Thymosin alpha-1 is a 28-amino-acid thymic peptide that enhances T-lymphocyte function, natural killer cell activity, and cytokine production in immunodeficiency and chronic infection models.
Peptide reference
Thymosin Alpha-1
Thymosin Alpha-1
Animal dataHow it works
A 28-amino-acid peptide originally isolated from calf thymic tissue. It modulates both innate and adaptive immunity — upregulating dendritic cell maturation, increasing T-cell activity, and enhancing natural killer cell function. Approved in over 35 countries under the brand name Zadaxin for viral hepatitis and as an adjuvant in immunocompromised patients. Not FDA-approved. It occupies an unusual regulatory position: extensive international clinical history, no approved US indication, compoundable as a 503A bulk substance.
Key studies
Frequently asked
What is Thymosin Alpha-1?
Thymosin alpha-1 is a naturally occurring 28-amino-acid peptide secreted by the thymus gland, involved in maturing T-cells and shaping immune response. A synthetic version, called thymalfasin, has been used as an immune-modulating drug outside the US for decades. It's structurally and functionally distinct from thymosin beta-4, the peptide behind TB-500; the shared "thymosin" name reflects thymus origin, not a chemical relationship.
What does the clinical evidence for Thymosin Alpha-1 actually show?
The largest controlled human trial of Thymosin alpha-1 to date tested it in over 1,100 sepsis patients and found no difference in 28-day mortality versus placebo, a null result. A subgroup analysis suggested a possible harm signal in patients under 60 that couldn't be ruled out. That 2025 trial substantially weakens the international case for using Thymosin alpha-1 as a sepsis adjuvant, even where it's already approved for that use.
Is Thymosin Alpha-1 approved by the FDA or on the PCAC docket?
The synthetic version, thymalfasin, is approved in dozens of countries outside the US for hepatitis B and C adjuvant therapy, but has never received FDA marketing approval, only orphan-drug designations. It's not on either of the FDA's 2026 or 2027 PCAC review waves either: PCAC already reviewed it in December 2024 and voted against adding it to the Section 503A compounding list.
Is Thymosin Alpha-1 banned for athletes?
Yes. Thymosin alpha-1 falls under WADA's S2 category for peptide hormones and immunomodulatory substances without recognised therapeutic approval in the testing jurisdiction, prohibited at all times for athletes subject to testing.
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