A mitochondrial-derived peptide represented in FDA compounding-risk and advisory-committee records.↗↗↗
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. 2
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates MOTS-c-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.
Three selected human reports measured naturally occurring MOTS-c during exercise studies or in patients with coronary endothelial dysfunction. None of these reports tested administering MOTS-c to people.↗↗↗
What the reviewed sources report
Human studies associate endogenous MOTS-c with exercise or vascular measurements. Exercise interventions and biomarker associations do not demonstrate the efficacy or safety of administered MOTS-c.↗↗↗
What remains unresolved?
What evidence directly evaluates administered MOTS-c in humans, separately from exercise and endogenous biomarker studies?↗↗↗
How do assay methods, confounding and population differences affect observed associations?↗↗↗
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.
Human studies of endogenous MOTS-c biomarkers and studies administering the peptide, distinguished explicitly; animal or cell exposure cannot establish a human treatment effect.
255 retrieved · 3 included · 0 excluded · 252 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"MOTS-c"[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 255 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 34351816 — include: Selected endogenous biomarker study; no MOTS-c was administered to the human participants. Study families: MOTS-c-acute-exercise-2021.
PubMed 34413391 — include: Selected endogenous biomarker study; no MOTS-c was administered to the human participants. Study families: NCT01140282.
PubMed 29242099 — include: Selected endogenous biomarker study; no MOTS-c was administered to the human participants. Study families: MOTS-c-coronary-observational-2018.
PubMed 42633281 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42633878 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42734848 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42716952 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42640735 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42611943 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42576277 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42349896 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42321010 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42128272 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41966639 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42650220 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42592019 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42142418 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41933740 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42324588 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42243958 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42228044 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42153537 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42266945 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42278864 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42126770 — 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.
8 retrieved · 0 included · 0 excluded · 8 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 8 of 8 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT04027712 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07438002 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03878706 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07638696 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06133946 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06500975 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07678073 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07505745 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about MOTS-c?
Three selected human reports measured naturally occurring MOTS-c during exercise studies or in patients with coronary endothelial dysfunction. None of these reports tested administering MOTS-c to people.123
Bottom line from this bounded source set
Human studies associate endogenous MOTS-c with exercise or vascular measurements. Exercise interventions and biomarker associations do not demonstrate the efficacy or safety of administered MOTS-c.123
Reviewed study record
Acute exercise and circulating peptides
Design
Participants were randomized to endurance exercise, resistance exercise or a control group, with blood and muscle measurements.1
Population
Thirty participants were assigned to three groups of ten.1
Outcomes reported
Humanin increased after endurance exercise; MOTS-c showed a trend toward an increase.1
Limitations
The intervention was exercise, not MOTS-c administration. A trend is not a demonstrated clinical benefit, and the small study measured short-term biomarkers.1
Reviewed study record
Exercise in breast cancer survivors
Design
A secondary analysis of a randomized 16-week exercise-versus-usual-care study measured circulating MOTS-c.2
Population
The analysis included 25 Hispanic and 24 non-Hispanic White breast cancer survivors.2
Outcomes reported
MOTS-c increased in the non-Hispanic White subgroup and was associated with changes in metabolic measures; a comparable increase was not reported in the Hispanic subgroup.2
Limitations
Small subgroup analyses and baseline differences limit interpretation. Associations do not establish that MOTS-c caused the metabolic changes, and no peptide was administered.2
Reviewed study record
Coronary endothelial dysfunction
Design
An observational human comparison measured endogenous MOTS-c; separate experiments exposed rodent vessels to the peptide.3
Population
Forty patients undergoing angiography for recurrent angina were classified into two groups of twenty by endothelial function.3
Outcomes reported
Circulating MOTS-c was lower in patients with endothelial dysfunction and correlated with vascular function measures.3
Limitations
The human findings are associations. Exposure experiments used rodent tissues, so they do not establish a therapeutic effect or safety in people.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1152/japplphysiol.00706.2019. 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 10.1038/s41598-021-96419-z. 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 10.1016/j.ijcard.2017.12.001. 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 MOTS-c?
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates MOTS-c-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
43
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 26289118 in Aging cell as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2015-08-20 (day precision). PeptideScanner associated the retained record with the identity slug mots-c. 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 MOTS-c-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.
PeptideScanner retained PubMed bibliographic metadata for PMID 42243958 at 2026-08-12T11:06:05.213Z. PubMed recorded a metadata revision date of 2026-08-12 and an Entrez history date of 2026-06-05. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42321010 at 2026-08-10T10:49:10.706Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2026-06-19. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42278864 at 2026-08-10T18:13:52.251Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-06-12. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
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.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42128272 at 2026-08-10T18:13:50.589Z. PubMed recorded a metadata revision date of 2026-07-16 and an Entrez history date of 2026-05-13. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41933740 at 2026-08-10T18:13:46.811Z. PubMed recorded a metadata revision date of 2026-07-14 and an Entrez history date of 2026-04-04. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41945630 at 2026-08-10T18:13:46.825Z. PubMed recorded a metadata revision date of 2026-07-14 and an Entrez history date of 2026-04-07. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41593376 at 2026-08-10T18:13:40.572Z. PubMed recorded a metadata revision date of 2026-07-13 and an Entrez history date of 2026-01-27. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41764620 at 2026-08-10T18:13:42.760Z. PubMed recorded a metadata revision date of 2026-07-10 and an Entrez history date of 2026-03-01. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41802484 at 2026-08-10T18:13:44.802Z. PubMed recorded a metadata revision date of 2026-07-10 and an Entrez history date of 2026-03-09. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41811086 at 2026-08-10T18:13:44.817Z. PubMed recorded a metadata revision date of 2026-07-10 and an Entrez history date of 2026-03-11. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41706383 at 2026-08-10T18:13:42.683Z. PubMed recorded a metadata revision date of 2026-07-08 and an Entrez history date of 2026-02-18. PeptideScanner associated this retained record with the identity slug mots-c. These dates describe PubMed metadata history, not the article's original publication date.↗