Evidence Grade C — Moderate human evidence. 57 published studies, 37 human. 0 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 0 registered clinical trials for Thymalfasin sourced from ClinicalTrials.gov.
No trials registered on ClinicalTrials.gov for this compound.
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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Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis. Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.
Zilucoplan is marketed as Zilbrysq (approved October 2023) for anti-acetylcholine receptor antibody-positive generalised myasthenia gravis in adults. Administered as a daily subcutaneous self-injection. In the RAISE trial, zilucoplan showed statistically significant improvements in both activities of daily living and quantitative muscle strength scores compared to placebo, with improvements evident from week one. Its key differentiator from existing complement inhibitors (eculizumab, ravulizumab) is the self-injectable format — those alternatives require hospital-based intravenous infusions. As with all complement inhibitors, patients require meningococcal vaccination before starting treatment due to increased susceptibility to meningococcal infection.
Daptomycin is marketed as Cubicin (approved September 2003). It is indicated for complicated skin and soft tissue infections and S. aureus bloodstream infections including right-sided endocarditis. Administered as a once-daily intravenous infusion. A key limitation is that daptomycin cannot be used for pneumonia — lung surfactant inactivates the drug. In the bacteraemia trial, daptomycin was non-inferior to vancomycin with significantly lower rates of kidney problems (11% versus 26%). Creatine kinase (CK) levels must be monitored during treatment, as daptomycin can cause muscle toxicity. Generics became available after patent expiry, significantly reducing cost.
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.
