Tissue repair research · Evidence review
TB-500
Are studies of a related molecule being confused with TB-500?
Why a trial of thymosin beta-4 eye drops cannot validate injectable TB-500 recovery claims.
What was actually studied
Adults with dry eye received a thymosin beta-4 ophthalmic formulation, not injectable TB-500.
What the paper found
- The selected trial missed its primary endpoints; some secondary outcomes improved.
Where the claim goes beyond the evidence
- The tested formulation, route, and condition differ from TB-500 injury-recovery claims.
- FDA identifies TB-500 as a thymosin beta-4 fragment; it should not be treated as interchangeable with the trial product.
Safety context
FDA describes immune-response and impurity concerns and missing human exposure information for the TB-500 fragment.
A research summary cannot establish that a product is suitable for you. Clinical decisions belong with a qualified health professional.
Read the original sources
- Original research — PubMed abstractThymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model. ↗
- FDA safety informationCertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks ↗