Ta1, Thymalfasin (research listing)
Evidence Grade B — Strong clinical evidence. 575 published studies, 344 human. 61 registered clinical trials.
Thymosin alpha-1 is an immune-modulating peptide originally isolated from the thymus gland. It has been studied extensively across conditions including hepatitis B, liver cancer, sepsis, and as a vaccine adjuvant. Its regulatory status varies widely by jurisdiction — it is used clinically in parts of Asia, Europe, and South America but has not been reviewed by the FDA or EMA.
575 published studies: 344 human, 185 animal, 123 in-vitro, 76 reviews
Thymosin alpha-1 has been studied across multiple indications including hepatitis B, hepatocellular carcinoma, sepsis, and as a vaccine adjuvant. A meta-analysis of hepatitis B trials reported a statistically significant treatment effect, but the largest individual Phase III trial did not reach significance.
The compound has been the subject of extensive clinical research but has not met FDA or EMA approval standards for any indication. Its regulatory status varies widely by jurisdiction — approved in over 35 countries, primarily in Asia and parts of Europe and South America. See also Thymalfasin (#74).
Research suggests thymosin alpha-1 may activate toll-like receptors on dendritic cells and influence T-cell differentiation. A meta-analysis of hepatitis B trials reported a significant treatment effect, though the pivotal Phase III trial did not confirm efficacy. The proposed immunomodulatory mechanisms are based on a combination of in vitro, animal, and clinical studies of varying quality.
Research suggests thymosin alpha-1 has been studied across multiple conditions including hepatitis B, liver cancer, sepsis, and as a vaccine adjuvant. A meta-analysis of hepatitis B trials reported a statistically significant treatment effect, but the largest individual Phase III trial did not reach significance. The largest sepsis trial (TESTS, 1,106 patients) was definitively negative on its primary endpoint. The disconnect between wide international approval (35+ countries) and rejection by the FDA and EMA reflects inconsistent efficacy across rigorous trials. The peptide is well-characterised scientifically and the mechanism (working through toll-like receptors on dendritic cells) is well-described, but clinical outcomes have not consistently matched the preclinical promise.
The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection
A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
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