preclinical-level evidence

TB-500

What the research and the regulators actually say, sourced to primary documents.

Studies indexed
0
Clinical trials
0
Next regulatory date
2026-07-23

Updated · sourced to primary documents

Research information only, not medical advice. Research peptide, not approved for human use anywhere. Up for an FDA advisory committee vote on July 23, 2026 (evaluated indication: Wound healing). Removed from the FDA 'do not compound' list in April 2026 but not yet compoundable.

TB-500 at a glance

As of June 2026 the human evidence is limited; most data is preclinical. See the indexed studies below, graded by evidence level.

All seven peptides on the agenda are covered in the July 2026 FDA peptide meeting. See also BPC-157 vs TB-500.

Evidence profile

100 studies
  • Human trial 9 · 9%
  • Review 23 · 23%
  • Animal 12 · 12%
  • In-vitro 37 · 37%
  • Unknown 19 · 19%

The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.

Regulatory status

  1. 2026-04-22 US-FDA

    Removed from the FDA 503A 'do not compound' Category 2 (nominations withdrawn) — still not eligible for compounding. source

  2. 2026-07-23 US-FDA · upcoming

    FDA Pharmacy Compounding Advisory Committee vote (evaluated indication: Wound healing); docket FDA-2025-N-6895. source

Clinical trials

  • NCT07487363 PHASE1, PHASE2 RECRUITING

    TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD

Indexed research

Sorted by evidence level, strongest first.

+ 90 more studies indexed for TB-500.

Frequently asked questions

Is TB-500 approved for human use?
Research peptide, not approved for human use anywhere. Up for an FDA advisory committee vote on July 23, 2026 (evaluated indication: Wound healing). Removed from the FDA 'do not compound' list in April 2026 but not yet compoundable.
What does the research on TB-500 show?
As of June 2026 the human evidence is limited; most data is preclinical. See the indexed studies below, graded by evidence level.