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Cat 2 — reviewCognitive

Semax

ACTH(4-7)PGP

Russian-developed neuropeptide approved in Russia for stroke and TBI. Increases BDNF and NGF. Intranasal administration crosses blood-brain barrier effectively. Under FDA review for US Category 1 status.

Evidence
Human data exists
Routes
nasal, injectable
Available since
Developed in Russia in 1982. Approved in Russia for neurological use. Western research access from approximately 2010s onward.

Mechanism of action

Stimulates BDNF (brain-derived neurotrophic factor) and NGF (nerve growth factor) production. Upregulates serotonin and dopamine receptors. Increases cerebral blood flow. Inhibits enkephalin degradation. Penetrates blood-brain barrier via intranasal route within minutes.

Effects in the body

Russia uses Semax clinically after strokes and traumatic brain injuries. It amplifies the brain's own repair factors — BDNF and NGF govern neuron survival and plasticity. Intranasal administration is uniquely effective because it bypasses the blood-brain barrier entirely.

Pros & cons (from the literature)

Pros
  • Clinically approved in Russia with published safety data
  • Nasal administration — no injection required
  • BDNF elevation without significant systemic side effects
  • Studied for stroke, TBI, ADHD, anxiety, and cognitive enhancement
  • Rapid onset via intranasal route within minutes
Cautions
  • Currently Category 2 — cannot be legally compounded in USA as of 2026
  • No completed Western randomized controlled trials
  • May cause anxiety or overstimulation at higher doses
  • Regulatory uncertainty limits access in USA
  • Long-term Western safety data not established

Protocol summary (from published research)

Nasal spray: 300–600 mcg per nostril 1–3 times daily in research protocols. Injectable: 200–300 mcg subcutaneous. Typical research cycles 2–4 weeks for acute cognitive applications, longer for neuroprotection protocols.

Dosing ranges reproduced from published research literature. Not a prescription, not medical advice.

FDA & regulatory status

PCAC VOTE — July 24, 2026: RECOMMENDED (8-5)
Research Use Only in the USA. Approved in Russia for stroke recovery and cognitive disorders. REGULATORY UPDATE — July 24, 2026: The FDA's PCAC voted 8-5 to recommend Semax for the 503A Bulks List, against FDA staff recommendation. This would bring 40+ years of Russian clinical experience into the US licensed compounding pathway. Formal rulemaking required. Legal compounding pathway not yet open.

Evidence base

Multiple Russian clinical trials published. Limited Western peer-reviewed independent data. Mechanism of BDNF elevation is well-established scientifically. Considered one of the most evidence-backed cognitive peptides by international researchers.

Primary research sources

Peer-reviewed literature referenced throughout this profile is drawn from PubMed, Cell Metabolism, and clinical trial registries cited in the evidence base above.

Expert perspective — Dr. Alex Tatem, Urologist

Dr. Alex Tatem is a board-certified Urologist and Men's Health Specialist who has studied peptides for 12 years. Videos featured for educational purposes. ThePeptide.expert is an independent platform.

Dr. Tatem covers Semax as a cognitive peptide — explaining its intranasal administration and neuroprotective research applications.

Common questions

Common questions about Semax

What is Semax approved for?

Semax is approved in Russia for stroke recovery, TBI, and cognitive disorders. It has 40+ years of clinical use in Russia. It is not FDA approved in the United States. The FDA's PCAC voted 8-5 to recommend Semax for the 503A compounding Bulks List on July 24, 2026 — formal rulemaking still required.

How is Semax administered?

Semax is typically administered intranasally (nasal drops) in research contexts. This allows central nervous system delivery without injection. Injectable administration is also studied. Intranasal is the most practical route for independent research use.

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Important. ThePeptide.expert summarizes published research. We are not a pharmacy, do not prescribe, and make no therapeutic claims. Regulatory status varies by jurisdiction.