Overview
AL-034 (TQ-A3334) is an oral toll-like receptor 7 agonist developed for the treatment of chronic hepatitis B (CHB) viral infection.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
AL-034 (JNJ-64794964 / TQ-A3334): A Comprehensive Profile of an Investigational Toll-like Receptor 7 Agonist
Executive Summary
AL-034 is an orally bioavailable, investigational small molecule therapeutic agent identified as a selective agonist of Toll-like Receptor 7 (TLR7). This positions the compound as a potent immunomodulator designed to harness the body's innate and adaptive immune systems to combat disease. Its primary therapeutic indication is the treatment of Chronic Hepatitis B (CHB) viral infection, a condition with a significant global health burden and a high unmet need for curative therapies. The overarching goal in this indication is to achieve a "functional cure," defined by sustained loss of hepatitis B surface antigen (HBsAg) and undetectable viral DNA after a finite course of treatment. The drug was also investigated for a secondary indication in advanced Non-Small Cell Lung Cancer (NSCLC), leveraging the same immune-activating mechanism, though this line of development has since been discontinued.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/18 | Phase 1 | UNKNOWN | |||
2019/12/17 | Phase 2 | UNKNOWN | |||
2019/11/27 | Phase 2 | UNKNOWN | |||
2017/09/18 | Phase 1 | Completed |
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. | |||||
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