Safety review recordSafety records

TB-500

Related names in cited records: N-terminal acetylated 17-23 fragment of thymosin beta-4

A thymosin beta-4 fragment represented in FDA identity and pharmacy-compounding review 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

This version supersedes public version 2.

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The evidence at a glance

What is its status in the cited records?

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 →

Official evidence assessment

What does the official evidence assessment say?

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 ↗

Which substance is being assessed?

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 ↗

What did FDA find about human studies?

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 ↗

What is known about harms?

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 ↗

Scope, source pin and remaining work

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.

Open versioned assessment data →

Official-source update

Reviewed 2026-09-19 · Preserved version 1

The fragment is not the full-length peptide

FDA’s July 2026 briefing defines TB-500 as an N-acetylated seven-amino-acid fragment of the 43-amino-acid thymosin beta-4. Results for the full-length molecule or an unacetylated fragment cannot automatically be assigned to TB-500. FDA PDF pp. 25 ↗

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.

Wound-healing claims lacked clinical evidence in the assessment

FDA reported no identified clinical information showing administration of the nominated TB-500 substances to patients for wound healing or another condition. This remains a dated, source-specific assessment. FDA PDF pp. 24 ↗

Product reports do not substitute for a safety study

The briefing found no clinical pharmacokinetic studies and described reports involving blended TB-500/BPC-157 products without safety assessments. These do not establish a TB-500-specific safety profile. FDA PDF pp. 30, 31 ↗

The toxicology gap is separate from efficacy

FDA reported no identified nonclinical toxicity studies for the nominated free base or acetate. That missing evidence should not be interpreted as either demonstrated safety or proof of a specific human harm. FDA PDF pp. 30 ↗

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.

  • FDA tb-500 briefing for the July 2026 advisory meeting ↗

    Source dated 2026-07-23; retrieved 2026-09-19.

    • The fragment is not the full-length peptide · PDF pp. 25 of 41
    • Wound-healing claims lacked clinical evidence in the assessment · PDF pp. 24 of 41
    • Product reports do not substitute for a safety study · PDF pp. 30, 31 of 41
    • The toxicology gap is separate from efficacy · PDF pp. 30 of 41

    SHA-256: 973cffba12fec26da77d67b3e08604500b754eaa48d15912acb9596f3090b5a4

Open versioned findings and source records →

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.

Open machine-readable coverage and record decisions →

PubMed search

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

Search terms, record decisions and remaining work

"TB-500"[Title/Abstract] OR "LKKTETQ"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T13:04:53.361962+00:00 · HTTP 200 · SHA-256 d23131a6c1719d9bbc196f6b18320c0941ffd67bb517fe7974d1610837e0528b.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T13:04:55.026531+00:00 · HTTP 200 · SHA-256 8fb5c54503bf790a2568785c68300c63dd00e5dfd28876eaa3b00a6f4de1abcf.

  • Regulator and trial-registry searches and non-indexed reports require separate reconciliation.
  • Full-text appraisal, study-family linkage and citation follow-up remain open.
  • The BPC-157/TB4 combination report PMID34324435 is a citation lead outside this name query; the exact TB4 formulation has not been established. This ledger does not assert worldwide absence of human reports.
  • PMID 26472487 describes a urine assay; whether TB-500 itself was administered to people is unresolved without the full report. No eligible human-administration report has been established in this query.

Showing 25 of 32 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 26472487 — unresolved: Urine extraction method mentions the fragment, but sample origin and any human TB-500 administration are not established in the abstract. Full-text reconciliation is needed.
  2. PubMed 42635865 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  3. PubMed 42578445 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  4. PubMed 41966639 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  5. PubMed 42542926 — exclude: Animal administration or animal wound-healing study; not administration to people.
  6. PubMed 42021992 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  7. PubMed 41490200 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  8. PubMed 41476424 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  9. PubMed 41359360 — exclude: The abstract reports human corneal cells and a wound model; indexed species include mice. No human administration is described.
  10. PubMed 40681595 — exclude: Unrelated acronym or term match; the reported exposure is not the TB-500 peptide fragment.
  11. PubMed 38382158 — exclude: Animal administration or animal wound-healing study; not administration to people.
  12. PubMed 35730516 — exclude: Unrelated acronym or term match; the reported exposure is not the TB-500 peptide fragment.
  13. PubMed 33318598 — exclude: Unrelated acronym or term match; the reported exposure is not the TB-500 peptide fragment.
  14. PubMed 31791503 — exclude: Unrelated acronym or term match; the reported exposure is not the TB-500 peptide fragment.
  15. PubMed 30063851 — exclude: Analytical, synthesis or cell/tissue experiment; no primary report of administration to people.
  16. PubMed 28887173 — exclude: Analytical, synthesis or cell/tissue experiment; no primary report of administration to people.
  17. PubMed 27569051 — exclude: Analytical, synthesis or cell/tissue experiment; no primary report of administration to people.
  18. PubMed 26578461 — exclude: Analytical method includes TB-500, but the described human elimination samples concern GHRP-6, GHRP-2 or LHRH, not TB-500.
  19. PubMed 25469748 — exclude: Analytical, synthesis or cell/tissue experiment; no primary report of administration to people.
  20. PubMed 25382550 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  21. PubMed 24906629 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.
  22. PubMed 23318763 — exclude: Animal administration or animal wound-healing study; not administration to people.
  23. PubMed 23084823 — exclude: Animal administration or animal wound-healing study; not administration to people.
  24. PubMed 22962027 — exclude: Analytical, synthesis or cell/tissue experiment; no primary report of administration to people.
  25. PubMed 20179146 — exclude: Secondary review or clinical-practice discussion; not a primary report of this fragment administered to people.

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

Search terms, record decisions and remaining work

products.active_ingredients.name:"TB-500"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:29.051067+00:00 · HTTP 404 · SHA-256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da.

  • 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

    Search terms, record decisions and remaining work

    Case-insensitive word-boundary identity terms: ["TB-500", "N-terminal acetylated 17-23 fragment of thymosin beta-4"]

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

    • 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

      Search terms, record decisions and remaining work

      Case-insensitive word-boundary identity terms: ["TB-500", "N-terminal acetylated 17-23 fragment of thymosin beta-4"]

      Source retrievals and payload pins
      • Open the source endpoint ↗

        Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

      • 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

        Search terms, record decisions and remaining work

        Case-insensitive word-boundary identity terms: ["TB-500", "N-terminal acetylated 17-23 fragment of thymosin beta-4"]

        Source retrievals and payload pins
        • Open the source endpoint ↗

          Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

        • 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.

          1 retrieved · 0 included · 0 excluded · 1 awaiting a decision · 0 full-text appraisals

          Search terms, record decisions and remaining work

          "TB-500" OR "N-terminal acetylated 17-23 fragment of thymosin beta-4"

          Source retrievals and payload pins
          • Open the source endpoint ↗

            Retrieved 2026-09-15T11:27:07.321076+00:00 · HTTP 200 · SHA-256 17aa1ce59dbc05c7f5d07f5f7ddad1dbfe5678d01f319e9253be717ec5708438.

          • 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 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

          1. ClinicalTrials.gov NCT07487363 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          Explore status sources, recent additions, and coverage gaps

          Living status brief

          What is the current status of TB-500?

          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.

          Evidence present

          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.

          Coverage gaps

          What remains unknown or unsupported?

          PeptideScanner 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.

          Explore the Evidence Map and record counts

          Evidence Map v1

          What kinds of records connect to TB-500?

          Compare collection coverage →

          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.

          7Selected dated records
          15Connected citations
          3Populated source years2018–2026
          3/4Record lanes present

          Registered human studies

          Trial composition

          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 →

          PhasesPhase 1 1Phase 2 1
          Status at observationRecruiting 1

          PubMed bibliography

          Publication composition

          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.

          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
          7

          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.

          Profile publication history and record counts

          Research hub

          Explore the TB-500 evidence record

          Open all 7 records →
          7Dated records
          3Evidence types
          14Cited public sources
          3Source years

          Change ledger

          Recently changed for TB-500

          Open all 9 events →

          PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

          Record added

          Federal Register notice 2026-07361

          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 change date
          August 21, 2026
          Cited source date
          April 16, 2026
          Evidence lane
          Regulatory
          Record added

          ClinicalTrials.gov record NCT07487363

          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.

          PeptideScanner change date
          August 14, 2026
          Cited source date
          March 23, 2026
          Evidence lane
          Clinical trials

          Official-source collections

          Source records for TB-500

          Open the full research atlas →

          Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

          Evidence types

          Coverage by source year

          Selected records span February 8, 2018 to July 24, 2026.

          Continue exploring

          Profiles with overlapping source-year coverage

          Open the research atlas →

          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.

          Glucagon3 shared source years308 dated records · 4 evidence typesSemaglutide3 shared source years237 dated records · 4 evidence typesLeuprolide3 shared source years215 dated records · 4 evidence typesLiraglutide3 shared source years167 dated records · 4 evidence types

          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 TB-500-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.

          Cited context

          Related records

          Organizations named in cited records

          Dated source history

          Updates connected to this profile

          Open the full cross-source timeline →
          1. Regulatory

            FDA committee met on seven peptide-related groups of bulk drug substances

            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.

          2. Regulatory

            Federal Register notice 2026-07361

            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.

          3. Clinical trials

            ClinicalTrials.gov record NCT07487363

            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.

          4. Literature metadata

            PubMed record PMID 22962027

            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.

          5. Literature metadata

            PubMed record PMID 23084823

            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.

          6. Literature metadata

            PubMed record PMID 38382158

            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.

          7. Literature metadata

            PubMed record PMID 28887173

            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.