Thymosin alpha-1

Investigated uses

• Sepsis, viral infection, cancer adjunctive therapy and immune modulation.

Mechanism and hypotheses

• Thymosin alpha-1 is a 28-amino-acid thymic peptide with immunomodulatory activity studied in randomized human trials.
• Hypothesized: Benefits vary by disease context and do not establish equivalence of an unapproved vendor vial.

Human evidence

• Thymosin alpha-1 has been studied in randomized trials for severe infection and other immune-related conditions. Limitations: Results are indication-specific and heterogeneous; no FDA-approved product was identified.

Safety highlights

• Unknown or insufficiently characterized for the exact catalog product.
• Identity, purity, sterility, endotoxin, aggregation, immunogenicity, concentration and route-specific risks are not adequately characterized.

Regulatory context

No FDA-approved thymosin alpha-1/thymalfasin product was identified; FDA lists it among substances presenting significant compounding safety concerns.