Semax

What people use it for

• Focus, memory and mental work in healthy people (nootropic use)S3S4
• Prevention of mental fatigue and stress (Russian label use)S2
• Cognitive problems after vascular brain disease, after head injury or surgery, optic nerve disease (Russian label uses)S1S2

Reported regimens

Reported side effects

• nasal irritation, burning or mild congestionS2S6
• headache (mild)S6
• sleep trouble if taken late in the dayS6
• brief anxiety or restlessness, nausea, dizziness, small blood pressure changes (less common)S6

Reported benefits (claims, not shown in trials)

• better focus, cognitive drive and productivityS3

Cautions

• The Russian label for the 0.1% drops lists pregnancy, breast-feeding, acute psychoses, disorders with anxiety, a history of seizures and age under 5 years as contraindications.S1
• Peptidepedia says combining Semax with SSRIs, SNRIs, MAOIs, antipsychotics or stimulants could give amplified or unpredictable effects, and that no formal interaction studies exist.S6
• Many community users take modified forms such as NA-Semax. A wiki says these have no published clinical data.S3
• Research-grade products obtained outside regulated supply carry purity and mislabeling risks.S6

Status notes

• As of 2026-10-30, HHS's draft policy says it does not plan to act against licensed pharmacies or physicians that make Semax free base for a patient with a prescription, under strict conditions. It gives no legal rights and does not bind HHS or the public. It does not grant FDA approval or add the substance to the 503A bulks list, the list of ingredients allowed for this compounding. The listed route is through the nose (intranasal).S9S10
• Only a licensed pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician, can compound under this policy. They need a valid prescription for the individual patient. The original manufacturer must register with FDA under section 510 and meet current good manufacturing practice (CGMP) standards and other applicable federal drug requirements. A valid certificate of analysis, the batch's test report, must identify the manufacturing site and meet Appendix B's testing standards. The ingredient must match Appendix B's identity, including its amino acid sequence, chemical structure, molecular weight, and molecular formula. Tests must cover identity, purity, potency, and harmful contaminants, including endotoxins, heavy metals, microbes, and impurities. If an FDA-registered repacker, relabeler, or reseller supplies it, that business must document checks of the original manufacturer and its certificate. The product must contain only one active ingredient from Appendix A.S9
• Compounders must report products, serious adverse events, and product quality problems to FDA and the states where they make and send the products. Each product report must give the active ingredient, its strength per unit, the original manufacturer, and the manufacturing facility's unique identifier. It must also give the dosage form and route. Compounders must report serious adverse events to FDA MedWatch even if they do not consider the drug responsible. The patient's label must explain how to report adverse events and problems with identity, strength, purity, or quality. It must state: "This is a compounded drug product. Not for resale."S9
• Any device packaged with the drug, or containing it, must be an FDA 510(k)-cleared syringe. All other applicable federal drug requirements still apply, including sanitary conditions.S9
• This 503A policy does not cover 503B outsourcing facilities, research chemicals, supplements, or blends. It applies only until a final rule includes or excludes the substance from the 503A bulks list. HHS may reconsider the policy, including if safety or product quality problems arise.S9
• Federal Register document 2026-22192 was filed on 2026-10-28 and published on 2026-10-30. Docket: HHS-OASH-2026-0496. The notice allows comments for two weeks after publication. That gives a comment date of 2026-11-13.S10
• In Russia, the Vidal drug reference lists Semax 0.1% nasal drops as dispensed by prescription.S2
• On 2026-07-24 the FDA Pharmacy Compounding Advisory Committee voted 8-5 with 1 abstention to recommend Semax for the 503A bulks list. The nominated uses were cerebral ischemia, migraine and trigeminal neuralgia. FDA staff had said the criteria weighed against expanding access. The vote is a non-binding recommendation.S7S8

Community sources

• S1Семакс (Semax) - capli nazalnye, instruktsiya (RLS)rlsnet.rucarries seller links, not linked
• S2Semax - Vidal drug reference (Russia) (opens in a new tab)vidal.ru
• S3Semax: Community Protocols & Reportspeptideprotocolwiki.comcarries seller links, not linked
• S4Semax Dosage Guidepeptidepedia.orgcarries seller links, not linked
• S5Semax (NA-Semax) (opens in a new tab)peptide-db.com
• S6Semax Side Effectspeptidepedia.orgcarries seller links, not linked
• S7FDA panel backs 6 peptides for compounding (opens in a new tab)ajmc.com
• S8FDA Advisory Committee Recommends Adding Six of Seven Peptides to Compounding List (opens in a new tab)americanmedspa.org
• S9HHS interim 503A peptide enforcement policy, Appendix B (opens in a new tab)hhs.gov
• S10Federal Register 2026-22192, published 2026-10-30 (opens in a new tab)federalregister.gov