Thymosin A1 Peptide (Tα₁) is a small, biologically active polypeptide consisting of 28 amino acid residues, which was originally isolated from mammalian thymic tissue-primarily from calf thymus. Characterized by a molecular formula (MF) of C129H215N33O55 and a unique CAS registry number of 62304-98-7, it stands out as one of the most well-studied and functionally potent members of the thymosin family. Its core biological function revolves around regulating cellular immune responses, a property that endows it with significant clinical value in treating immune deficiency disorders, combating various infectious diseases, and serving as an adjuvant therapeutic agent for tumor management.
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Thymosin A1 COA
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| Certificate of Analysis | ||
| Compound name | Thymosin A1 | |
| Grade | Pharmaceutical grade | |
| CAS No. | 62304-98-7 | |
| Quantity | 52kg | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090056 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.54% |
| Loss on drying | ≤1.0% | 0.42% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.90% |
| Single impurity | <0.8% | 0.52% |
| Total microbial count | ≤750cfu/g | 95 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 500ppm |
| Storage | Store in a sealed, dark, and dry place below -20°C | |
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In the treatment of infectious diseases
Thymosin A1 Peptide is mainly used for antiviral treatment of chronic hepatitis B, which can improve the rate of virological response and the probability of functional cure, especially for patients with poor immune response; In severe infections such as COVID-19, it can promote T cell proliferation, regulate inflammatory cytokine expression, thereby reducing all-cause mortality and shortening hospitalization time.
In the field of tumor therapy
It acts as an immune modulator to inhibit tumor progression by enhancing dendritic cell antigen presentation, promoting T cell proliferation, and natural killer cell activity; Recent research has focused on its combined use with immune checkpoint inhibitors (such as PD-1/PD-L1 inhibitors) and radiotherapy and chemotherapy.
For example, in the neoadjuvant therapy of solid tumors such as gastric cancer and colorectal cancer, it can improve complete remission rate and event free survival rate, while possibly reducing chemotherapy-induced immune suppression. In vaccine assisted applications, it can be used as an adjuvant to enhance vaccine efficacy by increasing antibody titers, accelerating immune response, or prolonging the protection period. It is particularly suitable for immunocompromised populations or low responders, and may achieve vaccine reduction to reduce adverse reactions.
In terms of immune deficiency diseases
It is used to treat immune dysfunction related diseases, improving patient prognosis by correcting T cell subpopulation imbalance and enhancing immune surveillance function; In addition, its regulatory role in autoimmune and allergic diseases has also received attention, but further research is needed to verify it.
Molecular Composition and Structural Characteristics
It is a linear polypeptide composed of 28 amino acid residues, with the amino acid sequence of Ac-Ser-Asp-Ala-Ala-Val-Asp-Thr-Ser-Ser-Glu-Ile-Thr-Thr-Lys-Asp-Leu-Lys-Glu-Lys-Lys-Glu-Val-Val-Glu-Glu-Ala-Glu-Asn-OH. Its N-terminus is acetylated, a modification critical for maintaining its biological activity and structural stability. The molecule contains no disulfide bonds and exists as a single-chain structure overall.
Molecular Weight and Isoelectric Point
The theoretical molecular weight of it is approximately 3108 Da, and its isoelectric point (pI) is 4.2, classifying it as an acidic polypeptide. It tends to carry a negative charge in neutral or weakly alkaline environments, and can be separated and purified by methods such as ion exchange chromatography.
Solubility and Stability
It has good water solubility and is easily dissolved in polar solvents like water and normal saline, but poorly soluble in organic solvents such as methanol and ethanol. Its structural stability is affected by temperature and pH: it can be stably stored under refrigerated conditions (2–8℃). High temperatures (>60℃) or extreme pH conditions (strong acid/strong alkali) will cause conformational changes in the polypeptide chain, thereby leading to the loss of biological activity.
Feasibility of Chemical Synthesis
Thymosin a1 peptide can be prepared by solid-phase peptide synthesis or genetic engineering technology. In solid-phase synthesis, precise synthesis is achieved through the stepwise coupling of amino acid residues. For genetic engineering expression, Escherichia coli is mostly used as the host, and the target polypeptide is expressed via recombinant plasmids. Both methods can yield high-purity it, and the chemical structure of the synthetic product is consistent with that of natural extracts.
Reaction Characteristics
As a polypeptide substance, it can undergo hydrolysis with proteases and be decomposed into small-molecule amino acid fragments. The functional groups in its molecule, such as carboxyl and amino groups, can participate in conventional peptide bond formation reactions, and can also bind to certain modification reagents for targeted modification (e.g., fluorescent labeling, PEGylation) to expand its application scenarios.
Regulating the Differentiation and Activation of T Lymphocytes
It induces the differentiation of precursor T cells in the thymus into CD4⁺ helper T cells and CD8⁺ cytotoxic T cells, enhances the expression efficiency of receptors on the surface of mature T cells, promotes the secretion of key cytokines such as interferon-γ and interleukin-2, and improves the ability of T cells to recognize and eliminate antigens.
Enhancing the Killing and Antigen-presenting Functions of Innate Immune Cells
It increases the targeted killing activity of natural killer cells (NK cells) against virus-infected cells and tumor cells, promotes the maturation process of dendritic cells, enhances their antigen-presenting ability, and builds a response bridge between innate immunity and adaptive immunity.
Improving the Immune Suppression State of the Organism
For immune insufficiency caused by chemotherapy, radiotherapy or chronic infections, it can effectively restore the quantity and function of immune cells, reduce the risk of secondary infections, and maintain the immune homeostasis of the organism.
Modulating the Balance of Immune Response
It precisely regulates the response ratio of Th1/Th2 cells, inhibits the apoptosis of abnormally activated immune cells, alleviates the pathological damage related to autoimmune diseases or immune disorders, and maintains the stable operation of the immune system.
Administration and Safety
Main Administration Routes
Subcutaneous injection is the preferred administration route in clinical practice, which is easy to operate and ensures stable drug absorption. In addition, for severe infections or specific treatment needs, intravenous injection or nebulized inhalation can also be explored, and the specific route should be adjusted by clinicians according to the indications and individual conditions of patients.
Local Adverse Reactions
The incidence of local reactions after medication is relatively low, mainly manifested as mild pain, redness, induration or itching at the injection site. These reactions are mostly temporary, do not require special treatment, and usually resolve spontaneously within 1-3 days after drug withdrawal.
Systemic Adverse Reactions
Systemic adverse reactions are relatively rare, with occasional mild symptoms such as low-grade fever, fatigue, dizziness or muscle soreness. The symptoms are mostly mild and will not affect the continuation of medication. If persistent high fever or severe discomfort occurs, timely drug withdrawal and medical evaluation are required.
Contraindicated and Special Populations Requiring Caution
Patients allergic to thymosin a1 peptide or any component in the preparation are absolutely contraindicated and prohibited from use; pregnant women, lactating women, children and special populations with severe immune deficiency need to use it with caution. The benefits and risks should be fully evaluated before medication, and physical indicators should be closely monitored during the medication period.
Development of Novel Administration Routes and Dosage Forms
Currently, injection is the main clinical dosage form, and the future R&D focus will be on oral, sublingual or long-acting sustained-release preparations. These dosage forms can reduce the pain and operational threshold of injection administration, improve patient medication compliance, and are particularly suitable for chronic disease populations requiring long-term immunomodulatory therapy.
Expansion of Clinical Indication Application Scope
Beyond the existing applications in viral hepatitis and adjuvant tumor therapy, the potential value of it in COVID-19, autoimmune diseases, neurodegenerative diseases and other fields will be further explored. Through the optimization of combination medication regimens, it is expected to become a therapeutic option for more immune-related diseases.
Optimization and Upgrading of Combined Immunotherapy Regimens
The synergistic effects of it combined with immune checkpoint inhibitors, targeted drugs, tumor vaccines and other agents will be thoroughly studied. By regulating the body's immune microenvironment, it can enhance the therapeutic effects of anti-tumor and anti-viral treatments, providing new ideas for overcoming refractory tumors and chronic infectious diseases.
Breakthroughs in Localized and Low-cost Production Technologies
With the advancement of genetic engineering and solid-phase peptide synthesis technologies, the production process of domestic it will be continuously optimized, and the production cost will be gradually reduced. This can improve drug accessibility and meet the clinical medication needs of more primary medical institutions and developing countries.
Preliminary Exploration of Thymus Extracts
In the 1960s and 1970s, immunology research focused on the immunomodulatory role of the thymus. Scientists extracted crude thymosin mixtures from the thymus tissues of animals such as cattle and pigs, and found that these extracts could promote lymphocyte proliferation and restore immune function in immunodeficient animals, laying the foundation for the subsequent isolation of bioactive peptides.
Isolation, Purification and Structural Identification of it
In 1977, the research team led by American scientist Alan L. Goldstein isolated a group of highly bioactive peptides from thymus extracts. Through chromatography and amino acid sequencing analysis, they identified the complete sequence of a peptide composed of 28 amino acids, named it thymosin a1 peptide, and discovered that its N-terminal acetylation modification is the key structural feature for maintaining biological activity.
In-depth Verification of Bioactivity Mechanism
From the 1980s to the 1990s, researchers verified the core functions of it through in vitro cell experiments and animal models, confirming that it could specifically induce the differentiation and maturation of precursor T cells, enhance the killing activity of NK cells, and had no obvious toxic and side effects. This clarified its action targets and molecular mechanism as an immunomodulator, providing a theoretical basis for clinical translation.
Artificial Synthesis and Clinical Application Transformation
After the 1990s, with the development of genetic engineering technology and solid-phase peptide synthesis technology, researchers successfully achieved the artificial synthesis of it, solving the problems of low purity and large batch differences of natural extracts. In 1997, synthetic it was first approved for marketing in Italy for the adjuvant treatment of chronic hepatitis B, and then gradually expanded to multiple clinical fields such as tumors and immunodeficiency diseases.
F A Q
What does the product do?
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It has a very prominent role in both immunity control and inflammation (Table 2). So far, it has been used in various pathologic conditions: Infections, sepsis, immune deficiencies and malignancies, just to name a few.
What are the side effects of the product?
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As with all injections, redness and pain at the site of injection may be present. Rare adverse reactions include erythema, transient muscle atrophy, polyarthralgia combined with hand edema, and rash. A transient increase in ALT to more than twice baseline value can occur during it therapy.
Is it the same as TB500?
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While it is heavily involved in immune function, Thymosin Beta-4-more commonly known as TB-500-focuses on cellular migration and tissue repair. Researchers studying wound healing, muscle repair, or injury recovery often compare these peptides for their complementary roles.
Is the product legal?
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As of now, substances like BPC-157, Tα1, TB-500 (Thymosin β4 fragment), CJC-1295, Ipamorelin, AOD-9604, GHK-Cu (injectable), Melanotan II, KPV, Selank, Semax, and others are essentially off-limits to compound (unless and until FDA changes their status)
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