TB-500 dosage: what has actually been published
Published figures for the two routes HHS’s 2026 policy lists. There are no human dosing data.
There is no established human dose of TB-500, and FDA has identified no human exposure data for it. The published figures come from animal work, not dosing trials. Published protocols vary; a licensed provider sets your dose; never self-dose. Below is what has been published for the two routes the 2026 policy lists: subcutaneous and intramuscular.
TB-500 is not FDA-approved. Since HHS’s October 2026 interim policy, a state-licensed 503A pharmacy may compound it on a patient-specific prescription under listed conditions.
REMEVi does not currently offer TB-500.
Published TB-500 doses by route
| Route | Human dose | Published animal study doses | Source |
|---|---|---|---|
| Subcutaneous injection | No established human dose; FDA has identified no human exposure data | Horses: one 10 mg injection in each of two animals, in a doping-detection study (not a dosing or treatment study) | Ho et al. 2012; FDA |
| Intramuscular injection | No established human dose; FDA has identified no human exposure data | No published TB-500 dose by this route found | FDA |
This table reports what studies used. It is not a dosing recommendation, and an animal dose must not be scaled to a human dose.
Published protocols vary; a licensed provider sets your dose
Published protocols vary; a licensed provider sets your dose; never self-dose. TB-500 “dosage charts” online do not come from human trials, because there are none to draw on.
A prescriber who decides TB-500 is appropriate writes the dose, route and schedule on a patient-specific prescription, and the 503A pharmacy labels the product to match. Follow that label, not a chart.
Why published TB-500 dosage charts differ
- They mix up TB-500 and full-length thymosin beta-4. The 2010 human trial gave intravenous thymosin beta-4 at 42 to 1,260 mg: a different molecule, by a route the policy does not list.
- They borrow from veterinary and doping literature, where doses were chosen for detection, not effect.
- They assume vials hold what the label says. Research-use vials have no patient-specific label and no pharmacy answerable for content.
- Many charts dose TB-500 together with BPC-157. The 2026 policy covers one active ingredient per product, so combined dosing has no place in a compounded prescription.
Reconstitution basics for injectable TB-500
If a provider prescribes TB-500, the pharmacy label and the prescriber’s instructions govern everything: whether it arrives as a solution or a powder, what to reconstitute it with, how much, and how to store it. General sterile-technique basics:
- Wash your hands and clean the vial stopper with an alcohol swab before every use.
- Use a new sterile syringe for every injection; never reuse or share one. Under the policy, the one device packaged with the drug is an FDA 510(k)-cleared syringe.
- Reconstitute and store exactly as the pharmacy label says, and discard by the date on the label.
- Do not use the product if it looks cloudy, discolored or has particles, and call the pharmacy.
- Never combine it with another product in the same syringe or vial.
How much TB-500 should I take per week?
No study has established a human dose of TB-500, per day or per week, and FDA has identified no human exposure data for it. Weekly figures online are not from human trials and often borrow from full-length thymosin beta-4 research. Published protocols vary; a licensed provider sets your dose; never self-dose.
Is TB-500 injected subcutaneously or intramuscularly?
HHS’s 2026 policy lists both subcutaneous and intramuscular injection for compounded TB-500. No published human study compares the two routes, and no human dose exists for either. Which route, if any, is a decision for the licensed provider who writes the prescription; the pharmacy label then governs.
Sources
- Ho et al., J Chromatogr A 2012 — Doping control analysis of TB-500, a synthetic version of an active region of thymosin β4, in equine urine and plasma by LC-MS (read November 2, 2026)
- FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 04/22/2026) (read November 2, 2026)
- Ruff et al., Ann N Y Acad Sci 2010 — A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers (read November 2, 2026)
- HHS — Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, notice of availability, 91 FR 68526 (October 30, 2026) (read November 2, 2026)
- Foley & Lardner (Holtz, Beaver, Rosen), National Law Review, Oct 30 2026 — Peptides: HHS announces limited enforcement discretion for compounding six peptides (read November 2, 2026)
- Nutritional Outlook (Bigica), Nov 2 2026 — HHS peptide compounding policy: supplement industry implications (read November 2, 2026)
Medically reviewed by Linda West-Conforti, RN · CA RN #389453 ·