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  1. pharmadog
  2. ›drugs
  3. ›Nerlynx
drug · small molecule
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neratinib

Marketedupdated 3mo ago
by $PBYI PUMA BIOTECHNOLOGY, INC.🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neoplasm and 8 investigational indications.

targets

Epidermal growth factor receptorReceptor tyrosine-protein kinase erbB-2Receptor tyrosine-protein kinase erbB-4

all catalysts(0)

nothing on the calendar yet

Trials studying neratinib

  • phase2Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancersrecruitingn=30
  • phase2Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Carecruitingn=83
  • phase2Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Canceractive not recruitingn=34
  • phase2Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancersrecruitingn=30
  • phase2Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancerrecruitingn=36
  • phase2Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancerterminatedn=21
  • phase2Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)active not recruitingn=100
  • phase2INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)recruitingn=460
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 15, 2028
~2.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (9)

  • Jul 18, 2031method-of-use (U-3047)US 86692734.9y
  • Dec 29, 2030compositionUS 73998654.4y
  • Nov 20, 2030formulationUS 85184464.3y
  • Nov 5, 2030formulationUS 87907084.2y
  • Mar 24, 2030method-of-use (U-3097)US 92112913.6y
  • Aug 4, 2029method-of-use (U-3047)US 92657843.0y
  • Oct 15, 2028method-of-use (U-3097)US 100357882.2y
  • Oct 15, 2028method-of-use (U-2043)US 91395582.2y
  • Oct 15, 2028method-of-use (U-3097)US 96309462.2y

News(1)

  • Post–T-DXd Sacituzumab Govitecan Plus Trastuzumab Yields Low ORR in HER2+ Metastatic Breast Cancer
    Sacituzumab govitecan plus trastuzumab following T-DXd did not meet the primary end point of the SATEEN trial in HER2+ metastatic breast cancer.
    onclive · 3mo ago
brand
Nerlynx
generic
neratinib
MOA
Epidermal growth factor receptor erbB1 inhibitor; Receptor protein-tyrosine kinase erbB-2 inhibitor; Receptor protein-tyrosine kinase erbB-4 inhibitor
indication
Metastatic Brain Tumor
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 9m ago
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