Compound reference

TB-500 Dosage Guide 2026: The Research vs Reported Use

By the Decadewise team Education only Last updated 3 August 2026 12 cited sources

Short answer

Seven amino acids out of forty-three: TB-500 is a synthetic fragment of thymosin beta-4, the full repair peptide. A vial labeled TB-500 holds the fragment, not the parent.

Every human dose on record belongs to the parent: thymosin beta-4 itself, at 42 to 1,260 mg intravenous in healthy volunteers (Ruff, 2010), and as 0.1% eye drops in the dry eye trials.

The strongest single result: in severe dry eye, 0.1% drops cut ocular discomfort 35.1% versus vehicle at day 56 (Sosne, Cornea 2015).

No published trial has put the fragment into a person: none in PubMed or Europe PMC on 29 July 2026. The one ClinicalTrials.gov record naming it is a fictional example.

Milligrams a week, against a barrel marked in units: the protocols posted online run 2 to 6 mg a week.

In the FDA record: no approved product, and a compounding file. The agency proposed against the 503A list on 23 July 2026, and its advisory committee voted the other way, 8 to 6.

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On this page

Community reports, not a protocol

What do people report running?

Where these figures were collected from: dosage guides, forum threads, and the schedule pages that rank for this query. They sit here so they can be read next to the research record above, not as a protocol.

The posted pattern: a loading phase of 4 to 6 mg a week, split into two injections, for 4 to 6 weeks.

Then maintenance: 2 to 2.5 mg a week, sometimes stretched to one injection every two weeks.

How the threads describe injecting it: subcutaneous in the ones we read, intramuscular in a few. They are written around the 5mg vial, with 2mg and 10mg vials sold beside it.

The compound it gets paired with: the injury threads we read run TB-500 alongside BPC-157, the two treated as one repair block rather than two decisions.

Where the numbers come from: not from any published trial we could find, on the literature searches set out further down. Nothing published names a schedule for the fragment, so these figures circulate forum to forum and guide to guide.

The label they get given: the guides present these as research protocols. There is no research behind them, and they deserve to be labeled as what they are: reported use.

Peer-reviewed trial data

What does the research show?

The identity first: TB-500 is the acetylated seven-amino-acid fragment Ac-LKKTETQ, derived from the active site of thymosin beta-4 (Rahaman et al., J Chromatogr B, 2024).

And that same paper says the fragment's effects are undocumented: it states the biological effects of TB-500 have not been established. In its own assays, only the metabolite Ac-LKKTE showed significant wound healing activity, not the parent fragment.

So every human dose on record belongs to somebody else's molecule: the six studies below all dosed thymosin beta-4 itself, in hospitals and clinics, and none of them dosed the fragment.

StudyWhat was dosedPeopleWhat happened
Ruff 2010thymosin beta-4, IV, 42 to 1,260 mg, then daily for 14 days40 healthy volunteersno serious adverse events, no dose-limiting toxicity
Treadwell 2012thymosin beta-4, two phase 2 wound trialsstasis and pressure ulcer patientshealing about a month faster in those who healed
Sosne & Ousler 20150.1% eye drops, 28 days72 with dry eyeprimary endpoints missed; discomfort down 27% at day 28; abstract reports no adverse events, full paper records an ocular event in 2 of 36 active and 5 of 36 placebo
Sosne, Dunn & Kim 20150.1% eye drops, six times daily, 28 days9 with severe dry eyediscomfort down 35.1% and staining down 59.1% at day 56
Wang 2021recombinant thymosin beta-4, IV, seven single-dose cohorts from 0.05 to 25 mcg/kg, then 0.5, 2.0 or 5.0 mcg/kg daily for 10 days54 healthy volunteers, then 30 moreevents mild to moderate, no dose-limiting toxicity, no serious adverse events
Zhang 2025recombinant thymosin beta-4 after STEMI96 patientsearly-treated subgroup improved at 90 days; overall not significant
Every row dosed thymosin beta-4, the parent molecule. None dosed the TB-500 fragment.

The safety study: Ruff et al. (Annals of the New York Academy of Sciences, 2010) ran four cohorts of ten healthy volunteers at 42, 140, 420, or 1,260 mg intravenous, single dose and then daily for 14 days.

What that cohort reported: adverse events infrequent and mild or moderate, with no dose-limiting toxicities and no serious adverse events.

The wound trials: Treadwell et al. (same journal, 2012) reviewed the dermal healing work, including two phase 2 trials in stasis and pressure ulcers. In the patients who did heal, healing came almost a month faster.

The larger eye trial: Sosne and Ousler (Clinical Ophthalmology, 2015) randomized 72 subjects to 0.1% drops or placebo for 28 days. Both primary endpoints missed significance; secondary endpoints improved, with discomfort down 27% on day 28. Its abstract reports no adverse events. The full paper's treatment-emergent section does not: 2 of 36 on the active drop and 5 of 36 on vehicle had at least one ocular event, and one further subject left the study with vomiting the investigators judged unrelated to treatment.

The smaller eye trial: Sosne, Dunn and Kim (Cornea, 2015) treated nine patients with severe dry eye, twelve eyes on the 0.1% drops and six on vehicle, dosed six times daily. At day 56, ocular discomfort was down 35.1% and corneal staining down 59.1% versus vehicle.

The first-in-human study of the recombinant protein: Wang et al. (Journal of Cellular and Molecular Medicine, 2021) gave 54 healthy volunteers a single intravenous dose of recombinant human thymosin beta-4 or placebo, across seven ascending cohorts from 0.05 to 25 mcg/kg, then ran a second stage in 30 more at 0.5, 2.0 or 5.0 mcg/kg daily for 10 days. Events were mild to moderate, with no dose-limiting toxicities and no serious adverse events.

The cardiac trial: Zhang et al. (Cardiovascular Research, 2025) randomized 96 heart attack patients after stenting. The subgroup dosed within 8 hours, 43 patients, showed smaller infarcted areas at 90 days; across all 96, the difference was not significant.

Why none of it adds up to a TB-500 figure: a different molecule, given by different routes, for different conditions. Nothing published exists on the fragment's side to add them to.

What our own search returned, with the queries so it can be rerun: PubMed, searched for TB-500 across all fields on 29 July 2026, returns 16 records, and not one is a clinical trial: they are doping-control assay methods, in vitro and rat metabolism work, reviews, and one paper matched on an unrelated abbreviation. Europe PMC, searched the same day for the quoted phrase "TB-500", returns 99 records including preprints. Narrowing that same query with Europe PMC's own publication-type filters, Clinical Trial and Randomized Controlled Trial, returns three records between them: a 2020 paper on tuberculosis incidence in respiratory patients, a 2020 plant-extract trial, and a 2025 cocoa-powder trial. None of the three is about the fragment. FDA reached the same place independently in its July 2026 briefing document, stating that it did not identify data, such as clinical studies, on the use of TB-500 in humans, by any route.

What that does and does not establish: it is a statement about two databases, two query strings and one date, not about the whole world. An earlier version of this page reported 92 Europe PMC records without printing the query behind them, and we could not reproduce that figure on 29 July 2026, so it has been replaced by a count we ran and can show. What holds is narrow and checkable: on those queries, on that date, no clinical trial of the seven-residue fragment appears.

What the record does NOT contain: corrected 29 July 2026, an earlier version of this page reported NCT07487363 as a recruiting phase 1/2 study of the fragment. That registry entry is explicitly a specimen. ClinicalTrials.gov's own brief summary for it begins "This fictional study is an example of a ClinicalTrials.gov-style record", and its sponsor, dates, enrollment and arms are part of that example. We re-pulled that record on 30 July 2026, HTTP 200, and the fictional-example line is still the first line of its summary, with the record still marked recruiting, which is why a status field alone settles nothing. We also searched the registry the same day on three terms: thymosin beta 4 returns 18 studies, TB-500 returns 1, and the seven-residue sequence LKKTETQ returns 0. The single record the second query returns is NCT07487363 itself. So the claim is withdrawn, and what stands in its place is narrower: on those three queries, on that date, the only registered trial naming the fragment is the specimen.

35.1%

ocular discomfort down at day 56 vs vehicle, severe dry eye trial, parent molecule

59.1%

corneal staining down at day 56, same trial

1,260mg

top intravenous dose tested in healthy volunteers, thymosin beta-4

0

published human trials of the TB-500 fragment itself, PubMed and Europe PMC, 29 July 2026

0

genuine registered trials of the fragment; the single ClinicalTrials.gov record naming it is one the registry labels a fictional example, re-pulled 30 July 2026

Sosne, Dunn & Kim, Cornea 2015; Ruff et al., Ann N Y Acad Sci 2010; fragment gap: Rahaman et al., J Chromatogr B 2024, our own PubMed and Europe PMC searches of 29 July 2026, our own ClinicalTrials.gov searches of 30 July 2026, and FDA's July 2026 briefing document; Wang et al., J Cell Mol Med 2021.

Is the research dose the same as the posted dose?

The dodge, which on this compound is the whole subject: most pages either skip the question or post a schedule with nothing behind it. Here the gap is not a detail of the answer, it is the answer.

What the research dosed

The molecule that was dosed: thymosin beta-4, the parent, in hospitals and clinics. Intravenous doses up to 1,260 mg in healthy volunteers, 0.1% eye drops in dry eye, recombinant protein after heart attacks.

The purpose: safety, wound, eye, and cardiac studies. None was a dose-ranging study of TB-500 for recovery.

What the posts show

The molecule that gets injected: the fragment, at home, 2 to 6 mg a week, subcutaneous, on a loading-then-maintenance pattern the guides copy from each other.

What stands behind it: no trial, no published protocol, no dose-ranging study. The two columns share a name and very little else.

1,260mg intravenously in a hospital and 2 to 6mg a week under the skin at home are not the same experiment scaled down.

What the left-hand column is actually evidence about: thymosin beta-4, given by routes and at amounts nobody in the right-hand column is using. Borrowing it for the fragment requires the assumption that a piece of a protein behaves like the protein, and no study in the reference list below tests that assumption.

How does the units math work on a 5mg or 10mg vial?

General arithmetic, no dose attached: the numbers below belong to a vial and a water volume, not to a person.

The 10mg vial, mixed with 2mL: a 10mg vial reconstituted with 2mL of bacteriostatic water holds 5mg per mL, which is the same thing as 5,000mcg per mL.

Against the barrel: a U-100 is marked 100 units to the milliliter, which makes one unit 0.01mL, holding 50mcg, or 0.05mg, in this mix. 2mg lands on 40 units, and 5mg fills the barrel at 100.

The same vial in 1mL instead of 2mL: half the water, so the concentration doubles, to 10mg per mL.

The per-unit value doubles with it: a unit carries 0.1mg where it carried 0.05mg. The same 2mg is now 20 units, not 40.

Down to the 5mg vial: 5mg in 2mL is 2.5mg per mL, each unit is worth 25mcg, and the same 2mg reads as 80 units.

Reversed, a bare "40 units" stops being a quantity at all: on the first mix those 40 units hold 2mg, on the second they hold 4mg, and the barrel reads identically both times.

Three TB-500 vial setups, worked out on a U-100 syringe
Vial plus waterConcentration1 unit equalsWhat the article works out
10mg + 2mL5mg per mL (5,000mcg per mL)0.05mg (50mcg)2mg is 40 units, 5mg is 100 units
10mg + 1mL10mg per mL0.1mg2mg is 20 units, not 40
5mg + 2mL2.5mg per mL0.025mg (25mcg)2mg is 80 units
Syringe scale, before any concentration math
SyringeUnits per mL1 unit equals
U-100100 units per mL0.01mL
U-4040 units per mL0.025mL
0.025mL against 0.01mL, a ratio of 2.5 fixed by the printing on the barrel and independent of the vial it draws from.

What the three-row table cannot show, because every row is the same row in one respect: all three assume a U-100 barrel. Swap that for a U-40 and each unit carries 0.025mL where it carried 0.01mL, so a third variable is sitting underneath the table without a column of its own, and the barrel prints the same "40 units" either way.

How many units is 2mg of TB-500?

Three mixes, three readings: at 5mg per mL, a 10mg vial plus 2mL of water, 2mg reads as 40 units on a U-100 syringe. At 10mg per mL, the same vial plus 1mL, it reads 20 units. At 2.5mg per mL, a 5mg vial plus 2mL, it reads 80 units.

None of those three is more correct than the others: they are three arithmetically identical statements about three different liquids that happen to share a vial label. Our dose math index is organized around exactly that point.

What's not known yet?

A compounding file, not an approval file: that is where TB-500 appears in the FDA record, and the same is true of thymosin beta-4 itself in everything we could retrieve.

The event that already happened: FDA's compounding advisory committee took up TB-500-related bulk drug substances, free base and acetate, on 23 July 2026, under docket FDA-2025-N-6895, with wound healing as the use the agency evaluated. It is a compounding-access question, not an approval.

How the two sides of that room split: FDA's own briefing document says the nominator supplied no clinical evidence for wound healing, that the agency's search found no data on the use of TB-500 in humans, and that on balance the criteria weigh against adding either form to the 503A list. The committee was then asked whether each form should be placed on the list, and voted yes. The Associated Press and NBC News, reporting from the meeting on 23 July 2026, put the tally at 8 in favor, 6 against and 1 abstention. The committee advises and the agency decides by rulemaking, and as of 29 July 2026 the meeting page publishes an agenda, briefing documents and slides, with no minutes, no vote record and no decision of its own.

What the category list says: TB-500 now sits on FDA's list of bulk drug substances nominated but withdrawn, under the entry "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500". The agency describes that list as substances previously in category 2 of the interim policies that the nominators withdrew. Procedural, not an endorsement, and the page carrying it is current as of 22 April 2026.

For athletes: the WADA 2026 Prohibited List, in effect since 1 January 2026, names thymosin beta-4 and its derivatives, TB-500 among them, under S2.3, growth factors and growth factor modulators. That sits inside class S2, which the list marks prohibited at all times, in and out of competition.

The parent's drug program: RegeneRx Biopharmaceuticals, which developed the thymosin beta-4 eye drop RGN-259, reports in its annual report to the SEC that the three ARISE dry eye trials covered over 1,600 patients and that ARISE-2 and ARISE-3 did not meet their designated co-primary endpoints, alongside an FDA orphan drug designation for RGN-259 in neurotrophic keratitis. Company-reported, and a designation is a development incentive, not an approval.

Three absences, and every one of them is about the fragment:

  • No published trial has dosed the TB-500 fragment in humans, on the searches described above, so there is no verified dose, schedule, or duration for it. Nothing registered stands behind it either: the only ClinicalTrials.gov record naming the fragment is the fictional example described above.
  • No verified safety data for injected TB-500; every adverse-event number on this page belongs to the parent molecule, and FDA's adverse event system returned no TB-500 reports at all, which it says does not imply safety.
  • No controlled study of the community loading and maintenance patterns that dominate online discussion.

No dataset closes those three, so no page can cite one.

And one more, upstream of all three: the vial is sold as a seven-amino-acid fragment, and its own label is the only thing that says so.

Taken on faith, every time: that it is the fragment and not the parent, that it is pure, that it is sterile, and that the strength on the label is the strength in the vial.

Which puts the first question on the supply chain, not on the dose: whether the vial holds what its label claims comes before any unit count, and that is where our own worry starts.

How this page is sourced

Papers, filings and regulator records, read directly: every trial figure above came off the cited paper itself, with reviews named as reviews, and the pipeline status came off the sponsor's own annual report filed with the SEC, printed below with its filing date.

Twelve sources, three of them regulatory: seven papers with their DOIs and PubMed IDs, two FDA compounding records, the current WADA Prohibited List, the sponsor's SEC filing, and one entry for the news reporting of the committee vote. Each is listed below with its identifier, and every figure on this page traces back to one of them.

The regulatory lines: the FDA, compounding, and WADA status lines were re-pulled on 29 July 2026 and carry a 90-day re-verify date. They move fast.

How the absence claim on this page was tested, because an absence claim needs testing: saying nothing has been published is a statement about the whole literature, so on 29 July 2026 we ran it ourselves rather than inheriting it, and the query strings are printed on the page so a reader can rerun them. PubMed returned 16 records for TB-500 across all fields. Europe PMC returned 99 for the quoted phrase "TB-500", and its Clinical Trial and Randomized Controlled Trial filters on that query returned three records between them, none about the fragment. FDA reports the same absence independently. ClinicalTrials.gov was searched separately on 30 July 2026 on three terms, thymosin beta 4, TB-500 and LKKTETQ, returning 18 studies, 1 and 0: the single record the middle query returns is the fictional specimen described above. That is the claim's exact scope: those databases, those queries, those dates, and a regulator's search alongside them. It is not a claim that no such trial exists anywhere.

What changed on 29 July 2026: registry record NCT07487363 was removed, because ClinicalTrials.gov states that record is a fictional example and an earlier version of this page reported it as a real recruiting study; the first-in-human recombinant thymosin beta 4 trial that had been missing from the page was added in its place; the flat "not one trial, at any dose, by any route" was replaced by the searches that support it; and the Europe PMC count was re-run and re-stated with its query. The July committee vote was added alongside the meeting record, which still publishes no result of its own.

What changed on 30 July 2026: that repair had left three sentences elsewhere on the page still pointing at the deleted registry record, describing one study as recruiting and unreported, and all three now say what the registry actually holds. The first-in-human trial added in its place carried an author list belonging to no paper we could find, so the entry was rebuilt from the PubMed and Crossref records for its DOI and the trial is now worked through in the research section and shown in the table like every other study. The dry eye trial's adverse-event line moved from "in both arms" to the counts the full paper prints.

How a citation gets checked before it ships: the full standard sits on the methodology page. Any correction to any number here lands there first.

Last reviewed: 19 July 2026.

  1. 1

    Ruff D, Crockford D, Girardi G, Zhang Y. 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. doi:10.1111/j.1749-6632.2010.05474.x. PMID 20536472.

  2. 2

    Treadwell T, Kleinman HK, Crockford D, Hardy MA, Guarnera GT, Goldstein AL. The regenerative peptide thymosin β4 accelerates the rate of dermal healing in preclinical animal models and in patients. Ann N Y Acad Sci. 2012;1270:37-44. doi:10.1111/j.1749-6632.2012.06717.x. PMID 23050815.

  3. 3

    Sosne G, Ousler GW. Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model. Clin Ophthalmol. 2015;9:877-84. doi:10.2147/OPTH.S80954. PMID 26056426. The adverse-event figures on this page come from the full text, not the abstract, and the two disagree, so the route is recorded here: the article is open access as PMC4445951, and on 31 July 2026 the PMC web page returned a reCAPTCHA challenge under an HTTP 200 while the NCBI E-utilities endpoint efetch.fcgi?db=pmc&id=4445951&retmode=xml returned the full article XML, 81,011 bytes. Read there, the results section states that the total number of subjects with at least one ocular treatment-emergent adverse event was two, 5.6 percent, in the 0.1 percent thymosin beta 4 group and five, 13.9 percent, in the placebo group, of 36 subjects assigned to each; and that one subject was withdrawn for moderately severe vomiting suspected to be unrelated to the study treatment. The abstract says no adverse events were observed.

  4. 4

    Sosne G, Dunn SP, Kim C. Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015;34(5):491-6. doi:10.1097/ICO.0000000000000379. PMID 25826322.

  5. 5

    Zhang Y, Dong Q, Bian X, et al. Recombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion. Cardiovasc Res. 2025;121(17):2747-2758. doi:10.1093/cvr/cvaf223. PMID 41229390.

  6. 6

    Rahaman KA, Muresan AR, Min H, et al. Simultaneous quantification of TB-500 and its metabolites in in-vitro experiments and rats by UHPLC-Q-Exactive orbitrap MS/MS and their screening by wound healing activities in-vitro. J Chromatogr B Analyt Technol Biomed Life Sci. 2024;1235:124033. doi:10.1016/j.jchromb.2024.124033. PMID 38382158.

  7. 7

    U.S. Food and Drug Administration. July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee: meeting notice and agenda listing TB-500-related bulk drug substances (TB-500 free base and TB-500 acetate) with wound healing as the use evaluated. Docket FDA-2025-N-6895; page content current 22 July 2026. Retrieved 29 July 2026, HTTP 200. Meeting page, FDA briefing document, TB-500, FDA presentations, 23 July 2026.

  8. 8

    U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, including the table headed "Bulk drug substances nominated but withdrawn", entry "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500". Content current as of 22 April 2026. Retrieved 29 July 2026, HTTP 200. fda.gov, category 2 and withdrawn nominations.

  9. 9

    World Anti-Doping Agency. World Anti-Doping Code International Standard, Prohibited List 2026, in effect 1 January 2026. Section S2, peptide hormones, growth factors, related substances and mimetics, marked prohibited at all times, in and out of competition; subsection S2.3, growth factors and growth factor modulators, names thymosin beta-4 and its derivatives, giving TB-500 as the example. Retrieved 29 July 2026, HTTP 200. Re-checked 31 July 2026: an automated request returned HTTP 202 with an empty body, which is a bot challenge rather than a missing document, so this source could not be re-retrieved by script on that date. Prohibited List 2026 (PDF).

  10. 10

    Wang X, Liu L, Qi L, et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin beta 4 in healthy Chinese volunteers. J Cell Mol Med. 2021;25(17):8222-8228. doi:10.1111/jcmm.16693. PMID 34346165. Correction, 30 July 2026: an earlier version of this entry printed an author list, a truncated title and no pagination, and the author list belonged to no paper we could find. All three were replaced against the PubMed esummary and the Crossref record for this DOI, both HTTP 200 the same day, which agree with each other. This entry replaced a reference to registry record NCT07487363 on 29 July 2026: ClinicalTrials.gov states that record is a fictional example, and an earlier version of this page reported it as a real recruiting study.

  11. 11

    News reporting of the committee vote, not an FDA record. Perrone M. FDA reviews BPC-157, TB-500 and other peptides favored by RFK Jr. Associated Press, 23 July 2026. apnews.com. NBC News, 23 July 2026, giving 8 yes, 6 no and 1 abstention for BPC-157, KPV and TB-500. nbcnews.com. Both retrieved 29 July 2026, HTTP 200. The voting questions are in FDA's own meeting questions document, HTTP 200 the same day.

  12. 12

    RegeneRx Biopharmaceuticals, Inc. Annual report on Form 10-K for the fiscal year ended 31 December 2022, filed 11 April 2023 (CIK 0000707511), business section on RGN-259: the ARISE-1, ARISE-2 and ARISE-3 dry eye trials, "over 1,600 patients", the co-primary endpoint results, and the FDA orphan drug designation in neurotrophic keratitis. Retrieved from SEC EDGAR 29 July 2026, HTTP 200. SEC EDGAR, Form 10-K.

The disclaimer

Every page is reviewed by medical professionals before it ships, and written with longtime biohackers who were doing this before it was a trend. Reviewed still does not mean prescribed: nothing here is medical advice.

It is research, trial data, and reported use, with the numbers intact so you can check them. For decisions about your body, see a doctor who can look at your labs.

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