What records are connected here?
- Evidence lanes
- 3
- Source years
- 3
- Drugs@FDA applications
- 0
These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.
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
This version supersedes public version 2.Start here
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates TB-500-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.↗
Status sources checked through July 29, 2026. See status sources and coverage →
FDA assessment dated May 15, 2026 · Read September 15, 2026 · Preserved version 1
FDA's assessment of TB-500 free base and TB-500 acetate for the nominated use of wound healing. The assessment was prepared for the July 2026 Pharmacy Compounding Advisory Committee meeting. FDA document ↗
FDA describes TB-500 free base as an N-terminal acetylated seven-amino-acid fragment of thymosin beta-4. It also warns that the common name has been used for different substances. Findings about full-length thymosin beta-4 cannot be assumed to apply to this fragment. FDA pp. 7, 8 ↗
FDA reported that it did not identify clinical studies of TB-500 administered to people and found insufficient evidence to evaluate effectiveness for wound healing. The nomination's references concerned thymosin beta-4 rather than human administration of the specified fragment. FDA pp. 23, 24 ↗
FDA reported no identified human pharmacokinetic or clinical safety studies. Its FAERS search through March 26, 2025 found no reports, while a separate complaint system contained two reports about blended TB-500 and BPC-157 without safety assessments. These findings do not establish safety or adverse-event rates. FDA pp. 30, 31 ↗
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
Source: FDA briefing document for TB-500. SHA-256: 973cffba12fec26da77d67b3e08604500b754eaa48d15912acb9596f3090b5a4.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Open machine-readable coverage and record decisions →
Primary human administration reports for the specified molecule; other peptides, preclinical experiments and secondary reviews are separate.
32 retrieved · 0 included · 31 excluded · 1 awaiting a decision · 0 full-text appraisals
"TB-500"[Title/Abstract] OR "LKKTETQ"[Title/Abstract]
Retrieved 2026-09-15T13:04:53.361962+00:00 · HTTP 200 · SHA-256 d23131a6c1719d9bbc196f6b18320c0941ffd67bb517fe7974d1610837e0528b.
Retrieved 2026-09-15T13:04:55.026531+00:00 · HTTP 200 · SHA-256 8fb5c54503bf790a2568785c68300c63dd00e5dfd28876eaa3b00a6f4de1abcf.
Showing 25 of 32 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
products.active_ingredients.name:"TB-500"
Retrieved 2026-09-15T11:10:29.051067+00:00 · HTTP 404 · SHA-256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
Case-insensitive word-boundary identity terms: ["TB-500", "N-terminal acetylated 17-23 fragment of thymosin beta-4"]
Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
Case-insensitive word-boundary identity terms: ["TB-500", "N-terminal acetylated 17-23 fragment of thymosin beta-4"]
Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
Case-insensitive word-boundary identity terms: ["TB-500", "N-terminal acetylated 17-23 fragment of thymosin beta-4"]
Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.
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 name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
1 retrieved · 0 included · 0 excluded · 1 awaiting a decision · 0 full-text appraisals
"TB-500" OR "N-terminal acetylated 17-23 fragment of thymosin beta-4"
Retrieved 2026-09-15T11:27:07.321076+00:00 · HTTP 200 · SHA-256 17aa1ce59dbc05c7f5d07f5f7ddad1dbfe5678d01f319e9253be717ec5708438.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Living status brief
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates TB-500-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.
These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.
Regulatory · source date July 24, 2026
FDA committee met on seven peptide-related groups of bulk drug substances↗Added to PeptideScanner July 29, 2026Regulatory · added August 21, 2026
Federal Register notice 2026-07361↗Source date April 16, 2026Clinical trials · added August 14, 2026
ClinicalTrials.gov record NCT07487363↗Source date March 23, 2026Literature metadata · added August 10, 2026
PubMed record PMID 22962027↗Source date January 28, 2026PeptideScanner currently has no selected 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.
Evidence Map v1
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.
1 of 1 selected trial records include at least one phase value; 1 of 1 include a status value in the retained structured contract.
1 public history versions connect to 1 of these trial records across 1 submitted years. Open the record-history collection →
0 of 4 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Bibliography fields unavailable here for 4 selected records; the records remain visible as metadata observations.
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.
Research hub
PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.
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.
PeptideScanner retained ClinicalTrials.gov record NCT07487363 at 2026-07-30T16:22:22.342Z. Its registry update date was 2026-03-23, and PeptideScanner's reviewed identity mapping was tb-500.
0 with attributed title, venue, publication-date, and type metadata.
1 public history versions across these dated registry records; status labels apply only to each cited observation.
FDA- and HHS-attributed document metadata connected by exact reviewed peptide-name matches, with official GovInfo PDFs.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
Selected records span February 8, 2018 to July 24, 2026.
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
FDA's July 2026 briefing evaluates TB-500-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.↗
Cited context
Dated source history
Regulatory
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.↗
Regulatory
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.↗
Clinical trials
PeptideScanner retained ClinicalTrials.gov record NCT07487363 at 2026-07-30T16:22:22.342Z. Its registry update date was 2026-03-23, and PeptideScanner's reviewed identity mapping was tb-500.↗
Literature metadata
PeptideScanner retained PubMed bibliographic metadata for PMID 22962027 at 2026-07-30T16:30:49.822Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2012-09-11. PeptideScanner associated this retained record with the identity slug tb-500. These dates describe PubMed metadata history, not the article's original publication date.↗
Literature metadata
PeptideScanner retained PubMed bibliographic metadata for PMID 23084823 at 2026-07-30T16:30:49.836Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2012-10-23. PeptideScanner associated this retained record with the identity slug tb-500. These dates describe PubMed metadata history, not the article's original publication date.↗
Literature metadata
PeptideScanner retained PubMed bibliographic metadata for PMID 38382158 at 2026-07-30T18:48:13.580Z. PubMed recorded a metadata revision date of 2024-03-11 and an Entrez history date of 2024-02-21. PeptideScanner associated this retained record with the identity slug tb-500. These dates describe PubMed metadata history, not the article's original publication date.↗
Literature metadata
PeptideScanner retained PubMed bibliographic metadata for PMID 28887173 at 2026-07-30T21:13:36.164Z. PubMed recorded a metadata revision date of 2018-02-08 and an Entrez history date of 2017-09-10. PeptideScanner associated this retained record with the identity slug tb-500. These dates describe PubMed metadata history, not the article's original publication date.↗