Overview
Thymosin Beta 4 has been investigated for the treatment of STEMI, Dry Eye, Diabetes, Pressure Ulcers, and Dry Eye Syndrome, among others.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
An Expert Monograph on Thymosin Beta-4 (Timbetasin): Mechanisms, Clinical Development, and Therapeutic Potential
Executive Summary
Thymosin beta-4 (Tβ4), also known by the recommended International Nonproprietary Name (INN) timbetasin, is an investigational, naturally occurring 43-amino acid peptide with a remarkable array of biological activities centered on tissue protection, repair, and regeneration. This monograph provides a comprehensive analysis of Tβ4, synthesizing its physicochemical properties, dual mechanisms of action, extensive preclinical evidence, and complex clinical development history. The therapeutic rationale for Tβ4 is founded on its pleiotropic functions, which include potent pro-migratory, pro-angiogenic, anti-inflammatory, anti-apoptotic, and anti-fibrotic effects. These activities stem from a unique dual-mechanism profile: intracellularly, it is the primary G-actin sequestering protein, regulating cytoskeletal dynamics, while extracellularly, it functions as a "moonlighting" signaling molecule released at sites of injury to orchestrate the entire healing cascade.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/23 | Not Applicable | Not yet recruiting | |||
2024/09/19 | Not Applicable | Recruiting | Yousheng Mao | ||
2023/12/20 | Phase 4 | Recruiting | Jun Wang | ||
2023/11/18 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2022/09/27 | Phase 3 | Recruiting | |||
2022/08/04 | Not Applicable | UNKNOWN | Nanjing Medical University | ||
2021/10/21 | Phase 3 | Recruiting | |||
2021/05/25 | N/A | Not yet recruiting | Sun Yat-sen University | ||
2020/08/24 | Phase 4 | UNKNOWN | |||
2020/03/24 | Phase 3 | UNKNOWN | Shanghai Jiao Tong University School of Medicine |
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 |
|---|---|---|---|---|---|
| ZADAXIN INJECTION | SIN07483P | INJECTION | 1.6 mg/vial | 9/9/1993 |
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 |
|---|---|---|---|---|---|
| ZADAXIN FOR INJ. 1.6MG | N/A | N/A | N/A | 3/21/2003 |
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. | |||||
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