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Protocols

TB-500 protocols in the published literature

StatusPreclinical only

PeptideHound Staff · Last editorially reviewed · 18 sources

No study among the research behind this page has administered a measured amount of TB-500 to a person, and that has to be settled before any figure attached to the name can be read. The amounts in the literature were given as thymosin β4, the full protein, not the fragment named TB-500.

A 2026 sports medicine review lists the two as separate entries, naming one TB-500 (thymosin beta-4 fragment), and the clinical trial registry files the fragment under Thymosin Beta 4 17-23 Fragment. The animal protocols are specific, and they are large. Pregnant mice were weighed and treated with an intraperitoneal injection of TB4 at 6 mg/kg in PBS, meaning into the abdominal cavity, on two days of gestation. A 2023 Alzheimer's model gave Tβ4 (5 mg/kg, i.v.) immediately after a challenge, again at two and four hours, and then once daily for 6 days. Those are milligrams per kilogram of mouse, which is a different order of magnitude from the microgram figures common elsewhere in this category.

The human record carries schedules and almost no published amounts. Nine patients with non-healing corneal defects were treated with thymosin beta 4 (Tbeta4) sterile eye drops for 28 or 49 days. In a randomised trial in 96 heart-attack patients, the dosing detail reported is timing rather than quantity: the treated group received the first dose of rhTB4 within 8 h after PCI. A 2026 scoping review covering TB-500 found that significant heterogeneity existed in dosing and route of administration.

Nothing sold as TB-500 is an approved medicine, so no vial of it carries a labelled amount. FDA records hold four Class II recalls of compounded thymosin beta-4 injections — 15 mg presentations, a 2000 MCG/ML 5 ML vial, and one combined presentation — every one of them for sterility assurance.

Evidence: Not dosing guidance · no established human amount, frequency or duration for TB-500 · every figure below was administered as full-length thymosin β4, not as the fragment · one registered trial of TB-500 itself, recruiting, no results

How much TB-500 should I take daily?

human pilot / early trial

Nothing among the research behind this page answers that. No study among the research behind this page has given a stated amount of TB-500 to a person and written up what happened, so a daily figure would have to be invented rather than quoted. One study of the fragment itself is on the registry. It is TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD, listed as recruiting, with 80 people.18 An entry of that kind records who is being signed up rather than how much they are given, and no result has been posted. Two 2026 reviews fill in the rest. One finds that many unapproved peptides demonstrate favorable tissue repair and metabolic outcomes in animal models, but rigorous human safety data are scarce.8 The other reports that significant heterogeneity existed in dosing and route of administration.9 Spread of that size tells a reader the work has no standard in it, rather than handing them a range to pick from.

What amounts appear in the published thymosin beta-4 studies?

animal model

Three animal protocols carry a figure, and all three are written in milligrams per kilogram of animal. In a 2021 mouse study of fetal development, mice were weighed and treated with an intraperitoneal injection of TB4 (Regene RX, Rockville, MD, USA; 6 mg/kg in PBS) on two fixed days of gestation.5 Intraperitoneal means into the abdominal cavity. A 2023 study in an Alzheimer's mouse model used a lower figure on a denser schedule: Tβ4 (5 mg/kg, i.v.) or PBS, was administered immediately following and at 2 and 4 h after the PBS or LPS challenge, and then once daily for 6 days.6 The third gives a duration without a quantity. In C57BL/6J mice, 7-day rhTB4 treatment prevented cardiac dysfunction and fibrosis 28 days post-I/R surgery, with the amount left in the full paper rather than the summary.7 Taken together these are three separate experiments with three designs, not three points on one scale.

Thymosin beta-4 amounts in the three mouse studies described above. Animal amounts in milligrams per kilogram of mouse, not converted to a person and not a dosing guide.
StudyAmount studiedRouteSchedule
2021 fetal development study6 mg/kgInto the abdominal cavityTwo fixed days of gestation
2023 Alzheimer's model5 mg/kgInto a veinImmediately, at 2 and 4 h, then once daily for 6 days
C57BL/6J heart studyNot stated in the summaryNot stated7 days

Do those thymosin beta-4 amounts apply to a TB-500 vial?

human pilot / early trial

In the research behind this page, that step has not been tested, and it is the weakest link in every protocol circulating under this name. The naming makes the problem visible. A 2026 review lists the compound as TB-500 (thymosin beta-4 fragment), and the registry files the molecule under study as the Thymosin Beta 4 17-23 Fragment, a numbered stretch of the parent protein.818 A 2026 scoping review runs the pair together as one item, listing its subject as thymosin beta-4 or TB-500, which is how a figure measured on the protein ends up quoted for the fragment.9 A quantity in milligrams per kilogram is a property of a specific molecule at a specific weight. Shortening the molecule changes what that quantity means, and nothing among the research behind this page has given both forms to the same animals at matched amounts. So the figures above describe what was done to mice with the whole protein, and the arithmetic that would carry them across to a fragment has not been performed by anybody.

How much TB-500 do people take for an injury?

animal model

No published figure covers that use. The review that went looking for one said so plainly. A 2026 scoping review searched six compounds against bone, fracture, muscle, tendon, ligament, meniscus and cartilage. It found that 67% of the publications it identified relied on preclinical animal models, and that human clinical studies were confined to a handful of investigations, most lacking robust controls or rigorous study designs.9 A search aimed straight at torn tissue came back with animal work and little else. The one human setting with a stated course is skin rather than tendon. A 2016 review records that Tβ4 also accelerated the rate of repair in phase 2 trials with patients having pressure ulcers, stasis ulcers, and epidermolysis bullosa wounds.3 Those were trials of the whole protein, laid on open skin. That is a different molecule, a different tissue and a different route from a fragment injected near a strained tendon.

What is a TB-500 cycle, and how long does one run?

animal model

Four published courses exist and no two of them correspond, which is the honest answer to a question expecting a standard duration. The shortest is two administrations. Pregnant mice received material at 10:00 a.m. on day E14 and E17 of gestation, separated by three days, with nothing afterwards.5 Next is six days: an Alzheimer's model administered material to mice immediately after an inflammatory challenge, again at two and four hours, and then once daily for 6 days.6 Then seven, because in C57BL/6J mice, 7-day rhTB4 treatment preceded a further four weeks of observation.7 The longest course is human and it is topical. Nine patients with chronic corneal defects were treated with thymosin beta 4 (Tbeta4) sterile eye drops for 28 or 49 days with a follow-up period of 30 days.1 Every one of those durations was selected to suit a particular experiment rather than to establish a course, so none of them constitutes a cycle in the sense the question intends.

Is there a TB-500 dosage chart?

human pilot / early trial

Not one that comes from a trial, a regulator or a manufacturer. A chart requires a standard to simplify, and the literature on this compound does not contain one. The 2026 scoping review states the position in a single clause: significant heterogeneity existed in dosing and route of administration.9 That is a finding about the published work, covering six compounds across animal and human studies, and it is the nearest thing to a summary of schedules anybody has produced. A 2026 sports medicine review adds the other half, reporting that rigorous human safety data are scarce for the unapproved peptides it surveys.8 A chart maps an input onto an output amount, and both ends of that map are missing here. What circulates under the name is therefore a convention rather than a protocol, and conventions have no measurement underneath them.

How was thymosin beta-4 administered in the studies?

animal model

Four routes appear, and none of them is the injection under the skin that the fragment is presented for. The fetal development work used an intraperitoneal injection of TB4, placed into the abdominal cavity.5 The Alzheimer's model used Tβ4 (5 mg/kg, i.v.), delivered straight into a vein.6 The corneal work used sterile eye drops, applied to the surface of the eye.1 A 2017 colitis experiment went further still: AAV-Tβ4 was prepared and intracolonically used to mediate the secretory expression of Tβ4 in mouse colons, which means a virus was used to make the animal produce the protein locally.4 Route decides how much reaches a tissue and how quickly, so a quantity cannot be carried from one route to another without a study connecting them. No such study exists for this compound, and the gap is wider than usual because one of the four routes is not an administration of the peptide at all.

What did the registered human trials administer?

registered trial

Phase and enrolment are on the public record; the amounts are not. The registry holds A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers with 54 people and A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers with 30, both completed.1516 A Phase 2 study, Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction, enrolled 90 and is also completed.17 An earlier entry, A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers, is marked withdrawn with nobody enrolled.14 One of those lines has published, and the dosing detail it reports is a deadline rather than a quantity. In a randomised, placebo-controlled, double-blind trial involving 96 STEMI patients, the treated arm received the first dose of rhTB4 within 8 h after PCI.7 STEMI is a major heart attack and PCI is the procedure that reopens the blocked artery. Timing was the variable the investigators controlled, and the quantity sits in the full report rather than in anything indexed here.

What does a 15 mg TB-500 vial contain?

regulatory action

A quantity of dry material and nothing else, and the only documented presentations come from recall records. FDA enforcement records list four. One covers Thymosin Beta-4, 15 mg Injection from a Florida compounding pharmacy.13 A second covers THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial from an Indiana clinic, which is ten milligrams of material spread through five millilitres of liquid.12 A third covers Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations.11 A fourth documents a combined product, BPC-157/Thymosin Beta-4 for Injection, at 10/10mg and 15/15mg.10 Every one of those was pulled for lack of assurance of sterility, which describes how a batch was manufactured rather than what the molecule does. A vial size is a packaging fact. It states what a container held before any water went in, and it carries no information at all about what anybody should draw out of it.

How do you reconstitute a TB-500 vial?

regulatory action

The arithmetic is fixed and it runs on two numbers the vial and the syringe already supply. The inputs are the stated quantity of dry material and the volume of bacteriostatic water introduced. The concentration of the liquid is the first divided by the second. A vial stated at 15 mg, reconstituted with 3 mL of water, holds 5 mg in every millilitre, which is identical to 5,000 mcg per millilitre, because one milligram is a thousand micrograms. Alter the volume of water and the concentration alters with it, while the quantity inside the vial does not move. The recall records show why the second number matters. One presentation was recorded as Thymosin Beta-4 (TB4) for Injection, 15mg, and another as THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, which is a concentration rather than a dry quantity.1112 Those are two different things written on two different labels, and reading one as the other is the most common arithmetic error on this compound.

How do mg, mcg and syringe units relate?

regulatory action

Three units measure three different things, and the labels on this compound use two of them interchangeably. Milligrams and micrograms measure the peptide, millilitres measure the liquid carrying it, and the markings on an insulin syringe measure volume alone. One milligram is a thousand micrograms, so a label reading 2000 MCG/ML describes the same concentration as one reading 2 mg/mL.12 A U-100 insulin syringe divides a single millilitre into 100 units, which makes each unit one hundredth of a millilitre. Converting a marking into a quantity means multiplying that fraction of a millilitre by the concentration of the reconstituted vial. The error people make is treating a syringe unit as a quantity of peptide. It is a volume, and the quantity inside it depends entirely on how much water went into the vial beforehand. Two identical vials reconstituted differently will give different quantities at the same marking, and the syringe cannot tell a reader which one is in front of them.

Why the animal figures do not convert to a person

animal model

Two separate gaps have to be crossed, and crossing either one without a study is guesswork dressed as arithmetic. The first is species. Both published milligram-per-kilogram figures, 6 mg/kg in PBS in pregnant mice and Tβ4 (5 mg/kg, i.v.) in an Alzheimer's model, were set for mice and read against mouse endpoints.56 A per-kilogram figure is not a conversion factor; it is a property of the experiment it came out of, and nothing among the research behind this page validates a human equivalent for this protein. The second gap is the molecule, and it has no parallel on most pages of this kind. Those amounts were given as the full protein, while the material sold under the TB-500 name is listed in a 2026 review as TB-500 (thymosin beta-4 fragment).8 Crossing species and changing the molecule at the same time leaves a figure with nothing measured behind it. This page publishes no such conversion.

Why do the reported protocols vary so much?

human pilot / early trial

Because nothing in the published record ties them together, and a 2026 scoping review says so outright: significant heterogeneity existed in dosing and route of administration.9 Purpose is the main driver. A 2012 review describes a molecule that binds to actin and promotes cell migration, which is a general mechanism rather than a targeted one, and the experiments built on it chase very different endpoints.2 A colitis model worked on mouse colons, an eye study worked on corneal surfaces, and a cardiac study worked on heart tissue after reperfusion.41 Form is the second driver. The published work includes a recombinant protein, a synthetic peptide, eye drops and a virus engineered to make the protein inside an animal. Those are four different products carrying one name, and a figure attached to any of them describes that form alone rather than the category it sits in.

What we don’t know

The gaps in the evidence matter as much as the findings.

  1. 01What amount of TB-500 does anything in a person. No trial among the research behind this page has attached a quantity of the fragment to a measured result, so there is no human figure to report.
  2. 02Whether the thymosin β4 amounts carry across to the fragment. Nothing among the research behind this page has given both to the same animals, and a protein can be cut in several places with a different molecule resulting each time.
  3. 03What quantity the registered human trials used. The registry entries record phase, enrolment and status rather than the amount administered.
  4. 04What a cycle length should be. Published courses run from two injections to six days to seven weeks of eye drops, and none of them was designed to find a duration.
  5. 05Whether a weekly loading period exists in any study. No published protocol describes one, so there is no published interval behind the idea.
  6. 06What happens past seven weeks. That is the longest documented human course, and it was topical drops on an eye rather than injection.
  7. 07What is inside a vial. Four compounded thymosin beta-4 presentations have been recalled for sterility assurance, and no analysis among the research behind this page has measured what a research-grade vial contains.
  8. 08Whether injection site changes anything. No study among the research behind this page of either the protein or the fragment has compared sites or rotation.

Sources

  1. 1Treatment of chronic nonhealing neurotrophic corneal epithelial defects with thymosin beta4 Ann N Y Acad Sci 2010. doi:10.1111/j.1749-6632.2010.05471.xreview
  2. 2Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications Expert Opin Biol Ther 2012. doi:10.1517/14712598.2012.634793in vitro
  3. 3Thymosin β4 Promotes Dermal Healing Vitam Horm 2016. doi:10.1016/bs.vh.2016.04.005review
  4. 4Recombinant adeno-associated virus carrying thymosin β(4) suppresses experimental colitis in mice World J Gastroenterol 2017. doi:10.3748/wjg.v23.i2.242animal model
  5. 5Thymosin beta-4 prenatal administration improves fetal development and halts side effects due to preterm delivery Eur Rev Med Pharmacol Sci 2021. doi:10.26355/eurrev_202101_24411animal model
  6. 6Thymosin beta 4 prevents systemic lipopolysaccharide-induced plaque load in middle-age APP/PS1 mice Int Immunopharmacol 2023. doi:10.1016/j.intimp.2023.109951animal model
  7. 7Recombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion Cardiovasc Res 2025. doi:10.1093/cvr/cvaf223animal model
  8. 8Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance Sports Med 2026. doi:10.1007/s40279-026-02437-0review
  9. 9Peptide Supplements and Their Therapeutic Applications in Sports Medicine Am J Sports Med 2026. doi:10.1177/03635465261464420human pilot / early trial
  10. 10BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELI sourceregulatory action
  11. 11Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. sourceregulatory action
  12. 12THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN sourceregulatory action
  13. 13Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 sourceregulatory action
  14. 14A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers NCT00743769registered trial
  15. 15A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers NCT04555824registered trial
  16. 16A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers NCT04555850registered trial
  17. 17Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction NCT05984134registered trial
  18. 18TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD NCT07487363registered trial