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.
The peptides on the agenda are covered in the July 2026 FDA peptide meeting . See also BPC-157 vs TB-500 .
Evidence profile
74 studies- Human trial 1 · 1%
- Review 22 · 30%
- Animal 6 · 8%
- In-vitro 33 · 45%
- Unknown 12 · 16%
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
- 2026-04-22 US-FDA
Removed from the FDA 503A 'do not compound' Category 2 (nominations withdrawn) — still not eligible for compounding. source
- 2026-07-23 US-FDA · upcoming
FDA Pharmacy Compounding Advisory Committee vote (evaluated indication: Wound healing); docket FDA-2025-N-6895. source
Clinical trials
-
TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
Indexed research
Sorted by evidence level, strongest first.
- Human trial 2026Project Title:"A 3-Month Pilot Pre-Trial of a Multi-Peptide Protocol (BPC-157/KPV/GHK-Cu Blend + TB-500 + Ara290 + Semax) for Arthritis, Cartilage Repair, Neuropathic Pain, and Mobility in Older Adults
This pilot pre-trial investigated a multi-peptide protocol for arthritis, cartilage repair, neuropathic pain, and mobility in older adults.
- Review 2026Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
- Review 2026Therapeutic peptides in gerontology: mechanisms and applications for healthy aging
- Review 2026Peptide Therapies in Thyroid Health: Emerging Applications in Endocrine and Immune Modulation
- Review 2026Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions
- Review 2026Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians
- Review 2026Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
This narrative review summarizes the pharmacology, safety, and regulatory status of approved and unapproved peptides used for musculoskeletal injuries and athletic performance, noting limited human safety data for unapproved compounds.
- Review 2025Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
This preprint reviews the pharmacology, safety, and regulatory status of approved and unapproved peptides used for musculoskeletal injuries and athletic performance, highlighting the lack of rigorous human safety data for unapproved compounds.
- Review 2023Thymosin beta-4 denotes new directions towards developing prosperous anti-aging regenerative therapies
- Review 2026Therapeutic Peptides: An Evidence-Tiered Survey Across Neuroplasticity, Anti-Ageing, Fitness, and Tissue Repair: A Critical Review
This critical review surveys 20 therapeutic peptides across four clinical domains using a four-tier evidence framework, highlighting that most compounds lack robust human evidence.
+ 64 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.