AI illustration · not actual product photoDetails from the source.
Source-listed TB500(Thymosin B4 Acetate） (SKU BT10): 10mg*10vials. PriceList(1).pdf lists 132 per 10 vials but does not specify currency; the website displays $132 per 10 vials in USD per owner instruction. The source row does not establish the supplier-specific item's identity, lot quality, or approval.
- Catalogue code
- BT10
- Source specification
- 10mg*10vials
- Source document
- PriceList(1).pdf, page 2
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
The catalogue label makes a thymosin beta-4/TB-500 peptide identity claim, but does not verify the exact contents. HHS defines TB-500 acetate as a synthetic, N-acetylated seven-amino-acid peptide fragment, distinct from full-length thymosin beta-4 (43 amino acids). Do not infer that the supplied vial contains that fragment or the full-length peptide without sequence and lot-specific identity documentation.
Biological mechanism
For the defined TB-500 fragment, FDA describes a proposed mechanism in which its LKKTET region may bind globular actin (G-actin) and affect actin dynamics; whether this explains angiogenesis or wound-healing findings remains uncertain. Cell movement and cytoskeletal effects are research hypotheses, not established effects of the catalogue item. Findings about full-length thymosin beta-4 should not be transferred to the fragment or unverified vial.
Research focus
Research includes actin binding, cell movement, angiogenesis and wound repair. In vitro and animal findings are preclinical. Full-length or recombinant thymosin beta-4 formulations have also been studied in human safety research and wound-related clinical trials; those are different formulations and do not establish evidence for TB-500 or these SKUs.
Potential applications in the evidence
Wound repair and cell-migration biology are areas investigated in preclinical work. Human studies of separately identified thymosin beta-4 formulations have investigated wound-related indications, but no clinical application or efficacy is established for the catalogue item. No treatment claim is supported.
Human evidence
FDA's review found no clinical studies administering TB-500 free base or TB-500 acetate to people for wound healing or another disease or condition. Separate early-phase work on recombinant full-length thymosin beta-4 in healthy volunteers reported short-term safety and pharmacokinetic observations, not efficacy for this product. A completed phase II registry record describes a topical full-length thymosin beta-4 venous-ulcer study with 72 participants, but the record reviewed did not provide outcome results establishing benefit. Evidence for full-length or recombinant formulations is not proof for TB-500 acetate or this supplier's vial.
Known and potential effects
No adverse-effect profile is established for these supplier-specific vials. In a small phase I study of a distinct recombinant full-length thymosin beta-4 product, adverse events were generally mild or moderate and no serious adverse events or dose-limiting toxicities were reported; recorded events included laboratory, urinalysis and ECG abnormalities. These findings do not establish safety for TB-500 acetate or the exact catalogue product.
Safety and contraindications
FDA's assessment identified uncertainty about human safety for TB-500 acetate and potential immunogenicity, aggregation and peptide-related impurities for injectable preparations. The catalogue and imported product records do not identify the manufacturer, lot, full sequence, formulation source, or lot-specific quality results such as identity, purity, sterility, endotoxin and impurity testing. No reliable contraindication list for the exact vial can be verified. Do not infer safety from the product name, strength, or studies of another formulation.
U.S. FDA / regulatory status
As of 2026-10-30, approval status for the exact supplier-specific vial cannot be verified. HHS's interim enforcement-discretion policy includes TB-500 for a narrow 503A compounding pathway, but compounded drugs are not FDA-approved. For TB-500 acetate the policy depends on matching the defined peptide identity and route and meeting quality, manufacturer, certificate-of-analysis, single-active-ingredient and patient-specific prescription conditions. The supplied records do not establish that this item is compounded, meets those conditions, or qualifies for the policy. The policy does not approve the compound or transfer approval to this vial.
Evidence limitations
The principal limitation is identity: the source label supplies no sequence, manufacturer, lot, formulation source, jurisdiction or certificate of analysis. Animal and in-vitro findings are not human evidence. Human evidence for full-length or recombinant thymosin beta-4 does not establish the effectiveness or safety of TB-500 acetate or this catalogue item. No FDA approval for the exact product can be verified from the available information. Catalogue prices have no stated currency. Keywords are omitted because the exact supplier-vial identity is not sufficiently established.
Supporting sources
- HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances U.S. Department of Health and Human Services · Official interim policy and identity appendix. Supports: Defined TB-500 acetate identity; narrow, conditional 503A enforcement-discretion policy; distinction between compounding enforcement discretion and FDA approval.
- FDA Pharmacy Compounding Advisory Committee Review of TB-500 U.S. Food and Drug Administration · Regulatory staff briefing document. Supports: TB-500 fragment identity, proposed mechanism, preclinical evidence, absence of identified TB-500 human clinical studies, and FDA's safety-evidence concerns.
- Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers ClinicalTrials.gov, U.S. National Library of Medicine · Clinical trial registry. Supports: Design, completion and enrollment of a human phase II study of a topical full-length thymosin beta-4 formulation; registry record does not establish clinical benefit for the supplier item.
- A First-in-Human, Randomized, Double-Blind, Single- and Multiple-Dose, Phase I Study of Recombinant Human Thymosin β4 in Healthy Chinese Volunteers Journal of Cellular and Molecular Medicine, via PubMed Central · Peer-reviewed primary human study. Supports: Short-term safety findings for a distinct recombinant full-length thymosin beta-4 product in healthy volunteers; not evidence for TB-500 or the supplied vial.
- Progress on the Function and Application of Thymosin β4 Frontiers in Endocrinology, via PubMed Central · Peer-reviewed review. Supports: General mechanisms and research areas for full-length thymosin beta-4, preclinical versus clinical evidence, and an overview of human studies.