Semax

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• Selank vs Semax

Mechanism

Semax is reported to rapidly elevate BDNF and its TrkB receptor in the rat hippocampus (Dolotov et al., 2006) and to activate neurotrophin gene transcription, and to modulate dopaminergic/serotonergic systems; it may also interact with melanocortin (MC4/MC5) receptors. Primary sources note the precise mechanism of action in humans is not established, and the evidence is predominantly preclinical and Russian clinical work.

Regulatory Status by Region

• United States (FDA)Not FDA-approved; unscheduled. Historically placed on the FDA 503A Category 2 bulk drug substances list (significant safety concerns) restricting compounding; part of ongoing 2026 FDA compounding review. On July 24, 2026, the Pharmacy Compounding Advisory Committee voted 8-5 to recommend semax (for cerebral ischemia, migraine and trigeminal neuralgia) for the Section 503A Bulk Drug Substances List; the vote is advisory and non-binding, and the FDA had not made a final decision as of publication.
• Australia (TGA)Not approved by the TGA and not on the ARTG; no registered therapeutic product.
• European Union (EMA)No EMA marketing authorisation; not an approved medicine in the EU.
• WADANot listed by name; because it lacks approval by major (stringent) regulatory authorities, it is generally treated as captured by the S0 'Non-Approved Substances' category, prohibited at all times. Athletes should treat it as prohibited.

See the full regulatory status matrix

Key Studies

• Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus (opens in a new tab) (Dolotov OV, et al. Brain Res. 2006 Oct 30;1117(1):54-60. PMID: 16996037.)
• Neurotrophin gene expression in rat brain under the action of Semax, an analogue of ACTH(4-10) (opens in a new tab) (Agapova TY, et al. Neurosci Lett. 2007. PMID: 17353092.)
• Semax and Pro-Gly-Pro Activate the Transcription of Neurotrophins and Their Receptor Genes after Cerebral Ischemia (opens in a new tab) (PMC11498467.)

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Common Questions

What is Semax?

Semax is a synthetic heptapeptide analog of the ACTH(4-10) fragment of adrenocorticotropic hormone, developed in Russia and included on Russia's List of Vital and Essential Medicines for uses such as ischemic stroke and cognitive disorders. It is not approved by the FDA, EMA or TGA, and most of its evidence is from Russian-language studies not independently replicated in large Western trials.

Is Semax approved for medical use?

Semax is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not FDA-approved; unscheduled. Historically placed on the FDA 503A Category 2 bulk drug substances list (significant safety concerns) restricting compounding; part of ongoing 2026 FDA compounding review. On July 24, 2026, the Pharmacy Compounding Advisory Committee voted 8-5 to recommend semax (for cerebral ischemia, migraine and trigeminal neuralgia) for the Section 503A Bulk Drug Substances List; the vote is advisory and non-binding, and the FDA had not made a final decision as of publication. European Union (EMA): No EMA marketing authorisation; not an approved medicine in the EU. Australia (TGA): Not approved by the TGA and not on the ARTG; no registered therapeutic product.

How does Semax work?

Semax is reported to rapidly elevate BDNF and its TrkB receptor in the rat hippocampus (Dolotov et al., 2006) and to activate neurotrophin gene transcription, and to modulate dopaminergic/serotonergic systems; it may also interact with melanocortin (MC4/MC5) receptors. Primary sources note the precise mechanism of action in humans is not established, and the evidence is predominantly preclinical and Russian clinical work.

Is Semax legal in Australia?

Semax in Australia (TGA): Not approved by the TGA and not on the ARTG; no registered therapeutic product.

Is Semax banned in sport?

Semax under the World Anti-Doping Agency (WADA) code: Not listed by name; because it lacks approval by major (stringent) regulatory authorities, it is generally treated as captured by the S0 'Non-Approved Substances' category, prohibited at all times. Athletes should treat it as prohibited.