Overview
Abivertinib is a tyrosine kinase inhibitor targeted against mutant forms of both human epidermal growth factor receptor (EGFR) and Bruton's tyrosine kinase (BTK). It has been investigated for use in the treatment of non-small cell lung cancer (NSCLC) and B-cell malignancies. In binding to and inhibiting EGFR and BTK receptors, abivertinib exerts immunomodulatory effects by preventing the production and release of pro-inflammatory cytokines (e.g. TNF-alpha, interleukins). Abivertinib's potential to depress cytokine production has led to its investigation in the treatment of hospitalized patients with moderate-to-severe COVID-19. The cytokine storm associated with COVID-19 is thought to contribute to disease progression and is associated with poor outcomes in patients - as abivertinib inhibits the release of multiple cytokines at once, it may provide more pronounced clinical benefits as compared to agents targeting single pathways (e.g. interleukin-6 inhibitors). The study is expected to be completed in March 2021.
Background
Abivertinib is a tyrosine kinase inhibitor targeted against mutant forms of both human epidermal growth factor receptor (EGFR) and Bruton's tyrosine kinase (BTK). It has been investigated for use in the treatment of non-small cell lung cancer (NSCLC) and B-cell malignancies. In binding to and inhibiting EGFR and BTK receptors, abivertinib exerts immunomodulatory effects by preventing the production and release of pro-inflammatory cytokines (e.g. TNF-alpha, interleukins). Abivertinib's potential to depress cytokine production has led to its investigation in the treatment of hospitalized patients with moderate-to-severe COVID-19. The cytokine storm associated with COVID-19 is thought to contribute to disease progression and is associated with poor outcomes in patients - as abivertinib inhibits the release of multiple cytokines at once, it may provide more pronounced clinical benefits as compared to agents targeting single pathways (e.g. interleukin-6 inhibitors). The study is expected to be completed in March 2021.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/05/05 | Phase 2 | Suspended | |||
2020/08/27 | Phase 2 | Completed | |||
2020/06/19 | Phase 2 | Completed | |||
2019/02/27 | Phase 3 | UNKNOWN | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | ||
2017/02/23 | Phase 1 | UNKNOWN | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | ||
2015/05/19 | Phase 1 | Terminated |
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. | |||||