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Semax: status, evidence, storage and handling

What Semax is, why it's an approved drug in Russia but not in the US, where it stands after the July 2026 FDA vote, and how to store it.

Reviewed October 11, 2026Not FDA-approved4 min read
What it is7 amino acid peptide
FDA statusNot approved in the US
Human evidenceMostly Russian studies
Usual formNasal

What Semax is

Semax is a synthetic peptide of seven amino acids, built from a fragment of the hormone ACTH with three amino acids added to make it last longer. It was developed in Russia, where it is registered as a nasal drug for conditions including stroke.

In the US it is marketed for focus, memory, and mood. None of those uses has been tested in trials that meet FDA standards.

Regulatory status in 2026

Semax is not approved in the US and is not on the compounding list. It was part of the July 2026 FDA review.

  1. Semax is developed and later registered as a drug in Russia.

  2. Semax is removed from FDA's Category 2 list. Removal does not make it legal to compound.

  3. FDA's advisory committee votes 8 to 5, with one abstention, to recommend adding Semax to the compounding list for stroke-related brain injury, migraine, and a facial nerve pain condition.

  4. FDA has not added Semax to the compounding list.

Regulatory status can change. Check the sources linked at the bottom of this page before relying on anything here.

Claims vs. what the research shows

Most Semax research was done in Russia, and much of it is not available in English or hasn't been independently repeated.

Common claim

Aids stroke recovery.

What the evidence shows

Russian clinical studies report benefits. Large, independent randomized trials are lacking.

Animal or limited evidence
Common claim

Improves focus and memory in healthy people.

What the evidence shows

Not established in quality human trials.

Insufficient data
Common claim

Protects the brain.

What the evidence shows

Supported mostly by animal and lab studies.

Animal or limited evidence

Storage and stability

Peptides break down with heat, light, moisture, and repeated freezing and thawing. Degraded product is one common reason two vials of the "same" peptide behave differently. These are general peptide handling practices. Your supplier's certificate of analysis or label takes priority. Nasal solutions should be handled per the product label.

Sealed powder (lyophilized)

  • Refrigerate at 36 to 46°F (2 to 8°C) for routine storage.
  • Freezer is generally used for long-term storage.
  • Keep in its original sealed vial, away from light.
  • Let a cold vial reach room temperature before opening to limit condensation.

After reconstitution

  • Keep refrigerated. Do not freeze.
  • Protect from light. Clear glass lets it through.
  • Opened multi-dose bacteriostatic water is typically discarded 28 days after first puncture.
  • Log the mix date so you know the vial's age at a glance.

Light exposure is easy to overlook in a fridge door that opens dozens of times a day. VIALTIGHT is building stackable cases that block light from every side. See vialtight.com for updates.

Reconstitution math

Concentration is just the amount of peptide divided by the volume of water added. On a U-100 insulin syringe, 100 units equals 1 mL, so each unit is 0.01 mL. Enter what is on your vial label and what you added to see the concentration.

2.5mg per mL
2,500mcg per mL
25mcg per syringe unit

This shows concentration only. It is not a dosing recommendation. VialTracker runs this math for every vial you log and keeps it with the vial's history.

Safety flags

Product quality is unverified. Gray-market vials have been found underdosed, mislabeled, or contaminated. A certificate of analysis from the seller is not the same as independent testing.

Limited independent data. Safety information comes mostly from one country's research and regulatory system.

Nasal products vary. Concentration and preservatives in gray-market nasal sprays are unverified.

FAQ

Is Semax legal in the US?

It is not FDA-approved and not on the compounding list, so it cannot be legally marketed for human use.

Is Semax the same as Selank?

No. Both are Russian-developed nasal peptides, but they are different molecules marketed for different effects.

Does VialTracker tell me what to take?

No. VialTracker organizes the information you enter and runs the math. It does not recommend doses, products, or protocols.

Sources

  1. FDA: Bulk drug substances that may present significant safety risks
  2. FDA: Pharmacy Compounding Advisory Committee

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