Semax

What is Semax used for?

Semax is registered as a drug in Russia and sold there as 0.1% and 1% nasal drops [1]. Online, it is marketed for a long list of unrelated conditions: anxiety, depression, memory, stroke, nerve regeneration, diabetic neuropathy, ADHD, opioid withdrawal, ALS, Parkinson's disease, Alzheimer's disease, and more [1]. FDA's briefing reviewed clinical references on cerebral ischemia, migraine and trigeminal neuralgia and concluded there is insufficient evidence of effectiveness for each [1].

Is Semax FDA-approved?

No. FDA's Semax briefing found no USP or NF monograph for semax and confirmed it is not a component of an FDA-approved drug [1]. Semax was previously nominated for FDA's section 503A or 503B bulks lists, but FDA's list, current as of April 22, 2026, records that the nomination was withdrawn [2]. No FDA-approved semax product exists [1].

What did FDA's advisory committee decide?

FDA's advisory committee reviewed semax-related bulk drug substances on July 24, 2026, alongside emideltide and epitalon [3]. It voted 8 to 5, with one abstention, to recommend adding semax, as free base and acetate, to the 503A bulks list [4]. That went against FDA's own briefing, which concluded a balancing of the criteria weighs against listing [1]. The committee "does not make law and does not issue approvals"; FDA must still complete notice-and-comment rulemaking, which "could occur in 2027 or extend into a multi-year process" [4].