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TB-500 half-life: what do the studies show?

The FDA's briefing document (memo dated 15 May 2026) reports finding no human pharmacokinetic study of TB-500 by any route, so it gives no human half-life. The only plasma time course it cites comes from horses: in a 2012 study of thoroughbred geldings (number not stated in the FDA summary), plasma TB-500 peaked 60 to 120 minutes after treatment and fell below the quantifiable level 6 to 10 hours after it, a time course in one animal species that is not a half-life and does not describe people (Ho et al., *Journal of Chromatography A*, 2012, as summarised by the FDA).

Published 2026-10-14Updated 2026-10-14Written by Form Laboratories research team10 min read

Think about how your body clears a cup of coffee. The body clears caffeine over time, because the liver and kidneys work on whatever enters the blood. Peptides face the same clearance, plus enzymes that cut chains apart. That is why scientists look first for a half-life, the time the amount in the blood takes to fall by half.

This page is part of the TB-500 hub. It reports what the FDA's briefing document of 15 May 2026 and published studies recorded about TB-500 in the body, which is little. It names the animal or laboratory system behind every number. It also answers the question people ask next: how long studies took to measure any effect.

Key facts

Key facts for TB-500 half-life: what do the studies show?
Common nameTB-500
Sequence in two 2012 papersAc-LKKTETQ, 7 amino acids (Ho et al., 2012; Esposito et al., 2012)
Human half-lifeNot reported in the FDA briefing document (memo dated 15 May 2026), which reports finding no human pharmacokinetic study of TB-500 by any route
Horse plasma time courseIn one 2012 horse study, plasma peaked 60–120 minutes after treatment and fell below the quantifiable level at 6–10 hours; one animal species, number of horses not stated in the FDA summary, not a half-life (Ho et al., 2012, as summarised by the FDA)
Rat urineIn rats, the breakdown product Ac-LKK was detected in urine up to 72 hours; number of rats not stated in the abstract, a detection window and not a half-life (Rahaman et al., 2024)
Full-length thymosin beta-4, a different moleculeIn the first part of a 2021 trial of 54 healthy Chinese volunteers (44 treated, 10 placebo), peak times were 3–15 minutes and half-lives 0.5–2.08 hours across the six cohorts with pharmacokinetic sampling; sponsor-run trial in healthy adults, no TB-500 given (Wang et al., 2021)
Records checked14 October 2026
Journal of Chromatography A 2012FDA briefing document, 15 May 2026

What is the half-life of TB-500?

The FDA's briefing document (memo dated 15 May 2026) reports that its search found no clinical study of TB-500's pharmacokinetics (what the body does to a compound over time) or pharmacodynamics (what a compound does in the body) by any route, so it gives no human half-life. The only plasma time course it cites is a 2012 study in thoroughbred geldings, in which plasma TB-500 peaked at 0.05 to 0.08 ng/mL between 60 and 120 minutes after treatment and became unquantifiable between 6 and 10 hours after it; the FDA summary gives no number of horses and no half-life, and the result describes one animal species (Ho et al., Journal of Chromatography A, 2012, as summarised by the FDA).

That time course is not a half-life. The FDA's summary of the horse study gives when levels peaked and when they fell below the quantifiable limit, and it gives no half-life. The FDA also says the study did not include the comparison needed to work out absolute bioavailability, the share of a compound that reaches the blood (FDA briefing document, memo dated 15 May 2026).

The horse study used a veterinary preparation sold as TB-500, and its aim was anti-doping detection. The authors built a method that found N-acetylated LKKTETQ in horse urine at 0.01 ng/mL and in horse plasma at 0.02 ng/mL, a detection limit for horse samples that says nothing about how long the peptide persists in people (Ho et al., 2012). The TB-500 research guide gathers the published studies in one place.

FDA briefing document, 15 May 2026

Evidence limits

What has not been measured about TB-500 in the body?

Most of what a half-life needs was not found by the FDA. The FDA's briefing document (memo dated 15 May 2026) says it did not identify any human pharmacokinetic or pharmacodynamic study of TB-500, or any acute toxicity, repeat-dose toxicity, genotoxicity, reproductive or carcinogenicity study of TB-500. It also did not identify any clinical study of immune reactions to TB-500. Those statements describe the FDA's own database search, not every source that exists. Every number below comes from a horse, a rat, a laboratory dish or a different molecule.

A search of the FDA's adverse event database through 26 March 2025 retrieved no reports for TB-500, and the FDA notes that such data have limits, so the empty result does not show safety or clearance (FDA briefing document, memo dated 15 May 2026). The FDA's search also did not find published case reports of TB-500 in people.

Journal of Chromatography A 2012Journal of Chromatography B 2024Journal of Proteomics 2016

What does the body do to TB-500?

In horse liver tissue tested in the laboratory, TB-500 was cut into shorter pieces, called metabolites: N-acetylated LKKTET, LKKTE, LKKT, LKK and LK, a result that does not show what happens inside a living horse or a person (Ho et al., Journal of Chromatography A, 2012, as summarised by the FDA). Shortened pieces were also found in plasma and urine from horses treated with TB-500, a result in horses (number not stated in the FDA summary) that does not describe people (Ho et al., 2012, as summarised by the FDA).

In urine from treated rats (number not stated in the abstract), Ac-LK was the breakdown product at the highest concentration over the first 0 to 6 hours and Ac-LKK was detected up to 72 hours, detection windows for breakdown products in one species that are not the half-life of TB-500 and do not establish a result in people (Rahaman et al., Journal of Chromatography B, 2024).

In a laboratory comparison, human kidney and liver preparations showed high metabolic activity against TB-500 and human serum produced fewer breakdown products (number of preparations not stated in the abstract), a dish result that does not show how fast a body clears TB-500 or establish a result in people (Zvereva et al., Journal of Proteomics, 2016). Kidney microsomes are small particles of kidney cell membrane that carry its enzymes. They show how a peptide can be broken down, not how fast a body clears it.

In cultured fibroblasts with scratch wounds, one breakdown product, Ac-LKKTE, was the only one with significant wound-closure activity compared with control, while the parent TB-500 did not show significant activity in the same test; that is a cell result and it does not establish an effect in any animal or person (Rahaman et al., 2024).

FDA briefing document, 15 May 2026Joint Diseases and Related Surgery 2026Journal of Chromatography B 2024Wound Repair and Regeneration 2003

How long did studies take to measure an effect of TB-500?

The FDA's briefing document (memo dated 15 May 2026) reports that its literature search found no article in which TB-500 was given to humans, and no human study was found in the sources opened for this page on 14 October 2026, so this page reports no timed effect of TB-500 in people. The time points reported on this page come from animals and cells, and they show when researchers measured, not when an effect starts. In a rat Achilles tendon study of 32 rats, outcomes were measured at four weeks, a measurement point in one animal model that does not describe people (Biçer et al., Joint Diseases and Related Surgery, 2026). In cultured fibroblasts (number of cultures not stated in the FDA summary), wound closure after 8 hours with TB-500 was not significantly different from vehicle, a cell result that does not establish an effect in any animal or person (Rahaman et al., Journal of Chromatography B, 2024, as summarised by the FDA).

In 32 male rats, eight per group, after Achilles tendon transection and repair, maximum load to failure at four weeks (measured on four tendons per group) was higher in the group treated with TB-500 than in controls and reached statistical significance (p < 0.05), in what the authors call an exploratory study that does not establish a result in people; the paper labels its test substance synthetic thymosin beta-4 (TB-500) without stating a sequence, and the study did not measure how quickly any change began (Biçer et al., 2026).

A 2003 mouse study used the non-acetylated fragment LKKTETQ, not TB-500, and checked wounds at day 7 in aged mice (number not stated in the FDA summary), so its result cannot be moved across to TB-500 (Philp et al., Wound Repair and Regeneration, 2003, as summarised by the FDA). The FDA warns that acetylation changes a peptide's charge, size and binding. The FDA also found websites that market TB-500 for many conditions and found no human article behind those claims (FDA briefing document, memo dated 15 May 2026).

Journal of Cellular and Molecular Medicine 2021Annals of the New York Academy of Sciences 2010

What is known about thymosin beta-4's half-life in people?

Full-length thymosin beta-4 has been measured in healthy volunteers. In the first part of a 2021 first-in-human trial of recombinant human thymosin beta-4 in 54 healthy Chinese volunteers (44 treated, 10 placebo), peak times ranged from 3 to 15 minutes and half-lives from 0.5 to 2.08 hours across the six cohorts with pharmacokinetic sampling, in a trial sponsored by the product's maker that tested safety and blood levels and gave no TB-500 (Wang et al., Journal of Cellular and Molecular Medicine, 2021). Thymosin beta-4 is the 43-amino-acid parent protein, and the trial's product was a 44-amino-acid recombinant version, not TB-500, so those numbers describe a different molecule.

The 2021 trial had a second part of 30 healthy volunteers (24 treated, 6 placebo), and every volunteer was followed for 28 days. In the two healthy-volunteer parts of that trial of recombinant thymosin beta-4 (54 and 30 volunteers), the authors reported adverse events that were mild to moderate and no serious adverse events, in a sponsor-run trial of healthy Chinese adults that did not test TB-500 (Wang et al., 2021). In the second part (30 volunteers, 24 of them treated), the authors reported no obvious accumulation of recombinant thymosin beta-4, a healthy-volunteer result for a different molecule that does not describe TB-500 (Wang et al., 2021). An earlier randomised trial in four groups of 10 healthy volunteers reported that blood levels rose in proportion to the amount given and that half-life rose with the amount, with a synthetic form of full-length thymosin beta-4, not TB-500; its abstract gives no single half-life value (Ruff et al., Annals of the New York Academy of Sciences, 2010).

A shorter, acetylated fragment need not behave like its parent protein. The TB-500 and thymosin beta-4 page sets the two side by side.

Journal of Chromatography A 2012FDA briefing document, 15 May 2026

Is research-use TB-500 the same material the studies measured?

The studies opened for this page did not measure the contents of any catalogue vial. The horse study used a veterinary preparation sold as TB-500 (Ho et al., Journal of Chromatography A, 2012). The FDA's briefing document (memo dated 15 May 2026) says it found several salts and derivatives sold under the TB-500 name, that the free base and the acetate salt are different bulk drug substances, and that inconsistent naming leaves a reference standard hard to match to a product. Research material is not a medicine and is not for human or animal use.

The catalogue lists TB-500 reference material as laboratory stock. Reading its paperwork is a skill of its own; the peptide quality and verification hub explains what a certificate records and what it cannot show. The Australian status of TB-500 is a separate question from any measurement on this page.

Comparison

Where each published measurement came from. Only the last two rows involve people, and both use full-length thymosin beta-4, not TB-500. Each result cell names its model, main limit and source. Results from different studies are not pooled.

Comparison: TB-500 half-life: what do the studies show?
ModelSubstanceWhat was measuredResult, limit and source
Thoroughbred geldings (horses)TB-500Plasma concentration over timeIn horses (number not stated in the FDA summary), plasma peaked at 0.05–0.08 ng/mL at 60–120 minutes and was unquantifiable by 6–10 hours; one animal species, no half-life reported, no comparison allowing bioavailability to be worked out (Ho et al., 2012, as summarised by the FDA)
Horse liver tissue (laboratory)TB-500 in tissueBreakdown productsIn horse liver tissue (number of samples not stated in the FDA summary), five N-acetylated shortened pieces formed (LKKTET, LKKTE, LKKT, LKK, LK); a laboratory result that does not show breakdown in a living animal or a person (Ho et al., 2012, as summarised by the FDA)
RatsTB-500, given to the ratsUrine breakdown productsIn rats (number not stated in the abstract), Ac-LK was highest over 0–6 hours and Ac-LKK was detected up to 72 hours; detection windows for breakdown products in one species, not a half-life and not a result in people (Rahaman et al., 2024)
Human serum, kidney and liver preparations (laboratory)TB-500 in a dishBreakdown activityIn laboratory preparations, kidney and liver material showed high activity and serum produced fewer products (number not stated in the abstract); a dish result that does not show how fast a body clears TB-500 or establish a result in people (Zvereva et al., 2016)
Healthy volunteers, 54 in the first partFull-length recombinant thymosin beta-4 (44 amino acids)Blood levels over timeIn 54 healthy Chinese volunteers (44 treated, 10 placebo), peak times were 3–15 minutes and half-lives 0.5–2.08 hours across the six cohorts with pharmacokinetic sampling; a different molecule from TB-500, in a sponsor-run trial of healthy adults only (Wang et al., 2021)
Healthy volunteers, four groups of 10Synthetic full-length thymosin beta-4Blood levels over timeIn four groups of 10 healthy volunteers, blood levels rose in proportion to the amount given and half-life rose with the amount; a different molecule from TB-500, and the abstract gives no single half-life value (Ruff et al., 2010)

FAQ

What is TB-500's half-life?

The FDA's briefing document (memo dated 15 May 2026) reports finding no human pharmacokinetic study of TB-500 by any route, so it gives no half-life in people. A 2012 horse study (number not stated in the FDA summary) reported plasma levels peaking at 60 to 120 minutes and falling below the quantifiable level at 6 to 10 hours; that is a time course in one species, not a half-life (Ho et al., Journal of Chromatography A, 2012, as summarised by the FDA).

How long does TB-500 stay in the body?

No human measurement appears in the sources opened for this page on 14 October 2026. In rats (number not stated in the abstract), the breakdown product Ac-LKK was detected in urine up to 72 hours, a detection window for a breakdown product in one species, not a clearance time for TB-500 and not a result in people (Rahaman et al., Journal of Chromatography B, 2024).

How long did studies take to measure an effect of TB-500?

The FDA's briefing document (memo dated 15 May 2026) reports that its literature search found no article in which TB-500 was given to humans, so this page reports no timed effect in people. A cell study (number of cultures not stated in the FDA summary) found no significant wound-closure difference from vehicle after 8 hours with TB-500 (Rahaman et al., 2024, as summarised by the FDA), and a rat study of 32 rats measured outcomes at four weeks (Biçer et al., Joint Diseases and Related Surgery, 2026); neither measured when an effect starts, and neither establishes a result in people.

Is TB-500's half-life the same as thymosin beta-4's?

Not shown. In the first part of a 2021 first-in-human trial of 54 healthy Chinese volunteers, recombinant full-length thymosin beta-4 had half-lives of 0.5 to 2.08 hours across the six cohorts with pharmacokinetic sampling, in a sponsor-run trial of healthy adults (Wang et al., Journal of Cellular and Molecular Medicine, 2021). TB-500 is a seven-amino-acid acetylated fragment, and the FDA's briefing document reports no human half-life for it.

Citations

8 sources
  1. Ho EN, Kwok WH, Lau MY, Wong AS, Wan TS, Lam KK, Schiff PJ, Stewart BD. Journal of Chromatography A. 2012;1265:57-69.
    doi:10.1016/j.chroma.2012.09.043

  2. Esposito S, Deventer K, Goeman J, Van der Eycken J, Van Eenoo P. Drug Testing and Analysis. 2012;4(9):733-738.
    doi:10.1002/dta.1402

  3. Rahaman KA, Muresan AR, Min H, Son J, Han HS, Kang MJ, Kwon OS. Journal of Chromatography B. 2024;1235:124033.
    doi:10.1016/j.jchromb.2024.124033

  4. Zvereva I, Semenistaya E, Krotov G, Rodchenkov G. Journal of Proteomics. 2016;149:85-97.
    doi:10.1016/j.jprot.2016.08.016

  5. Wang X, Liu L, Qi L, Lei C, Li P, Wang Y et al. Journal of Cellular and Molecular Medicine. 2021;25(17):8222-8228.
    doi:10.1111/jcmm.16693

  6. Ruff D, Crockford D, Girardi G, Zhang Y. Annals of the New York Academy of Sciences. 2010;1194:223-229.
    doi:10.1111/j.1749-6632.2010.05474.x

  7. Biçer O, Adanir O, Güleryüz Y, Balci EC, Dinçel YM, Yenigün MY et al. Joint Diseases and Related Surgery. 2026;37(3):822-837.
    doi:10.52312/jdrs.2026.2951

  8. Philp D, Badamchian M, Scheremeta B, Nguyen M, Goldstein AL, Kleinman HK. Wound Repair and Regeneration. 2003;11(1):19-24.
    doi:10.1046/j.1524-475x.2003.11105.x

Written by

Form Laboratories research team

Perth, Western Australia. We supply research-use-only reference material. Available reports cover historical samples; current batch certification is unverified.

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TB-500 reference material — laboratory research only

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Read the TB-500 research guide

Form Laboratories supplies research-use-only reference material. This article is an educational summary of published third-party literature. It is not medical advice, not a use instruction, and research material is not for human or animal use.

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