Representative packaging image · verify the ordered lot
Decision summary
Key benefits
Research themes include neurotrophin transcription, monoaminergic signalling, ischemia-related molecular responses and neurobiology models
Most evidence is preclinical, and these themes are not clinical benefit claims.
Published research context is presented for literature orientation only. It is not a dosing, treatment or human-use instruction.
Qualification data
Specifications to confirm against the released lot
CAS
80714-61-0
Formula
C37H51N9O10S
Molecular weight
813.9 g/mol
Appearance
White lyophilized powder
Purity
≥ 99.0% · target, verify batch COA
Storage
Store and ship according to the batch-specific COA, SDS and stability statement for the exact supplied form. Do not infer bulk-powder or solution stability from a foreign finished product; request matrix-specific solution-stability data when required.
Identity, purity and content are separate release questions.
Identity
Confirm the stated molecule and supplied form. Start with the matching batch COA; request sequence-level evidence only when the buyer's written procedure requires it and availability or a separate scope has been agreed.
Purity
Review RP-HPLC method conditions, wavelength, integration and related-peak handling. A percentage without the method is not enough.
Content
Net peptide content is not the same as gross lyophilized powder weight. Ask which assay supports the stated amount and whether water/counter-ion is addressed.
Stability
Follow the storage condition stated on the batch COA or label from receipt onward.
Research context
What researchers study about Semax
Semax is the synthetic linear heptapeptide Met-Glu-His-Phe-Pro-Gly-Pro (MEHFPGP), commonly described as an ACTH(4-7) fragment extended with Pro-Gly-Pro. It has a long Russian research history and substantial preclinical literature, but the available human studies are small, methodologically limited or focused on exploratory biomarkers and imaging. FDA's May 11, 2026 briefing review found insufficient evidence of effectiveness for the evaluated uses. Historical or foreign-market use does not establish FDA approval or suitability of this RUO lot for administration.
Reported research topics include neurotrophin signalling, cognition-related models, ischemia and neural-injury models
FDA's 2026 evaluation found insufficient evidence of effectiveness for cerebral ischemia, migraine or trigeminal neuralgia
No FDA-approved or broadly validated therapeutic indication is established.
Mechanism context
The question the literature is testing
Animal and in-vitro studies report changes in BDNF/NGF-related transcription, dopaminergic and serotonergic readouts, and gene expression after experimental ischemia. Literature also discusses melanocortin-receptor interactions, but FDA's 2026 review found no clearly identified target receptor and notes that the contribution of metabolites remains unresolved. Exploratory biomarker or imaging changes do not establish direct nose-to-brain transport, a clinical mechanism or efficacy for an independently supplied RUO lot.
Evidence map
Research routes and exposure context
Evidence tierApproved finished-product contextResearch areaNeurocognitive researchRoutes reported in sources
Intranasal
Dose / exposure contextProtocol-specific; verify the cited primary source
Routes and exposure contexts summarize cited studies or approved finished-product labels. They are not instructions for administering this RUO material; no customer dose is provided.
Evidence boundaries
Compatibility, limitations and decision context
This material is an RUO reagent, not a finished drug or sterile preparation
FDA's 2026 review found no human pharmacokinetic study for either evaluated form and identified unresolved safety concerns, including potential aggregation- and impurity-related immunogenicity and a possible bleeding signal that could not be characterized from the available evidence
Comprehensive long-term human safety is not established, and no human or veterinary administration guidance is provided.
Interactions reported in the literature
No controlled interaction dataset supports combination recommendations for this RUO material
Any co-exposure or formulation study requires its own compatibility, assay-interference and safety assessment.
Literature context is not a supplier release result or human-use instruction. Follow your institution's approved laboratory risk assessment.
Batch documentation
Semax batch COAs
Laboratory: Manufacturer's QC laboratoryTests: HPLC purity · MS identity · endotoxin · fill amount
5 mg
10 mg
11 mg
Previews are blurred on purpose so the documents cannot be reused; third-party reports show their first page only. Sales sends the clear full version for the product and strength you ask about.
Published COAs show recent representative batches and may not be the newest. For a quote or shipment, sales confirms the lot and sends its COA.
Third-party reports, added progressively
Previews of the first page of third-party reports are on our Quality page and on the matching product pages; sales sends the full report on request. You can also send any vial from your order to an independent laboratory of your choice. Unless agreed otherwise in writing, the buyer pays for optional testing.
Help reviewing your COA
Need help reading a batch COA or third-party report? Sales can explain the test items, specifications and how the results relate to the lot under discussion.
On every batch COA: HPLC purity · MS identity · endotoxin · fill amount · Verify LyoPep
Ask for the current packet, not a generic certificate
Begin with the matching batch COA and review the supplied form, tests, specifications and results recorded for that lot
Request any additional sequence, content, aggregate, solvent or storage evidence only when the buyer's written procedure requires it and the scope has been agreed
FDA specifically noted gaps in publicly available aggregate, bacterial-endotoxin and microbial-bioburden controls
HPLC area purity alone does not establish identity, content, sterility, endotoxin status, immunogenicity risk or solution stability.
Batch COA for the released lotHPLC purity with method contextMS identity resultEndotoxin resultFill amount (measured content per vial)SDS and handling statement
Available fills
Quote the fill and pack configuration you need
Reference SKUFillBase pack
SX22 mg10 vials
SX55 mg10 vials
SX1010 mg10 vials
SX1111 mg10 vials
SX1515 mg10 vials
SX3030 mg10 vials
Other format
Also available as a nasal spray (US stock)
10 mL nasal spray bottle
Besides lyophilized vials, Semax is also supplied as a nasal spray solution, shipped from our US stock.
Strengths
10 mg
Bottle sizes
10 mL or 20 mL
Minimum order
10 bottles per strength and bottle size
Ships from
Our US stock
Handling
Plan storage before the parcel arrives
Store and ship according to the batch-specific COA, SDS and stability statement for the exact supplied form. Do not infer bulk-powder or solution stability from a foreign finished product; request matrix-specific solution-stability data when required.
State the destination and timing so receipt can be planned, then move the material into its stated storage condition on arrival.
Buyer FAQ
Terms to settle before the purchase order
Can a buyer arrange third-party testing?+
Yes. You can send any vial from your order to an independent laboratory of your choice. If you want the laboratory, specification, sampling, method and acceptance rule agreed with us before testing, sales confirms them in writing. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.
What if my own lab test shows the product is out of specification?+
Send any vial from your order to an independent laboratory of your choice. If the report shows the product does not meet the specification on its COA — purity below the stated minimum, or an identity that does not match — share the report with our sales team and we refund that product in full.
Does HPLC purity prove peptide content?+
No. Chromatographic purity describes the relative peak profile under a stated method. Identity, water, counter-ion, residual solvents and assay/content may require separate methods.
How should material be stored after delivery?+
Move it into the storage condition stated on the batch COA or label as soon as it arrives, and record the package condition on receipt.
How are payment terms handled?+
Available methods and milestones depend on order value, destination and project type. The pro forma invoice should state currency, bank details, fees, payment milestones and the release condition.
Why must the testing laboratory understand peptide chemistry?+
Free-base and salt forms, hydrophilic and hydrophobic sequences, aggregation and adsorption can change sample preparation and method suitability. Use a laboratory experienced with the molecule class.
These are buyer-qualification references, not claims that this RUO material is regulated, certified or released under those frameworks. Applicability depends on the buyer's workflow and jurisdiction.
Selected sources
Literature behind the research context
1) FDA briefing evaluation dated May 11, 2026 (PCAC, Semax free base and Semax acetate): neither form is a component of an FDA-approved drug; FDA found insufficient evidence of effectiveness for cerebral ischemia, migraine or trigeminal neuralgia and concluded that the characterization, effectiveness and safety criteria weigh against 503A Bulks List inclusion. The scheduled advisory discussion is not a final determination. 2) Gusev et al. (2018, Zhurnal Nevrologii i Psikhiatrii, PMID 29798983): a 110-person post-ischemic-stroke rehabilitation study reported plasma BDNF and functional associations, but the abstract does not report randomization or blinding, so it does not establish broad clinical efficacy. 3) Lebedeva et al. (2018, Bull Exp Biol Med, PMID 30225715): a small resting-state fMRI study of 24 healthy volunteers (14 Semax, 10 placebo) reported a default-mode-network imaging difference after one exposure; this exploratory surrogate endpoint is not a clinical outcome. 4) Medvedeva et al. (2014, BMC Genomics 15:228, PMC3987924): a rat focal-cerebral-ischemia transcriptomic study reported 96 altered genes at 3 hours and 68 at 24 hours, supporting a preclinical research hypothesis rather than human efficacy.
01
Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain
Journal of Neurochemistry · 2006 · peer-reviewed original research
Novel Insights into the Protective Properties of ACTH(4-7)PGP (Semax) Peptide at the Transcriptome Level Following Cerebral Ischaemia-Reperfusion in Rats
Genes (Basel) · 2020 · peer-reviewed original research
The free-peptide reference is the linear sequence Met-Glu-His-Phe-Pro-Gly-Pro (MEHFPGP), CAS 80714-61-0, PubChem CID 9811102, formula C₃₇H₅₁N₉O₁₀S and average molecular weight about 813.9 Da. FDA's 2026 briefing table separately lists Semax acetate as C₃₉H₅₅N₉O₁₂S with molecular weight 874.0 g/mol and notes inconsistent CAS usage. The label and batch COA must therefore identify the supplied form rather than treating free peptide and acetate as interchangeable.
What does the published evidence establish for Semax?+
Peer-reviewed animal and in-vitro studies report effects on neurotrophin transcription, monoaminergic systems and ischemia-related molecular readouts, and a few small or methodologically limited human studies report biomarker or imaging outcomes. FDA's 2026 review found insufficient evidence of effectiveness for cerebral ischemia, migraine or trigeminal neuralgia. The precise receptor-level mechanism and broad clinical efficacy are not established by high-quality, independently replicated human trials, so preclinical or exploratory findings must not be presented as clinical outcomes.
What is the current US regulatory context for Semax?+
Neither Semax free base nor Semax acetate is a component of an FDA-approved drug. FDA's May 11, 2026 briefing evaluation recommends against adding either substance to the 503A Bulks List based on unresolved characterization, effectiveness and safety limitations. The substances are scheduled for PCAC discussion on July 24, 2026; committee advice is non-binding, and FDA states that no final determination will be issued until the advisory process and reviews are complete.
