NERLYNX

PeakSM

neratinib

NDAORALTABLET
Approved
Jul 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7

Mechanism of Action

(EGFR), HER2, and HER4. In vitro , neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2,…

Clinical Trials (5)

NCT05491057N/ANot Yet Recruiting

Treatment Patterns of Neratinib in HER2+ EBC in China

Started Sep 2022
500 enrolled
Breast Cancer
NCT05252988Phase 2Active Not Recruiting

Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Started Aug 2022
NCT05243641Phase 1/2Terminated

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Started Aug 2022
10 enrolled
Metastatic Breast CancerBreast Cancer
NCT05599334N/ACompleted

A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

Started Jul 2022
111 enrolled
Breast CancerAdjuvant TherapyHER2-positive Breast Cancer
NCT04502602Phase 1Active Not Recruiting

Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

Started Aug 2020
18 enrolled
Advanced Solid TumorOvarian Cancer

Loss of Exclusivity

LOE Date
Jul 18, 2031
65 months away
Patent Expiry
Jul 18, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
10035788
Oct 15, 2028
U-3097
9139558
Oct 15, 2028
U-2043
9630946
Oct 15, 2028
U-3097
9265784
Aug 4, 2029
U-3047
9211291
Mar 24, 2030
U-3097