Overview
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.
Indication
⑴慢性乙型肝炎(简称乙肝)。本品是用来治疗那些18岁或以上的慢性乙型肝炎患者，患者的肝病有代偿性，和有乙型肝炎病毒复制（血清HBV-DNA阳性），在那些血清乙肝表面抗原（HBsAg）阳性最少6个月，且有ALT升高的患者所做的研究显示，本品治疗可以产生病毒性缓解（血清HBV-DNA失去）和ALT水平复常，在一些做出应答的患者，本品治疗可除去血清表面抗原。本品与α-干扰素联用时可能比单用本品或单用干扰素增加应答率。 ⑵作为免疫损害患者的疫苗增强剂。免疫系统功能受到抑制者，包括接受慢性血液透析和老年病患者，本品增强患者对病毒性疫苗，例如流感疫苗或乙肝疫苗的免疫应答。血液透析患者在接种流感疫苗后，应用本品作为佐剂者有65％患者产生抗流感病毒抗体，滴度水平增加4倍以上，安慰剂组只有24％患者做出此反应。
Associated Conditions
- Chronic Hepatitis B Infection
- Chronic Hepatitis C Virus (HCV) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/17 | Phase 2 | Recruiting | |||
2025/02/11 | Phase 1 | Recruiting | |||
2024/09/04 | Phase 2 | Recruiting | |||
2024/06/17 | Phase 2 | Recruiting | |||
2023/09/28 | Phase 2 | Active, not recruiting | |||
2023/09/06 | N/A | Not yet recruiting | |||
2023/03/30 | Phase 2 | Recruiting | Second Affiliated Hospital of Soochow University | ||
2021/07/15 | Early Phase 1 | Completed | |||
2020/07/27 | Phase 2 | Terminated | |||
2020/06/11 | Phase 2 | Active, not recruiting | William B. Ershler, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.