TB-500 official evidence assessment · version 1
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What does the official evidence assessment say?
FDA assessment dated May 15, 2026 · Read September 15, 2026 · Preserved version 1
FDA's assessment of TB-500 free base and TB-500 acetate for the nominated use of wound healing. The assessment was prepared for the July 2026 Pharmacy Compounding Advisory Committee meeting. FDA document ↗
Which substance is being assessed?
FDA describes TB-500 free base as an N-terminal acetylated seven-amino-acid fragment of thymosin beta-4. It also warns that the common name has been used for different substances. Findings about full-length thymosin beta-4 cannot be assumed to apply to this fragment. FDA pp. 7, 8 ↗
What did FDA find about human studies?
FDA reported that it did not identify clinical studies of TB-500 administered to people and found insufficient evidence to evaluate effectiveness for wound healing. The nomination's references concerned thymosin beta-4 rather than human administration of the specified fragment. FDA pp. 23, 24 ↗
What is known about harms?
FDA reported no identified human pharmacokinetic or clinical safety studies. Its FAERS search through March 26, 2025 found no reports, while a separate complaint system contained two reports about blended TB-500 and BPC-157 without safety assessments. These findings do not establish safety or adverse-event rates. FDA pp. 30, 31 ↗
Scope, source pin and remaining work
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
Source: FDA briefing document for TB-500. SHA-256: 973cffba12fec26da77d67b3e08604500b754eaa48d15912acb9596f3090b5a4.