Reader’s guide · First edition · September 2026 · Revised September 23, 2026
Semax
A guide to the Russian nasal drops sold as a nootropic: thirty years of use in one country, no controlled trial anyone outside it can read, and a July 2026 committee vote the FDA's own reviewers argued against
Semax is a seven-amino-acid peptide built from a fragment of the stress hormone ACTH, designed in Moscow in the 1980s and registered in Russia as nasal drops for stroke, cognitive complaints, and a long list of neurological uses. In rats it raises the growth factor BDNF in the brain. In people it has been given for three decades in Russia, in studies that are open, unblinded, mostly in Russian, and mostly by the group that made it. American sellers offer it as a focus and memory spray, and as a vial to inject, on the strength of that record. This guide covers what the Russian label says, what the human studies actually were, why the FDA's reviewers found no usable evidence for any use, how the sprays and vials are dosed, and what the July 2026 advisory vote did and did not change.
Who this is for
Written for adults who are using, or being offered, Semax for focus, memory, mood, or recovery, and for the clinics and sellers describing it. It summarizes the Russian prescribing information, the published record, and the regulatory position as of the edition date. It is not medical advice.
Adrenocorticotropic hormone, ACTH, tells the adrenal glands to make cortisol. A short piece of it, amino acids 4 through 10, was known by the 1970s to affect attention and memory in animals without touching the adrenals. Semax is that idea made into a drug: the ACTH 4-to-7 fragment with three amino acids added to the end so enzymes in the nose and blood do not destroy it at once. It was synthesized at the Institute of Molecular Genetics in Moscow under Igor Ashmarin and Nikolai Myasoedov, and it is sold in Russia by a company called Peptogen as 0.1 percent and 1 percent nasal drops.
- Class
- Synthetic heptapeptide (Met-Glu-His-Phe-Pro-Gly-Pro), an ACTH(4-10) analog with no corticotropic or melanotropic hormone activity
- Registered uses, Russia
- The 0.1 percent drops: cognitive complaints after stroke, head injury, or anesthesia; encephalopathy; 'mental fatigue in operators'; optic nerve disease; and as a nootropic in children with 'minimal brain dysfunction.' The 1 percent drops: the acute period of ischemic stroke
- Label doses
- 0.1 percent: 200 to 2,000 mcg per dose, up to 5,000 mcg a day, for 3 to 14 days. 1 percent, stroke: 6,000 to 20,000 mcg a day for 10 days. One drop of the 0.1 percent product is 50 mcg
- Forms sold in the United States
- Pre-mixed nasal sprays of 30 mg in 10 mL (300 to 375 mcg per spray); lyophilized vials of 5 and 10 mg for reconstitution as spray, drops, or injection; grey-market imports of the Russian drops. Whether a product is the free base, the acetate, or an N-acetyl derivative is often not stated
- Price as sold
- $55 to $85 for a 10 mg vial; $77 to $130 for a 30 mg spray bottle; a seller month runs $60 to $130
- Status
- Not approved outside Russia. Left FDA's Category 2 in April 2026 when its nominations were withdrawn; FDA's advisory committee voted 8 to 5 in July 2026 to recommend it for the 503A compounding list, against FDA staff's advice; no rulemaking has followed
- Anti-doping
- Not named on WADA's list. The catch-all S0 class covers substances with no approval from any government regulator; Semax is approved in Russia, so its position is unsettled and no WADA ruling exists. Treat it as at risk
Approved somewhere is not the same as tested
Sellers lean on the Russian registration: a drug used for thirty years in a large country. The registration is real. What it rests on is the question, and the answer is a set of open, unblinded studies, most of them by the inventors, none of which FDA's reviewers could use.
The animal work is consistent and mechanistic: in rats, a single nasal dose raises BDNF and its receptor in the hippocampus, shrinks the damaged area after an induced stroke, and increases serotonin turnover. The human work is a different kind of thing. It is thirty years of Russian clinical papers, nearly all open-label, none blinded against placebo in patients, and most co-authored by the Moscow group. No independent randomized trial exists in any language.
| Study | Who and what | What it reported | The catch |
|---|---|---|---|
| Gusev et al., 1997 | 30 people with acute stroke on Semax against 80 on usual care; 12 to 18 mg a day by nose for 5 to 10 days | 'Some influence' on the rate of motor recovery | Not randomized or blinded; Russian only; FDA could not use it |
| Gusev et al., 2005 | 187 people with chronic cerebrovascular disease | 'Significant clinical improvement' | No control group, no blinding |
| Gusev et al., 2018 | 110 stroke patients in early or late rehabilitation, 6 mg a day in two 10-day courses | Higher blood BDNF and better motor scores with early rehabilitation | Open, not randomized |
| Polunin et al., 2000 | Optic nerve disease, three groups | Faster recovery of acuity and fields | Group sizes not reported in the abstract; unblinded |
| Koroleva et al., 1996 | 37 adults with migraine or facial pain, one nasal dose | 4 of 12 migraine patients said the headache stopped; the authors wrote that Semax 'does not exhibit analgesic activity by itself' | The only migraine evidence FDA found; no control, no scores |
| Lebedeva 2018; Panikratova 2020 | 24 and 52 healthy volunteers, one 1.2 mg dose, brain imaging against placebo | Changes in resting-state connectivity | A scan, not a symptom; the inventor is a co-author |
| Any Western trial | None | No randomized, double-blind trial of Semax in patients exists in any country |
FDA's reviewers, under their own rules, could not consider untranslated papers, which removed every stroke study from the record. What remained for the uses they evaluated was one meeting abstract and one uncontrolled single-dose study.
Randomized, double-blind trials of Semax in patients, in any language
Human reports FDA tabulated; in each, adverse events were either 'not discussed' or 'none reported'
Rise in hippocampal BDNF in rats after a single nasal dose, the finding the whole marketing rests on
What would count as evidence
A randomized, placebo-controlled trial in the people it is sold to, measuring what a buyer would notice: attention or memory testing over weeks in healthy adults, or functional recovery after stroke. The Russian label lists nine uses; none has a trial of that kind behind it. The cognition claim rests on rats and on a 1996 volunteer study that FDA could not locate in full.
| Form | Instruction | What is known |
|---|---|---|
| Nasal spray, 30 mg in 10 mL | One to two sprays (300 to 750 mcg) once or twice daily, morning and early afternoon; two weeks on, two off, or 4 to 6 week courses | Inside the Russian 0.1 percent label range for adults. The dose per spray assumes a 0.1 mL pump that no one has qualified; FDA found no human absorption study by any route |
| Vial, reconstituted, by injection | 250 to 600 mcg subcutaneous once daily | No human data for injection of any kind; the Russian product is nasal only |
| Vial, reconstituted as drops | Home-mixed solution dropped into the nose | At the common 5 mg/mL mix, one drop carries about 250 mcg, five times the Russian 0.1 percent drop |
| Russian drops, imported | As the label: 2 to 3 drops per nostril, 1 to 3 times daily, for 3 to 14 days | The one form with a label; still an unapproved drug in the United States |
What the next table is, and is not
It expresses the common seller protocol for a 10 mg vial so the arithmetic can be checked, and it is written for injection because that is what a syringe measures. No human study has given Semax by injection. The Russian label is nasal, and even that route has no published absorption data. A vial's identity, strength, and sterility are unverified.
- Vial
- 10 mg lyophilized Semax, as sold; identity and salt form usually unstated
- Water added
- 2 mL bacteriostatic water
- Concentration
- 5 mg/mL (5,000 mcg/mL). One concentration for the whole vial.
- Syringe
- 0.3 mL or 0.5 mL U-100 insulin syringe; the doses are small
| Weeks | Daily dose | Draw | Units | Used per 4 weeks |
|---|---|---|---|---|
| 1–2 | 300 mcg | 0.06 mL | 6 | 8.4 mg (about 1 vial) |
| 3–6 | 600 mcg | 0.12 mL | 12 | 16.8 mg (about 2 vials) |
| After 6 | Stop for 2 to 4 weeks |
By nose, the same solution is dosed in drops: 0.05 mL per drop is about 250 mcg, so one drop per nostril is 500 mcg. Sellers' cycles have no pharmacology behind them; the Russian label runs courses of 3 to 14 days, or 30 days in children.
What each draw looks like · 0.5 mL (50-unit) U-100 insulin syringe
The plunger tip sits on the line for the dose. Units are marks on a U-100 syringe: 100 units is 1 mL. The picture assumes the concentration in the table above; a different amount of water changes every line.
- The Russian label's daily maximum for adults is 5,000 mcg of the 0.1 percent product. Seller nasal protocols sit at the bottom of that range; the stroke doses of 6 to 20 mg a day are for a hospital, not a desk.
- N-acetyl Semax and the amidated version are sold as longer-acting. No published human comparison supports the claim; the numbers on vendor pages have no source.
- Nasal sprays bought pre-mixed have an unknown shelf life in solution and an unknown dose per spray; the Russian drops come with a stated concentration and a date.
Semax was nominated twice for the 503A compounding list, by a pharmacy and by a peptide trade group, for analgesia, ADHD, and 'nootropic' use. Both nominators withdrew, FDA took it off Category 2 in April 2026 as a result, and then evaluated it anyway for cerebral ischemia, migraine, and trigeminal neuralgia at the July 23 and 24 meeting. FDA's briefing memo said the criteria weighed against listing it. The committee voted 8 to 5 to recommend it.
| Criterion | What the reviewers found |
|---|---|
| Characterization | No certificate of analysis for the free base; unspecified impurities up to 1 to 2 percent; aggregates; no solubility data; the two nominators' certificates and identifiers contradicted each other |
| Dosage form | No information on how a metered nasal pump would be chosen or qualified |
| History of compounding | No outsourcing-facility reports; a Kentucky pharmacy was sentenced for illegal compounding that included Semax in 2018 to 2020 |
| Safety | No human pharmacokinetics by any route; no injection data at all; immunogenicity untested; anticoagulant effects in rats; potentiation of amphetamine's dopamine release in rats with no abuse-liability studies; one adverse event report (May 2025) of eye pain and burning leading to hospitalization after drops bought online |
| Effectiveness | One meeting abstract and one uncontrolled single-dose study; the Russian stroke trials were untranslated and could not be considered |
| Question | Answer |
|---|---|
| Is Semax approved? | In Russia. Not in the United States, and the vote is not an approval |
| Can a pharmacy compound it now? | No. The committee advises; FDA decides by rulemaking, which has not begun |
| Is the spray or vial now legal to use? | No. It remains an unapproved new drug |
| What would listing cover? | Semax free base and acetate, for the three uses on the ballot; not focus, memory, or ADHD |
| Was Semax in the August warning letters? | No. The five letters named GLP-1 drugs, SS-31, PT-141, and tesamorelin; the reasoning about 'research use only' labels applies to any peptide sold with dosing guidance |
Reading the headline
Sellers report the vote as the FDA recognizing Semax. The record says the agency's reviewers found no usable evidence of effectiveness, no human safety data by any route, and an unresolved question about abuse potential, and an advisory panel recommended listing it anyway, for stroke and pain, not for the uses it is sold for.
Three units of measure meet in a Semax product: micrograms on the label, drops or sprays at the nose, and units on a syringe. Sellers move between them loosely. The concentration is what ties them together, and it changes with the water.
units = (dose mcg ÷ concentration mcg/mL) × 100 ÷ 1,000
A 10 mg vial with 2 mL is 5,000 mcg/mL: 300 mcg is 0.06 mL, or 6 units; 600 mcg is 12 units. With 5 mL of water the same vial is 1,000 mcg/mL and 300 mcg becomes 30 units, easier to measure. As nasal drops, a 0.05 mL drop of the 5,000 mcg/mL mix is 250 mcg; the Russian 0.1 percent product is 50 mcg a drop.
| Preparation | Concentration | 300 mcg is | 600 mcg is |
|---|---|---|---|
| 10 mg + 2 mL | 5,000 mcg/mL | 6 units, or about 1 drop | 12 units, or about 2 drops |
| 10 mg + 5 mL | 2,000 mcg/mL | 15 units | 30 units |
| 5 mg + 5 mL | 1,000 mcg/mL | 30 units | 60 units |
| 30 mg spray, 10 mL | 3,000 mcg/mL | 1 spray at 0.1 mL | 2 sprays |
| Russian 0.1 percent drops | 1,000 mcg/mL | 6 drops | 12 drops |
Refrigerate after mixing. No stability data exist for home-mixed solutions or for pre-mixed sprays; the Russian product carries a date.
- The Russian label
- Side effects: 'slight irritation of the nasal mucosa' with prolonged use, rare allergic reactions. Contraindications: pregnancy and breastfeeding, acute psychosis, anxiety disorders, a history of seizures, and young children. Avoid nasal decongestants at the same time.
- What FDA found
- No human pharmacokinetics by any route, no injection safety data, no toxicology studies it could identify, immunogenicity untested. In rats: reduced clotting, and a large increase in amphetamine-driven dopamine release, which the reviewers flagged as an abuse-liability question with no studies to answer it.
- Reported by users
- Nasal burning and irritation, headache, feeling wired or anxious, insomnia when dosed late. Hair shedding appears on vendor pages and forums with no study behind it.
- The one adverse event report
- A May 2025 report to FDA of eye pain and burning after 0.1 percent drops bought online, with hospitalization and symptoms persisting at least a year. It is one report; it is also the only one.
- Who should be careful
- Anyone on anticoagulants, stimulants, or with a seizure, anxiety, or psychotic disorder, on the label's own terms and FDA's; anyone pregnant.
- Product
- Free base, acetate, and N-acetyl forms are sold under one name; sprays have unqualified pumps; vials are not certified sterile for injection.
- Unknown
- Long-term use, injection, interactions, and the true rate of any side effect, because in eight human reports adverse events were 'not discussed.'
- What am I trying to change, and how will we know if it changed? Focus and memory can be tested; a feeling cannot.
- Do I understand that no randomized, blinded trial of Semax exists anywhere, and that the Russian registration rests on open studies by its inventors?
- Which form is this: free base, acetate, or N-acetyl? Does the seller say?
- By nose or by injection? Injection has no human data at all.
- What is the concentration, and what does one spray, drop, or unit deliver?
- Do I take anticoagulants or stimulants, or have a seizure, anxiety, or psychotic disorder?
- Am I tested for anti-doping? Semax's status is unsettled and no ruling exists.
- Has FDA published a rule since July 2026? If not, nothing has changed.
What does have evidence for what Semax is sold for
For attention: sleep, exercise, and, where ADHD is diagnosed, the approved stimulants and non-stimulants, with decades of controlled trials. For low mood: treatment with outcome data. For stroke: emergency care within hours, then rehabilitation, which is where the Russian studies found their effect too. Semax has a mechanism in rats and a country's habit; it does not have a trial.
Latest
Developments since this edition, newest first. Items here are dated and sourced; they update the guide without re-editing it.
August warning letters to five vendors do not name Semax
FDA's letters dated August 24 cite GLP-1 drugs, SS-31, PT-141, tesamorelin, and bacteriostatic water at five online sellers. Semax is absent, but the letters' reasoning, that a dosing chart and reconstitution water show intended human use, covers any peptide sold that way.
Law firm: the vote produced no legal change and rulemaking has not begun
Only notice-and-comment rulemaking or an act of Congress can add Semax to the 503A list; FDA may still act against pharmacies compounding it in the meantime.
HHS secretary must approve before any pharmacy can compound Semax
The pharmacists' association lists Semax among the six recommended peptides and notes the secretary must formally approve any addition, with compounding unlawful until final rulemaking.
Advisory committee votes 8 to 5 to recommend Semax over FDA objections
The committee backed Semax for cerebral ischemia, migraine, and trigeminal neuralgia after FDA staff reported insufficient evidence; public commenters stressed the Russian approval. Emideltide was rejected the same afternoon.
FDA officials 'voiced their reservations' about every peptide on the agenda
Trade coverage of the second day records the Semax tally as 8 to 5 and notes the agency's reviewers opposed all of the nominations put to the committee.
References
- 1.U.S. Food and Drug Administration. Briefing document, Pharmacy Compounding Advisory Committee meeting, July 23-24, 2026: Semax (free base) and Semax acetate. Memorandum dated May 11, 2026. https://www.fda.gov/media/193348/download
- 2.U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee, July 24, 2026: FDA presentation slides (emideltide, epitalon, Semax). https://www.fda.gov/media/193774/download
- 3.U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23-24, 2026: agenda, materials, and vote summary. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- 4.Gusev EI, Skvortsova VI, Miasoedov NF, et al. Effectiveness of Semax in the acute period of hemispheric ischemic stroke. Zh Nevrol Psikhiatr Im S S Korsakova. 1997;97(6):26-34. Russian. https://pubmed.ncbi.nlm.nih.gov/11517472/
- 5.Gusev EI, Martynov MY, Kostenko EV, Petrova LV, Bobyreva SN. The efficacy of Semax in the treatment of patients at different stages of ischemic stroke. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3-2):61-68. Russian. https://pubmed.ncbi.nlm.nih.gov/29798983/
- 6.Dolotov OV, Karpenko EA, Inozemtseva LS, et al. Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Res. 2006;1117(1):54-60. https://pubmed.ncbi.nlm.nih.gov/16996037/
- 7.Holland & Knight. FDA advisory committee endorses compounding of certain peptides. August 4, 2026. https://www.hklaw.com/en/insights/publications/2026/08/fda-advisory-committee-endorses-compounding-of-certain-peptides
- 8.Semax nasal drops 0.1% and 1% (Peptogen, Russia): patient leaflet, English translation. https://russianmeds.com/pdf/semax.pdf
- 9.Representative Semax nasal-spray and vial listings and seller protocol pages, as sold September 2026.
- 10.STAT News. FDA peptide compounding panel backs epitalon and Semax, rejects emideltide. July 24, 2026. https://www.statnews.com/2026/07/24/fda-peptide-compounding-panel-backs-epitalon-rejects-emideltide/