🧠CognitiveUnder FDA Review

Semax

ACTH(4-10) Analog

In simple terms

Semax is a peptide people usually talk about for Cerebral ischemia / stroke recovery and Trigeminal neuralgia. It is still in the FDA review process, so people are watching both the research and the access question closely.

Why does this matter?

Semax matters because a lot of people hear about it online without a clear sense of what it may actually help with. This page gives you the plain-English version first, then shows where the research is strongest, what is still uncertain, and where the peptide stands in the FDA review process.

Molecular weight

813.97 g/mol

Molecular formula

C₃₉H₅₁N₉O₁₀S

Amino acid count

7

Review date

July 23-24, 2026

Sequence / structure

Met-Glu-His-Phe-Pro-Gly-Pro (ACTH 4-7 + PGP)

Other names

Semax, ACTH(4-7)-PGP, Heptapeptide Semax, NA-Semax (N-acetyl Semax — enhanced version), NA-Semax-Amidate (further modified version)

Status

Under FDA review for cerebral ischemia and trigeminal neuralgia

Research summary

Semax is a brain-focused peptide best known for sharper thinking, better memory, and stronger neuroprotection. It has a real-world track record too, with prescription use in Russia and Ukraine for more than two decades in settings that include stroke recovery and cognitive support. That combination of everyday mental-performance interest and longer clinical experience is what keeps Semax in the spotlight.

How it works

The quick version before the deep dive

  • People usually talk about Semax for Cerebral ischemia / stroke recovery and Trigeminal neuralgia.
  • Trigeminal neuralgia.
  • Potently increases Brain-Derived Neurotrophic Factor expression (up to 3-4x in animal models).
  • Increases Nerve Growth Factor and other neurotrophins (NT-3, NT-4).
Deep Dive: Mechanism of Action +
1

BDNF Upregulation — Potently increases Brain-Derived Neurotrophic Factor expression (up to 3-4x in animal models)

2

NGF Enhancement — Increases Nerve Growth Factor and other neurotrophins (NT-3, NT-4)

3

Melanocortin System — Acts on MC3/MC4 receptors (without adrenal stimulation)

4

Neuroplasticity — Enhances synaptic plasticity and long-term potentiation

5

Anti-oxidative — Reduces oxidative stress in neural tissue

6

Anti-inflammatory (CNS) — Modulates neuroinflammation

7

Dopaminergic Modulation — Influences dopamine and serotonin turnover

8

Gene Expression — Modulates expression of 24+ genes related to immune and vascular function in brain

9

NO System — Does NOT affect adrenal cortisol (unlike full ACTH)

Clinical applications

Where people usually see it discussed

Neurological (FDA Review Indications) +
  • Cerebral ischemia / stroke recovery
  • Trigeminal neuralgia
Cognitive (Approved in Russia) +
  • Cognitive impairment
  • Memory enhancement
  • ADHD (pediatric, approved in Russia)
  • Learning disabilities
  • Age-related cognitive decline
Neuroprotective +
  • Stroke prevention and recovery
  • Traumatic brain injury
  • Optic nerve atrophy (approved in Russia)
  • Neurodegenerative diseases (research)
Mental Health +
  • Depression (adjunctive)
  • Anxiety
  • PTSD
  • Chronic fatigue
Clinical trials

Formal evidence and study snapshots

Deep Dive: Clinical Trials +

Russian Phase III (multiple)

Human clinical

Ischemic stroke

Improved neurological outcomes, reduced disability

Eremin et al. 2004

Human clinical

Optic nerve

Improved visual function in optic atrophy

Kaplan et al. 1996

Human clinical

Cognitive

Enhanced memory and attention in healthy subjects

Russian pediatric trials

Human clinical

ADHD

Improved attention and behavior in children

Dolotov et al.

Preclinical

BDNF

3-4x increase in BDNF mRNA in rat brain

Safety profile

What the current safety discussion looks like

  • 20+ years of clinical use in Russia without significant safety signals
  • Approved prescription medication in Russia (0.1% nasal drops)
  • No hormonal effects — does not stimulate adrenal cortex (unlike ACTH)
  • No addiction/tolerance reported
  • No sedation (unlike many cognitive-enhancing drugs)
  • Side effects (rare): Mild nasal irritation (intranasal), occasional headache
  • No hepatotoxicity, cardiotoxicity, or nephrotoxicity reported
  • Safe in pediatric populations (approved for ADHD in children in Russia)
  • No withdrawal effects
Regulatory status

How the status timeline currently reads

1996

Approved prescription medication in Russia

2001

Additional approvals (optic nerve, ADHD)

2011

Added to Russian Essential Drug List

Pre-2023 (US)

Category 1 — eligible for 503A compounding

September 2023

Moved to Category 2 in US

July 23-24, 2026

FDA advisory committee review for cerebral ischemia and trigeminal neuralgia

Dosing information

How dosing is usually described

Intranasal (Primary route — as approved in Russia)

Standard: 200-600 mcg/day divided into 2-3 doses Acute stroke: 1200-1800 mcg/day (clinical setting) Cognitive enhancement: 200-400 mcg/day Duration: 10-14 day courses, repeatable

Subcutaneous (Research)

200-400 mcg/day

Administration

0.1% solution (1 mg/mL) is the standard Russian formulation 1-2 drops per nostril, 2-3x daily Course duration: 10-14 days (can repeat after 2-4 week break)

Research protocols only. Not medical advice.

Key papers

The citations behind the page

Deep Dive: Key Research Papers +
  1. 1

    Ashmarin IP, et al.*. "Regulatory peptides in cognitive processes." Neuroscience and Behavioral Physiology 2007.

  2. 2

    Dolotov OV, et al.*. "Semax, an analogue of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus." Brain Research 2006.

  3. 3

    Filippenkov IB, et al.*. "Effects of Semax on the transcriptome of the rat brain during ischemia." Molecular Biology 2019.

  4. 4

    Myasoedov NF, et al.*. "Mechanisms of action of Semax and its analogs." Molecular Genetics, Microbiology and Virology 2015.

  5. 5

    Eremin KO, et al.*. "Semax (ACTH 4-10 analogue) in the treatment of optic nerve atrophy." European Journal of Ophthalmology 2004.

  6. 6

    Levitskaya NG, et al.*. "Nootropic and analgesic effects of Semax following different routes of administration." Neuroscience and Behavioral Physiology 2008.

  7. 7

    Grivennikov IA, et al.*. "Neuroprotective effects of Semax in conditions modeling ischemic infarction." Bulletin of Experimental Biology and Medicine 2008.

FAQ

Common questions about Semax

What is Semax? +

Semax is ACTH(4-10) Analog, one of the peptides currently under review in connection with cerebral ischemia and trigeminal neuralgia.

What is Semax being reviewed for? +

The current advisory review focuses on cerebral ischemia and trigeminal neuralgia, with a listed review date of July 23-24, 2026.

Which category does Semax belong to? +

Semax is grouped in this library under Cognitive.

How many amino acids are in Semax? +

Semax is presented here as a 7-amino-acid peptide or peptide analog based on the source research and naming conventions.

What is the sequence or structure note for Semax? +

Met-Glu-His-Phe-Pro-Gly-Pro (ACTH 4-7 + PGP).

What research applications are most associated with Semax? +

Cerebral ischemia / stroke recovery, Trigeminal neuralgia, Cognitive impairment, and Memory enhancement

How is Semax described as working in the current research? +

Potently increases Brain-Derived Neurotrophic Factor expression (up to 3-4x in animal models). Increases Nerve Growth Factor and other neurotrophins (NT-3, NT-4).

How is Semax usually discussed in protocols or treatment plans? +

Semax is most often described with intranasal and subcutaneous protocols in the source material.

What does the safety discussion say about Semax? +

20+ years of clinical use in Russia without significant safety signals Approved prescription medication in Russia (0.1% nasal drops)

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