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Thymosin Beta-4: A Real Clinical Programme, For Eyes and Hearts

Thymosin beta-4 is a 43-amino-acid protein with a genuine registered clinical programme — 18 trials, three of them phase 3. None of them studies the injury it is sold to heal.

43-amino-acid protein — the parent molecule of TB-500Not approved anywhere18 registered trials, 3 of them phase 3

Caroline S · Published 2026-09-16

Length

43 amino acids

Sequence

SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES — the product of the human gene TMSB4X. The seven residues at positions 17 to 23, LKKTETQ, are the region reproduced synthetically and sold as TB-500.

Origin

A naturally occurring intracellular protein found in most human cell types, where its main established job is binding G-actin and holding it in reserve for cytoskeletal assembly. It was not designed; it was discovered, and the marketed compounds came afterwards.

Last reviewed

2026-09-16

What is it good for?

It is sold, almost always under the name TB-500, for tendon, ligament and muscle injury and general recovery. What it is actually being developed for by the companies running trials is dry eye disease and damage to heart muscle after a heart attack — two indications with no overlap with the marketing.

Illustration: An empty, clear ophthalmic dropper bottle with a copper cap on a white surface.
Illustration

Thymosin beta-4 is the molecule behind a name most people meet second-hand. Almost everything sold on the peptide market under the healing-and-recovery heading is labelled TB-500, and TB-500 is a seven-amino-acid fragment of this 43-amino-acid protein. The parent protein is the subject of this entry, and it turns out to have something most compounds in this library do not: a real, registered, multi-phase clinical programme.

That programme is for eyes and for hearts. It is not for injuries.

What it is

Thymosin beta-4 is not a drug that someone designed. It is a protein the body already makes, encoded by the gene TMSB4X, present in most human cell types. Its best-established job inside a cell is unglamorous and specific: it binds monomeric actin — G-actin, the free-floating form — and holds it in reserve, so the cell has a pool to draw on when it needs to build or rebuild its internal scaffolding. A molecule that manages the actin supply is a plausible starting point for a story about wound repair and cell migration, and that is the story the market tells about it.

At 43 amino acids it sits exactly on the fuzzy line between a peptide and a protein, and the literature calls it both. What a peptide actually is covers why that line is a convention rather than a rule.

The registered record, counted

On 2026-09-16, ClinicalTrials.gov held 18 interventional studies naming thymosin beta-4, enrolling 2,460 participants in total. For a compound in this library that is a large number — most entries here report zero.

Sorting those 18 by what they were studying is the whole finding:

What the trials studied Condition entries Highest phase
Eye surface — dry eye disease, neurotrophic keratopathy 7 Phase 3 (three studies)
Heart — acute myocardial infarction, ischemia, STEMI 6 Phase 2
Skin wounds — pressure ulcers, venous stasis ulcers 2 Phase 2
Blood vessels — atherosclerotic disease, endothelial dysfunction 2 Phase 1/2
Healthy volunteers (safety and pharmacokinetics) 2 Phase 1
Tendon, ligament, muscle or sports injury 0

Every one of the three phase 3 studies is an eye drop: RGN-259 ophthalmic solution, sponsored by ReGenTree, LLC. The heart studies — sponsored by Beijing Northland Biotech — are phase 2, two of them completed and one not yet recruiting when this entry was written.

The bottom row is the one that matters to anyone who arrived here from a product page. The compound is sold, overwhelmingly, for recovery from tendon and muscle injury. Nobody has registered a trial for that.

Two withdrawn, two terminated

Eighteen registrations is not eighteen completed studies. Two of the records are withdrawn, meaning they never enrolled a participant, and two were terminated before finishing. A registry count measures intent as much as it measures evidence, and reading it as a body of results overstates what is there — a distinction this library applies to every entry that quotes a registry number, including the ones where the number is zero.

Sixteen of the 18 come from three sponsors: ReGenTree (6), RegeneRx Biopharmaceuticals (5) and Beijing Northland Biotech (5). That is a concentrated field. It is not a reason to discount the work, but it does mean the record has not been assembled by many independent groups checking each other.

Published literature

602 PubMed records name thymosin beta-4 in the title or abstract as of 2026-09-16. Of those, 330 carry the human MeSH tag and three carry the randomized-controlled-trial publication type. A large literature with a very small randomized core is the normal shape for a molecule studied first as cell biology and only later as a candidate treatment — most of those 602 papers are about what actin-sequestering proteins do, not about what happens when you give one to a patient.

The fragment, and why the distinction is not pedantry

TB-500 reproduces residues 17 to 23 of this protein — the sequence LKKTETQ, with the front end acetylated — and nothing else. Seven residues out of forty-three.

The reason to insist on the difference is that different regions of this protein do different things. A separate fragment of the same molecule, the four-residue Ac-SDKP, is cut out in the body by an enzyme called prolyl oligopeptidase and acts on inflammation and fibrosis — a genuinely different activity from the region TB-500 copies. So "research on thymosin beta-4" is not automatically research on TB-500, and neither is automatically research on Ac-SDKP. Our entry on TB-500 and what it actually is covers the fragment itself.

One thing did change recently on that side of the ledger. NCT07487363 — a phase 1/2 study of TB-500 itself, described in its own title as the thymosin beta-4 17–23 fragment, looking at cardiovascular biomarkers in stable atherosclerotic disease — was recruiting when this entry was written. It is the first registered trial of the fragment as such, and it is worth noting that it too is a cardiovascular study, not a musculoskeletal one.

Where this leaves a reader

The honest summary is narrow and a little surprising. Thymosin beta-4 has a better clinical record than almost anything else in this library, and that record says nothing about the use it is sold for. Three phase 3 studies exist and they are eye drops. Six heart studies exist and they are phase 2. Zero studies exist for tendons, ligaments and muscles.

An absence in a registry is not proof that something does not work. It is proof that nobody has run the experiment, which is a different and more useful fact — and it is one anyone can check for themselves in a minute. Questions about treatment belong with a clinician, not with a product page or with this one.

What the research shows

Has been given to people in registered clinical trials

18 interventional records on ClinicalTrials.gov, 2,460 participants in total, queried 2026-09-16. Three are phase 3 and all three are eye drops.

Has been tested in phase 3 for an eye-surface disease

Three phase 3 records for RGN-259 ophthalmic solution in dry eye disease and neurotrophic keratopathy, sponsored by ReGenTree

Has been tested after a heart attack

Three phase 2 records in acute myocardial infarction and STEMI, sponsored by Beijing Northland Biotech, two completed and one not yet recruiting

Has been tested for tendon, ligament or muscle injury

No registered trial for any musculoskeletal injury. Zero of the 18 records names a tendon, ligament, muscle or sports-injury condition — this is the use the compound is overwhelmingly sold for

Has been tested in a randomized controlled trial reported in the published literature

3 PubMed records carry the randomized-controlled-trial publication type, against 602 records overall

Bars show how much of the evidence is in humans, not how well anything works.

Where it stands

United States

No approved product. Thymosin beta-4 appears on the FDA's compounding page under nominations that were withdrawn, not on the current Category 2 list. Material sold under the name TB-500 carries a research-use-only label, which is a statement by the seller about intended use and not a finding by any regulator.

Published record

602 PubMed records name thymosin beta-4 in title or abstract as of 2026-09-16. 330 carry the human MeSH tag. 3 carry the randomized-controlled-trial publication type. The separate marketing name TB-500 appears in 31 records.

Trial registry

18 interventional studies on ClinicalTrials.gov, 2,460 participants, queried 2026-09-16. Three sponsors account for sixteen of them: ReGenTree (6), RegeneRx Biopharmaceuticals (5) and Beijing Northland Biotech (5). Two are withdrawn and two terminated.

What the programme is for

Dry eye syndrome and dry eye (6 condition entries), acute myocardial infarction, myocardial ischemia and STEMI (6), neurotrophic keratopathy, pressure ulcers, venous stasis ulcers, atherosclerotic cardiovascular disease and endothelial dysfunction, plus two healthy-volunteer studies. The distribution is the entry's main finding.

Relationship to TB-500

TB-500 is a synthetic seven-residue fragment, Ac-LKKTETQ, corresponding to residues 17–23 of this protein. They are different molecules and the research on one does not transfer automatically to the other.

Frequently asked questions

Is thymosin beta-4 the same thing as TB-500?

No. Thymosin beta-4 is a 43-amino-acid protein that occurs naturally in human cells. TB-500 is a synthetic seven-amino-acid fragment of it, Ac-LKKTETQ, corresponding to residues 17 to 23. Product pages use the two names interchangeably; the literature does not, and the distinction changes what the evidence covers. There are 602 published records for the protein and 31 for the fragment.

Has thymosin beta-4 been given to people?

Yes, in registered clinical trials — 18 of them on ClinicalTrials.gov as of 2026-09-16, with 2,460 participants between them. That is an unusually real clinical record for a compound in this library. What it is not is a record about injury recovery.

What are the trials actually studying?

Two things, and neither is what the compound is sold for. Six condition entries concern the eye surface — dry eye disease and neurotrophic keratopathy — and all three phase 3 studies are in that group, testing RGN-259 eye drops. Another six concern the heart after a heart attack, in phase 2. The rest are pressure ulcers, venous stasis ulcers, endothelial function and healthy-volunteer safety studies.

Is there a trial for tendon or muscle injury?

Not one. Across all 18 registered studies, no condition entry names a tendon, ligament, muscle or sports injury. That absence is checkable in about a minute against the registry, and it sits directly against the marketing, which is almost entirely about recovery from that kind of injury.

Why do eye drops keep coming up?

Because the corneal surface is where a wound-healing protein is easiest to deliver and easiest to measure. An eye drop puts the molecule directly on the tissue being studied, and corneal staining and tear-film measures give an endpoint that can be scored in a clinic. The companies developing thymosin beta-4 went where the trial was tractable, which is a normal development decision and not a comment on any other use.

Does a positive eye-drop result mean it works for an injury?

No, and the step from one to the other is larger than it looks. A different molecule (the fragment rather than the protein), delivered a different way (injection rather than a drop), to a different tissue, for a different endpoint, is a new question that the eye studies do not answer. Anything about a person's own treatment is a question for a clinician.

Who is running the research?

Three companies account for 16 of the 18 registrations: ReGenTree with six, RegeneRx Biopharmaceuticals with five and Beijing Northland Biotech with five. A concentration like that is worth knowing about. It is not a criticism of the work, but it does mean the record has not been built by many independent groups testing each other's results.