Peptide dossier, updated Oct 31, 2026
Semax
A seven-amino-acid synthetic peptide, an analog of a fragment of the hormone ACTH. FDA lists the sequence Met-Glu-His-Phe-Pro-Gly-Pro and says Semax is a registered drug in Russia, sold as nasal drops. FDA found no human pharmacokinetic studies of it. Since Oct 30, HHS has said it will pause enforcement against some pharmacies that compound it. This page lays out what each source actually says.
See all 9 verified records for Semax on the Records page
Human studies
ClinicalTrials.gov returns no study for “Semax” as of Oct 31, 2026. The human studies we found are published papers, listed under Published research below.
Registry entries are written by the sponsors and are not reviewed for scientific merit. Russian trials may be recorded in registries we did not search.
Registered in Russia
FDA says Semax is a registered drug in Russia. We could not open Russia’s official register.
| Where | What the source says | How we checked |
|---|---|---|
| Russia | FDA: “Semax is a registered drug in Russia and is available as 0.1% and 1% nasal drops.” | FDA briefing document, read directly. |
| Russia | A drug-information site reproduces a state register entry for the trade name Semax (Семакс), registration number Р N000812/01. The page is in Russian only. | rlsnet.ru. A secondary site, not the register. |
FDA also says there is no monograph for Semax in the European, Japanese or International Pharmacopoeias. Being registered in one country is not approval by FDA or by any other regulator.
FDA review
Two FDA documents address Semax: the safety-risk page (content current Apr 22, 2026) and a briefing document for the July advisory committee, in a memo dated May 11, 2026.
What the briefing document found
- FDA evaluated Semax (free base) and Semax acetate for the 503A bulks list. The nominations were withdrawn, so FDA reviewed both on its own initiative.
- The uses evaluated were cerebral ischemia, migraine and trigeminal neuralgia. The nominated products were an intranasal spray or a subcutaneous injection at 7,500 or 1,000 µg/mL. Semax was also nominated for ADHD and as a “nootropic”; FDA did not evaluate ADHD because it found no supporting literature.
- FDA lists the sequence and the CAS number 80714-61-0. It notes that “Semax” is a common name, not a United States Adopted Name, and that no USP or National Formulary monograph exists and neither form is part of an FDA-approved drug.
- No human pharmacokinetic studies by any route, and no safety data for the proposed subcutaneous route. The only route in the literature was intranasal, and the papers often do not say whether the free base or a salt was used.
- FDA cites rodent findings including an anticoagulant and antithrombotic effect, and a study in which Semax raised amphetamine-induced dopamine release in mice. It raised bleeding risk as a concern from one 2002 paper on antithrombotic properties.
- A search of FDA’s adverse event database (FAERS) retrieved one report, from a consumer: eye pain and burning after using 0.1% Semax nasal drops bought online in May 2024.
What FDA concluded
- It proposed not adding either form to the list.
- FDA called both forms not well characterized: names that do not follow standard nomenclature, and no impurity, aggregate, endotoxin or microbial test results in the literature or the nominations. It also said it lacked information on the container and pump for a nasal spray.
- It said the extent of use in compounding is unclear. It found no studies of Semax as a compounded product and no pharmacies marketing it.
- It found the effectiveness evidence insufficient for the three evaluated uses. It said only two references were available, they lacked design detail, and they showed a lack of effectiveness with small samples.
- It said approved drugs exist for cerebral ischemia, migraine and trigeminal neuralgia.
Published research
PubMed returns 234 results for “Semax.” Eight are human clinical papers from Russian journals, all with English abstracts. The rest are reviews and animal or lab work.
Human studies (abstracts)
- Acute stroke, 1997. 30 patients given Semax alongside standard therapy were compared with 80 stroke patients on standard therapy. The authors say it had some influence on the rate of recovery of neurological function. Zh Nevrol Psikhiatr PubMed
- Optic nerve disease, 2000. Three groups: nasal drops, endonasal electrophoresis, and a control. The authors report better recovery and visual function when Semax was added. Vestn Oftalmol PubMed
- Motor neuron disease, 2007. An open-label trial of 12 mg a day intranasally. The authors report no influence on the course of partial denervation or on the clinical measures. Zh Nevrol Psikhiatr PubMed
- Ischemic stroke, 2018. 110 patients examined. The authors say early rehabilitation plus Semax raised plasma BDNF, sped functional recovery and improved motor performance. Zh Nevrol Psikhiatr PubMed
- ADHD guidance, 2026. A Russian expert council places Semax in a group with a limited evidence base, to be used only as part of a multidisciplinary approach. Zh Nevrol Psikhiatr PubMed
Lab studies and read with care
- Rodent and cell work, 2021–2025. Papers on gene expression in rat brain after stroke-like injury, a rat chronic-stress model, a transgenic Alzheimer model and mouse spinal-cord injury. Br J Pharmacol PubMed Eur J Pharmacol PubMed
- Seized products, 2020. A chemistry paper found Semax and another peptide in two seized preparations and says they have not, to the authors’ knowledge, completed any clinical trials. Drug Test Anal PubMed
- The human papers are small, mostly from Russian clinical groups, and several test Semax as an add-on to other treatment. We read abstracts only.
- FDA says the human papers often do not say which form of Semax was used.
- Mouse and cell results are not evidence of an effect in people.
FDA warning letters
We found one FDA warning letter that names Semax. It is addressed to a compounding pharmacy, not about Semax’s safety. This rests on web searches, not a full pull of FDA’s database.
| Recipient | Date | Letter | What it says |
|---|---|---|---|
| Tailor Made Compounding LLC, a compounding pharmacy | Apr 1, 2020 | Warning letter 594743 | FDA says an inspection found the firm compounding with a list of 22 bulk substances that includes Semax, and that drugs made from them were not eligible for the section 503A exemptions. The letter says none of them is covered by a USP or NF monograph or is a component of an FDA-approved drug, and that Semax had not been nominated for the bulks list. We read the letter text. |
A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find.
SEC filings
We did not find an SEC filing that names Semax. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.
What a company says in a filing is its own claim about its business. It is not a finding about Semax.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six compounded peptides, Semax among them
State-licensed pharmacies, federal facilities and licensed physicians would not face enforcement for compounding it, under conditions including a patient-specific prescription and quality testing. Not FDA approval. HHS says it may revisit the policy if a safety or quality problem arises.
- July 23–24, 2026RegulatoryFDA advisory committee recommends Semax for the compounding list
The committee recommended six of the seven peptides it reviewed; emideltide was the exception. The vote is nonbinding: compounding stays unlawful until FDA finishes rulemaking or Congress changes the law. Vote counts differ between trade-press reports, and no official tally was in the FDA documents we could read.
- May 11, 2026RegulatoryFDA staff brief the committee: it proposes not adding Semax
The briefing memo concludes that the balance of criteria weighs against listing. Details above.
- Apr 22, 2026RegulatoryFDA’s safety-risk page lists Semax
The page showed content current as of Apr 22, 2026. Its wording on this peptide is quoted above.
- Jan 1, 2022Anti-dopingWADA’s 2022 Prohibited List does not name Semax
We checked the 2022 and 2026 lists. Neither names Semax. Section S0 covers substances with no current approval from any government health authority; FDA says Semax is registered in Russia. We found no WADA statement on Semax.
- Apr 1, 2020EnforcementFDA warning letter to a compounding pharmacy names Semax among 22 substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
- Mar 2020LiteratureChemistry paper finds Semax in seized preparations
Published in Drug Test Anal. The authors say the peptide has not completed clinical trials.
- 1997–2018LiteratureSmall clinical studies in stroke, optic nerve disease and motor neuron disease
Published in Russian journals with English abstracts. Details above.
Still not covered
Left off rather than guessed:
- Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. “Semax free base: intranasal use” comes from a law-firm summary of that list, not from the document itself.
- Russian register: the official State Register of Medicines did not load for us. The registration number comes from a secondary site.
- Russian-language sources: we read English abstracts only. Full texts, other Russian trial registries and non-English publications were not read, and translations could add to this page.
- Panel vote counts: not in the FDA documents we could read, and trade-press tallies differ.
- Patents: not researched for this dossier.
- Seller claims and independent lab reports: how it is marketed versus what testing finds. FDA notes it is marketed in the US for many uses, but we have not collected testing data.
- Unread items: full text of every paper; WADA lists for years other than 2022 and 2026.
- Warning letter and SEC completeness: web searches only.