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Semax

B
best evidence
Peptide
also called — Semax · ACTH(4-7) analog (also written ACTH(4-10) analog) · sequence Met-Glu-His-Phe-Pro-Gly-Pro (MEHFPGP). INCI: none
neuro / cognitiveneuroprotectionBDNF (research context)

Research / reference — not for sale. No dosing, reconstitution, or administration is published (intentional). Neutral scientific reference only. Unlike most compounds in this register, Semax is an approved prescription drug in Russia — so the honest task is to credit real clinical standing and flag

In brief

Semax is a synthetic heptapeptide analog of an ACTH fragment and an approved neuroprotective/nootropic drug in Russia (since 1994). Its strongest evidence is for ischemic-stroke recovery — multiple Russian randomized trials and routine clinical use — but that evidence is Russian and not independently replicated to Western standards, and the popular "cognitive enhancement in healthy people" use is much weaker than the stroke use. It does not stimulate cortisol, and it is not approved in the US or EU.

Legal standing, by region
European Union
Not approved

Not approved; not eligible for magistral/officinal compounding (no Ph. Eur. monograph).

United States · your region
Not FDA-approved (under review)

Not FDA-approved. On the PCAC agenda for 24 July 2026 (day two, with DSIP/Epitalon), with cerebral ischemia as the reviewed indication; removed from Category 2 in April 2026; FDA's pre-meeting briefing documents proposed not adding it to the 503A Bulks List. Advisory only; no final rule.

International
Approval limited to Russia/CIS

Approval limited to Russia/CIS.

Evidence, by outcome

An honest grade per outcome — drawn from the evidence, not any catalogue. Hype and undemonstrated marketing claims grade low.

OutcomeEvidence base · effectGrade
Ischemic-stroke recovery (on-label in Russia)
Strongest use, but Russian-only, no Western replication; trial methodology varies from FDA/EMA standards
Multiple Russian RCTs; routine use added to standard stroke care · Improved recovery / functional outcomes / lower mortality reported
C
BDNF/NGF upregulation & neuroprotection (mechanism)
Animal/in-vitro; does not by itself prove the human cognitive claims
Consistent rodent studies (e.g. single intranasal dose ↑BDNF; Romanova 2006 ↓infarct volume) · Robust in animals
B
Cognitive enhancement in healthy adults (the popular use)
The healthy-user "nootropic" case is far weaker than the stroke case — the opposite of how it's marketed
Extrapolated; few direct RCTs · Suggestive
D
Optic-nerve disease
Small, regional
Small Russian trials · Suggestive
D
Antidepressant / anxiety / stress
Early; interestingly, the PGP fragment alone shows activity
Preclinical + some Russian data · Suggestive
D
Marketed "limitless-style" cognitive enhancement
Not supported by rigorous evidence in healthy people
None rigorous · Not demonstrated
F
Safety
Long-term / Western safety data limited
Approved drug in Russia (intranasal), broad clinical use · Generally well tolerated

Identity a synthetic heptapeptide (7 amino acids, < 40 aa → peptide) — the ACTH(4-7) active fragment (Met-Glu-His-Phe) with a C-terminal Pro-Gly-Pro extension added for metabolic stability. Developed at the Institute of Molecular Genetics, Russian Academy of Sciences (1980s). Crucially, despite being ACTH-derived, the (4-7/4-10) fragment does not stimulate cortisol/adrenal steroidogenesis (that requires ACTH 1-24). ## Development & history - Semax was engineered in the 1980s at the Institute of Molecular Genetics, Russian Academy of Sciences, out of a Soviet programme studying ACTH fragments for cognition and neuroprotection. Adding the Pro-Gly-Pro tail to the ACTH(4-7) fragment both stabilised the molecule and stripped its hormonal (cortisol-releasing) activity.

  • It was registered as a drug in Russia in 1994, first for cerebrovascular disease (ischemic stroke), with cognitive and optic-nerve indications added later. It remains a Russia/CIS-approved medicine and is now under US compounding review (July 2026). ## Mechanism (as proposed) Semax is proposed to upregulate BDNF and NGF (with increased TrkB signalling), modulate dopamine/serotonin/acetylcholine systems, and provide neuroprotection during ischemia and against oxidative/neuroinflammatory injury — while, unlike parent ACTH, not triggering cortisol release. Much of the mechanistic detail is from animal work; the stroke-recovery use is better substantiated than the healthy-cognition use.
Sources — 5 cited
01(Original development — Institute of Molecular Genetics, Russian Academy of Sciences; Russian regulatory registration, 1994.)
02Romanova GA, et al. (Semax reduces infarct volume after photoinduced cortical ischemia in rats.) 2006.
03Eremin KO, et al. (Semax activates dopaminergic and serotonergic systems.) 2005.
04(Russian clinical trials of Semax in acute ischemic stroke — cite specific trials before publishing.)
05Independent reviews framing the evidence (Russian data, no Western RCT replication; stroke > nootropic).
Review status
Not yet reviewed

A credentialed reviewer (PharmD / PhD / MD) will be named before this entry is finalised. Until then, treat it as a working draft. Last updated July 2026 (US review status evolving — re-check the July PCAC outcome and any Federal Register rule).

Grades reflect the published evidence, not our interest. No dosing, reconstitution, or administration is published for research compounds — that restraint is deliberate.

Related compounds
DSIP (Delta Sleep-Inducing Peptide / Emideltide)C
Peptide
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Semax — evidence, nootropic claims & status · Vallydia