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U.S. FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks FDA material discussing Thymosin Alpha-1 and potential concerns related to immunogenicity, aggregation, peptide impurities and characterization.
U.S. FDA — December 2024 Pharmacy Compounding Advisory Committee Materials FDA documentation regarding evaluation of Thymosin Alpha-1 free base and acetate for the 503A bulk list.
FDA Orphan Drug Designation Database — Thymalfasin FDA records showing orphan designations and that thymalfasin was not FDA-approved for those orphan indications.
Dinetz E, Lee E. Comprehensive Review of the Safety and Efficacy of Thymosin Alpha 1 in Human Clinical Trials. 2024. PubMed PMID: 38308608.
Thymosin Alpha 1: A Comprehensive Review of the Literature. World Journal of Virology. 2020. PubMed PMID: 33362999.
The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B. Randomized clinical trial involving 316 patients; PubMed PMID: 15850471.
Safety and efficacy of Thymosin α1 in HBV-related acute-on-chronic liver failure. Randomized controlled trial; ClinicalTrials.gov identifier: NCT03082885; PubMed PMID: 35616850.
Singapore National Drug Formulary — ZADAXIN Injection Current product information listing Thymosin Alpha-1 1.6 mg/vial and product-specific reconstitution information.
Last Scientifically Reviewed
September 10, 2026
Scientific content basis: FDA regulatory materials, PubMed-indexed literature and official international product information.
Reviewer: BacScience Scientific Content Team