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Compound reference

TB-500

Thymosin Beta-4 fragment

Peptides1 cited findingClinical review: not reviewed

Identity & applicability

Regulatory recordSupporting passage inspected

TB-500 in FDA’s review is a thymosin beta-4 fragment, not full-length thymosin beta-4. The agency did not identify human exposure or pharmacokinetic evidence for the fragment; studies of the parent peptide cannot establish fragment-specific injury-recovery effects.[1]

  • Research-market use of the name may be inconsistent, and product identity requires chemical confirmation.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Used FDA’s 2026 exact-fragment review and explicitly separated parent-peptide studies.

  • Exact-fragment human efficacy, kinetics and clinical safety remain unresolved.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

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References

  1. FDA July 2026 Pharmacy Compounding Advisory Committee briefing: Thymosin beta-4 fragment (TB-500)

    2026-07. Regulatory document.

    Inspected location: Identity and Figure 5, PDF p. 25; human exposure and effectiveness, PDF pp. 29–30

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-fda-tb500-2026: Identity and Figure 5, PDF p. 25; human exposure and effectiveness, PDF pp. 29–30
  • July 23–24, 2026 FDA compounding advisory meeting page checked; committee review distinguished from approval.

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