Neuropeptides

Semax

US status
PCAC-recommended · pending
Class
Neuropeptides
Approved product
None
Route
None lawful; sold as research-use-only material

By Peptide America · Publisher · Reviewed August 2026

Regulatory record

3 dated actions on record; no FDA final action yet.
April 2026
Removed from Category 2 without Category 1 listing.
July 2026
PCAC votes 8–5 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
FDA final action
None as of August 2026.

Every entry above is dated; the record is current as of the review date.

Definition

Semax is a synthetic heptapeptide built from the ACTH(4–7) fragment of adrenocorticotropic hormone with a proline-glycine-proline tail added for stability. It was developed in Moscow in the 1980s and is a registered prescription drug in Russia, given as a nasal spray for stroke recovery and cognitive complaints.

That registration is the molecule's defining fact and its defining asterisk: Semax has never been reviewed by FDA, and a drug approved abroad holds no US marketing status of any kind.

Evidence

The mechanistic literature is real: Semax raises brain-derived neurotrophic factor and trkB receptor expression in rat hippocampus [1] and binds brain tissue with measurable specificity [2]. The clinical literature, by contrast, lives almost entirely in Russian-language journals — a representative modern example followed 110 post-stroke patients through rehabilitation with Semax, tracking plasma BDNF and functional scores [3].

None of this record has passed through FDA review, and no English-language randomized trial supports a cognitive-enhancement use. The nootropic market sells the compound on the Russian dossier's reputation rather than on evidence an American regulator has examined.

Lawful access

Semax was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing. In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 8–5 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [4, 5]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary and this page says so wherever it appears. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound Semax as of August 2026.

Nasal sprays and vials sold to US buyers today are research-use-only or gray-market imports, outside pharmacy oversight; the pending page tracks the rulemaking that could change the compounding question.

The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Semax among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [13].

Supply

No lawful US supply route exists for this molecule today. Lawfully available alternatives are recorded in the molecule index; the regulatory record on this page tracks the rulemaking that could change this.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

References

  1. Dolotov OV, Karpenko EA, Inozemtseva LS, et al. Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Res. 2006;1117(1):54–60. PMID 16996037
  2. Dolotov OV, Karpenko EA, Seredenina TS, et al. Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain. J Neurochem. 2006;97 Suppl 1:82–86. PMID 16635254
  3. Gusev EI, Martynov MY, Kostenko EV, Petrova LV, Bobyreva SN. [The efficacy of semax in the tretament of patients at different stages of ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3. Vyp. 2):61-68. Russian. The title is reproduced exactly as PubMed indexes it, misspelling included; correcting an indexed title would make the citation unverifiable against the record it points to. PMID 29798983
  4. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance. Source
  5. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance. Source
  6. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "Semax" OR "ACTH(4-10) Pro-Gly-Pro" OR "Met-Glu-His-Phe-Pro-Gly-Pro" — returning 216 indexed records, 49 carrying the Humans MeSH term, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type]. By language: 93 records are Russian-language and 125 English-language; the trial-type filters combined with English[Language] return 0 under either type, and combined with Russian[Language] return all 4; 22 English-language records carry the Humans term. Adding the terms nootropic or cognit* to the clinical-trial filter returns the same 4 records. All four trial-type records were opened and read: a 1997 acute-stroke study of 30 patients against 80 controls, a 2000 optic-nerve-disease study, a 2007 motor-neuron-disease study of 27 patients that its own abstract describes as open-label in sequential groups and that PubMed tags as randomized, and a 2018 post-stroke rehabilitation study of 110 patients; all four are published in Russian in that country's journals. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. Source
  7. Gusev EI, Skvortsova VI, Miasoedov NF, et al. [Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study)]. Zh Nevrol Psikhiatr Im S S Korsakova. 1997;97(6):26–34. Russian. PMID 11517472
  8. Serdiuk AV, Levitskiĭ GN, Miasoedov NF, Skvortsova VI. [The study of chronic partial denervation and quality of life in patients with motor neuron disease treated with semax]. Zh Nevrol Psikhiatr Im S S Korsakova. 2007;107(4):29–39. Russian. PMID 18379501
  9. Polunin GS, Nurieva SM, Baiandin DL, Sheremet NL, Andreeva LA. [Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease]. Vestn Oftalmol. 2000;116(1):15–18. Russian. PMID 10741256
  10. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Semax (heptapeptide). Read September 2026. The entry states that compounded drugs containing semax may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, that FDA has no, or limited, safety-related information for proposed routes of administration, and that the agency therefore lacks sufficient information to know whether the drug would cause harm if administered to humans. Source
  11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: "Semax" occurs nowhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. Source
  12. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "semax": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. Source
  13. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. Source