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Statements

Subject Item
n2:DB04900
rdf:type
n3:Drug
n3:description
Thymalfasin is a chemically synthesized version of thymosin alpha 1 that is identical to human thymosin alpha 1. Thymosin alpha 1 is an acetylated polypeptide.Thymosin alpha 1 is now approved in 35 developing countries for the treatment of Hepatitis B and C. It is also used to boost the immune response in the treatment of other diseases.
n3:generalReferences
# Chien RN, Liaw YF: Thymalfasin for the treatment of chronic hepatitis B. Expert Rev Anti Infect Ther. 2004 Feb;2(1):9-16. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/15482167 # Sjogren MH: Thymalfasin: an immune system enhancer for the treatment of liver disease. J Gastroenterol Hepatol. 2004 Dec;19 Suppl 6:S69-72. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/15546253 # Liaw YF: Thymalfasin (thymosin-alpha 1) therapy in patients with chronic hepatitis B. J Gastroenterol Hepatol. 2004 Dec;19 Suppl 6:S73-5. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/15546254 # Sjogren MH: Thymalfasin: an immune system enhancer for the treatment of liver disease. J Gastroenterol Hepatol. 2004 Dec;19(12):S69-72. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/15641207 # Liaw YF: Thymalfasin (thymosin-alpha 1) therapy in patients with chronic hepatitis B. J Gastroenterol Hepatol. 2004 Dec;19(12):S73-5. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/15641208 # Vemuri S: Comparison of assays for determination of peptide content for lyophilized thymalfasin. J Pept Res. 2005 Apr;65(4):433-9. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/15813890 # Rustgi VK: Thymalfasin for the treatment of chronic hepatitis C infection. Expert Rev Anti Infect Ther. 2005 Dec;3(6):885-92. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/16307501 # Rustgi VK: Thymalfasin for the treatment of chronic hepatitis C infection. Ann N Y Acad Sci. 2007 Sep;1112:357-67. Epub 2007 Jun 28. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/17600289 # Gramenzi A, Cursaro C, Andreone P, Bernardi M: Thymalfasin: clinical pharmacology and antiviral applications. BioDrugs. 1998 Jun;9(6):477-86. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/18020580 # Pierluigi B, D'Angelo C, Fallarino F, Moretti S, Zelante T, Bozza S, De Luca A, Bistoni F, Garaci E, Romani L: Thymosin alpha1: the regulator of regulators? Ann N Y Acad Sci. 2010 Apr;1194:1-5. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/20536444
n3:group
investigational approved
n3:halfLife
Approximately 2 hours. There is no evidence of accumulation following multiple subcutaneous doses.
n3:indication
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.
owl:sameAs
n11:DB04900 n14:DB04900
dcterms:title
Thymalfasin
adms:identifier
n13:PA164748387 n15:DB04900
n3:mechanismOfAction
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.
n3:synonym
Zadaxin Talpha1 Thymalfasin Thymosin alpha 1 Thymosin alpha1 Valopicitabine
n3: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.
n3:synthesisReference
Christian Birr, Ulrich Stollenwerk, "Method of preparing thymosin alpha 1 and derivatives thereof." U.S. Patent US4466918, issued April, 1979.
n5:hasConcept
n6:M0086869
foaf:page
n8:zadaxin.htm
n3:Molecular-Formula
n9:271B5E31-363D-11E5-9242-09173F13E4C5
n3:Molecular-Weight
n9:271B5E30-363D-11E5-9242-09173F13E4C5
n3:absorption
Rapidly absorbed with peak serum levels achieved at approximately 2 hours.
n3:affectedOrganism
Humans and other mammals
n3:casRegistryNumber
62304-98-7
n3:category