Thymosin Alpha-1

Batch #432421Batch #432421
Report #53459Report #53459
Tested at 7.04mgTested at 7.04mg
Size: 5mg
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RESEARCH USE ONLY
These compounds are NOT intended for human consumption, clinical use, or veterinary applications. We are not affiliated with any pharmaceutical companies or their commercial medications. By placing an order, you certify these materials will be used exclusively for in vitro testing and laboratory experimentation only. Bodily introduction of any kind into humans or animals is strictly forbidden by law. This product should only be handled by licensed, qualified professionals. This product is not a drug, food, or cosmetic and may not be misbranded, misused or mislabeled as a drug, food or cosmetic.

About Thymosin Alpha-1

Thymosin Alpha 1 is a synthetic peptide that has been studied for its role in modulating immune pathways and cellular processes. Research has explored its potential applications in areas such as immune response cellular signaling and mechanisms related to homeostasis and tissue dynamics. Its properties have made it a focus of interest in studies involving regulatory functions within biological systems.

Thymosin Alpha-1 Product Specifications

Lyophilized Powder in 3ml vial.

Application

Research peptide with potential in immune system modulation

Appearance

Solid, white powder in 3mL glass ampule

Chemical Formula

C129H215N33O55

PubChem CID

16130571

CAS Number

62304-98-7

Molecular Weight

3108.31 g/mol

Synonyms

TA1, Thymalfasin

Storage

Store at ≤6°C, sealed, away from heat, light, and moisture.

Thymosin Alpha 1 Research

1) Clinical Overview

Thymosin alpha 1 (Ta1, thymalfasin) is a 28–amino acid thymic peptide that functions as an immunomodulator. It enhances T-cell and dendritic-cell activity, biases responses toward Th1 immunity, up-regulates antigen presentation (e.g., MHC-I), and modulates Toll-like receptor (TLR)–dependent signaling (notably TLR9 and TLR2) to increase cytokines such as IL-2 and interferons. Ta1 has been marketed internationally (as Zadaxin®/thymalfasin) but is not FDA-approved in the United States; historical company filings note approvals in >30 countries, primarily in Asia, the Middle East, and Latin America.

 

2) Human Clinical Findings

Chronic Hepatitis B (CHB)

In HBeAg-positive CHB, adding Ta1 (1.6 μg three times weekly) to interferon showed a trend toward higher HBeAg loss vs interferon alone at 72 weeks (45.8% vs 28.0%; difference 17.8%, P=0.067), without significant differences in secondary endpoints. In anti-HBe, HBV-DNA–positive CHB, a randomized study of Ta1 monotherapy vs no treatment found no increase in major virologic response rates, though ALT reductions were observed and treatment was well tolerated.

Sepsis

The multicenter ETASS randomized trial (n=361 severe sepsis) reported lower 28-day mortality with Ta1 vs control (26.0% vs 35.0%; RR 0.74, 95% CI 0.54–1.02; log-rank P=0.049) and improved monocyte HLA-DR recovery; no serious drug-related adverse events were recorded. However, a large 2024 randomized trial (“TESTS,” BMJ) did not show a mortality reduction at 28 days (authors concluded no clear evidence Ta1 decreases 28-day mortality) .

Viral vaccine adjuvant

Reviews and small clinical/pilot studies (e.g., hemodialysis or immunocompromised cohorts) suggest Ta1 can enhance influenza vaccine immunogenicity, though many studies are small or single-center and heterogeneous in endpoints. FDA staff’s 2024 synthesis likewise characterizes the vaccine-adjuvant evidence as limited and variable in quality.

COVID-19 (observational and meta-analyses)

Evidence is mixed: a 2022 meta-analysis found no statistically significant benefit of Ta1 on mortality in hospitalized adults overall, while other analyses suggest signals in certain subgroups but emphasize the need for RCTs. A multicenter cohort reported association with worse “non-recovery” when confounding was accounted for, underscoring uncertainty and timing/selection biases.

 

3) Mechanism & Effects

Ta1 promotes dendritic-cell maturation and antigen presentation via TLR9/MyD88 pathways, priming Th1 responses and IFN signaling; it also modulates MAPK/NF-κB cascades and increases MHC-I/viral-antigen expression, improving immune recognition of infected or malignant cells. These mechanisms underpin its study as an adjunct in infections (HBV/HCV, sepsis), vaccine adjuvancy, and oncology combinations.

4) Safety & Considerations

Across controlled studies and reviews, Ta1 is generally well tolerated; common issues are mild local injection reactions and transient flu-like symptoms when combined with interferon. ETASS reported no serious drug-related adverse events. Narrative reviews summarize a favorable short-term safety profile across varied indications.

Regulatory status

Ta1 is not FDA-approved; U.S. FDA compounding reviews (2024) summarize proposed uses and highlight limitations of the clinical evidence for several indications.

Evidence quality

While immunologic endpoints are reproducible, clinical outcome data are mixed or limited outside specific contexts (e.g., inconsistent results in sepsis and COVID-19; modest or nonsignificant effects in CHB monotherapy). Ta1 should be investigated within rigorously designed research protocols.

 

References

  1. Lim SG, et al. Antivir Ther. 2006. Randomized, placebo-controlled Ta1 + interferon vs interferon alone in HBeAg-positive CHB.
  2. Zavaglia C, et al. Dig Dis Sci. 2000. Randomized Ta1 monotherapy vs no treatment in anti-HBe, HBV-DNA–positive CHB.
  3. Wu J, et al. ETASS trial. Crit Care. 2013. Severe sepsis RCT; registry NCT00711620.
  4. BMJ TESTS Trial. 2024. Randomized sepsis trial reporting no clear 28-day mortality benefit .
  5. Dominari A, et al. World J Exp Med. 2020. Comprehensive mechanistic and clinical review.
  6. Bozza S, et al. Int Immunol. 2007. TLR9/MyD88/IRF7-dependent DC priming by Ta1; Romani L, et al. Blood. 2004. DC activation and Th1 priming.
  7. Ershler WB, Carraro G, et al. Vaccine-adjuvant data for influenza (reviews/trials); FDA 2024 review of adjuvant evidence.
  8. Shang W, et al. 2022 meta-analysis: no overall mortality benefit in adult COVID-19.
  9. SciClone 10-K (2004/2005): international approvals and non-U.S. marketing of Zadaxin®.

 

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