Directory
Research PeptidesTISSUE REPAIR & VASCULAR
Evidence grade D
TB-500
Graded D: FDA found no human studies of TB-500 itself; human trials of the full-length parent protein do not transfer to a 7-residue fragment.
- Strengths
- 5, 10, 15 mg
- Also known as
- Ac-LKKTETQ, Thymosin β4 (17–23) fragment, acetylated, Tβ4 acetate (catalog synonym; TB-500 is a fragment, not the full protein)
- Molecule
- Synthetic acetylated 7-amino-acid peptide (heptapeptide)
- Formula
- C38H68N10O14
- Mol. weight
- 889.02 g/mol
- CAS
- 885340-08-9 (free base)
- Sequence
- Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH
Origin
A short, lab-made piece of thymosin beta-4, a natural 43-amino-acid protein involved in cell movement and repair. It copies residues 17–23, the protein's actin-binding motif.
How it works
The parent protein, thymosin beta-4, is the main protein that holds single actin units inside cells, which supports cell migration and, in animals, blood-vessel growth and wound repair. The LKKTET stretch in this fragment is the conserved actin-binding motif. Much of the full protein contacts actin, so the fragment may not reproduce the whole protein's activity.
What the research shows
There are no human studies of TB-500 itself, no human pharmacokinetic data and no FDA adverse-event reports for it alone. The full-length protein has been tested in people (RGN-259, including phase 3 dry-eye trials) without leading to approval, and none of those results apply to the fragment. In animal and cell work, a non-acetylated version aided wound healing in aged mice, while TB-500 did not significantly speed wound closure in cultured skin cells. Whether the fragment reproduces the parent protein's effects in living animals is not known.
Key studies
- FDA PCAC Briefing Document, TB-500, 2026 Found no clinical studies, human PK/PD data or case reports for TB-500.
- RegeneRx RGN-137 phase 2 trials, 2009 Full thymosin β4 gel in venous and pressure ulcers: no statistically significant healing benefit; well tolerated.
- RegeneRx RGN-352 phase 1, 2009 Full thymosin β4 IV in 80 healthy volunteers: no drug-related adverse events.
- RegeneRx RGN-259 (ARISE-1/2/3; SEER-1) Full-protein eye drops: favorable pooled dry-eye results; only a trend in neurotrophic keratopathy; not approved.
Safety findings
Human safety is unknown because there are no human studies. FDA cites immune-reaction and aggregation risk with research-grade peptides, and the certificates it reviewed lacked identity, assay and endotoxin results. One FDA adverse-event case of skin and gum darkening involved a BPC-157/TB-500 blend, so the cause can't be assigned to either peptide; no repeat-dose, genetic, reproductive or cancer toxicity studies exist.
Regulatory status
Not FDA-approved for any use. It was on FDA's Category 2 safety list from 2023 until April 2026. In July 2026 FDA's Pharmacy Compounding Advisory Committee voted 8–6–1 to recommend adding it to the 503A bulks list for wound healing; the vote is advisory, no final rule had been issued as of October 2026, and it concerns pharmacy compounding, not research-grade material. WADA prohibits it at all times (S2).
Catalog notes
Available in 5, 10 and 15 mg; only the 10 mg strength has a current certificate (lot TB10-0803, 99.68% purity, COA7595). It is the same 7-amino-acid fragment as TB-500 FRAG, not full thymosin beta-4.
In kits: Ironclad Bundle, Wolverine Bundle