At a glance
- Semax is not an FDA-approved drug: Drugs@FDA has no record of it.
- It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
- PubMed lists 210 publications mentioning it, including 1 randomized controlled trial and 145 animal-only studies.
- No study registered on ClinicalTrials.gov tests it as an intervention.
- FDA's adverse event system (FAERS) holds 2 reports mentioning it; 1 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- [Expert Council resolution: adjunctive pharmacotherapy for hyperkinetic disorders (attention deficit hyperactivity disorder) in children and adolescents].
- [Changes in retinal light sensitivity and morphometry during surgical treatment of primary glaucoma with physiotherapeutic stimulation].
- Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards.
- Quantitative MRI Pharmacokinetic Modeling and MALDI Mass Spectrometry Imaging Biodistribution of a pH Mapping MRI Contrast Agent.
- [Effect of a combined physiotherapeutic approach on changes in functional parameters after endovitreal surgery of rhegmatogenous retinal detachment with a favorable anatomical outcome].
- Multi-Layer Magnetic Shields Based on Fe-Based Nanocrystalline and Co-Based Amorphous Ribbons.
- Digitally Guided Hybrid Maxillary Expansion with Supragingival Mandibular Miniplates for Class III Correction in Late Adolescents: A Pilot Clinical Study.
- Therapeutic peptides in gerontology: mechanisms and applications for healthy aging.
- Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions.
- The Potential of the Peptide Drug Semax and Its Derivative for Correcting Pathological Impairments in the Animal Model of Alzheimer's Disease.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
No registered study on ClinicalTrials.gov lists this peptide as an intervention.
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2
- Serious
- 1
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.