The traceable evidence consists of analytical, cell, rat, and equine work on the seven-amino-acid fragment.
Why this matters
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
N-acetylated thymosin beta-4 heptapeptide fragment
TB-500 is a synthetic seven-amino-acid fragment of thymosin beta-4. It is not the full 43-amino-acid molecule. No human TB-500 studies were located, and human thymosin beta-4 findings should not be transferred to this fragment.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
The traceable evidence consists of analytical, cell, rat, and equine work on the seven-amino-acid fragment.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
No human exposure, pharmacokinetic, safety, or efficacy study of verified TB-500 was located.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: Detectability and metabolites in horses do not establish tissue repair, a human amount, safety, or equivalence to full-length thymosin beta-4. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
The short version
TB-500 is a synthetic seven-amino-acid fragment of thymosin beta-4. It is not the full 43-amino-acid molecule. No human TB-500 studies were located, and human thymosin beta-4 findings should not be transferred to this fragment.
Includes FDA's May 2026 evidence review, the July 23 PCAC vote, the 2024 metabolism and fibroblast study, equine detection research, analytical identity literature, and the 2026 WADA list. Final FDA action was not located by the cutoff.
What the evidence says
None located. FDA found no clinical study or human exposure data for TB-500 free base or acetate by any route.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Whether TB-500 has any clinically meaningful human effect, how it behaves in people, repeated-exposure safety, and whether a labeled material is actually the stated free base or acetate.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
TB-500 was broken down into shorter acetylated peptides. Parent TB-500 did not improve fibroblast scratch-wound closure at the tested concentration; one shorter metabolite, Ac-LKKTE, showed activity.
The parent peptide and multiple C-terminally shortened metabolites were detected in equine plasma and urine.
Administration and handling
A withdrawn nomination described a lyophilized injectable for subcutaneous or intramuscular use. FDA found no human study using either route and no approved dose, schedule, injection site, or reconstitution procedure. Nomination details and animal protocols are not consumer instructions.
FDA reported supplier-level bulk storage observations for free base and acetate, while emphasizing that peptide stability depends on formulation, manufacturing, impurities, aggregation, temperature, light, and moisture. There is no FDA-approved finished product, reconstitution method, beyond-use period, or universal procedure.
Primary-source ledger
2026-07-23
2026-07-21
2026-01-01
2024-03-15 · PMID 38382158 · DOI 10.1016/j.jchromb.2024.124033
2012-11-23 · PMID 23084823 · DOI 10.1016/j.chroma.2012.09.043
2012-09-07 · PMID 22962027 · DOI 10.1002/dta.1402