Semax

Areas of active research — not promised effects

Each tag links to other compounds with research into that goal. Research use only: these are areas of study, not human-use claims.

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Semax has no FDA approval for any human indication in the United States. It was previously listed on FDA's Category 2 bulk drug substances list (substances raising significant safety concerns that may not be compounded). Effective April 23, 2026, it was removed from Category 2 following withdrawal of the underlying nomination. It is now scheduled for Pharmacy Compounding Advisory Committee (PCAC) review on July 24, 2026 (docket FDA-2025-N-6895), where the committee will evaluate evidence for cerebral ischemia, migraine, and trigeminal neuralgia. Removal from Category 2 does not constitute compounding approval; the compound remains outside the 503A Bulk Drug Substances positive list pending the PCAC outcome. It may be sold for in vitro research or laboratory use only.

No verifiable third-party COA path in this market

Transparent blend · bci-1.0 · never paid-placement

Primary name

Semax

Origin

Semax is a synthetic heptapeptide (Met-Glu-His-Phe-Pro-Gly-Pro) designed at the Institute of Molecular Genetics of the Russian Academy of Sciences. It was constructed by appending the Pro-Gly-Pro tripeptide to the ACTH(4-7) core fragment (Met-Glu-His-Phe), which preserves regulatory activity while removing the adrenocorticotropic hormonal domain responsible for glucocorticoid release. The compound has been registered in Russia as a nasal spray since the 1990s for cerebrovascular and neurological indications.

Registry IDs

PubChem CID

9811102

CAS

80714-61-0

InChIKey

AFEHBIGDWIGTEH-AQRCPPRCSA-N

Molecular formula

C37H51N9O10S

Molar mass

813.9 g/mol

Monoisotopic

813.34796003 Da

InChIKey

AFEHBIGDWIGTEH-AQRCPPRCSA-N

Appearance

White to off-white lyophilized powder

Solubility

Soluble in water and aqueous buffers; limited solubility in organic solvents

Sequence not available in current seed.

Stability: Susceptible to proteolytic degradation in plasma; stable as lyophilized peptide under cold-chain conditions. Avoid repeated freeze-thaw cycles of reconstituted

Vial sizes

5 mg · 10 mg

Purity grades

≥98% HPLC

Salt forms

Free base (primary)

• GHS hazard class on file
• PPE & spill response
• Disposal guidance
• Not-for-human-consumption posture

How much research exists, and of what maturity — never a verdict on whether it works.

Mechanism of action

• Semax upregulates brain-derived neurotrophic factor (BDNF) and its receptor TrkB transcription, promoting neuronal survival, synaptic plasticity, and axonal growth in ischemic and degenerative models
• It modulates catecholaminergic neurotransmission — increasing dopaminergic and serotonergic tone — and attenuates neuroinflammation partly through effects on immune gene expression, including immunoglobulin and chemokine pathways
• The peptide also elevates intracellular calcium signalling in rat neurons and alters opioid receptor activity; its primary metabolite Pro-Gly-Pro (PGP) is independently bioactive and accumulates in brain tissue, likely extending functional duration beyond the short plasma half-life of the parent compound

Pharmacokinetics (ADME)

Half-life

Parent peptide plasma half-life approximately 2–5 minutes (rat data); PGP metabolite persists substantially longer in brain tissue

Clearance

Rapid proteolytic clearance in plasma; nasal-to-brain transport demonstrated in rodents (approximately 0.09% of dose per gram brain tissue at 2 min post-administration)

PK–PD note: Pharmacodynamic effects persist 20–24 hours despite short plasma half-life, attributed to active PGP metabolite accumulation and sustained BDNF induction. CSF:plasma ratio for Semax approaches 60–70% …

Reading the evidence

• Evidence quality and gaps vary by application — see the cited grades above.
• Indexed-article counts span all evidence tiers, not only completed human trials.
• No first-party human-dosing, efficacy, or benefit claims are made here.

Key reviews & evidence-gap sources

• Alzheimer's Drug Discovery Foundation — Cognitive Vitality Report: Semax (For Researchers) — Independent evidence appraisal; notes Semax used in Russia as neuroprotective stroke drug but little evidence of efficacy by Western trial standards.
• Radchenko et al., Acta Naturae 2025;17(4):110-120 — Semax and derivative in APP/PS1 Alzheimer's mouse model — Recent preclinical (animal) review/study; demonstrates cognitive improvement and reduced amyloid inclusions in transgenic mice.
• Superpower — Semax: An ACTH(4-7)-Derived Heptapeptide and Melanocortin Receptor Modulator (physician-reviewed guide) — Aggregator review; characterizes Gusev 2018 110-patient trial as non-randomized, non-placebo-controlled, single Russian group; not FDA-approved in US.
• Peptides.org — Semax: Reviews, Clinical Trials, and Safety — Community/aggregate review; lists Russian clinical studies (glaucomatous optic neuropathy, ischemic stroke) and notes no FDA review/approval.

No registered human trials found for this compound.

Status

No registered trials found

Summary (literature)

In Russian clinical experience and published animal toxicology, Semax is characterised as low-toxicity with no evidence of addiction or major organ toxicity. The most commonly reported adverse effects with intranasal administration are transient nasal mucosal discolouration (repo…

WADA status

Not specifically listed on the WADA 2026 Prohibited List. Semax does not appear as a named substance; however, WADA's catch-all provisions for peptide hormones,…

Dominant research route: Intranasal (IN)

Humans (Russian registered drug since 1994 for ischemic stroke/cognitive impairment) and rats; tritium-labeled distribution/PK studies

Bioavailability: Intranasal CNS bioavailability estimated at 1-3% of administered dose; plasma half-life ~2-3 minutes due to rapid enzymatic degradation, yet peak brain concentrations reached within ~30 minutes with detectable levels in hippocampal/cortical tissue persisting 24+ hours; delivery via olfactory and trigeminal pathways bypasses first-pass hepatic metabolism and the blood-brain barrier.

Dominant route in published human research and the registered Russian drug formulation; intranasal Semax was more effective than intraperitoneal at improving learning in rats but had no analgesic effect, indicating route-dependent mechanism/brain-structure engagement.

White rats (Manchenko et al., 2010/2012) given different doses via IP and intranasal routes

Bioavailability: IP administration produced both nootropic and analgesic effects in rats, with dose-response characteristics differing between the two effects; systemic absorption via IP is akin to IV in rodents.

Studied as a comparator systemic route in rat pharmacology; IP Semax had nootropic and analgesic actions, whereas intranasal Semax improved learning but lacked analgesic activity, supporting distinct mechanisms/brain structures per route.

Mechanistic/stability reasoning (peptidase degradation); no primary oral PK study retrieved

Bioavailability: Oral bioavailability characterized as effectively zero because gastric and small-intestinal peptidases degrade the heptapeptide on contact; the Pro-Gly-Pro C-terminal extension provides only partial proteolytic protection and does not survive oral administration.

Oral route is not a studied administration route in the retrieved literature; the oral-stability note reflects peptide-chemistry reasoning, not an oral-absorption study.

Research-planning/community discussion; reconstituted lyophilized vials described for subcutaneous research use

Bioavailability: Described as providing more predictable systemic bioavailability than intranasal in aggregator/clinic contexts; no primary SC pharmacokinetic study retrieved.

Subcutaneous injection appears in research-planning and clinic-formulation discussions rather than as a primary studied route in published pharmacology literature; not the registered Russian drug route.

Animal & human figures are kept visibly separate so studied animal doses are never misread as human guidance.

Sorted A–Z by vendor — never by price

Weekly median $/mg from the live vendor crawl.

Researched storefront prices, bucketed

p25 $2.55 · median $4.25 · p75 $4.50 · 10 researched vendors

Legit, COA-backed band: $3.00–$6.00/mg.

Value rule: don't just buy the cheapest — a price under $3/mg is a red flag. Pair price with COA and independent-test grade.

Estimated cost of research (10 mg)

Vial (best researched price)

$21

Bacteriostatic water (generic estimate)

$6

Syringes / supplies (generic estimate)

$12

What each test proves — general guidance, plus this compound's researched purity data

Purity on the current market (researched)

Independent third-party (Janoshik Analytical) HPLC testing of a Semax batch reported 98.342% purity with identity confirmed by mass spectrometry (5.47 mg detected). Sigma-Aldrich lists research-grade Semax at ≥98% (HPLC). Vendor marketing claims of ≥99% were not independently verified here.

Independent labs cited for this compound

No Semax-specific FDA recall or market withdrawal was found in FDA enforcement databases reviewed. Semax has no FDA-approved drug product in the U.S., so traditional drug recalls are not applicable; enforcement has occurred via import seizure (CBP) and import-alert detention rather than recall.

Buyer red-flag checklist

• No FDA-approved Semax drug product exists; U.S. sales with therapeutic claims are unapproved new drugs subject to Import Alert 66-41 DWPE.
• Semax is not on the FDA Section 503A Bulk Drug Substances List; compounding is not authorized (pending July 2026 PCAC review).
• CBP seized mis-manifested Semax shipments smuggled from China in master-carton schemes (Dec 2025-Mar 2026).
• Semax contains a methionine residue at position 1 highly susceptible to oxidation, which can degrade active content without obvious visual change.
• Research-grade material is not manufactured to cGMP/sterile standards; endotoxin and sterility are not guaranteed unless separately tested.
• A 2025 FAERS report documented hospitalization for persistent eye pain after use of an intranasal Semax product bought online.
• Vendor purity claims of ≥99% frequently lack independent, batch-specific COAs; only one Janoshik report (98.342%) was publicly located.

GMP vs research-grade: the chemistry (SPPS + HPLC + MS) is identical — the difference is the quality system.

Underdosing / mislabeling: No aggregate independent lab testing program (Janoshik/MZ Biolabs/Finnrick) publishing a Semax-specific underdosing prevalence figure was located. A single Janoshik report detected 5.47 mg in a vial labeled for a Semax product, but the labeled claim amount was not published alongside, so an underdosing rate cannot be computed.

• Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. Semax, which has no FDA-approved application, is subject to DWPE when imported with disease-treatment or structure/function claims. Published 06/24/2026 (revision dated 05/19/2026).66-41
• An RUO label is not an import exemption — CBP judges actual intended use.
• Lyophilized powder is ambient-stable in transit; temperature control needed for > 7-day transit.
• US-warehouse vendors dodge import scrutiny — they cost more but ship more reliably.

Every item dated & sourced

Not listed on the WADA Prohibited List as of the 2025 List (in force 1 January 2025). Semax is not named on the Prohibited List; however, unapproved peptides may be caught under S0 (non-approved substances) if identified on a drug test. Athletes should verify current status with their anti-doping organization.

No granted patents identified in current seed. Composition-of-matter coverage is limited given the peptide's synthetic origin.

• IACUC / IRB research context
• RUO buyer responsibilities & documentation
• Veterinary / alternative-use where lawful
• Jurisdiction-aware "who may lawfully obtain"

What people discuss

Reported concerns — discussion, not established effects

Reading caveats

• self-selection toward positive responders
• vendor-affiliated review channels
• extrapolation from Russian clinical evidence

Manually researched from reddit, youtube— theme weights are research estimates, not live counts; aggregated & de-identified. No individual posts, quotes, or usernames are ever shown.

Relative research / market volume — populated once the activity stream is wired

Inline tooltips for lyophilized, RUO, EU/mg, SPPS, 503A and more.

Toggle plain-language ↔ scientific in the header.

• How to read a COA
• Free base vs acetate
• Understanding evidence grades

Synthetic ACTH(4-7)-PGP heptapeptide approved in Russia for ischemic stroke; studied for neuroprotection and cognitive function via BDNF upregulation. Approximately 205 articles are indexed (literature last scanned 2026-05-29). US regulatory status: Research use only; not FDA-approved; removed from 503A Category 2 April 2026; PCAC review pending July 2026. Research use only.

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