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Insufficient data in the current dataset

• whether study material was free base, acetate or another semax-related form
• robust efficacy from adequately powered, blinded, randomized trials with patient-important outcomes
• human pharmacokinetics and route/formulation comparability
• long-term immunogenicity, carcinogenicity, reproductive and developmental safety
• clinical significance of BDNF and resting-state fMRI changes
• future Russian/EAEU registration, label or presentation changes after the 2025 product renewals
• current Thailand, EU and UK marketing-authorisation status pending direct local verification

• human bioavailability, half-life, tissue distribution and blood-brain exposure after administration
• safe exposure range and short- or long-term adverse effects
• whether endogenous Humanin measurements are analytically comparable across assays
• whether observational longevity associations are causal
• clinical relevance of cell and rodent neuroprotection findings
• current product-specific regulatory and anti-doping status across jurisdictions

English translation is not yet verified for 1 excerpt(s). This is a language gap, not an absence of risks or uncertainty.

• The human literature includes small imaging studies, meeting abstracts, Russian-language reports, uncontrolled studies and concomitant therapies. FDA could not determine whether clinical-study material was free base or a salt, found no human pharmacokinetic studies and judged the effectiveness evidence insufficient for cerebral ischemia, migraine and trigeminal neuralgia. Russian registration does not resolve these evidence limitations or create approval elsewhere.

• The human literature mainly measures endogenous Humanin and often uses small exercise cohorts or observational associations. Preclinical studies use heterogeneous sequences, analogues, routes and models. HNG results cannot be assigned to native Humanin, and human-derived cells or ex-vivo sperm are not human administration evidence. Assay specificity may also be complicated by Humanin-like sequences.

• Thai FDA · CEREBROLYSIN 1C 43/32 · data dated 30 June 2025
• CASTA · PMID 22282884
• CARS · PMID 26564102

• https://www.fda.gov/media/193348/download
• https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
• https://www.lsgeotar.ru/drugs/semax-BAZ7
• https://files.dev.lsgeotar.ru/public/4oK6BsG8RZ0KmNXJaX969w.pdf
• https://pubmed.ncbi.nlm.nih.gov/29798983/
• https://pubmed.ncbi.nlm.nih.gov/30225715/
• https://pubmed.ncbi.nlm.nih.gov/32342318/
• https://pubmed.ncbi.nlm.nih.gov/17603664/
• https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list
• https://products.mhra.gov.uk/

• https://pertento.fda.moph.go.th/fda_search_drug/SEARCH_DRUG/FRM_SEARCH_DRUG.aspx
• https://www.accessdata.fda.gov/scripts/cder/daf/
• https://precision.fda.gov/uniisearch/srs/unii/H975EUX36G
• https://www.ema.europa.eu/en/medicines
• https://precision.fda.gov/ginas/app/ui/substances/625c3f53-6384-46c7-9421-0a03aba06a64
• https://pubmed.ncbi.nlm.nih.gov/11717357/
• https://pubmed.ncbi.nlm.nih.gov/27923980/
• https://pubmed.ncbi.nlm.nih.gov/32271093/
• https://pubmed.ncbi.nlm.nih.gov/34351816/
• https://pubmed.ncbi.nlm.nih.gov/23836030/
• https://pubmed.ncbi.nlm.nih.gov/32575074/
• https://pubmed.ncbi.nlm.nih.gov/30959025/
• https://clinicaltrials.gov/study/NCT04449419
• https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list
• https://products.mhra.gov.uk/

Complete evidence profile (Thai)

Complete evidence profile (Thai)

Complete evidence profile (Thai)