Product Description
Poziotinib is an investigational, orally administered, irreversible tyrosine kinase inhibitor targeting EGFR and HER2 with exon 20 insertion mutations. (Sourced from: https://www.sppirx.com/347-spectrum-products-development-poziotinib.html)
Mechanisms of Action: HER2 Inhibitor, TK Inhibitor, EGFR Inhibitor, HER4 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Non-Small-Cell Lung Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Assertio Holdings
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Japan, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
- PDUFA date for Spectrum Pharmaceuticals' Rolontis set on October 24, 2020, for FDA review; potential positive impact on healthcare providers.
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer|Small Cell Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03066206 |
NCI-2017-00831 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-12-31 |
12% |
2024-05-25 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05378763 |
PINNACLE | P3 |
Suspended |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2027-12-25 |
33% |
2023-02-01 |
Primary Endpoints|Treatments|Trial Status |
JapicCTI-205304 |
JapicCTI-205304 | P2 |
Active |
Non-Small-Cell Lung Cancer |
2025-03-31 |
|||
2020-005213-40 |
SPI-POZ-501 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2024-10-24 |
12% |
2022-03-13 |
Treatments |