Evidence & concentration worksheet · Immune & Inflammation
Thymosin Alpha-1 5 mg
Human efficacy and a validated dose have not been established for this compound. The former regimen has been withheld; only concentration arithmetic remains available.
Evidence review
No established human dosing protocol
Human efficacy and a validated dose have not been established for this compound. The former regimen has been withheld; only concentration arithmetic remains available.
How it works
Thymosin alpha-1 is a 28-amino-acid peptide; chemically produced thymalfasin has the same amino-acid sequence. It is distinct from thymosin beta-4 and TB-500.[1][2]
Thymalfasin products have country-specific approvals outside the United States, including defined uses in Italy, India, and Hong Kong. Those authorizations apply to particular regulated products and indications and do not establish FDA approval or equivalence of a U.S. compounded or online vial.[1]
Benefits & side effects
Human studies exist across hepatitis, infection, sepsis, COVID-19, cancer, vaccine response, and other conditions, but their relevance and quality vary. A Cochrane review found the chronic-hepatitis-B evidence insufficient for firm conclusions.[3]
FDA's 2024 review concluded that subcutaneous thymosin alpha-1 free base or acetate lacked adequate effectiveness evidence for every evaluated use. Limitations included small samples, retrospective or single-arm designs, inadequate controls, outdated comparator therapy, heterogeneous populations, unclear endpoints, and concurrent treatments that prevented attribution.[1] Evidence from older therapeutic settings should not be presented as proof of benefit alongside modern standard care.
Calculator
Concentration and measurement calculator
Use this only to check arithmetic from an authoritative product label, registered study protocol, or qualified clinician.
Arithmetic only — not a dose recommendation
Enter only a concentration and target supplied by an authoritative product label, a registered study protocol, or a qualified clinician. A correct conversion does not establish that a substance, vial, route, or dose is safe or effective.
Enter only a concentration and target supplied by an authoritative product label, a registered study protocol, or a qualified clinician. A correct conversion does not establish that a substance, vial, route, or dose is safe or effective.
Source concentration
Source-supplied target
References
References
- U.S. FDA — FDA evaluation of thymosin alpha-1-related bulk drug substances (2024)
- NIH LiverTox — Thymalfasin (2019)
- Cochrane Database of Systematic Reviews — Thymosin alpha-1 for chronic hepatitis B (2009)
- U.S. FDA — December 2024 Pharmacy Compounding Advisory Committee meeting (2024)
Other vial sizes