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Thymalfasin | CAS No: 62304-98-7 | GMP-certified suppliers
A medication that supports improved immune responses to influenza and hepatitis B vaccination in older adults and hemodialysis patients with inadequate prior immunization.
Therapeutic categories
Primary indications
- Indicated as an adjuvant for influenza vaccine in elderly patients and as an adjuvant for both influenza and hepatitis B vaccines in chronic hemodialysis patients who failed to achieve adequate antibody titers from previous immunization
Product Snapshot
- Thymalfasin is an injectable peptide supplied as a lyophilized powder for intramuscular or subcutaneous administration
- It is used as an immunomodulatory adjuvant to enhance vaccine response in elderly populations and in hemodialysis patients with inadequate antibody titers to influenza or hepatitis B vaccination
- It is currently investigational with no FDA or EMA marketing approval
Clinical Overview
Thymalfasin exhibits pharmacodynamic activity focused on T‑cell–mediated immunity. In vitro studies show enhanced T‑cell differentiation and maturation with increases in CD3+, CD4+, and CD8+ subsets. It stimulates production of Th1‑type cytokines including interferon gamma and interleukin‑2 and promotes expression of the interleukin‑2 receptor following activation. Additional findings include increased natural killer cell cytotoxicity, enhanced responses to T‑cell‑dependent antigens, and protection of thymocytes from dexamethasone‑induced apoptosis. Upregulation of toll‑like receptors such as TLR2 and TLR9 in dendritic cells and activation of NF‑kB and JNK/P38/AP1 signaling pathways provide further mechanistic context for its immunomodulatory and antiviral effects.
The mechanism of action is not fully defined but is broadly attributed to augmentation of cellular immune function, including effects on thymocyte maturation and activation of pluripotent precursor cells. In vivo animal models demonstrate protective effects against chemotherapy‑ or irradiation‑induced immunosuppression and reduced susceptibility to opportunistic infections, though these findings are model‑specific.
Absorption, distribution, metabolism, and excretion characteristics are not comprehensively defined in clinical literature. Safety experience reflects its use as an immunomodulator, with attention to immune activation effects and the need for monitoring in populations with altered immune status.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of peptide synthesis, impurity profiles, and consistency of sequence fidelity, as well as robust quality documentation aligned with global regulatory expectations.
Identification & chemistry
| Generic name | Thymalfasin |
|---|---|
| Molecule type | Biotech |
| CAS | 62304-98-7 |
| UNII | W0B22ISQ1C |
| DrugBank ID | DB04900 |
Pharmacology
| Summary | Thymalfasin is a synthetic 28‑amino‑acid peptide that modulates immune function primarily through enhancing T‑cell differentiation, maturation, and activation. It promotes Th1‑type cytokine production, augments natural killer cell activity, and influences dendritic cell signaling pathways such as TLR2/TLR9 and NF‑kB. These coordinated actions support its use as an immunologic adjuvant to improve vaccine responsiveness. |
|---|---|
| Mechanism of action | The mechanism of action of thymalfasin is not completely understood but is thought to be related to its immunomodulating activities, centered primarily around augmentation of T-cell function. In various in vitro assays, thymosin alpha 1 has been shown to promote T-cell differentiation and maturation; for example, CD4+, CD8+, and CD3+ cells have all been shown to be increased. Thymosin alpha 1 has also been shown to increase production of IFN-g, IL-2, IL-3, and expression of IL-2 receptor following activation by mitogens or antigens, increase NK cell activity, increase production of migratory inhibitory factor (MIF), and increase antibody response to T-cell dependent antigens. Thymosin alpha 1 has also been shown to antagonize dexamethasone-induced apoptosis of thymocytes in vitro. In vivo administration of thymosin alpha 1 to animals immunosuppressed by chemotherapy, tumor burden, or irradiation showed that thymosin alpha 1 protects against cytotoxic damage to bone marrow, tumor progression and opportunistic infections, thereby increasing survival time and number of survivors. Many of the in vitro and in vivo effects of thymosin alpha 1 have been interpreted as influences on either differentiation of pluripotent stem cells to thymocytes or activation of thymocytes into activated T-cells. Thymalfasin also has been shown in vitro to upregulate expression of toll like receptors (TLR) including TLR2 and TLR9 in mouse and human dendritic cells, as well as activate NF-kB and JNK/P38/AP1 pathways. Thymalfasin's activation of dendritic cells provides another possible pathway explaining thymalfasin's immunomodulatory and antiviral effects. |
| Pharmacodynamics | Thymalfasin is a 28-amino acid polypeptide produced synthetically but originally isolated from thymosin fraction 5, a bovine thymus extract containing a number of immunologically active peptides. In vitro studies have shown that Thymalfasin can influence T-cell production and maturation, stimulate production of Th1 cytokines such as interferon-gamma and interleukin-2, and activate natural killer cell-mediated cytotoxicity. |
ADME / PK
| Absorption | Rapidly absorbed with peak serum levels achieved at approximately 2 hours. |
|---|---|
| Half-life | Approximately 2 hours. There is no evidence of accumulation following multiple subcutaneous doses. |
Formulation & handling
- Lyophilized peptide requires reconstitution with suitable diluent and protection from proteolytic degradation during processing and storage.
- Formulated exclusively for parenteral use (IM/SC), with sensitivity to thermal stress and moisture necessitating low‑temperature, low‑humidity handling.
- As a biotech peptide, adsorption to surfaces and oxidation should be controlled through appropriate container materials and antioxidant or stabilizing excipients.
Regulatory status
Safety
| Toxicity | There are no reported instances of deliberate or accidental overdosage in humans. Animal toxicology studies have shown no adverse reactions in single doses up to 20 mg/kg and in repeated doses up to 6 mg/kg/day for 13 weeks, which were the highest doses studied. The highest single dose tested in animals represents 800-times the clinical dose. |
|---|
- Animal studies showed no adverse reactions at single doses up to 20 mg/kg or repeated doses up to 6 mg/kg/day for 13 weeks, indicating a wide toxicological safety margin relative to clinical exposure
- The highest single dose evaluated in animals (20 mg/kg) was approximately 800-fold higher than the human clinical dose, with no dose-limiting toxicities observed
- No documented cases of human overdosage have been reported, and available data do not indicate acute toxicity concerns under intended handling and manufacturing conditions
Thymalfasin is a type of Immunostimulants
Immunostimulants are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in bolstering the immune system. These substances, also referred to as immunomodulators, are designed to enhance the body's natural defense mechanisms and promote a more robust immune response. Immunostimulants are widely used in the development of drugs and vaccines, particularly for the treatment and prevention of infectious diseases.
These pharmaceutical compounds work by activating various components of the immune system, such as macrophages, natural killer cells, and T-cells. By stimulating these immune cells, immunostimulants help in improving the body's ability to recognize and eliminate pathogens, thereby reducing the risk of infection and enhancing overall health.
Immunostimulants can be derived from various sources, including synthetic chemicals, plant extracts, and biological agents. Examples of commonly used immunostimulants include interferons, interleukins, and Toll-like receptor (TLR) agonists. These substances can be administered through different routes, such as oral ingestion, injection, or topical application, depending on the desired therapeutic effect.
Pharmaceutical companies invest significant resources in the research and development of immunostimulant APIs due to their potential to revolutionize disease management. By harnessing the power of the immune system, these APIs offer promising solutions for various medical conditions, including viral infections, cancer, and autoimmune disorders.
In conclusion, immunostimulants are a critical subcategory of pharmaceutical APIs that stimulate the immune system to enhance its defense mechanisms. Their use holds great potential in the prevention and treatment of various diseases, making them an essential focus for pharmaceutical research and development.
Thymalfasin (Immunostimulants), classified under Immunomodulators
Immunomodulators, a category of pharmaceutical active pharmaceutical ingredients (APIs), are substances that help regulate and modify the immune response of an individual. These compounds play a crucial role in treating various immune-related disorders and diseases. Immunomodulators work by either enhancing or suppressing the immune system, depending on the specific condition being treated.
Immunomodulators are used in the treatment of autoimmune disorders, such as rheumatoid arthritis, multiple sclerosis, and psoriasis. By suppressing the immune system, these APIs help reduce the overactive immune response associated with these conditions, thereby alleviating symptoms and preventing further damage to the body's tissues.
On the other hand, immunomodulators are also employed to boost the immune system in cases of immunodeficiency disorders. These APIs stimulate the immune response, enabling the body to better fight off infections and diseases. Additionally, immunomodulators are utilized in the prevention and treatment of organ transplant rejection, where they help modulate the immune system to accept the transplanted organ.
The development and production of immunomodulators require rigorous testing and quality control to ensure their safety and efficacy. Pharmaceutical companies carefully formulate these APIs into various dosage forms, including tablets, capsules, injections, and topical preparations, to cater to different patient needs.
In summary, immunomodulators form a vital category of pharmaceutical APIs that regulate and modify the immune system. With their ability to modulate immune responses, these compounds contribute significantly to the management and treatment of various immune-related disorders and diseases, improving the quality of life for many patients.
Thymalfasin API manufacturers & distributors
Compare qualified Thymalfasin API suppliers worldwide. We currently have 6 companies offering Thymalfasin API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Chengdu Shengnuo Biopharm... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 33 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hainan Shuangcheng | Producer | China | China | CoA | 11 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 34 products |
| Polypeptide Labs | Producer | Sweden | Unknown | CoA, USDMF | 21 products |
| Suzhou Tianma Pharma Grou... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, JDMF, KDMF, MSDS, USDMF | 25 products |
When sending a request, specify which Thymalfasin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Thymalfasin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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