TB-500
A synthetic seven-amino-acid fragment, Ac-LKKTETQ, associated with the actin-binding region of thymosin beta-4. Most repair research used the full 43-amino-acid protein, not TB-500 itself.
Last reviewed October 8, 2026
The short version
TB-500 is the synthetic, N-terminally acetylated sequence Ac-LKKTETQ. It is much shorter than thymosin beta-4, the natural 43-amino-acid protein from which that motif comes. This distinction controls how the evidence reads: most animal repair experiments and the small human safety study tested full-length thymosin beta-4, not TB-500.
TB-500 is not FDA-approved. FDA’s current table lists its compounding nomination as withdrawn and retains a safety note. A licensed provider’s clinical decision does not change those FDA facts.
What it is
TB-500 is a synthetic heptapeptide, meaning seven amino acids, with an acetyl group attached at the beginning. Its sequence corresponds to residues 17 through 23 of thymosin beta-4 and includes the parent protein’s LKKTET actin-binding motif. Full-length thymosin beta-4 occurs widely in human cells and contains 43 amino acids. TB-500 itself is a synthetic fragment, not the natural full protein.
The sequence is Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, commonly shortened to Ac-LKKTETQ. Its molecular formula is C38H68N10O14 and reported molecular weight is 889.02 daltons. Anti-doping analytical literature explicitly defines TB-500 as the short fragment.1
Where the research stands
Direct TB-500 evidence is largely chemical identification and anti-doping detection. The widely cited tissue-repair studies used full-length thymosin beta-4. They can explain why the short fragment attracted interest, but they do not show that TB-500 reproduces the parent protein’s effects.
How far the evidence has climbed
- Cell studiesLimitedMostly full-protein or structural work
- Animal studiesLimitedRepair studies largely use full protein
- Small human pilotsNoneFull protein studied, not TB-500 fragment
- Controlled human trialsNoneNo controlled fragment trial
- FDA approvalNoNot approved for any use
Here is what selected studies looked at. Every card says whether it tested TB-500 or full-length thymosin beta-4.
Partial-protein hybrid: actin binding
X-ray crystallography examined a hybrid containing the C-terminal half of thymosin beta-4 fused to gelsolin G1 and bound to actin. The molecule studied was not full-length thymosin beta-4 or TB-500.2
Full protein: skin wounds
Rats with full-thickness skin wounds received full-length thymosin beta-4. Researchers measured re-epithelialization, contraction, collagen and blood-vessel growth; the fragment was not tested.3
Full protein: heart model
In a mouse coronary-ligation model, researchers measured ILK/Akt signaling, myocyte survival and cardiac function after full-length thymosin beta-4. Cell migration was measured separately in embryonic-heart tissue and cultured cardiomyocytes. The study cannot establish a human or TB-500 outcome.4
Full protein: phase 1 safety
A placebo-controlled phase 1 study gave full-length synthetic thymosin beta-4 to 40 healthy volunteers and measured short-term tolerability and pharmacokinetics. It did not test the TB-500 fragment.5
TB-500: anti-doping detection
An equine analytical study defined TB-500 as the acetylated LKKTETQ fragment and developed a mass-spectrometry method to detect it and its metabolites. It did not test clinical benefit.1
Full protein: a null functional result
In dystrophin-deficient mice, the study measured regenerating muscle fibers, muscle strength, heart function and fibrosis after full-length thymosin beta-4. It did not test the TB-500 fragment or people.6
What the research can’t tell you
Fragment and parent are not interchangeable
TB-500 contains only seven residues from a 43-amino-acid protein. A full-protein result cannot establish that the fragment behaves the same way.1
No controlled human fragment trial
The human phase 1 study used full-length thymosin beta-4. It cannot establish TB-500 safety or effectiveness.5
More repair markers may not mean function
The mouse muscular-dystrophy study found more regenerating fibers without better strength or heart function.6
A theoretical tumor question
Full-length thymosin beta-4 influences cell migration and angiogenesis in models. Concern about tumor biology is mechanism-based, not a finding in people using TB-500.
Research-product identity can vary
Analytical identification is central to the TB-500 literature because the short fragment can be confused with the parent protein or modified products.1
Banned in sport
WADA names TB-500 among thymosin beta-4 derivatives prohibited at all times.7
FDA status
Not FDA-approved for any use
FDA’s page, content current as of April 22, 2026, lists the nomination for the thymosin beta-4 fragment LKKTETQ, identified as TB-500, as withdrawn while retaining a safety note. Withdrawal does not change the other requirements that apply to compounding.8
TB-500 is not on FDA’s finalized list of additional bulk substances for patient-specific compounding.9 Before a July 2026 advisory meeting, FDA staff proposed against listing it; FDA had posted no official vote record as of September 17, 2026.10
Compounded drugs are not FDA-approved.11 Promise prescribes TB-500 now through licensed U.S. providers. A provider reviews every request and decides; not everyone qualifies.
A prescription route
Promise prescribes TB-500 now. Here is the route to a licensed U.S. provider’s review; not everyone qualifies:
Start on Promise’s TB-500 page
The page has a visit-start link and a price. A request does not guarantee a prescription.
Share your health information
A licensed U.S. provider reviews every request, including health history, medicines and goals, and can decline. Not everyone qualifies.
Pharmacy review is a separate step
A prescription does not guarantee preparation or dispensing. A licensed U.S. compounding pharmacy must review whether it can fulfill the prescription under the applicable requirements. Compounded medications are not FDA-approved.
A prescription does not make TB-500 FDA-approved or convert full-protein thymosin beta-4 findings into evidence for the fragment; it reflects an individualized clinical decision.
TB-500 at Promise
Start a visit request. A licensed U.S. provider reviews it and can decline.
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U.S. patients only. Availability varies by state and treatment. A licensed U.S. provider reviews every request; not everyone qualifies.
Questions
What is the relationship between TB-500 and thymosin beta-4?
TB-500 is the synthetic acetylated sequence Ac-LKKTETQ, drawn from the actin-binding region of the full 43-amino-acid protein thymosin beta-4.1
Are there human clinical trials on TB-500?
The cited human phase 1 study used full-length thymosin beta-4, not TB-500. No controlled human fragment trial is identified here.5
Is TB-500 a steroid?
No. It is a synthetic seven-amino-acid peptide fragment. Its chemical structure and anti-doping category are different from anabolic steroids.
Sources
- Ho EN, Kwok WH, Lau MY, Wong AS, Wan TS, Lam KK, Schiff PJ, Stewart BD. Doping control analysis of TB-500, a synthetic version of an active region of thymosin beta-4, in equine urine and plasma. J Chromatogr A. 2012;1265:57-69. PubMed 23084823
- Irobi E, et al. Structural basis of actin sequestration by thymosin-beta4: implications for WH2 proteins. EMBO J. 2004. PubMed 15329672
- Malinda KM, et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol. 1999. PubMed 10469335
- Bock-Marquette I, et al. Thymosin beta4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair. Nature. 2004. PubMed 15565145
- Ruff D, et al. A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers. Ann N Y Acad Sci. 2010. PubMed 20536472
- Spurney CF, et al. Evaluation of skeletal and cardiac muscle function after chronic administration of thymosin beta-4 in the dystrophin deficient mouse. PLoS One. 2010. PubMed 20126456
- World Anti-Doping Agency. The 2026 Prohibited List (S2.3).
- U.S. Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Content current as of April 22, 2026.
- U.S. Food and Drug Administration. Bulk drug substances used in compounding under section 503A of the FD&C Act.
- U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee.
- U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers.