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.
Background
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 |
|---|---|---|---|---|---|
| Thymalfasin for Injection | 国药准字H20020545 | 化学药品 | 注射剂(注射用无菌粉末) | 1/5/2021 | |
| Thymalfasin for Injection | 国药准字H20051916 | 化学药品 | 注射剂 | 8/3/2020 | |
| Thymalfasin for Injection | 国药准字H20213434 | 化学药品 | 注射剂 | 6/1/2021 | |
| Thymalfasin for Injection | 国药准字H20103201 | 化学药品 | 注射剂 | 3/12/2020 | |
| Thymalfasin for Injection | 国药准字H20193345 | 化学药品 | 注射剂 | 11/28/2019 | |
| Thymalfasin for Injection | 国药准字H20223429 | 化学药品 | 注射剂 | 6/28/2022 | |
| Thymalfasin for Injection | 国药准字H20193180 | 化学药品 | 注射剂 | 6/24/2019 | |
| Thymalfasin for Injection | 国药准字H20143112 | 化学药品 | 注射剂 | 4/6/2023 | |
| Thymalfasin for Injection | 国药准字H20193385 | 化学药品 | 注射剂 | 12/18/2019 | |
| Thymalfasin for Injection | 国药准字H20113520 | 化学药品 | 注射剂（冻干） | 6/25/2021 |
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. | |||||