TB-500
Medium EvidenceA naturally occurring peptide involved in cell migration and tissue repair, studied for wound healing and recovery.
What It Is
TB-500 is a synthetic version of Thymosin Beta-4 (Tβ4), a 43-amino acid peptide naturally produced by the thymus gland. It plays a role in cell migration, blood vessel formation, and tissue repair. Research has explored its potential in wound healing, cardiac repair, and reducing inflammation. In 2026, new human trial data emerged from a study enrolling patients recovering from acute myocardial infarction (AMI), randomized to receive Thymosin Beta-4 or placebo as adjunct therapy after standard revascularization. The trial showed measurable improvements in cardiac recovery metrics. The injectable formulation RGN-352, containing synthetic Tβ4, has progressed toward Phase 2 clinical trials for acute myocardial infarction based on these and earlier preclinical findings. Mechanistically, TB-500 upregulates VEGF expression in cardiac tissue, modulates the inflammatory cascade to preserve clearance while blunting prolonged inflammation that contributes to adverse cardiac remodeling, and activates epicardial progenitor cells. The FDA Pharmacy Compounding Advisory Committee will meet July 23–24, 2026 to discuss TB-500 and other peptides for potential addition to the 503A Bulks List. Public comments can be submitted via docket FDA-2025-N-6895, open until July 22, 2026.
Regulatory Status
Moved from Category 2 back to Category 1 per HHS announcement February 27, 2026. FDA PCAC will review TB-500 (free base and acetate) on July 23, 2026 for potential 503A Bulks List inclusion for wound healing. Public comment docket FDA-2025-N-6895 open until July 22, 2026.
Effective: February 2026
View FDA SourceWhy Researchers Study It
TB-500 is studied for its role in cell migration and tissue remodeling. As a synthetic form of Thymosin Beta-4, it is one of the most abundant intracellular proteins, suggesting fundamental biological significance in wound repair and cardiovascular regeneration research.
Proposed Mechanisms
- Sequesters G-actin monomers, promoting cell motility and migration
- Stimulates angiogenesis and new blood vessel formation
- Reduces pro-inflammatory cytokines at injury sites
- Promotes keratinocyte and endothelial cell migration for wound closure
- May support cardiac progenitor cell activation post-injury
Evidence Snapshot
| Study Type | Model | Outcome | Link |
|---|---|---|---|
| Animal (mouse) | Dermal wound model | Accelerated wound closure and reduced scarring | Source |
| Animal (rat) | Myocardial infarction | Improved cardiac function and reduced infarct size | Source |
| In vitro | Endothelial cell migration assay | Significant increase in cell migration rate | Source |
| Human (2026) | Acute myocardial infarction — adjunct to standard revascularization | Measurable improvements in cardiac recovery; VEGF upregulation and epicardial progenitor cell activation observed | Source |
Commonly Discussed Benefits
Safety & Cautions
- Primarily studied in animal models, though 2026 human cardiac trial data has emerged
- Human clinical data is still limited
- Not FDA-approved
- Potential interactions not fully characterized
- RGN-352 formulation advancing toward Phase 2 for cardiac indications
Comparisons
See how TB-500 compares to related peptides:
Calculator Tools
Use our research tools to explore dosing and reconstitution data:
Citations
- [1] Goldstein AL. et al. — Thymosin β4: a multi-functional regenerative peptide. Expert Opin Biol Ther. 2012 PubMed
- [2] Crockford D. — Development of thymosin beta4 for wound healing. Ann N Y Acad Sci. 2007 PubMed
- [3] TB-500 and Cardiac Recovery: What the 2026 Human Trial Data Shows — PeptIQ 2026 PubMed
- [4] FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee PubMed
Continue Your Research
Track your research notes and set reminders in the companion app.
Related Peptides
BPC-157
Medium EvidenceA pentadecapeptide derived from human gastric juice, studied for tissue repair and gut-protective properties.
GHK-Cu
High EvidenceA naturally occurring copper-binding peptide studied for skin regeneration, wound healing, and anti-aging effects.