# Semax

Semax is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is limited-human: a few small studies, all from Russia. FDA found no good evidence that it helps any use it reviewed.

Status checked: 2026-10-25. Last verified: 2026-10-26. Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Semax (free base), Semax acetate, Semax (heptapeptide), Met-Glu-His-Phe-Pro-Gly-Pro | primary | 2026-10-25 | [source](https://www.fda.gov/media/193348/download) |
| Class | neuro-and-cognitive | primary | 2026-10-25 | [source](https://www.fda.gov/media/193348/download) |
| Regulatory status | limbo | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) |
| Status source read | 2026-10-23 | primary | 2026-10-25 | [source](https://www.fda.gov/media/94155/download) |
| Evidence grade | limited-human | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) |

## Name

Semax

Source: https://www.fda.gov/media/193348/download

## Summary

A chain of seven amino acids made in a lab, based on a piece of a hormone the body makes. It is in no FDA-approved drug. It is sold for memory, focus and mood.

Source: https://www.fda.gov/media/193348/download

## Short answer

Semax is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is limited-human: a few small studies, all from Russia. FDA found no good evidence that it helps any use it reviewed.

Source: https://peptideindex.ai/methodology#short-answer

## Known risks

- FDA warns that Semax given as a shot or a nose spray may set off the immune system. Peptides can clump together, which can make this worse [^1] [^6].
- In rats, Semax slowed blood clotting. FDA warns this raises a risk of bleeding, mostly for people prone to bleeding or taking drugs that raise it [^6].
- In mice, Semax boosted the brain's dopamine response to amphetamine. FDA calls this a concern, because drugs of abuse cause the same response [^6].
- FDA has one report of harm from Semax in its files. A person had eye pain and went to the hospital after using nose drops bought online [^6].
- FDA says the name Semax is used for more than one form. A product sold as Semax may not hold the form a doctor ordered [^6].
- FDA warns that shots made outside drug rules can carry germs or toxins straight into the body. That can cause a life-threatening illness [^9].

Source: https://www.fda.gov/media/193348/download

## What nobody knows yet

- No study has measured how the human body takes up and clears Semax [^6].
- No study has tested Semax shots under the skin in people, so their safety is unknown [^6].
- Most studies in people did not discuss harms. Nobody knows how often Semax causes harm [^6].
- FDA did not review Semax for anxiety or depression, and found no studies for attention problems. Websites sell it for all three [^6].
- No animal study has tested Semax's harms when it is given again and again over a long time [^6].

Source: https://www.fda.gov/media/193348/download

## What it is

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].

Source: https://www.fda.gov/media/193348/download

## Where it stands legally

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].

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

## What the evidence shows

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].

Source: https://www.fda.gov/media/193348/download

## Legitimate ways to get it

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].

Source: https://www.fda.gov/media/193348/download

## How people are getting it anyway

This section describes what happens and is not a recommendation.

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].

Source: https://www.fda.gov/media/193348/download

## Access routes

Source: https://www.fda.gov/media/193348/download

### None

Detail: There is no legal route to Semax in the US today. It is in no approved drug, has no official quality standard, and is not on the list pharmacies may use.

Source: https://www.fda.gov/media/193348/download

## Unofficial channels

Source: https://www.fda.gov/media/193348/download

### Research use seller

What it is: Sold on websites as nose sprays or shots, sometimes with a label saying it is for research purposes only.

Legal position: FDA treats these products as unapproved new drugs when the seller's claims show they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)

Documented risks:

- FDA warns that injected drugs bypass some of the body's defenses and can carry toxins or germs that cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)
- FDA found that none of the websites it searched say which form of Semax they sell, so a person may get a different substance than the one a doctor ordered. (source: https://www.fda.gov/media/193348/download)

Enforcement:

- 2026-08-24: FDA warning letter to an online seller of research-use peptide shots. The letter did not name Semax. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026

### Compounding outside the rules

What it is: Made by a pharmacy from bulk Semax powder. FDA found one pharmacy that made and sold Semax products from 2018 to 2020.

Legal position: Semax has no official quality standard, is in no approved drug and is not on the federal list, so a pharmacy may not compound it under section 503A. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- FDA found no safety data for Semax given as a shot, and no study of how the human body handles it. (source: https://www.fda.gov/media/193348/download)
- FDA found no published tests of Semax powder for impurities, clumps or germ toxins. (source: https://www.fda.gov/media/193348/download)

Enforcement:

- 2020-04-01: FDA warning letter to a compounding pharmacy: Semax was among bulk substances that made its products ineligible under section 503A. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
- 2020-10-29: US Department of Justice: a Kentucky compounding pharmacy and its owner pleaded guilty to distributing unapproved new drugs, Semax among them. (source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### Clinic or med spa

What it is: Wellness clinics, concierge doctors and regenerative medicine clinics that market Semax shots and nose sprays for memory, mood and other uses.

Legal position: A clinic's prescription does not make Semax lawful to compound. It is still a substance that is not on the federal list. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- FDA has little or no safety information on Semax for the routes proposed, so it cannot say whether it would cause harm. (source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- FDA warns that Semax may slow blood clotting, a bleeding risk for people taking other drugs that raise it. (source: https://www.fda.gov/media/193348/download)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Recruiting trials

Snapshot date: 2026-10-25.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

None in this snapshot.

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=Semax+OR+Semax+acetate&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://www.fda.gov/media/193348/download

### 1. FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

### 2. FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 3. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 4. Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting

Type: regulatory

Tier: primary

Source: https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html

### 5. FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

### 6. FDA briefing document on Semax for the July 2026 committee meeting, 11 May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193348/download

### 7. FDA: questions put to the committee at the July 2026 meeting

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193711/download

### 8. FDA: presentations to the committee on 24 July 2026, including Semax

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193774/download

### 9. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026

### 10. FDA warning letter to a compounding pharmacy, 1 April 2020

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

### 11. US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020

Type: regulatory

Tier: primary

Source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

### 12. McDermott Will & Schulte: what the July 2026 committee votes on peptides mean

Type: legal-analysis

Tier: legal-analysis

Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/

### 13. Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers

Type: legal-analysis

Tier: legal-analysis

Source: https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers

### 14. ArentFox Schiff: a research-use-only label does not make selling peptides legal

Type: legal-analysis

Tier: legal-analysis

Source: https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy

### 15. Semax for migraine and facial nerve pain in adults, 1996, in Russian

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/8998343/

### 16. Semax in the first days after an ischemic stroke, 1997, in Russian

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/11517472/

### 17. Semax added to treatment of stomach ulcers that had not healed, Moscow, 2002

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/12459874/

### 18. Semax and a resting brain network in healthy adults, brain scans, Moscow, 2018

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/30225715/

### 19. Selank and Semax and brain connections in healthy adults, brain scans, Moscow, 2020

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/32342318/

### 20. Semax and the growth factor BDNF in the rat hippocampus, 2006

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/16996037/

### 21. Semax and gene activity in rat brains after a blocked artery, 2014

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/24661604/

### 22. NPR: FDA advisers vote to ease peptide limits despite agency concerns, 23 July 2026

Type: reference

Tier: established-news

Source: https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions

### 23. NBC News: FDA panel recommends easing peptide limits despite agency scientists

Type: reference

Tier: established-news

Source: https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879

Last verified: 2026-10-26.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=Semax+OR+Semax+acetate&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- https://www.fda.gov/media/193348/download
- https://www.fda.gov/media/94155/download

[^1]: FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[^2]: FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 https://www.fda.gov/media/94155/download
[^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^4]: Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html
[^5]: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
[^6]: FDA briefing document on Semax for the July 2026 committee meeting, 11 May 2026 https://www.fda.gov/media/193348/download
[^7]: FDA: questions put to the committee at the July 2026 meeting https://www.fda.gov/media/193711/download
[^8]: FDA: presentations to the committee on 24 July 2026, including Semax https://www.fda.gov/media/193774/download
[^9]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026
[^10]: FDA warning letter to a compounding pharmacy, 1 April 2020 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
[^11]: US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020 https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
[^12]: McDermott Will & Schulte: what the July 2026 committee votes on peptides mean https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/
[^13]: Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers
[^14]: ArentFox Schiff: a research-use-only label does not make selling peptides legal https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy
[^15]: Semax for migraine and facial nerve pain in adults, 1996, in Russian https://pubmed.ncbi.nlm.nih.gov/8998343/
[^16]: Semax in the first days after an ischemic stroke, 1997, in Russian https://pubmed.ncbi.nlm.nih.gov/11517472/
[^17]: Semax added to treatment of stomach ulcers that had not healed, Moscow, 2002 https://pubmed.ncbi.nlm.nih.gov/12459874/
[^18]: Semax and a resting brain network in healthy adults, brain scans, Moscow, 2018 https://pubmed.ncbi.nlm.nih.gov/30225715/
[^19]: Selank and Semax and brain connections in healthy adults, brain scans, Moscow, 2020 https://pubmed.ncbi.nlm.nih.gov/32342318/
[^20]: Semax and the growth factor BDNF in the rat hippocampus, 2006 https://pubmed.ncbi.nlm.nih.gov/16996037/
[^21]: Semax and gene activity in rat brains after a blocked artery, 2014 https://pubmed.ncbi.nlm.nih.gov/24661604/
[^22]: NPR: FDA advisers vote to ease peptide limits despite agency concerns, 23 July 2026 https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions
[^23]: NBC News: FDA panel recommends easing peptide limits despite agency scientists https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879