Evidence Grade C — Moderate human evidence. 57 published studies, 37 human. 61 registered clinical trials.
Medically reviewed by a licensed medical professional
Thymalfasin (thymosin alpha-1) is a synthetic immune-modulating peptide originally isolated from the thymus gland. It has been studied for hepatitis B, cancer, and sepsis, among other conditions. Its regulatory status varies dramatically by country — used clinically in parts of Asia, Europe, and South America but never reviewed by the FDA or EMA.
Thymalfasin is also known by these brand and alternate names:
57 published studies: 37 human, 1 animal, 2 in-vitro, 13 reviews
Thymalfasin has been marketed as Zadaxin in countries where it holds approval, but it has not been approved by the FDA or EMA. It has been studied in hepatitis B, hepatocellular carcinoma, and sepsis, among other conditions.
Clinical trial data exists from multiple studies, but no pivotal Phase III trial has met the evidentiary standards required for FDA approval. Its regulatory status varies significantly by jurisdiction. Any claims about its clinical effects should be interpreted in the context of the evidence level available and the absence of approval by major Western regulatory agencies.
Research suggests thymalfasin may interact with toll-like receptors on dendritic cells and influence T-cell differentiation pathways. The proposed mechanisms are based primarily on in vitro and animal model data. The compound's immunological effects and their clinical significance in humans remain areas of ongoing investigation.
Research suggests thymalfasin has been studied in multiple conditions but no single pivotal Phase III trial has met the evidentiary standards required by the FDA. The safety profile appears very favourable — injection site reactions and mild flu-like symptoms are the most commonly reported effects. The disconnect between wide international use (35+ countries) and absence of FDA/EMA review reflects the heterogeneous quality of international clinical trial data and different regulatory standards across jurisdictions. The immunological mechanism (working through toll-like receptors on dendritic cells) is well-described, but clinical outcomes have been inconsistent.
PeptideTrace tracks 61 registered clinical trials for Thymalfasin sourced from ClinicalTrials.gov.
A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
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
Thymalfasin (thymosin alpha-1) is a 28-amino-acid acetylated peptide (MW 3,108 Da) from thymic tissue, discovered 1977. N-terminal Ac-Ser, highly conserved. Approved in >35 countries (China, India, several EU/Asian) but never FDA-approved. SC 1.6 mg 1-2x weekly. Half-life ~2 hours.
Research suggests activation of TLR2/TLR9 on dendritic cells promoting maturation, antigen presentation, IL-12 production. Enhances T-cell differentiation, increasing CD4+/CD8+ populations, Th1 polarization. Stimulates NK cytotoxicity and antibody responses. Additional: macrophage oxidative burst, HSC differentiation, Treg/IDO pathway modulation.
Marketed as Zadaxin in approved countries (not FDA-approved). HBV trials (N=~2,000): HBeAg seroconversion ~40-50% combined with IFN vs. 20-25% IFN alone. HCC adjuvant (N=236): recurrence 33.0% vs. 49.2% (P=0.024). Sepsis RCT (N=361, CCM 2018): 28-day mortality 15.0% vs. 26.8% (HR 0.50, P=0.005). Extensively researched during COVID-19. SciClone NDA not FDA-approved.
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
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This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.
