Study 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.

Key result

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

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