A synthetic peptide discussed in FDA briefing material for a 2026 pharmacy-compounding advisory-committee meeting.↗↗
Citation markers ↗ open the public records supporting the adjacent statements.
Correction · September 15, 2026
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct. 1
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates Semax-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Two selected reports examine Semax alongside care for ischemic stroke. They concern specific stroke populations and do not establish effects in healthy people or other indications.↗↗
What the reviewed sources report
The authors reported better functional recovery measures with Semax-containing care. Unclear allocation and masking, concurrent rehabilitation and incomplete harms reporting limit causal conclusions.↗↗
What remains unresolved?
Can adequately randomized, masked studies reproduce the reported functional effects?↗↗
What do complete reports establish about missing outcomes, concomitant care and safety?↗↗
The 2026 assessment did not establish the nominated uses
FDA’s briefing found insufficient evidence for cerebral ischemia, migraine and trigeminal neuralgia. The reviewed clinical references had limited methods and outcome information; this is the agency’s scoped assessment. FDA PDF pp. 29 ↗
More findings and the sources behind them
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Uncontrolled symptom reports have limited interpretability
For migraine and trigeminal neuralgia, FDA described small uncontrolled studies with unclear rating scales and incomplete reporting. Before-and-after changes alone cannot distinguish treatment effects from other explanations. FDA PDF pp. 26, 28 ↗
Nonclinical effects are not established clinical benefits
The briefing discusses neurological and other effects in rodents but poorly understood mechanisms and missing toxicology relevant to the proposed subcutaneous route. Those findings cannot be promoted into demonstrated human efficacy. FDA PDF pp. 37 ↗
Form and safety reporting remain important gaps
Clinical references often did not specify free base versus salt, and many did not discuss safety. FDA raised questions about bleeding and injectable-product immunogenicity; these are concerns requiring evidence, not quantified risks established by these reports. FDA PDF pp. 37, 41 ↗
What remains to be checked
Check subsequent advisory records and any final FDA action separately from the staff briefing.
Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Primary human administration reports for the specified molecule; other peptides, preclinical experiments and secondary reviews are separate.
207 retrieved · 2 included · 0 excluded · 205 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"semax"[Title/Abstract]
Regulator and trial-registry searches and non-indexed reports require separate reconciliation.
Full-text appraisal, study-family linkage and citation follow-up remain open.
Showing 25 of 207 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 29798983 — include: Selected human report; abstract and record metadata reviewed. Study families: Semax-stroke-rehabilitation-2018.
PubMed 11517472 — include: Selected human report; abstract and record metadata reviewed. Study families: Semax-stroke-2001.
PubMed 42559144 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42195624 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42074872 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42021992 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41490200 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42366656 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41004910 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 40692165 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41479572 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41179234 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41171324 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 40650034 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 40496623 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39604801 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39767736 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39442746 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39418522 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 37510287 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 36828803 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 36553646 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 35853762 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 35080861 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 36083821 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Semax?
Two selected reports examine Semax alongside care for ischemic stroke. They concern specific stroke populations and do not establish effects in healthy people or other indications.12
Bottom line from this bounded source set
The authors reported better functional recovery measures with Semax-containing care. Unclear allocation and masking, concurrent rehabilitation and incomplete harms reporting limit causal conclusions.12
Reviewed study record
Stroke rehabilitation and functional measures
Design
Patients in early and late rehabilitation groups were subdivided according to whether they received Semax.1
Population
The report included 110 people after ischemic stroke.1
Outcomes reported
The authors reported higher BDNF levels and better Barthel functional scores with Semax-containing care; rehabilitation timing also affected outcomes.1
Limitations
The abstract does not establish random allocation or masking and does not provide a detailed harms account. Concurrent rehabilitation and group differences may confound the findings.1
Reviewed study record
Acute ischemic stroke
Design
A clinical and electrophysiological comparison assessed Semax added to conventional intensive care.2
Population
Thirty Semax-treated patients were compared with eighty conventionally treated patients with reportedly similar stroke severity and lesion location.2
Outcomes reported
The authors described faster neurological recovery, particularly in motor measures.2
Limitations
The abstract does not clearly describe randomization, masking, a prespecified primary endpoint or adverse events. Unequal groups and combined care limit causal interpretation.2
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.17116/jnevro20181183261-68. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Crossref check unavailableThe reviewed PubMed payload did not include a DOI, so this source could not be matched to a Crossref work endpoint.
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Semax?
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates Semax-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.↗
The cited status sources were checked through July 29, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected clinical trial records and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
Bibliography fields unavailable here for 24 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
1
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
42
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
The Federal Register published notice 2026-07361, attributed to FDA and its parent HHS department, on 2026-04-16. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500.
PubMed lists PMID 10944712 in Doklady biological sciences : proceedings of the Academy of Sciences of the USSR, Biological sciences sections as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2000 May-Jun (source-text precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
FDA's July 2026 briefing evaluates Semax-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
FDA convened its Pharmacy Compounding Advisory Committee on July 23-24, 2026, to discuss free-base and acetate bulk drug substances across seven peptide-related groups.↗
The Federal Register published notice 2026-07361, attributed to FDA and its parent HHS department, on 2026-04-16. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500.↗
PubMed lists PMID 18204410 in CNS spectrums as Letter, Research Support, Non-U.S. Gov't, with publication-date metadata of 2008-01 (month precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 23652441 in Doklady biological sciences : proceedings of the Academy of Sciences of the USSR, Biological sciences sections as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2013-05-08 (day precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 23821053 in Doklady biological sciences : proceedings of the Academy of Sciences of the USSR, Biological sciences sections as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2013-07-03 (day precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 32737723 in Bulletin of experimental biology and medicine as Journal Article, with publication-date metadata of 2020-08-01 (day precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 22096989 in Bioorganicheskaia khimiia as Journal Article, with publication-date metadata of 2011 Jul-Aug (source-text precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 15344653 in Bioorganicheskaia khimiia as English Abstract, Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2004 May-Jun (source-text precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 16523722 in Bioorganicheskaia khimiia as English Abstract, Journal Article, with publication-date metadata of 2006 Jan-Feb (source-text precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 17278839 in Doklady biological sciences : proceedings of the Academy of Sciences of the USSR, Biological sciences sections as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2006 Sep-Oct (source-text precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 18018999 in Bulletin of experimental biology and medicine as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2007-01 (month precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 19145359 in Bulletin of experimental biology and medicine as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2008-07 (month precision). PeptideScanner associated the retained record with the identity slug semax. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗