Summary
Thymosin alpha-1 is a 28-amino-acid peptide from the thymus that modulates T-cell and dendritic-cell function. As thymalfasin, it is approved in several countries outside the US for chronic hepatitis B and as a vaccine or chemotherapy adjunct. Large trials in sepsis have not shown a mortality benefit.
Structure
- S1
- D2
- A3
- A4
- V5
- D6
- T7
- S8
- S9
- E10
- I11
- T12
- T13
- K14
- D15
- L16
- K17
- E18
- K19
- K20
- E21
- V22
- V23
- E24
- E25
- A26
- E27
- N28
HydrophobicGly / ProPolarBasic (+)Acidic (−)
N-terminally acetylated. Originally isolated from calf thymus; the synthetic drug is thymalfasin.
How it works
Tα1 acts on Toll-like receptors on dendritic cells and promotes T-cell maturation, Th1 cytokine production and natural killer cell activity. It is described as an immune modulator rather than a stimulant because it can also dampen excessive inflammation.
Research use cases
Areas where Thymosin Alpha-1 has been studied. Inclusion here does not mean it works for that purpose.
- Chronic hepatitis B and C (approved outside the US)
- Vaccine response in immunocompromised people
- Sepsis and severe infection
- Adjunct in cancer immunotherapy research
What the research found
Literature review
A comprehensive review summarizes decades of trials in hepatitis, cancer and infection, and notes that results vary widely in quality and that many trials were small or open-label.1
Severe COVID-19 (retrospective)
A retrospective study from China in 2020 reported lower mortality and restored T-cell counts in severe COVID-19 patients given Tα1. Retrospective designs cannot rule out confounding.2
Sepsis RCT
A multicentre randomized trial in China (the TESTS trial) found no significant reduction in 28-day all-cause mortality with thymosin alpha-1 versus placebo in adults with sepsis.3
Safety and open questions
Generally well tolerated in clinical trials; local injection-site reactions are the most common effect.
Regulatory status
Approved as thymalfasin (Zadaxin) in a number of countries outside the US, including China, for hepatitis B and as an immune adjunct. Not FDA-approved. Named in the February 2026 HHS compounding announcement.
Status was accurate when this page was last reviewed on October 26, 2026. Regulations change; check with the relevant authority before relying on it.
Thymosin Alpha-1: common questions
Is thymosin alpha-1 related to thymosin beta-4 (TB-500)?
Only by name. Both were isolated from thymus extracts, but they are unrelated proteins with different structures and functions.
Is Thymosin Alpha-1 approved for human use?
Approved as thymalfasin (Zadaxin) in a number of countries outside the US, including China, for hepatitis B and as an immune adjunct. Not FDA-approved. Named in the February 2026 HHS compounding announcement.
References
- Dominari A, Hathaway D, Pandav K, et al. (2020). Thymosin alpha 1: A comprehensive review of the literature. World Journal of Virology.
- Liu Y, Pan Y, Hu Z, et al. (2020). Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells. Clinical Infectious Diseases.
- Wu J, Pei F, Zhou L, et al. (2025). The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ.
Links open a PubMed search for the exact title, or the original source where one is given.