Thymosin Alpha 1: Research Applications
🦠 Viral Infections (Hepatitis B & C)
Tα1 is most established for chronic Hepatitis B (CHB) and Hepatitis C (CHC). Clinical data demonstrates induction of HBeAg seroconversion, ALT normalization, and viral suppression, with synergistic effects when combined with interferon-alpha or nucleoside analogs. [5]
🎯 Oncology (Solid Tumors)
Research demonstrates efficacy in malignant melanoma, hepatocellular carcinoma (HCC), and NSCLC. Tα1 is used as an adjuvant to chemotherapy (e.g., dacarbazine) or immunotherapy (e.g., ipilimumab), reducing tumor growth, increasing survival, and mitigating chemo-induced toxicity. [14] [15]
🏥 Sepsis
In severe sepsis, Tα1 reverses immunosuppression by upregulating HLA-DR expression on monocytes and preventing lymphocyte apoptosis. The ETASS trial (n=361) showed 26% vs 35% mortality (P=0.049). [16]
🦠 COVID-19 / SARS
During the COVID-19 pandemic, Tα1 was used in severe cases to restore lymphocytopenia and reverse T-cell exhaustion. A Wuhan retrospective study (n=76) showed 11.1% vs 58.8% mortality in severe cases. [17]
💉 HIV/AIDS
Studied as adjunct to HAART, facilitating immune reconstitution by increasing CD4+ T-cell counts and sjTRECs (markers of thymic output). [18]
💉 Vaccine Adjuvant
Enhances immunogenicity of influenza, H1N1, and HBV vaccines, particularly in immunocompromised populations (elderly, hemodialysis study subjects). In hemodialysis study subjects, 89% vs 53% seroconversion with H1N1 vaccine (P<0.01). [19]
🫁 Cystic Fibrosis (CF)
Tα1 has shown potential to correct maturation/activity of mutated F508del-CFTR protein while simultaneously reducing lung inflammation, though reproducibility has been debated. [20]
🍄 Fungal & Bacterial Infections
Activates dendritic cells for Th1 resistance against invasive aspergillosis and enhances resistance to Pseudomonas in bone marrow transplant settings. [4]
🔬 Autoimmune Diseases
study subjects with psoriatic arthritis, rheumatoid arthritis, and SLE exhibit lower serum Tα1 levels. Administration may restore immune homeostasis and regulate inflammation. [21]
References
- Dominari A, Hathaway III D, Pandav K, et al. Thymosin alpha 1: A comprehensive review of the literature. World J Virol, 9(5), 67-78, 2020.
- Goldstein AL, Low TL, McAdoo M, et al. Thymosin alpha1: Isolation and sequence analysis of an immunologically active thymic polypeptide. Proc Natl Acad Sci USA, 74(2), 725-729, 1977.
- Li J, Liu CH, Wang FS. Thymosin alpha 1: biological activities, applications and genetic engineering production. Peptides, 31(11), 2151-2158, 2010.
- Romani L, Bistoni F, Gaziano R, et al. Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through toll-like receptor signaling. Blood, 103(11), 4232-4239, 2004.
- King R, Tuthill C. Immune Modulation with Thymosin Alpha 1 research application. Vitamins and Hormones, 102, 151-178, 2016.
- Pica F, Chimenti MS, Gaziano R, et al. Serum thymosin alpha 1 levels in study subjects with chronic inflammatory autoimmune diseases. Clin Exp Immunol, 186(1), 39-45, 2016.
- FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Tolerability Concerns. U.S. Food and Drug Administration, 2025.
- Elizondo-Riojas MA, Chamow SM, Tuthill CW, et al. NMR structure of human thymosin alpha-1. Biochem Biophys Res Commun, 416(3-4), 356-61, 2011.
- Billich A. Thymosin alpha1. SciClone Pharmaceuticals. Curr Opin Investig Drugs, 3(5), 698-707, 2002.
- Garaci E. Thymosin alpha1: a historical overview. Ann N Y Acad Sci, 1112, 14-20, 2007.
- Tao N, Xu X, Ying Y, et al. Thymosin alpha1 and Its Role in Viral Infectious Diseases: The Mechanism and Clinical Application. Molecules, 28(8), 3539, 2023.
- Romani L, Bistoni F, Perruccio K, et al. Thymosin alpha1 activates dendritic cell tryptophan catabolism and establishes a regulatory environment for balance of inflammation and tolerance. Blood, 108(7), 2265-74, 2006.
- Serafino A, Pica F, Andreola F, et al. Thymosin alpha1 Activates Complement Receptor-Mediated Phagocytosis in Human Monocyte-Derived Macrophages. J Innate Immun, 6(1), 72-88, 2014.
- Maio M, Mackiewicz A, Testori A, et al. Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in study subjects with metastatic melanoma. J Clin Oncol, 28(10), 1780-1787, 2010.
- Costantini C, Bellet MM, Pariano M, et al. A Reappraisal of Thymosin Alpha1 in Cancer Therapy. Front Oncol, 9, 873, 2019.
- Wu J, Zhou L, Liu J, et al. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Critical Care, 17(1), R8, 2013.
- Liu Y, Pan Y, Hu Z, et al. Thymosin alpha-1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells. Clin Infect Dis, 71(16), 2150-2157, 2020.
- Matteucci C, Grelli S, Balestrieri E, et al. Thymosin alpha 1 and HIV-1: recent advances and future perspectives. Future Microbiol, 12, 141-155, 2017.
- Carraro G, Naso A, Montomoli E, et al. Thymosin-alpha 1 (Zadaxin) enhances the immunogenicity of an adjuvanted pandemic H1N1v influenza vaccine. Vaccine, 30(11), 2001-2004, 2012.
- Romani L, Oikonomou V, Moretti S, et al. Thymosin alpha1 represents a potential potent single-molecule-based experimental protocol for cystic fibrosis. Nat Med, 23(5), 590-600, 2017.
- Pica F, Chimenti MS, Gaziano R, et al. Serum thymosin alpha 1 levels in chronic inflammatory autoimmune diseases. Clin Exp Immunol, 186(1), 39-45, 2016.
- Peng R, Xu C, Zheng H, et al. Modified Thymosin Alpha 1 Distributes and Inhibits the Growth of Lung Cancer in Vivo. ACS Omega, 5(18), 10374-10381, 2020.
- Garaci E, Mastino A, Pica F, Favalli C. Combination research application using thymosin alpha 1 and interferon after cyclophosphamide is able to experimental endpoint Lewis lung carcinoma in mice. Cancer Immunol Immunother, 36(5), 355-359, 1993.
- Simonova MA, Ivanov I, Shoshina NS, et al. Aging and Thymosin Alpha-1. Int J Mol Sci, 26(23), 11470, 2025.
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