Nilotinib, Imatinib — Competitive Intelligence Brief

Nilotinib, Imatinib (Nilotinib, Imatinib) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Tyrosine kinase inhibitor (TKI). Area: Oncology.

phase 3 Tyrosine kinase inhibitor (TKI) BCR-ABL, KIT, PDGFRA Oncology Small molecule

Target snapshot

Nilotinib, Imatinib (Nilotinib, Imatinib) — Seoul St. Mary's Hospital. Nilotinib and Imatinib are tyrosine kinase inhibitors that block BCR-ABL and other kinase signaling pathways to suppress abnormal cell proliferation in chronic myeloid leukemia and gastrointestinal stromal tumors.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Nilotinib, Imatinib TARGET	Nilotinib, Imatinib	Seoul St. Mary's Hospital	phase 3	Tyrosine kinase inhibitor (TKI)	BCR-ABL, KIT, PDGFRA
imatinib (IM)	imatinib (IM)	First Affiliated Hospital, Sun Yat-Sen University	marketed	Tyrosine kinase inhibitor	BCR-ABL, KIT, PDGFRA
Imatinib (Glivec)	Imatinib (Glivec)	Dermatologic Cooperative Oncology Group	phase 3	Tyrosine kinase inhibitor	BCR-ABL, KIT, PDGFRA
Vizimpro	Dacomitinib	Pfizer Inc.	marketed	Tyrosine kinase inhibitor (TKI); Pan-HER inhibitor	Cyclin-G-associated kinase, Receptor-interacting serine/threonine-protein kinase 2, Receptor-interacting serine/threonine-protein kinase 3
Maintenance icotinib	Maintenance icotinib	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor (TKI)	EGFR (epidermal growth factor receptor)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Tyrosine kinase inhibitor (TKI) class)

1. Seoul St. Mary's Hospital · 1 drug in this class