Not approved
FDA (U.S.): Not approved. The FDA noted possible immunogenicity and insufficient safety data when evaluating it for compounding (proposal withdrawn).
EMA (EU): Not approved. It is used as a medicine only in Russia (it has been on the Russian list of essential medicines since 2011, e.g., for stroke).
Typical intranasal regimen: 250-1000 µg/day for 10-14 days in cycles. Only approved in Russia.
Russian clinical study in the acute phase of hemispheric ischemic stroke: patients treated with Semax showed better neurological and electrophysiological recovery. Limited methodological quality and no independent replication.
View the study (clinical trial) →2025 review of its possible use in Alzheimer-type cognitive impairment: the data come mostly from experimental models. Rigorous clinical trials in people are lacking.
View the study (review) →In rats, Semax increases BDNF and its receptor in the hippocampus, a mechanism that could explain its cognitive effects. Animal study.
View the study (preclinical) →Information, not medical advice. Scientific evidence reflects the quality of the studies.