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SafetyEvidence-BasedSep 2026

TB-500 Side Effects: What the Evidence Shows

TB-500 side effects have not been measured in any human trial of the fragment found for this page, and that absence is the most important thing to understand before reading anything else about them. TB-500 is a synthetic version of a short piece of thymosin beta-4, the seven amino acid region LKKTETQ with an acetylated end, which emerged as a veterinary preparation.6 The human safety trials that exist used full thymosin beta-4, a 43 amino acid peptide, not the TB-500 fragment,15 and the TB-500 specific literature is doping control chemistry, detection in horses6 and laboratory characterization of the fragment,7 rather than human testing. This page lays out what those thymosin beta-4 trials reported, what the cell studies raise, and where the record is simply blank. It does not tell anyone what to take.

0

Human trials of the TB-500 fragment found in this research

7

Amino acids in the fragment, vs 43 in full thymosin beta-4

2018

Prohibited List that named TB-500 as an example (USADA)

This is general education, not medical advice, and not a diagnosis. No human trial of the fragment has surfaced in this research, and every dose figure below is a number a study recorded for full thymosin beta-4, quoted so the evidence level is visible and never a dose to copy. Nothing here is an instruction, a schedule, or a source for using any compound. Anyone weighing any of this belongs in a conversation with a licensed clinician who knows their history.

What is actually known about TB-500 safety

The honest headline is a gap. This research surfaced no human trial of the TB-500 fragment to draw a side effect list from. The human evidence that exists is about full thymosin beta-4, the parent protein.15 The cell findings concern that protein too (PMID 16364925, PMID 17072345, PMID 21621326). These findings do not establish the safety of the TB-500 fragment. So this page reports mostly what has been measured for the parent molecule and for detection in animals, and it marks every place where the fragment itself has not been tested.

If you want the compound itself rather than its safety record, the TB-500 profile covers what it is and how people use it, and the Wolverine stack guide covers running it with BPC-157. This page stays on the safety question. For the wider picture of how approved and unapproved peptides differ on side effect data, the peptide side effects by class guide sets the frame. For more reading, see the guide to MOTS-c side effects.

A fragment, not the whole protein

This distinction decides how to read everything below. Full thymosin beta-4 is a naturally occurring 43 amino acid peptide.5 TB-500 is not that molecule. It emerged as a veterinary preparation containing a synthetic version of the seven residue segment LKKTETQ, positions 17 to 23 of thymosin beta-4, which is the region responsible for actin binding, cell migration and wound healing.6 The key ingredient of TB-500 is that segment with an artificial acetyl group on the N-terminus, written Ac-LKKTETQ.67

Because the human trials below used the full 43 amino acid protein, their safety findings cannot simply be transferred to the 7 residue TB-500 fragment. Those trials therefore do not establish the safety profile of the TB-500 fragment, and no study in this research bridged that gap. Every time this page quotes a thymosin beta-4 result, read it as data on the parent protein, not a measurement of TB-500.

The human trials used thymosin beta-4, not TB-500

Here is the human record. Every figure in the table is a trial figure for full thymosin beta-4, not a recommendation and not a TB-500 dose. These studies were small and short, and the neurotrophic keratopathy phase 3 lists authors employed by the developer, ReGenTree, which is a real limit on how much they establish.4

Trial (route)What was given (thymosin beta-4)Adverse events reported
IV, healthy volunteers (Ruff 2010)42, 140, 420 or 1260 mg by a single IV dose, then the same dose daily for 14 days (trial dose, not a recommendation, PMID 20536472)Adverse events infrequent and mild or moderate; no dose limiting toxicities and no serious adverse events (PMID 20536472)
Eye drops, dry eye phase 2 (CAE model)72 subjects randomized 1:1 to placebo or a 0.1% ophthalmic solution for 28 days (trial dose, not a recommendation, PMID 26056426)No adverse events observed; the two primary endpoints were not met (PMID 26056426)
Eye drops, severe dry eye phase 29 patients treated with either vehicle or RGN-259 at 0.1% six times daily for 28 days (trial dose, not a recommendation, PMID 25826322)The authors described the drops as well tolerated in this small trial (PMID 25826322)
Eye drops, neurotrophic keratopathy phase 30.1% solution, 18 subjects, 10 on drug and 8 on placebo (trial dose, not a recommendation, PMID 36613994)Abstract reports no significant adverse effects (PMID 36613994); full text records 16 adverse events across 7 of 18 subjects, one of them judged treatment related, including one non-ocular serious adverse event judged unrelated to treatment (full text, PMC9820614)
Topical, venous stasis ulcers phase 2Topical dose-escalation, 73 patients at 8 European sites; this page has no verified per-dose figureSafety of all doses deemed acceptable and comparable to placebo (PMID 20536470)

The intravenous study tested full thymosin beta-4 in healthy people. Four cohorts of 10 received single ascending intravenous doses of 42, 140, 420 or 1260 mg of synthetic thymosin beta-4 or placebo, then the same dose daily for 14 days (trial dose, not a recommendation, PMID 20536472), and the authors reported that adverse events were infrequent and mild or moderate, with no dose limiting toxicities and no serious adverse events.1 In the dry eye phase 2, subjects were randomized to placebo or a 0.1% ophthalmic solution for 28 days (trial dose, not a recommendation, PMID 26056426), and the trial reported no adverse events observed.2 In the small severe dry eye trial, patients received vehicle or a 0.1% solution six times daily for 28 days (trial dose, not a recommendation, PMID 25826322), and the authors described the drops as well tolerated.3 A phase 3 in neurotrophic keratopathy reported in its abstract only that no significant adverse effects were observed, while its full text records 16 adverse events across 7 of 18 subjects, one of them judged treatment related, including one non-ocular serious adverse event judged unrelated to treatment, and its author list includes employees of the product developer.413 A topical venous ulcer trial in 73 patients reported the safety of all doses as acceptable and comparable to placebo.5

One caveat on the registry trail. A ClinicalTrials.gov entry for an intravenous phase 1 of thymosin beta in healthy volunteers, NCT00743769, is listed as withdrawn, and it could not be matched to the published intravenous study above, so this page cites that study by its publication only and does not present the withdrawn registry entry as its registration.11

No human trial of the TB-500 fragment surfaced in this research

The TB-500 specific studies that were retrieved are not safety trials at all. They are doping control chemistry: a method that detected the acetylated fragment in horse urine and plasma,6 and a paper that synthesized and characterized the N-terminal acetylated 17 to 23 fragment identified in TB-500, a product it describes as suspected of doping potential.7 No human clinical trial of the fragment itself surfaced in this research, which is itself the central finding rather than a footnote. That null has a stated limit: the searches behind it were a web search and a PubMed search, and a ClinicalTrials.gov registry search for TB-500 was not run for this research file, so the finding covers what was searched, not every registry.

Product quality is a separate question, and this page will not guess at it. No source fetched for this guide tested the purity, contamination or labelling accuracy of any specific TB-500 product, so it makes no claim about product quality in either direction. Whatever the source, a published certificate of analysis for the exact batch is worth reading, and how to verify a peptide certificate of analysis explains what to look for. A certificate does not by itself establish that a product is safe.

Cell studies and the cancer question

The safety questions that reach past the human trials come from biology, and they need careful reading because they concern the full protein, not the TB-500 fragment. Thymosin beta-4 is described as stimulating angiogenesis, the growth of new blood vessels,5 and the doping-control paper describes a claim that TB-500 promotes angiogenesis in dermal tissues (doping-control chemistry, not a human trial, PMID 23084823).6 The cell studies below concern the full protein and are worth stating plainly rather than burying.

  • In SW480 colon carcinoma cells, overexpressing thymosin beta-4 made the cells more resistant to apoptosis, which the authors say might help cancer cells survive metastasis and chemotherapy (cell study, human colon cancer line, PMID 16364925).
  • In colorectal carcinoma cells, thymosin beta-4 overexpression triggered an epithelial mesenchymal transition, a change linked to cancer progression, by upregulating integrin-linked kinase (cell study, colorectal carcinoma, PMID 17072345).
  • Thymosin beta-4 overexpression increased colon cancer cell migration and tumor metastasis through an ILK/IQGAP1/Rac1 signalling pathway, which shares integrin-linked kinase with the route above (cell study, colon cancer, PMID 21621326).

Read those carefully. They are overexpression experiments, forcing cancer cells to make more of the full thymosin beta-4 protein, not studies of the TB-500 fragment in an animal or a person.8910 No direct evidence that TB-500, the fragment, promotes tumours in animals was found in this research. That is not reassurance, it is an unanswered question: the mechanism is documented for the parent protein, while no study fetched here tested the fragment for that effect.

Doping status: what USADA confirmed

For an athlete, the clearest fact on this page is a regulatory one. According to USADA, in its summary of the 2018 Prohibited List dated October 2, 2017, thymosin-beta4 and its derivatives, for example TB-500, were added as examples of prohibited growth factors under section S2.3.12 The fragment is also detectable in testing: the doping control method confirmed the acetylated peptide at 0.02 ng/mL in equine plasma and 0.01 ng/mL in equine urine (doping-control detection, horses, PMID 23084823).6

We could not verify the current 2026 wording of the WADA Prohibited List for this page, because the live list could not be retrieved during research, so this page states only the 2018 addition that USADA confirmed and does not assert the present classification beyond it. Anyone subject to testing should read the current list directly rather than rely on a summary.

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Disclosure: Some links on this page are referral links. Peptides Vietnam may earn a fee at no cost to you. Editorial content is never sold.

TB-500 emerged as a veterinary preparation containing a synthetic version of the thymosin beta-4 fragment, and no human trial of the fragment surfaced in this research.6 For TB-500, this page links to our supply partner, Peptara Labs.

The short version

  • No human trial of the TB-500 fragment (Ac-LKKTETQ) itself surfaced in this research, so there is no measured side effect list for the fragment itself.
  • The human safety data belongs to full thymosin beta-4, a 43 amino acid protein, not the 7 residue TB-500 fragment, and the two are not interchangeable.
  • In those thymosin beta-4 trials, the IV study in healthy volunteers reported infrequent, mild or moderate adverse events and no serious ones, while the neurotrophic keratopathy phase 3 full text records 16 adverse events across 7 of 18 subjects, one judged treatment related, including one serious adverse event judged unrelated to treatment. The trials were small and short, and the phase 3 lists authors employed by the developer.
  • The cancer concern comes from overexpression studies of the full protein in cancer cells, not from studies of TB-500; no direct tumour evidence for the fragment was found.
  • USADA confirmed TB-500 was named as an example of a prohibited growth factor on the 2018 list, and the fragment is detectable in testing; the current 2026 wording was not verified here.
  • Every dose figure on this page is a study figure shown as evidence, never a recommendation, and this page does not tell anyone what to take.

Frequently asked questions

What are the side effects of TB-500?+

No human trial of the TB-500 fragment itself surfaced in this research to measure its side effects, so no trial-derived adverse event list for the fragment itself surfaced here. What exists is trials of full thymosin beta-4, the 43 amino acid parent protein, not the 7 residue TB-500 fragment. Those trials did not report a uniform picture. The fullest adverse event record in this research comes from a neurotrophic keratopathy phase 3 of thymosin beta-4 eye drops: its abstract reports no significant adverse effects (PMID 36613994), but its full text records 16 adverse events across 7 of 18 subjects, one of them judged treatment related, including one non-ocular serious adverse event judged unrelated to treatment (full text, PMC9820614). An intravenous study in healthy volunteers reported adverse events as infrequent and mild or moderate, with no dose limiting toxicities and no serious adverse events (PMID 20536472). A dry eye trial reported no adverse events observed (PMID 26056426), the authors of a small severe dry eye trial described the drops as well tolerated (PMID 25826322), and a topical venous ulcer trial reported a safety profile acceptable and comparable to placebo (PMID 20536470). The full trial by trial picture is in the table on this page. These were small, short trials of a different molecule. None of that is a measured safety record for TB-500.

Has TB-500 been tested in humans?+

No human clinical trial of the TB-500 fragment (N-acetylated LKKTETQ) surfaced in this research, which ran a web search and a PubMed search but not a ClinicalTrials.gov registry search for TB-500. The human safety data belongs to full thymosin beta-4, a different and larger molecule, and the TB-500 specific literature that does exist is doping control chemistry, detection of the fragment in horse urine and plasma and laboratory characterization of a product suspected of doping potential (PMID 23084823, PMID 22962027), not human safety testing.

Does TB-500 cause cancer?+

No study fetched for this page tested whether TB-500 causes cancer, so the honest answer is that it is unknown. The concern comes from cell studies of the full thymosin beta-4 protein: overexpressing it inside colon cancer cells increased their resistance to apoptosis (PMID 16364925), induced an epithelial mesenchymal transition in colorectal carcinoma (PMID 17072345), and increased cancer cell migration and metastasis (PMID 21621326). Those are overexpression experiments in cancer cells, not studies of the TB-500 fragment, and no direct evidence that the fragment promotes tumours in animals was found in this research.

Is TB-500 banned in sport?+

USADA documented TB-500 as an example of a prohibited growth factor in the 2018 list. According to USADA, in its summary of the 2018 Prohibited List dated October 2, 2017, thymosin-beta4 and its derivatives, for example TB-500, were added as examples of prohibited growth factors under section S2.3. The fragment is also detectable: a doping control method confirmed it at 0.02 ng/mL in equine plasma and 0.01 ng/mL in equine urine (doping-control detection, horses, PMID 23084823). We could not verify the current 2026 Prohibited List wording, so this page reports only the confirmed 2018 addition.

Is TB-500 safe?+

No source on this page establishes that. There is no human trial of the fragment in this research. The nearest human data is a handful of small, short trials of full thymosin beta-4, a different molecule, ranging from no adverse events observed in one dry eye trial to 16 adverse events across 7 of 18 subjects, one judged treatment related, in a neurotrophic keratopathy phase 3 (full text, PMC9820614). Absence of reported harm in those studies is not the same as a demonstrated safety record for TB-500, and this page does not tell anyone what to take.

Every study figure on this page traces to one of these sources, fetched on 2026-09-30. Numbers match the citation markers in the text.

Sources

  1. 1.PMID 20536472. 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;1194:223-9.
  2. 2.PMID 26056426. Sosne G, Ousler GW. Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial. Clin Ophthalmol. 2015;9:877-84.
  3. 3.PMID 25826322. Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015;34(5):491-6. Registry NCT01393132.
  4. 4.PMID 36613994. Sosne G et al. 0.1% RGN-259 (Thymosin beta4) Ophthalmic Solution in Neurotrophic Keratopathy, a randomized, placebo-controlled, double-masked Phase III trial. Int J Mol Sci. 2022;24(1):554. Authors include employees of the developer, ReGenTree, LLC.
  5. 5.PMID 20536470. Guarnera G, DeRosa A, Camerini R. The effect of thymosin treatment of venous ulcers. Ann N Y Acad Sci. 2010;1194:207-12. Describes thymosin beta 4 as a synthetic copy of the naturally occurring 43 amino acid peptide.
  6. 6.PMID 23084823. Ho EN et al. Doping control analysis of TB-500, a synthetic version of an active region of thymosin beta4, in equine urine and plasma by LC-MS. J Chromatogr A. 2012;1265:57-69.
  7. 7.PMID 22962027. Esposito S et al. Synthesis and characterization of the N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500, a product suspected to possess doping potential. Drug Test Anal. 2012;4(9):733-8.
  8. 8.PMID 16364925. Hsiao HL et al. Overexpression of thymosin beta-4 renders SW480 colon carcinoma cells more resistant to apoptosis. Carcinogenesis. 2006;27(5):936-44.
  9. 9.PMID 17072345. Huang HC et al. Thymosin beta4 triggers an epithelial-mesenchymal transition in colorectal carcinoma by upregulating integrin-linked kinase. Oncogene. 2007;26(19):2781-90.
  10. 10.PMID 21621326. Tang MC et al. Thymosin beta 4 induces colon cancer cell migration and clinical metastasis via enhancing ILK/IQGAP1/Rac1 signal transduction. Cancer Lett. 2011;308(2):162-71.
  11. 11.ClinicalTrials.gov NCT00743769. A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers, sponsor RegeneRx Biopharmaceuticals. Overall status: withdrawn. Could not be matched to the published Ruff study.
  12. 12.USADA. 2018 Prohibited List: Summary of Major Changes, page dated October 2, 2017. States thymosin-beta4 and its derivatives, e.g. TB-500, were added as examples of prohibited growth factors under S2.3.
  13. 13.PMC9820614, full text of PMID 36613994. Sosne G et al. 0.1% RGN-259 (Thymosin beta4) Ophthalmic Solution in Neurotrophic Keratopathy, Phase III. The abstract reports only that no significant adverse effects were observed; the full text records sixteen adverse events across seven of 18 subjects, one of them judged treatment related, and one unrelated non-ocular serious adverse event.

Related reading

This guide is for educational purposes only and is not medical advice. It describes what published research and a doping authority record say; it is not a dose or an instruction to use any compound. TB-500 emerged as a veterinary preparation for which no human trial of the fragment surfaced in this research. Consult a qualified healthcare professional before making any decision about your health.