Semax

Semax is a chain of seven amino acids made in a lab ^[6]. Amino acids are the building blocks of proteins. It is based on a piece of ACTH, a hormone the body makes ^{[6] [20]}. FDA says Semax keeps that piece's effects on the brain but not its hormone effects ^[6].

Semax is part of no FDA-approved drug and has no official US quality standard ^[6]. It comes as a free base and as an acetate salt, and FDA treats them as two different substances ^[6]. Semax is a registered drug in Russia, sold there as nose drops ^[6]. That says nothing about its status in the US. In the US, clinics and websites promote it for anxiety, memory, focus, stroke recovery, nerve pain and many other uses ^[6].

Semax is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 ^{[1] [2]}. That is not approval, and it does not make compounding lawful. FDA reviewed it for poor blood flow to the brain, migraine and a facial nerve pain. Websites sell it mostly for memory, focus and mood ^{[4] [6]}. Checked 23 October 2026.

Category 2 is FDA's list of substances that may present significant safety risks. Category 1 is the list of substances pharmacies may use while FDA reviews them ^[3]. The groups that nominated Semax withdrew their nominations, so it came off Category 2 ^{[1] [6]}. FDA then reviewed both forms on its own. FDA's scientists found too little evidence that it helps, and advised against adding it to the list ^{[6] [8]}.

On 24 July 2026, FDA's Pharmacy Compounding Advisory Committee met on Semax ^{[4] [5] [7]}. One legal report says the committee voted 8 to 5, with 1 member abstaining, to recommend adding both forms to the list ^[12]. News and other legal reports also name Semax among the six peptides the committee backed ^{[13] [14] [22]}. FDA's meeting page does not show the vote ^[5]. A committee vote is only advice ^[12]. FDA decides by writing a rule, after public comment ^{[12] [23]}.

Semax's registration as a drug in Russia does not change its US status ^[6]. Until FDA acts, a pharmacy that makes Semax is outside federal law ^{[3] [10]}. In 2020, FDA warned a compounder that Semax was not eligible for compounding ^[10]. The same year, that compounding pharmacy pleaded guilty to distributing unapproved new drugs, Semax among them ^[11]. Selling Semax for people to use is also illegal, even when the label says it is for research only ^{[9] [14]}.

The evidence grade is limited-human: a few small studies in people exist, all from groups in Russia, and FDA found none that shows Semax helps the uses it reviewed ^[6]. Most had few people, and several had no comparison group ^[6].

Pain: in a 1996 study, 12 adults with migraine got Semax once, in the nose ^{[6] [15]}. Headache stopped in 4 of them, and 8 still had pain ^[6]. In 16 adults with trigeminal neuralgia, a severe facial nerve pain, nothing changed ^[6]. The study had no comparison group and was not blinded ^[6]. FDA found no other study of Semax for either kind of pain ^[6].

Stroke: in a 1997 Russian study, 30 people with a recent stroke got Semax with usual care, and 80 got usual care alone ^[16]. The authors report somewhat faster recovery, mostly of movement ^[16]. The full report is in Russian, so FDA did not review it ^[6]. For poor blood flow to the brain, FDA found only a meeting summary with no clear health results ^[6].

Ulcers: in a 2002 Moscow study, adults had stomach ulcers that had not healed with treatment ^[17]. Ulcers healed by day 14 in about 9 in 10 people given Semax with standard drugs, against 3 in 10 without it ^[17]. FDA notes that the other drugs given with Semax make its own effect hard to judge ^[6].

Brain scans: two small Moscow studies scanned the brains of healthy adults before and after Semax in the nose ^{[18] [19]}. They saw changes in brain activity, but they did not measure any health result ^{[18] [19]}. FDA says the two may have used the same people ^[6].

Animals: in rats, Semax raised a growth factor called BDNF in the hippocampus, a brain area tied to memory ^[20]. In rats with a blocked brain artery, it changed the activity of genes tied to the immune system and blood vessels ^[21]. FDA also cites rat studies where it shrank stroke damage and eased pain ^[6]. FDA notes these rat studies mostly tested one amount and did not measure how much reached the blood ^[6].

There is no legal way to get Semax in the US today ^[6]. No approved drug contains it. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. Semax is neither ^{[3] [6]}. That could change if FDA adds it by writing a rule after the committee vote ^{[12] [14]}.

Semax is a registered drug in Russia, but that is not a legal route in the US ^[6]. Any open trial that gives Semax would appear in the trials block below, with the date the official registry was last checked. FDA notes that approved drugs already exist for stroke, migraine and trigeminal neuralgia ^[6].

People who use Semax in the US get it in three main ways ^[6]. The first is websites that sell it as nose sprays or shots ^[6]. Some say the product is for research purposes only ^[6]. FDA says that label does not make it legal to sell a drug meant for people ^{[9] [13]}. The second is pharmacies. From 2018 to 2020, one compounding pharmacy made and sold products with Semax, and it later pleaded guilty ^{[6] [11]}. The third is clinics. Wellness, concierge and regenerative medicine clinics market Semax shots and nose sprays ^[6].

In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA found no published tests of Semax powder for impurities, clumps or germ toxins ^[6]. None of the websites FDA searched say which form of Semax they sell ^[6]. FDA has one report of harm, eye pain after nose drops bought online. FDA says pharmacies seldom report harms, so its files may miss them ^[6].