakdown product and boosted amphetamine’s effects17. Mice: 3 mg/kg a day into the abdomen, 5 days a week for life, in a strain prone to breast tumors2.
What users report Anecdotal · not validated · not a recommendation
A nootropics review site (updated 5 September 2026) lists up to 750 to 1,000 µg a day as a nasal spray and 100 to 300 µg a day injected under the skin42.
- Half-life
- No human value found; lab and animal figures range from minutes to over an hour12FDA found no study of how semax is absorbed, spread or cleared in people by any route2. In rats it is rapidly broken down, and its main breakdown product is Pro-Gly-Pro2. Very little reaches the brain: FDA cites peak brain levels of about 0.005% of an IV dose and 0.072% of a nasal dose (at 2 minutes) in rats, while the developers’ review gives 0.01% and 0.093%12. The developers’ review gives conflicting figures, a half-life ‘in the body of a few minutes’ and more than 1 hour in serum, and says effects last 20 to 24 hours after a single dose, which it links to active breakdown pieces1.
- Routes
- Nasal drops (Russia’s 0.1% and 1% products; every human study FDA found used the nose)
- Nasal spray (sold by US clinics and online sellers; no human data found on these products)
- Subcutaneous injection, under the skin (proposed for US compounding and sold online; no human data found)
- Endonasal electrophoresis, a weak current that carries the drug into the nose lining (Russian eye studies and the 0.1% label)
- Intraperitoneal (into the abdomen) or intravenous injection (animal studies only)
Legal status
- United States
- Not approved by FDA for any use: FDA’s 2026 review says semax has no United States Pharmacopeia or National Formulary monograph and is not a component of any FDA-approved drug2. FDA notes that semax ‘is a common name and not a United States Adopted Name (USAN)’, and that it has seen multiple salts and derivatives, including different active molecules, sold under the same name2. No semax trial is registered on ClinicalTrials.gov: a search on 7 October 2026 returned no studies31. A Kentucky compounding pharmacy pleaded guilty to distributing unapproved new drugs from 25 October 2018 to 1 April 2020; its plea agreement says these included semax and selank. On 24 February 2021 it was sentenced to 3 years of probation and forfeited $1,788,906.82, its 2019 sales of these products35. In a 10 November 2021 warning letter to an Indianapolis firm, FDA noted that semax, selank and several other peptides ‘were not nominated for inclusion on the 503A bulks list’ at that time36.
- US pharmacies
- Section 503A of federal drug law covers compounding by pharmacies for individual patients. FDA added ‘Semax (heptapeptide)’ to Category 2 of its interim 503A bulks list, substances that raise significant safety concerns, in its 29 September 2023 update37. Its nominators, Wells Pharmacy Network and LDT Health Solutions, had proposed a nasal spray or an injection under the skin at 7,500 or 1,000 µg/mL, and FDA reviewed it for cerebral ischemia, migraine and trigeminal neuralgia; both nominations were withdrawn2. A law firm reported that on 15 April 2026 FDA announced it would remove semax and 11 other peptides from Category 2 because their nominators had withdrawn them; the firm stressed that removal does not make them eligible for compounding38. Semax is in no category of the list updated 14 May 2026, so US pharmacies cannot lawfully compound it under section 503A9. FDA’s safety-risk page lists it under ‘Bulk drug substances nominated but withdrawn’, substances ‘previously in category 2’ whose nominators withdrew them. It says semax ‘may pose risk for immunogenicity’ (unwanted immune reactions) and that the agency ‘lacks sufficient information to know whether the drug would cause harm if administered to humans’10. FDA reviewed the free base and the acetate salt on its own initiative and, in a review dated 11 May 2026, concluded that the balance of criteria ‘weighs against’ adding either2. On 24 July 2026 PCAC (FDA’s Pharmacy Compounding Advisory Committee) voted 8 for and 5 against adding semax, with 1 abstention5. Members in favor framed it as recognizing a decision ‘patients are already making’; dissenters pointed to weak preclinical evidence, characterization concerns and the risk of steering patients away from evidence-based therapies for serious conditions5. The vote is not binding: as a law firm notes, FDA must still go through formal rulemaking before a substance is permanently added to the list38. As of 5 October 2026 the meeting page, last updated 6 August 2026, listed no minutes, and the 503A list had not changed911. No 503B outsourcing facility (a larger compounder registered with FDA) has reported compounding semax since 20192.
- Other countries
- Russia: Vidal, a Russian drug reference, lists two prescription-only semax nasal drops registered to Peptogen. Semax 1% (registration ЛП-№(010596)-(РГ-RU), dated 18 June 2025, replacing Р N000812/01) is for the acute period of moderate or severe ischemic stroke, as part of combined treatment3. Semax 0.1% (ЛП-№(009449)-(РГ-RU), dated 26 March 2025, replacing ЛС-002553) lists memory and thinking problems from blood-vessel disease of the brain, recovery after stroke, brain injury, neurosurgery or anesthesia, prevention of mental fatigue, optic nerve disease and, from age 7, minimal brain dysfunction including ADHD4. Vidal shows both on Russia’s list of vital and essential medicines34. FDA’s review, citing the Russian register, also says semax is registered in Russia as 0.1% and 1% nasal drops, and that no monograph exists in the European, Japanese or International pharmacopeias2. The official Russian register (GRLS) could not be opened for this article. Canada: Health Canada lists semax and selank among unauthorized injectable peptides seized from and sold by an online seller (1 August 2025), says injectable peptides are regulated as prescription drugs in Canada, and says ‘For Research Use Only’ labels do not make products legal3940. Belgium: Sciensano, Belgium’s public health institute, identified semax and selank in two suspicious preparations encountered at the end of 2017 and 201841. Australia: semax is not named in the Poisons Standard in force from 1 October 2026. Corticotrophin (ACTH) is in Schedule 4 (prescription only), and the standard’s entries also cover derivatives, judged on structural, pharmacological and toxicological similarity, so whether that entry could reach semax is unresolved; we found no ruling34. UK and EU: not verified.
- Sport
- Semax is not named on WADA’s (World Anti-Doping Agency) 2026 Prohibited List or on the 2027 List, which takes effect on 1 January 20271233. Class S0 bans substances not covered elsewhere ‘with no current approval by any governmental regulatory health authority for human therapeutic use’; the 2027 List adds ‘peptides’ to its examples1233. By our reading, Russia’s current approval of semax nose drops puts it outside S034. The harder question is S2 (peptide hormones, growth factors, related substances and mimetics). S2 bans ‘corticotrophins and their releasing factors’, such as corticorelin and tetracosactide, and says that ‘other substances with similar chemical structure or similar biological effect(s)’ are also prohibited1233. Semax contains 4 amino acids of ACTH, a corticotrophin, and its Russian label describes it as a synthetic analog of corticotropin, but the same label and its developers say it has no hormonal activity13. We found no WADA ruling either way, so we mark its status unclear. WADA’s note on the 2027 List says that even if a peptide is not named, ‘utmost caution should be taken as it may still be prohibited and may be harmful to health’13.
Quality and the gray market
What testing finds
Finnrick, an independent testing service, lists 5 semax tests from 3 sellers between 12 March 2026 and 9 September 2026: 2 passed, 1 failed and 2 were incomplete under its ‘purity focus’ standard (purity of at least 99.5% and dose within 35% of the label)1443. One seller’s samples passed on 12 March 2026, failed on 27 May 2026 and passed again on 9 September 202614. Incomplete tests do not count toward the pass rate, and 5 tests are too few to judge the market43. FDA’s review found that the lab certificates (certificates of analysis) sent with both nominations were titled for semax acetate but listed the formula, weight and CAS number of the free base2. They allowed single impurities of up to 1.0% or 2.0% without saying what they were, and gave no results for clumping (aggregation) or microbes; FDA found no bacterial toxin (endotoxin) testing in published sources either2. FDA also had ‘strong concerns’ about nasal sprays because nothing was known about their container, closure and pump2. On one US seller’s site (accessed 5 October 2026), the ‘Semax’ page listed a formula and weight matching an acetylated, amidated variant (C39H54N10O10S, 854.99), while its ‘N-Acetyl Semax’ page listed plain semax’s formula with a weight (858.97) that fits neither form2144. In Belgium, Sciensano identified semax and selank in two suspicious preparations encountered at the end of 2017 and 201841. No FDA sampling or recall of semax was found.
How it is sold
In pages it viewed in December 2025, FDA found US health and wellness clinics, concierge medical services, functional and regenerative medicine clinics and online retailers marketing semax injections and nasal products for anxiety, depression, attention and memory, stroke, nerve regeneration, diabetic neuropathy, ADHD, opioid withdrawal, ALS, Parkinson’s and Alzheimer’s disease, optic nerve atrophy, pain and stomach protection2. Many sites did not clearly say whether the products were compounded, and none said whether they contained the free base or a salt2. One site sold a 2.5 mg/mL injection and a 1.25 mg/mL nasal spray, alone or as a ‘50:50’ blend with selank; another offered 30 mg ‘for research purposes only’2. Online sellers also offer research-labeled vials: one US seller listed semax 25 mg at $63 and ‘N-Acetyl Semax’ 25 mg at $60, ‘sold for laboratory research use only’ (accessed 5 October 2026)2144. A nootropics site whose author discloses a paid relationship with sellers calls semax ‘safe to use if you follow dosage recommendations’42. Demand signals are thin: Finnrick had logged only 5 semax tests by 9 September 202614. Health Canada has seized semax sold online39, and a Kentucky pharmacy whose plea agreement names semax among the unapproved drugs it distributed forfeited $1,788,906.82 in 202135.
Side effects and risks
- Unknown safety for the ways it is used in the US: FDA found no human data on how semax is absorbed or cleared, no human data at all for injection under the skin, and too little clinical information to characterize the safety of nasal use2.
- Unwanted immune reactions: FDA says semax ‘may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities’210.
- Bleeding: in rats, nasal semax raised anti-clotting and clot-dissolving activity in the blood; FDA says this raises concern about bleeding, especially in people at risk of bleeding or taking other drugs that raise that risk2.
- Possible abuse potential: in rodents semax strongly boosted amphetamine’s dopamine release, a response FDA links to drugs of abuse, and FDA found no study of whether semax itself is habit-forming217.
- Seizures and mental health: the Russian labels rule out use in acute psychiatric disorders, anxiety disorders or with a history of seizures34. A 1999 study in 73 patients with brain damage from lack of oxygen reported, in some cases, episodes of abnormal (paroxysmal) EEG activity after semax and advised giving the first dose under EEG monitoring45.
- Missing safety studies: FDA found no studies of genetic damage (genotoxicity) or of effects on fertility and development; one study in a tumor-prone mouse strain reported smaller breast tumors, which FDA said should be interpreted with caution2.
- Age and pregnancy limits: the 1% label rules out use under 18, the 0.1% label under 7, and both rule out pregnancy and breastfeeding, noting that no clinical studies were done in them34.
- Wrong or mislabeled product: FDA warns that inconsistent naming means patients ‘may be dosed with a different’ substance than the doctor ordered, one seller’s pages listed formulas that did not match their product names, and 1 of 5 Finnrick tests failed21444. At the July 2026 meeting, the acting chair warned that the name could be confused with semaxanib, a different compound5.
- Few reports do not mean few harms: compounders under section 503A generally do not report adverse events to FDA, and FDA found only one adverse event report for semax2.
- Legal and sport risk: a Kentucky pharmacy whose plea agreement names semax among the unapproved drugs it distributed was sentenced in 2021, Health Canada has seized semax products, and its status under the sport banned list is unclear133539.
Documented harms
- May 2024A consumer reported directly to FAERS (the FDA Adverse Event Reporting System, report #25343150) eye pain and eye burning in May 2024 after using Semax 0.1% nasal drops bought online. The report says the person was hospitalized and that the eye pain had not resolved when it was filed in May 2025. It was the only semax report FDA’s search of FAERS found through 3 December 2025, and FDA found no case reports in the medical literature2.
- 1999In a Russian study of 73 patients with brain damage after oxygen loss, 14 of them in a persistent vegetative state, EEG recordings in some cases showed episodes of paroxysmal (abnormal burst) activity after semax was given; the authors advised that the first dose be given while monitoring brain activity45.
Questions people ask
Is Semax FDA approved?
No. FDA has not approved semax for any use, and US pharmacies may not compound it29. Russia registers Semax 0.1% and 1% nose drops as prescription medicines34.
Did the FDA panel vote to allow semax?
Its advisers did, but that did not make it legal to compound. On 24 July 2026 FDA’s compounding advisory committee voted 8 to 5, with 1 abstention, to add semax to the list of substances pharmacies may use, after FDA staff had advised against it25. As of 5 October 2026 FDA had posted no minutes and had not changed the list911.
Semax vs selank: what’s the difference?
Both are Russian nasal peptides of 7 amino acids that end in the same Pro-Gly-Pro tail1. Semax starts with a piece of ACTH, a stress hormone, and is sold for stroke and memory; selank starts with tuftsin, a small immune peptide, and is sold for anxiety1. FDA found a ‘50:50’ blend of the two marketed in the US2.
What is N-acetyl semax?
A modified form sold online, with an acetyl group capping the start of the chain21. It is a different molecule from the Russian medicine: in a lab study, acetylation changed how semax binds copper and removed its protection against copper toxicity in nerve-like cells22. We found no human study of it.
Does semax raise BDNF?
In rats, nasal semax raised BDNF, a protein that supports nerve cells, in part of the forebrain within 3 hours15. In people, a 2018 stroke study without a placebo group reported higher blood BDNF levels with semax6. Whether that improves memory or recovery has not been shown in a placebo-controlled trial we could find.
Is semax banned in sports?
It is not named on WADA’s 2026 or 2027 Prohibited List1233. Russia’s approval likely keeps it out of the catch-all class for unapproved drugs, but WADA bans corticotrophins and substances with similar structure or effects, and semax is built from part of ACTH133. With no WADA ruling, athletes should treat it as risky13.
What is still unknown
- Is semax’s registration current in the official Russian State Register of Medicines (GRLS)? Vidal lists both registrations and FDA cites the register, but GRLS showed a CAPTCHA and could not be checked directly.
- Was the 1996 study of healthy men placebo-controlled or randomized? Only its abstract could be read, and it mentions neither.
- What did the pediatric studies FDA lists (120 children aged 12 to 14 with depression; 331 children with tics) find? FDA saw only meeting abstracts, and we could not open them.
- What doses did two human studies really use? FDA lists 600 mg a day for 10 days in a 2002 meeting abstract on chronic ischemic brain disease, 30 times the 1% label’s daily maximum of 20 mg, and 0.5 mg/kg once in a 1996 pain study; neither original could be opened. The 600 mg may be a slip for 600 µg, a mix-up found in the English summary of a 2013 semax study.
- Is semax approved anywhere besides Russia? Other countries’ registers were not checked.
- Does WADA’s S2 ban on corticotrophins and similar substances cover semax? No WADA ruling was found.
- Does Australia’s corticotrophin entry, which also covers derivatives, extend to semax? No ruling was found.
- Will FDA act on its advisers’ 24 July 2026 vote? As of 5 October 2026 no minutes or FDA decision had been posted.
- What are the safety and effects of N-acetyl semax and amidated variants sold online? No human data were found.
- What did the vials Finnrick tested contain? Only pass, fail and incomplete results are public; purity and content figures need a login.
- What is the legal status of semax in the UK and EU? Not verified.
- How large is US demand? Reddit and Google Trends could not be checked for this article.
Sources
- 1A New Generation of Drugs: Synthetic Peptides Based on Natural Regulatory Peptides Neuroscience & Medicine (Scientific Research Publishing), Dec 2013. scirp.org
- 2FDA Evaluation of Semax-Related Bulk Drug Substances (Semax (Free Base) and Semax Acetate), PCAC briefing document U.S. Food and Drug Administration, 11 May 2026. fda.gov
- 3Семакс (Semax) 1% nasal drops: instructions for use Vidal Russia drug reference, 18 Mar 2021. vidal.ru
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- 5The PEPTIDE-L Wave Rolls On! PCAC Adds Two More Bulk Drug Substances for the 503A List FDA Law Blog (Hyman, Phelps & McNamara), 28 Jul 2026. thefdalawblog.com
- 6The efficacy of semax in the tretament of patients at different stages of ischemic stroke (in Russian) Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova, 2018. pubmed.ncbi.nlm.nih.gov
- 7Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study) (in Russian) Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova, 1997. pubmed.ncbi.nlm.nih.gov
- 8Synthetic ACTH analogue Semax displays nootropic-like activity in humans Neuroscience Research Communications, Sep 1996. doi.org
- 9Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
- 10Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration, 22 Apr 2026. fda.gov
- 11July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee U.S. Food and Drug Administration, 6 Aug 2026. fda.gov
- 12World Anti-Doping Code International Standard: Prohibited List 2027 World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
- 13Summary of Major Modifications and Explanatory Notes: 2027 Prohibited List World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
- 14Semax Safety Testing Results & Vendor Ratings Finnrick, 9 Sep 2026. finnrick.com
- 15Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain Journal of Neurochemistry, Apr 2006. pubmed.ncbi.nlm.nih.gov
- 16Semax and selank inhibit the enkephalin-degrading enzymes from human serum (in Russian) Bioorganicheskaia Khimiia, May 2001. pubmed.ncbi.nlm.nih.gov
- 17Semax, an ACTH(4-10) analogue with nootropic properties, activates dopaminergic and serotoninergic brain systems in rodents Neurochemical Research, Dec 2005. pubmed.ncbi.nlm.nih.gov
- 18Evenly tritium-labeled peptides and their in vivo and in vitro biodegradation (in Russian) Bioorganicheskaia Khimiia, Mar 2006. pubmed.ncbi.nlm.nih.gov
- 19Development of Peptide Biopharmaceuticals in Russia Pharmaceutics, 27 Mar 2022. pubmed.ncbi.nlm.nih.gov
- 20ACTH (4-7), Pro-Gly-Pro- (semax; PubChem CID 9811102) PubChem, National Center for Biotechnology Information, accessed 7 Oct 2026. pubchem.ncbi.nlm.nih.gov
- 21N-Acetyl Semax Peptide for Sale (25mg) Core Peptides (vendor), accessed 5 Oct 2026. corepeptides.com (seller page, deliberately not linked)
- 22Influence 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, Nov 2016. pubmed.ncbi.nlm.nih.gov
- 23Semax in prevention of disease progress and development of exacerbations in patients with cerebrovascular insufficiency (in Russian) Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova, 2005. pubmed.ncbi.nlm.nih.gov
- 24The study of chronic partial denervation and quality of life in patients with motor neuron disease treated with semax (in Russian) Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova, 2007. pubmed.ncbi.nlm.nih.gov
- 25Therapy of peptic ulcer with semax peptide Bulletin of Experimental Biology and Medicine, Jul 2002. pubmed.ncbi.nlm.nih.gov
- 26Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease (in Russian) Vestnik Oftalmologii, Jan 2000. pubmed.ncbi.nlm.nih.gov
- 27The results of the application of the pre-formed physical factors and neuroprotective therapy for the rehabilitative treatment of the patients with diabetic retinopathy (in Russian) Voprosy Kurortologii, Fizioterapii, i Lechebnoi Fizicheskoi Kultury, Sep 2013. pubmed.ncbi.nlm.nih.gov
- 28A nootropic adrenocorticotropin analog 4-10-semax (15 years experience in its design and study) (in Russian) Zhurnal Vysshei Nervnoi Deiatelnosti imeni I.P. Pavlova, Mar 1997. pubmed.ncbi.nlm.nih.gov
- 29Effects of Semax on the Default Mode Network of the Brain Bulletin of Experimental Biology and Medicine, Sep 2018. pubmed.ncbi.nlm.nih.gov
- 30Functional Connectomic Approach to Studying Selank and Semax Effects Doklady Biological Sciences, Jan 2020. pubmed.ncbi.nlm.nih.gov
- 31ClinicalTrials.gov search for ‘semax’ (0 studies) ClinicalTrials.gov, accessed 7 Oct 2026. clinicaltrials.gov
- 32Neuroprotective and antiamnesic effects of Semax during experimental ischemic infarction of the cerebral cortex Bulletin of Experimental Biology and Medicine, Dec 2006. pubmed.ncbi.nlm.nih.gov
- 33World Anti-Doping Code International Standard: Prohibited List 2026 World Anti-Doping Agency, 24 Sep 2025. wada-ama.org
- 34Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327) Federal Register of Legislation, Australian Government, 28 Sep 2026. legislation.gov.au
- 35Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs U.S. Attorney’s Office, Eastern District of Kentucky, 24 Feb 2021. justice.gov
- 36Warning letter to Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine (MARCS-CMS 615908) U.S. Food and Drug Administration, 10 Nov 2021. fda.gov
- 37Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list updated 29 September 2023) U.S. Food and Drug Administration (copy hosted by the Alliance for Pharmacy Compounding), 29 Sep 2023. join.a4pc.org
- 38FDA to Remove 12 Popular Peptides from the Category 2 ‘Do Not Compound’ List Frier Levitt, 16 Apr 2026. frierlevitt.com
- 39Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807) Health Canada, 1 Aug 2025. recalls-rappels.canada.ca
- 40Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874) Health Canada, 9 Apr 2026. recalls-rappels.canada.ca
- 41The occurrence of putative cognitive enhancing research peptides in seized pharmaceutical preparations: An incentive for controlling agencies to prepare for future encounters of the kind Drug Testing and Analysis, Mar 2020. pubmed.ncbi.nlm.nih.gov
- 42Semax Nootropics Expert, 5 Sep 2026. nootropicsexpert.com
- 43Methodology Finnrick, accessed 5 Oct 2026. finnrick.com
- 44Semax Peptide for Sale (25mg) Core Peptides (vendor), accessed 5 Oct 2026. corepeptides.com (seller page, deliberately not linked)
- 45Use of semax at a follow-up of patients with posthypoxic encephalopathy (in Russian) Anesteziologiia i Reanimatologiia, Jan 1999. pubmed.ncbi.nlm.nih.gov
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