TB-500 is discussed as a recovery and tissue-repair compound, especially in athletic and post-injury communities.
The nominated fragment is not the same thing as proving a clinical effect, and FDA reported no identified human exposure data for the reviewed drug products.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
4 names in this peptide family.
The nominated TB-500 fragment (LKKTETQ) is not silently treated as interchangeable with full-length thymosin beta-4.
4 evidence questions.
Human benefitNo identified human exposureDoes TB-500 have established human clinical benefit for wound healing?
FDA approvalNo FDA approval identifiedIs TB-500 FDA approved?
503A statusRegulatory recordIs TB-500 on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled TB-500 automatically interchangeable?
See every TB-500 evidence question →Open the machine-readable record ↗PCAC gave a favorable advisory recommendation
The committee recommended TB-500-related bulk drug substances for possible inclusion on the 503A Bulks List.
FDA received advice from its expert compounding committee.
The compound was not FDA-approved, and the vote alone did not add it to the final 503A Bulks List.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
PCAC gave a favorable advisory recommendation
The committee recommended TB-500-related bulk drug substances for possible inclusion on the 503A Bulks List.
Read the source ↗FDA published its scientific briefing
FDA released its evaluation of TB-500-related bulk drug substances for the committee meeting.
Read the source ↗TB-500 entered FDA's 503A nomination record
The TB-500 fragment was nominated for wound healing. The nomination was later withdrawn, and FDA continued the evaluation on its own initiative.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
FDA reported no identified human exposure data for drug products containing the nominated TB-500 fragment.
Read the FDA review ↗Preclinical findings were reviewed separately and do not establish clinical benefit in people.
Read the FDA review ↗Researchers measured TB-500 and its metabolites in laboratory systems and rats; only one metabolite showed significant wound-healing activity in vitro. This is not a human treatment study.
Read the study on PubMed ↗Important unknowns.
- FDA reported no identified human exposure data for the drug products it reviewed.
- FDA identified uncertainty around active-ingredient characterization, peptide-related impurities, or aggregation.
- Limited evidence of harm should not be interpreted as evidence of safety.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
3 dated changes. 3 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.