Regulatory evidence record · TB-500

FDA evidence audit: TB-500 (thymosin beta-4 fragment LKKTETQ) human exposure

FDA states it has not identified human exposure data for drug products containing the TB-500 fragment.

Quick read

Regulatory evidence record

What this study tells us

This is a regulator evidence review, not a participant treatment trial. It is useful for showing what human exposure or safety evidence the regulator could — or could not — identify.

Who was studied?

No human drug-product exposure identified

How many?

Not applicable — this is a regulator evidence review, not a participant trial.

What happened?

FDA states it has not identified human exposure data for drug products containing the TB-500 fragment.

What stops us overclaiming?

This finding applies to the TB-500 fragment; it must not be replaced with clinical studies of full-length thymosin beta-4.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary →

Key result

FDA states it has not identified human exposure data for drug products containing the TB-500 fragment.

Study details

Study designRegulatory evidence review / no human exposure identified

PopulationNo human drug-product exposure identified

RouteAny

Regimen / exposureNot applicable

DurationNot applicable

ComparatorNot applicable

Primary endpoint / questionExistence of human exposure and safety data

Safety resultHuman safety cannot be characterized from direct drug-product exposure.

Key limitationsThis finding applies to the TB-500 fragment; it must not be replaced with clinical studies of full-length thymosin beta-4.

Registry / identifierFDA compounding safety review

Open TB-500 page →Open primary source →