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Peptide data sheet

Thymosin Beta-4

Recovery · Timbetasin · TB4

Verdict

unproven

tested in humans, benefit not demonstrated

By MrPepTalks Editorial

Reviewed for scientific accuracy · research information, not medical advice

Last updated Reviewed

Quick answer

Thymosin beta-4 is a 43-amino-acid protein that human cells make for themselves. It binds and sequesters actin monomers, which inhibits actin polymerisation, and that is why laboratories have studied it in wound, cornea and heart models. It is not the same molecule as TB-500, the seven-residue fragment sold under that name. Thymosin beta-4 itself has been through placebo-controlled human trials, including a 601-participant Phase 3 in dry eye. On the results those trials posted, it mostly did not separate from placebo. It is not approved by the FDA, and it is named on the WADA Prohibited List.

At a glance
Class
Actin-sequestering peptide (thymosin beta family)
Half-life
Not established in the published human data we could verify
FDA status
Not approved by the FDA; investigational in sponsor-run trials, and sold online for laboratory research use only
WADA banned?
Yes

Which form actually works?

Eye drops (investigational, RGN-259)

Unproven

The most heavily tested route. ReGenTree ran three late-stage dry-eye studies with a preservative-free thymosin beta-4 eye drop: ARISE-1 (Phase 2/3, 317 people), ARISE-2 (Phase 3, 601) and ARISE-3 (Phase 3, 700). ARISE-2 posted its results, and neither co-primary endpoint favoured the active drop. ARISE-3 finished in October 2021 and has no results posted on the registry.

Topical gel (investigational, wound studies)

Unproven

RegeneRx ran placebo-controlled Phase 2 gel studies in pressure ulcers, venous stasis ulcers and epidermolysis bullosa. In both ulcer studies the fraction of participants whose wound had closed by day 84 was no higher in the peptide arms than in the placebo arms. The epidermolysis bullosa study stopped early.

Injectable research vials sold online

Risky

We could find no approved injectable product in any market. RegeneRx registered an intravenous Phase 1 in healthy volunteers and an injectable Phase 2 in heart-attack patients, and withdrew both without enrolling a single person. What ships from research-chemical sites is unverified material, and the label on the vial is usually TB-500 rather than the full protein.

Third-Party Testing & Certificate of Analysis (COA)

A certificate of analysis (COA) is a lab document that reports what a specific batch of material actually contains. Reputable research suppliers publish one for every batch, tied to a lot number you can match against the vial you received.

HPLC — purity
High-performance liquid chromatography reports purity as a percentage: how much of the sample is the intended compound rather than impurities.
Mass spectrometry (MS) — identity
Mass spectrometry confirms identity by measuring the sample's molecular mass, so it matches the peptide the label names.

It also matters who ran the test. In-house results come from the seller's own lab; an independent third-party lab has no stake in the result, so its COA generally carries more weight. Look for a named testing laboratory, a batch or lot number, and a test date that lines up with the vial in hand.

New to reading one? This guide walks through a COA line by line: how to read a peptide COA.

Sources

  1. UniProt P62328 (TYB4_HUMAN), thymosin beta-4, gene TMSB4X: 44-residue sequence with the initiator methionine removed, mature chain 2-44, N-acetylserine at position 2, AcSDKP peptide at residues 2-5, and the function statement that it binds and sequesters actin monomers and inhibits actin polymerisation.
  2. PubChem CID 16132341, Timbetasin (thymosin beta-4): molecular formula C212H350N56O78S, molecular weight 4963, InChIKey, CAS 77591-33-4, UNII 2D5MRE3SSY, and the 43-residue acetylated sequence.
  3. Esposito S, Deventer K, Goeman J, Van der Eycken J, Van Eenoo P. 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. Identifies Ac-LKKTETQ in a commercial TB-500 formulation. PMID 22962027.
  4. FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2), content current as of 22 April 2026. Lists Thymosin beta-4, fragment (LKKTETQ), also known as TB-500, and states FDA has not identified human exposure data for products containing it.
  5. WADA 2026 Prohibited List, in force 1 January 2026. Section S2.3 growth factors and growth factor modulators names thymosin beta-4 and its derivatives, with TB-500 given as the example; the whole S2 class is prohibited at all times and is non-Specified.
  6. NCT00382174. RegeneRx Biopharmaceuticals. Randomized, double-blind, placebo-controlled dose-response Phase 2 study of thymosin beta 4 in pressure ulcers. Completed December 2008, 72 participants. Posted results: wound closure at day 84 in 3 of 18 on placebo and 8 of 54 across three peptide dose groups.
  7. NCT00832091. RegeneRx Biopharmaceuticals with sigma-tau i.f.r. S.p.A. Randomized, double-blind, placebo-controlled dose-response Phase 2 study of thymosin beta 4 in venous stasis ulcers. Completed January 2009, 72 participants. Posted results: wound closure without drainage at day 84 in 4 of 17 on placebo and 12 of 55 across three peptide dose groups.
  8. NCT00311766. RegeneRx Biopharmaceuticals. Phase 2 study of thymosin beta 4 in epidermolysis bullosa, funding source the FDA Office of Orphan Product Development. Terminated for lack of patient availability and expiration of study drug, 30 participants. Posted results: wounds healed at 56 days in 5 of 8 on placebo and 8 of 22 on the peptide.
  9. NCT02597803 (ARISE-1). ReGenTree, LLC. Phase 2/3 study of RGN-259 ophthalmic solution in dry eye. Completed July 2016, 317 participants; no results posted to the registry.
  10. NCT02974907 (ARISE-2). ReGenTree, LLC. Phase 3, multi-centre, randomized, double-masked, placebo-controlled study of RGN-259 ophthalmic solution, a preservative-free eye drop containing thymosin beta 4, in dry eye. Completed March 2018, 601 participants. Posted co-primary results at day 29 and adverse-event counts.
  11. NCT03937882 (ARISE-3). ReGenTree, LLC. Phase 3 study of RGN-259 ophthalmic solution in dry eye. Completed 7 October 2021, 700 participants; no results posted to the registry as of this record.
  12. NCT05555589 (SEER-2). ReGenTree, LLC. Phase 3 study of 0.1 percent RGN-259 ophthalmic solution in neurotrophic keratopathy; listed as recruiting, estimated 70 participants.
  13. NCT00743769. RegeneRx Biopharmaceuticals. Phase 1 intravenous thymosin beta 4 safety and pharmacokinetic study in healthy volunteers. Withdrawn with zero enrolment; reason given: study never initiated due to contract manufacturing issues.
  14. NCT01311518. RegeneRx Biopharmaceuticals. Phase 2 study of RGN-352, injectable thymosin beta 4, in acute ST elevation myocardial infarction. Withdrawn with zero enrolment; reason given: trial never initiated.
  15. Beijing Northland Biotech. Co., Ltd. thymosin beta 4 (NL005) programme: NCT04555824 and NCT04555850, completed Phase 1 studies in healthy volunteers (54 and 30 participants); NCT05485818 and NCT05984134, completed Phase 2 studies in acute myocardial infarction (62 and 90 participants). No results posted to the registry for any of the four.
  16. Narrative review. Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians. Am J Sports Med. 2026. States that TB-4 and its derivative TB-500 promoted angiogenesis and tissue repair in preclinical models, that human orthopaedic data are lacking, and that both remain banned substances in sports. PMID 41476424.
  17. Narrative review. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. Treats Tb4 (thymosin beta-4) and TB-500 (thymosin beta-4 fragment) as separate entries and notes that rigorous human safety data are scarce across the gray market. PMID 41966639.
  18. PubMed record counts run for this sheet on 26 July 2026: the exact string TB-500 returns 16 records, thymosin beta 4 returns 1,031.

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