FDA Maintains Restrictions on Thymosin Alpha-1 Amid Safety Concerns
Thymosin Alpha-1, a peptide with potential immune-boosting properties, remains restricted by the FDA in the United States. Despite being approved in over 30 countries for conditions like viral hepatitis, the FDA has placed it on the Category 2 list, prohibiting its use in compounding by pharmacists. This decision stems from concerns about the peptide's stability during manufacturing and the potential for increased immunogenicity if used at higher concentrations than those tested in clinical trials. The peptide, which enhances antibody response and T-cell activity, has shown promise in treating immunocompromised individuals, including COVID long-haulers. However, the FDA cites inadequate safety data as a reason for its continued restriction. 
