Thymosin Alpha-1
Thymosin alpha 1 · Thymosin alpha1 · Thymalfasin · Zadaxin
Snapshot
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Thymosin alpha-1 (thymalfasin) is a synthetic thymic peptide that enhances T-cell responses, which is the basis for its use as an immune-supporting injectable9. The United States (US) Food and Drug Administration (FDA) previously listed it among compounding substances with significant safety risks, citing immunogenicity, and the nominations were later withdrawn10. It is used as an adjunct in sepsis, chronic hepatitis B, and chemotherapy-treated lung cancer, and in coronavirus disease 2019 (COVID-19), mostly in hospitalized or immunocompromised patients. An Indonesian label approves it for chronic hepatitis B8.
Sepsis meta-analyses report lower mortality, with low-quality underlying trials1, 11. A Cochrane review in chronic hepatitis B rates the certainty of evidence as very low, and a COVID-19 meta-analysis found lower mortality in moderate to critical disease while calling for randomized trials. In 2026, a single-arm phase 2 trial added thymalfasin to immune checkpoint inhibitor chemotherapy before surgery in locally advanced gastric cancer and reported encouraging pathological response; no randomized trial has confirmed it12. Seven products list thymosin alpha-1 in the US supplement label database; Zadaxin is the marketed injectable abroad.
An FDA advisory committee briefing found a lack of evidence of effectiveness across these uses and raised concern about use after stem cell transplantation13. Per the Indonesian label, caution applies when combining it with other immune-modulating medications8.
Last updated October 17, 2026. Read how we make monographs.
In the full monograph
53 sources, 39 studies
- When to useThe situations practitioners use it for, each with the reason and the study behind it.
- SafetyWho should avoid it, who needs extra care, and the side effects reported in studies.
- InteractionsThe medicines and supplements it interacts with, the effect of each, and what labeling says to watch.
- Protocol notesThe doses used in studies, how and when they were taken, and how the forms on the market compare.
- How it worksWhat it is and how it works in the body, in plain terms.
- Published studiesThe studies behind each use, popular claims checked against them, and trials still under way.
- Word of mouthWhat patients and practitioners report online, kept separate from the clinical evidence.
- Clinical perspectiveA closing read of where the evidence is solid, where it is thin, and what has not been studied.
Sources
- 1The efficacy of thymosin α1 as immunomodulatory treatment for sepsis: a systematic review of randomized controlled trials.pubmed.ncbi.nlm.nih.govLiu, Wang, Wang et al. · BMC infectious diseases · 2016 · Pubmed
- 2Thymosin-ɑ1 for people with chronic hepatitis B.pubmed.ncbi.nlm.nih.govNaing, Ni, Aung et al. · The Cochrane database of systematic reviews · 2026 · Pubmed
- 3Safety and efficacy of Thymosin α1 in the treatment of hepatitis B virus-related acute-on-chronic liver failure: a randomized controlled trial.pubmed.ncbi.nlm.nih.govChen, Chen, Lei et al. · Hepatology international · 2022 · Pubmed
- 4Thymosin α1 improves the outcomes of patients with hepatitis B virus-related acute-on-chronic liver failure by restoring immune balance.pubmed.ncbi.nlm.nih.govLi, Wu, Zhu et al. · Immunopharmacology and immunotoxicology · 2026 · Pubmed
- 5Clinical efficacy and safety of synthetic thymic peptides with chemotherapy for non-small cell lung cancer in China: A systematic review and meta-analysis of 27 randomized controlled trials following the PRISMA guidelines.pubmed.ncbi.nlm.nih.govZeng, Xiao, Wang et al. · International immunopharmacology · 2019 · Pubmed
- 6Efficacy and safety of thymosin α1 combined with chemotherapy for gastric cancer: a systematic review and meta-analysis of randomized controlled trials.pubmed.ncbi.nlm.nih.govWang, Sun, Qu et al. · Frontiers in immunology · 2026 · Pubmed
- 7Efficacy of Thymosin α1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043).pubmed.ncbi.nlm.nih.govLiu, Qiu, Xi et al. · International journal of radiation oncology, biology, physics · 2022 · Pubmed
- 8Foreign drug labelema.europa.euThe label of a medicine with this ingredient approved outside the US (a regulator's Summary of Product Characteristics or prescribing information, or the manufacturer's official instructions). Labels in German, Italian or Russian are quoted in English translation, marked as translated. What one country approved for one product, not US approval
- 9Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma.pubmed.ncbi.nlm.nih.govMaio, Mackiewicz, Testori et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · Pubmed
- 10US statusfda.govWhat the FDA (its lists of substances nominated for pharmacy compounding, and Drugs@FDA) and the World Anti-Doping Agency's Prohibited List say about this ingredient, in their own words. A legal status, not evidence of benefit or harm
- 11Thymosin alpha1 based immunomodulatory therapy for sepsis: a systematic review and meta-analysis.pubmed.ncbi.nlm.nih.govLi, Bo, Liu et al. · International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2015 · Pubmed
- 12Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial.pubmed.ncbi.nlm.nih.govXu, Li, Li et al. · BMC medicine · 2026 · Pubmed
- 13FDA actionsfda.govFDA warning letters, import alerts and Pharmacy Compounding Advisory Committee documents that name this ingredient, in the FDA's words. Findings about products sold and a regulator's review, not evidence of harm from the ingredient itself