Semax

Human evidence can mean a controlled clinical study, an observational study, a safety or exposure report, or evidence from a particular finished formulation. Those are different kinds of information.

Limited human evidence. Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population.

Preclinical means research in cells, tissues, or animals rather than in people. It can help researchers form a hypothesis, but it cannot establish a human benefit or a complete human safety profile.

Animal studies, including rat focal-ischemia models, report neurobiological effects. These models do not establish a treatment effect or safety profile in humans.[2]

Preclinical findings do not establish outcomes in people.

Risk information may describe the compound, a finished product, a route, a population, or product-quality concerns. The cited material does not replace a current product label or an individual professional assessment.

This section is about the United States only. Status applies to a product, formulation, route, population, and use—not to a name in the abstract. A status shown here is not a recommendation or a statement about another country.

• Source/status dateJul 22, 2026

  Research only

  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 product form or route is not separately published in this status record.

  Open source context

The date above is the date attached to the published status record or source context. It is not necessarily the original approval date.

These prompts help organise a conversation with a qualified professional. They do not create a treatment recommendation, dose, or protocol.

• EvidenceWhich human evidence applies to the exact product, form, route, and use being discussed?
• What remains uncertainWhat is known, and what remains uncertain for this specific context?
• RisksWhich important warnings, common effects, and product-quality concerns should be discussed?
• U.S. statusWhat does the U.S. status cover, and what does it not cover?

Related means that the profiles share a topic, pathway, product context, or research question. It does not mean that they are equivalent.

• SelankBoth are synthetic peptides with limited non-U.S. intranasal human literature and no U.S. approval.

PeptideGrid review date: Jul 22, 2026. Sources support the specific sections that cite them. Publication does not imply endorsement, equivalence, or individual suitability.

1. 1

   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 source
2. 2

   Semax 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 source