Overview
Pyrotinib is under investigation in clinical trial NCT03756064 (Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Pyrotinib (SHR-1258): A Comprehensive Pharmacological and Clinical Monograph
Executive Summary
Pyrotinib is an orally bioavailable, small-molecule targeted therapy developed by Jiangsu Hengrui Medicine that has emerged as a potent and clinically significant agent in the management of Human Epidermal Growth Factor Receptor 2 (HER2)-positive cancers.[1] Identified by the internal code SHR-1258 and marketed in China under the brand name Irene, Pyrotinib functions as an irreversible, pan-ErbB receptor tyrosine kinase inhibitor (TKI).[4] Its primary mechanism of action involves the covalent and sustained inhibition of Epidermal Growth Factor Receptor (EGFR/HER1), HER2, and HER4, thereby blocking critical downstream oncogenic signaling pathways, including the PI3K/Akt and RAS/RAF/MAPK cascades, which are fundamental drivers of tumor cell proliferation and survival.[5]
The clinical development of Pyrotinib has been marked by a series of successful pivotal trials, primarily in the field of HER2-positive breast cancer. The Phase III PHOEBE trial established its superiority in the second-line metastatic setting, demonstrating statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) when combined with capecitabine, compared to the established TKI lapatinib with capecitabine.[8] In the first-line metastatic setting, the Phase III PHILA trial showed that the addition of Pyrotinib to a regimen of trastuzumab and docetaxel resulted in a profound extension of PFS versus the control arm, validating a powerful dual anti-HER2 blockade strategy.[11] Furthermore, promising data from neoadjuvant and extended adjuvant studies suggest its utility across the entire continuum of HER2-positive breast cancer care.[3]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/15 | Not Applicable | Recruiting | |||
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/06/13 | Phase 2 | Not yet recruiting | |||
2025/05/06 | Phase 2 | Recruiting | |||
2024/12/31 | N/A | Recruiting | zhangjie | ||
2024/12/05 | Not Applicable | Not yet recruiting | Nie Jianyun | ||
2024/12/05 | Phase 1 | Recruiting | |||
2024/11/18 | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | ||
2024/08/21 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2024/07/10 | Not Applicable | Not yet recruiting |
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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