A peptide also called DSIP 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 Emideltide-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 small studies examined delta sleep-inducing peptide (DSIP) in chronic insomnia. Their short observation periods and incompletely described formulations limit transfer to other preparations or uses.↗↗
What the reviewed sources report
The two reports differ: one described improved sleep and daytime measures, while the other found weak objective changes and no improvement in subjective sleep quality. These small studies do not establish durable benefit or adequately characterize harms.↗↗
What remains unresolved?
Are the preparations and study populations sufficiently comparable to combine these reports?↗↗
Do larger, longer randomized trials reproduce clinically meaningful sleep improvements?↗↗
Reviews summarize selected studies; their scope and limitations are shown above.
Research coverage and study families
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.
463 retrieved · 2 included · 0 excluded · 461 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"delta sleep-inducing peptide"[Title/Abstract] OR "DSIP"[Title/Abstract] OR "emideltide"[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 463 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 1299794 — include: Selected human report; abstract and record metadata reviewed. Study families: DSIP-1992-matched-pairs-linkage-unresolved.
PubMed 3622582 — include: Selected human report; abstract and record metadata reviewed. Study families: DSIP-1987-insomnia-linkage-unresolved.
PubMed 41490200 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39798527 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39444618 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 38854576 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 37884638 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 36042828 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 34500605 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 33918965 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 33019716 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 32456912 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 30107169 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 28549673 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 28462721 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 26931331 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 26902351 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 29124188 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 25805003 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 26470489 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 25581971 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 25257425 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 25063142 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 24607477 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 25898718 — 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 Emideltide?
Two selected small studies examined delta sleep-inducing peptide (DSIP) in chronic insomnia. Their short observation periods and incompletely described formulations limit transfer to other preparations or uses.12
Bottom line from this bounded source set
The two reports differ: one described improved sleep and daytime measures, while the other found weak objective changes and no improvement in subjective sleep quality. These small studies do not establish durable benefit or adequately characterize harms.12
Reviewed study record
Chronic insomnia: matched-pairs study
Design
A blinded placebo-controlled parallel-group study used matched pairs and five consecutive laboratory nights.1
Population
Sixteen patients with chronic insomnia participated.1
Outcomes reported
Sleep efficiency and sleep latency differed from placebo, but the authors described the effects as weak and partly attributable to changes in the placebo group. Subjective sleep quality did not improve.1
Limitations
The abstract does not describe random allocation or detailed adverse events. A short, small study cannot establish sustained benefit or uncommon harms.1
Reviewed study record
Chronic insomnia: sleep and daytime performance
Design
A blinded placebo-controlled study observed sleep and daytime performance over seven successive treatment nights.2
Population
Fourteen middle-aged participants with chronic insomnia were studied.2
Outcomes reported
The authors reported improved sleep, alertness and daytime performance, with sleep effects maintained on the first post-treatment night.2
Limitations
The abstract does not clearly describe allocation, the full comparator sequence or adverse events. The findings do not establish longer-term efficacy or safety.2
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1159/000118919. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1159/000116143. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Emideltide?
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates Emideltide-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.
0 of 0 selected trial records include at least one phase value; 0 of 0 include a status value in the retained structured contract.
PubMed bibliography
Publication composition
17 of 42 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 17Research Support, U.S. Gov't, Non-P.H.S. 8Research Support, Non-U.S. Gov't 5Comparative Study 3Research Support, U.S. Gov't, P.H.S. 2Review 1
Bibliography fields unavailable here for 25 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
44
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 11321250 in Folia biologica as Journal Article, with publication-date metadata of 2001 (year precision). PeptideScanner associated the retained record with the identity slug emideltide. 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 Emideltide-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 11321250 in Folia biologica as Journal Article, with publication-date metadata of 2001 (year precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 6132770 in Comparative biochemistry and physiology. C, Comparative pharmacology and toxicology as Comparative Study, Journal Article, with publication-date metadata of 1983 (year precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 3367267 in Journal of pineal research as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 1988 (year precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 3286557 in The International journal of neuroscience as Journal Article, Review, with publication-date metadata of 1988-02 (month precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 1800948 in Peptides as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 1991 Sep-Oct (source-text precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 6897115 in Peptides as Journal Article, with publication-date metadata of 1982 Jul-Aug (source-text precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 318193 in Brain research bulletin as Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S., with publication-date metadata of 1978 Nov-Dec (source-text precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 3768731 in Brain research bulletin as Comparative Study, Journal Article, Research Support, U.S. Gov't, Non-P.H.S., with publication-date metadata of 1986-08 (month precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 6895711 in Brain research bulletin as Comparative Study, Journal Article, Research Support, U.S. Gov't, Non-P.H.S., with publication-date metadata of 1981-12 (month precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 6549071 in Pharmacology, biochemistry, and behavior as Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S., with publication-date metadata of 1984-11 (month precision). PeptideScanner associated the retained record with the identity slug emideltide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗