U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Thymalfasin, a synthetic version of thymosin-α-1, a polypeptide (protein fragment) was being developed by SciClone Pharmaceuticals for the treatment of liver disease. SciClone developed and launched Thymalfasin, under the trade name Zadaxin, for the treatment of hepatitis B and hepatitis C virus infections. The drug is also being developed for the treatment of non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma. Thymalfasin exerts a dual action against infections: immune modulating and direct-acting effect. Thymalfasin exerts its immune-modulating activity through the interaction with Toll-like receptors (TLR), a group of proteins involved in the regulation of innate immunity, and in particular with TLR9 and TLR2 on dendritic cells (DCs) and precursor T-cells. Thymalfasin is also able to prevent a pro-inflammatory cytokine storm and possibly autoimmune events. Regarding direct-acting effects, Thymalfasin has been shown to increase the expression of MHC Class I and II, which are important for the antigen presentation and recognition by the immune system of the virally infected cells. v has also been shown to directly inhibit the in vitro growth of virally infected and cancer cells. Thymalfasin is not approved by the FDA but it is widely used in China and some other countries.

Approval Year

PubMed

PubMed

TitleDatePubMed
Thymosinalpha1 stimulates cell proliferation by activating ERK1/2, JNK, and increasing cytokine secretion in human pancreatic cancer cells.
2007-04-08
Future therapies for hepatitis C: where do we go from here?
2007-02
Melatonin is responsible for the nocturnal increase observed in serum and thymus of alpha1-thymosin and thymulin concentrations: observations in rats and humans.
2007-02
Hepatitis B virus genotype B is associated with better response to thymosin alpha1 therapy than genotype C.
2006-12
Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: a randomized controlled study.
2006-11-07
Synthesis and pharmacokinetics of valopicitabine (NM283), an efficient prodrug of the potent anti-HCV agent 2'-C-methylcytidine.
2006-11-02
New therapies: oral inhibitors and immune modulators.
2006-11
Thymosin alpha1 activates dendritic cell tryptophan catabolism and establishes a regulatory environment for balance of inflammation and tolerance.
2006-10-01
Liposomal plasmid DNA encoding human thymosin alpha and interferon omega potently inhibits liver tumor growth in ICR mice.
2006-10
Novel function of prothymosin alpha as a potent inhibitor of human immunodeficiency virus type 1 gene expression in primary macrophages.
2006-09
Thymosin alpha1 suppresses proliferation and induces apoptosis in human leukemia cell lines.
2006-09
Novel approaches for therapy of chronic hepatitis C.
2006-06
Antiviral therapy using lamivudine and thymosin alpha1 for hepatocellular carcinoma coexisting with chronic hepatitis B infection.
2006-04-13
Dual reporter genes enabling cell tracing with viable and reliable selection of various cell types.
2006-03
[Prevention and management of lung infections with thymosin alpha1 in critical patients with tracheotomy].
2006-01
Development and immunochemical evaluation of antibodies Y for the poorly immunogenic polypeptide prothymosin alpha.
2006-01
A randomized, placebo-controlled trial of thymosin-alpha1 and lymphoblastoid interferon for HBeAg-positive chronic hepatitis B.
2006
Construction and application of a yeast expression system for thymosin alpha1.
2005-12
Thymalfasin for the treatment of chronic hepatitis C infection.
2005-12
Gateways to clinical trials.
2005-09-24
Immunomodulatory function of orally administered thymosin alpha1.
2005-09
Immunoregulation of thymosin alpha 1 treatment of cytomegalovirus infection accompanied with acute respiratory distress syndrome after renal transplantation.
2005-08-20
[Immune response enhanced by genes encoding IFN-alpha 8 and T alpha 1 co-inoculated with HBV DNA vaccine].
2005-07
Activation of IKK by thymosin alpha1 requires the TRAF6 signalling pathway.
2005-06
Thymosin alpha 1 attenuates lipid peroxidation and improves fructose-induced steatohepatitis in rats.
2005-06
[Effects of cytokines on the immunogenic properties of hepatitis A vaccine].
2005-05-11
Construction, expression and characterization of human interferon alpha2b-(G4S)n-thymosin alpha1 fusion proteins in Pichia pastoris.
2005-05-07
The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B; results from a randomized clinical trial.
2005-05
Comparison of assays for determination of peptide content for lyophilized thymalfasin.
2005-04
[Hepatocellular carcinoma with tumor thrombi in the portal vein. A comparison of therapeutic effects by different treatments].
2005-03
[Combination of lamivudine with thymosin alpha1 in treatment of duck hepatitis B].
2005-03
[Anti-viral therapy using lamivudine and thymosin is helpful to prevent recurrence in hepatocellular carcinoma with coexisting active hepatitis B].
2005-02
A randomized, controlled, clinical study of thymosin alpha-1 versus interferon-alpha in [corrected] patients with chronic hepatitis B lacking HBeAg in China [corrected].
2005-02
High-purity lineage selection of embryonic stem cell-derived neurons.
2005-02
Overexpression of soluble human thymosin alpha 1 in Escherichia coli.
2005-02
Immunomodulatory therapy for chronic hepatitis B virus infection.
2005-02
Targeting brain stem centers of cardiovascular control using adenoviral vectors: impact of promoters on transgene expression.
2005-01-20
Enhancement of antiviral activity against hepatitis C virus in vitro by interferon combination therapy.
2005-01
Nm 283, an efficient prodrug of the potent anti-HCV agent 2'-C-methylcytidine.
2005
Antitumor activation of peritoneal macrophages by thymosin alpha-1.
2005
Triple combination of thymalfasin, peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C who have failed prior interferon and ribavirin treatment: 24-week interim results of a pilot study.
2004-12
Combination therapy of thymalfasin (thymosin-alpha 1) and peginterferon alfa-2a in patients with chronic hepatitis C virus infection who are non-responders to standard treatment.
2004-12
Thymalfasin (thymosin-alpha 1) therapy in patients with chronic hepatitis B.
2004-12
Thymalfasin: an immune system enhancer for the treatment of liver disease.
2004-12
Triple combination of thymalfasin, peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C who have failed prior interferon and ribavirin treatment: 24-week interim results of a pilot study.
2004-12
[Recombinant thymosin alpha1].
2004-11-26
[Effect of thymosin alpha1 on immunological function and metabolism in peritoneal sepsis rats].
2004-11-22
Thymosin alpha 1 in combination with interferon alpha and ribavirin in chronic hepatitis C patients who are non-responders or relapsers to interferon alpha plus ribavirin.
2004-11
[Primary assessment of treatment effect of thymosin alpha1 on chemotherapy-induced neurotoxicity].
2004-11
Thymosin-like peptides as potential immunostimulants. Synthesis via the polymeric-reagent method.
1990-01
Substance Class Protein
Created
by admin
on Mon Mar 31 20:42:32 GMT 2025
Edited
by admin
on Mon Mar 31 20:42:32 GMT 2025
Protein Sub Type
Sequence Type COMPLETE
Record UNII
W0B22ISQ1C
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
THYMOSINS THYMALFASIN
MI  
Preferred Name English
THYMALFASIN
INN   MART.   USAN   WHO-DD  
USAN   INN  
Official Name English
Thymalfasin [WHO-DD]
Common Name English
ZADAXIN
Brand Name English
THYMALFASIN [USAN]
Common Name English
THYMALFASIN [MART.]
Common Name English
thymalfasin [INN]
Common Name English
THYMOSINS THYMALFASIN [MI]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C548
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
FDA ORPHAN DRUG 132600
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
FDA ORPHAN DRUG 52990
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
FDA ORPHAN DRUG 218806
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
NCI_THESAURUS C308
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
FDA ORPHAN DRUG 109597
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
EU-Orphan Drug EU/3/02/110
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
Code System Code Type Description
EVMPD
SUB10990MIG
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
CAS
62304-98-7
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
FDA UNII
W0B22ISQ1C
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
MESH
C026455
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
MERCK INDEX
m10830
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY Merck Index
DRUG CENTRAL
2643
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
INN
7344
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
NCI_THESAURUS
C1253
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
EPA CompTox
DTXSID80211374
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
RXCUI
38221
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY RxNorm
SMS_ID
100000082130
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
ChEMBL
CHEMBL2103979
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
USAN
FF-51
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
DRUG BANK
DB04900
Created by admin on Mon Mar 31 20:42:32 GMT 2025 , Edited by admin on Mon Mar 31 20:42:32 GMT 2025
PRIMARY
Related Record Type Details
ACTIVE MOIETY

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
AMINO ACID SUBSTITUTION [1_1] SERINE N-ACETYLSERINE W98518XGZ3
Name Property Type Amount Referenced Substance Defining Parameters References
MOL_WEIGHT:SEQUENCE(CALCULATED) CHEMICAL
Molecular Formula CHEMICAL