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Moderate Human Evidence

Thymosin Alpha-1

A 28-amino-acid immunomodulatory peptide approved in many countries (as Zadaxin) for hepatitis B and as an adjunct in cancer and infection.

In plain English

Thymosin alpha-1 (Tα1) is a naturally occurring 28-amino-acid peptide first isolated from the thymus gland. As the drug Zadaxin, it is approved in more than 30 countries — including Italy and several Asian and Latin American nations — for chronic hepatitis B and as an immune adjuvant in cancer care, severe infection, and post-transplant settings. It is not approved by the U.S. FDA. Mechanistically, Tα1 modulates T-cell maturation and function, dendritic cell activity, and innate immune signaling. People commonly research thymosin alpha-1 for immune support, recovery from infection, and adjunctive cancer care.

What it is

Thymosin alpha-1 is a 28-amino-acid synthetic peptide identical in sequence to a naturally occurring thymic peptide.

Mechanism (summary)

Tα1 modulates T-cell maturation, increases Th1 cytokine responses, supports dendritic cell function, and engages TLR-9 signaling. Net effect is broad immunomodulation rather than simple immune stimulation.

Why people research it

  • Chronic hepatitis B
  • Adjuvant immune support in cancer therapy
  • Severe infection and sepsis
  • Immune recovery in transplantation

Human evidence

Multiple RCTs and meta-analyses support efficacy in chronic hepatitis B (especially combined with interferon) and as an adjuvant in select cancers. Trials in COVID-19 and severe sepsis have shown mixed but generally favorable signals.

Animal / lab evidence

Animal models support immunomodulatory effects across infection and cancer settings.

Key studies

Each summary explains the design, what was found, and what it doesn't prove.

Meta-analysis2008·Adults with chronic hepatitis B across multiple trials
Thymosin alpha 1 vs. standard treatment for chronic hepatitis B: meta-analysis

Pooled across trials, more chronic hepatitis B patients cleared the virus with thymosin alpha-1 than with control treatments.

Finding: Thymosin alpha-1 monotherapy or combination produced higher sustained virologic response than control across pooled trials.
Limitations: Heterogeneous trials; older control comparators relative to current standard of care.
Human observational2020·Adults hospitalized with severe COVID-19
Thymosin alpha 1 in severe COVID-19: an open-label cohort

Hospitalized severe COVID-19 patients who received thymosin alpha-1 had lower mortality than matched comparison patients.

Finding: Thymosin alpha-1 was associated with reduced mortality and improved lymphocyte recovery vs. matched controls.
Limitations: Not randomized; risk of residual confounding.

History

Originally isolated from calf thymus in the 1970s by Allan Goldstein. Synthetic Tα1 (Zadaxin) was developed by SciClone Pharmaceuticals.

Important:

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