Semax
Synthetic heptapeptide analogue of adrenocorticotropic hormone fragment ACTH(4-10) with a C-terminal Pro-Gly-Pro tripeptide stabilization sequence. Developed by the Institute of Molecular Genetics of the Russian Academy of Sciences. Approved in Russia for acute ischemic stroke, transient ischemic attack, and cognitive disorders; NOT approved by US FDA, EMA, or Egyptian Drug Authority. Restricted under FDA Category 2 compounding notice.
60-Second Scientific Briefing
Semax is a synthetic heptapeptide derived from the N-terminal fragment of adrenocorticotropic hormone (ACTH 4-10) with a C-terminal Pro-Gly-Pro tripeptide. Developed in Russia for ischemic stroke, traumatic brain injury, and cognitive enhancement. It is devoid of hormonal ACTH activity and is NOT approved by the US FDA or EMA.
What is Semax?
Pharmacological Classification & Molecular IdentitySynthetic heptapeptide analogue of ACTH(4-7) conjugated with the C-terminal tripeptide Pro-Gly-Pro.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Modulates expression of BDNF and nerve growth factor (NGF), enhances serotonergic and dopaminergic neurotransmission, and exhibits neuroprotective anti-ischemic activity.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsNot approved by the US FDA, European Medicines Agency, or Egyptian health authorities. Approved regionally in the Russian Federation.
Semax is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesClinical studies conducted primarily in Eastern Europe evaluated intranasal administration in acute ischemic stroke and optic nerve disease; lacks Western Phase 3 registration trials.
Clinical Evidence
Clinical studies conducted primarily in Eastern Europe evaluated intranasal administration in acute ischemic stroke and optic nerve disease; lacks Western Phase 3 registration trials.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesReported side effects include mild nasal mucosa irritation, transient headache, and mild sleep disturbances upon repeated intranasal use.
Long-term central nervous system surveillance and potential interaction profiles with prescription neuroactive medications.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNOT ESTABLISHED in FDA/EMA jurisdictions. Russian medical labeling prescribes 0.1% or 1% nasal drops in specific clinical settings.
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic heptapeptide analogue of ACTH(4-7) conjugated with the C-terminal tripeptide Pro-Gly-Pro.
- Targets & Selectivity: Modulates expression of BDNF and nerve growth factor (NGF), enhances serotonergic and dopaminergic neurotransmission, and exhibits neuroprotective anti-ischemic activity.
- Clinical studies conducted primarily in Eastern Europe evaluated intranasal administration in acute ischemic stroke and optic nerve disease; lacks Western Phase 3 registration trials.
- Safety considerations: Reported side effects include mild nasal mucosa irritation, transient headache, and mild sleep disturbances upon repeated intranasal use.
? Unknown / Under Ongoing Investigation
- Long-term central nervous system surveillance and potential interaction profiles with prescription neuroactive medications.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysSemax is classified as a Neurotrophic ACTH-Derived Peptide. Molecular structure: Synthetic heptapeptide analogue of ACTH(4-7) conjugated with the C-terminal tripeptide Pro-Gly-Pro..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Semax exerts biological activity via Modulates expression of BDNF and nerve growth factor (NGF), enhances serotonergic and dopaminergic neurotransmission, and exhibits neuroprotective anti-ischemic activity..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Regulatory status: Not approved by the US FDA, European Medicines Agency, or Egyptian health authorities. Approved regionally in the Russian Federation.
Investigational and research-only compounds cannot be legally distributed or marketed as prescription drugs.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Clinical evaluation status: Clinical studies conducted primarily in Eastern Europe evaluated intranasal administration in acute ischemic stroke and optic nerve disease; lacks Western Phase 3 registration trials.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Reported safety profile: Reported side effects include mild nasal mucosa irritation, transient headache, and mild sleep disturbances upon repeated intranasal use.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Key scientific uncertainties: Long-term central nervous system surveillance and potential interaction profiles with prescription neuroactive medications.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
NOT ESTABLISHED in FDA/EMA jurisdictions. Russian medical labeling prescribes 0.1% or 1% nasal drops in specific clinical settings.
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Storage status: NOT ESTABLISHED for Western pharmaceutical distribution. Regional formulations require refrigerated storage at 2°C to 8°C.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Yes. Unapproved pharmacological substances are strictly prohibited at all times in competitive sports under WADA Category S0 (Non-approved substances) or Category S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress (European Journal of Pharmacology, 2024-12-05)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesAntidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress ↗
https://doi.org/10.1016/j.ejphar.2024.177068