Mitochondrial & sleep · Research peptide
Also known as ACTH(4-7)-Pro-Gly-Pro, Met-Glu-His-Phe-Pro-Gly-Pro, Semax acetate
A synthetic peptide derived from an ACTH fragment, studied mainly in limited non-U.S. intranasal research. It is not FDA approved.[1]
Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population.
Reviewed Jul 22, 2026 · U.S.-focused reference profile
Read the context, not only the compound name. Evidence and status can change with the form, route, population, and use. This profile does not assess individual suitability.
Orientation
Start with identity and research context. Similar names do not establish equivalent products or evidence.
Published research or product contexts. These are not personal indications.
Evidence can change with chemical form, formulation, route, ingredients, and manufacturing. A brand, salt, fragment, or cosmetic ingredient may not represent the same evidence.
What is known
Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population. This is a description, not a rating or recommendation.
Energy, sleep and healthy-aging research
Small, mostly non-U.S. intranasal studies have examined neurological conditions, but FDA found the evidence insufficient for cerebral ischemia, migraine, or trigeminal neuralgia. Study quality, reporting, and substance-form details limit interpretation.
The administered chemical form is often unclear, independent replication is limited, and long-term safety and patient-centered benefit are not established. Intranasal findings cannot be transferred to injection.
Animal studies, including rat focal-ischemia models, report neurobiological effects. These models do not establish a treatment effect or safety profile in humans.[2]
More human evidence does not automatically transfer to a different product, route, population, or purpose. Limited evidence does not prove no biological activity; it means the relevant clinical question is not established by the reviewed material.
What needs caution
Known published concerns and unanswered questions are kept separate so absence of evidence is never presented as reassurance.
FDA identified limited safety characterization, a possible bleeding concern in the reviewed literature, and unresolved impurity, aggregation, immunogenicity, and formulation risks. Evidence for proposed subcutaneous use was absent.
Research or cosmetic products may add identity, strength, purity, sterility, contamination, or formulation concerns. This is separate from the evidence about the compound itself.Source [1]The administered chemical form is often unclear, independent replication is limited, and long-term safety and patient-centered benefit are not established. Intranasal findings cannot be transferred to injection.
Human outcomes, long-term safety, formulation identity, and product consistency remain limited or unresolved in the cited material.Source [1]Common effects, important warnings, product-quality concerns, and evidence gaps are different kinds of information. A risk in one product label may not apply to every formulation; an uncertainty proves neither safety nor harm.
Match the product
Form describes the specific product; route describes how it reaches the body. These are sourced descriptions, not instructions.
Human literature primarily concerns intranasal research formulations, often without clear free-base versus acetate identification. No FDA-approved formulation exists.
Intranasal administration describes the cited human literature only. FDA found no evidence supporting the proposed subcutaneous route.
U.S. product context
No FDA-approved medicine was identified for this defined material. Research findings and products sold outside reviewed trials should not be treated as approval.
Status applies to a product, formulation, route, population, and use. It does not apply to a name in the abstract.
Semax is not FDA approved. In a May 2026 staff briefing prepared for the July 23-24 advisory-committee meeting, FDA said the evaluation criteria weighed against 503A Bulks List inclusion; FDA stated that no final determination would be issued until the advisory process and reviews were complete.
Specific form or route not separately published in this record.View sourceTake it forward
Organize a conversation with a qualified professional without creating a treatment recommendation, dose, or protocol.
Trace the record
Each source supports the section that cites it; publication does not imply endorsement or suitability.
FDA staff briefing for Semax-related substances
U.S. Food and Drug Administration. FDA Evaluation of Semax-Related Bulk Drug Substances (Semax (Free Base) and Semax Acetate). Pharmacy Compounding Advisory Committee briefing document. 2026.
U.S. Food and Drug Administration · Published May 11, 2026 · Accessed Jul 22, 2026 · Regulatory source
Open sourceSemax in a rat focal ischemia model
Romanova GA, et al. Neuroprotective and antiamnesic effects of Semax during experimental ischemic infarction of the cerebral cortex. Bulletin of Experimental Biology and Medicine. 2006;142(6):663-666.
PubMed-indexed primary study · Published Dec 1, 2006 · Accessed Jul 22, 2026 · Preclinical study
Open sourceIdentity, human evidence, laboratory and animal findings, risks, uncertainty, and U.S. product status are shown separately. Missing information stays marked as unpublished instead of being inferred.
