TASIGNA

Peak

nilotinib

NDAORALCAPSULE
Approved
Oct 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
68

Mechanism of Action

BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays,…

Clinical Trials (5)

NCT05456191Phase 3Active Not Recruiting

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

Started Nov 2022
568 enrolled
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
NCT04903119Phase 1Recruiting

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Started Jun 2022
30 enrolled
Metastatic MelanomaBRAF Gene Mutation
NCT05143528Phase 3Not Yet Recruiting

Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease

Started Feb 2022
1,275 enrolled
Alzheimer Disease
NCT05743465N/ACompleted

A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia

Started Oct 2021
1,769 enrolled
Leukemia
NCT03874858Phase 2Completed

A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia

Started Mar 2019
124 enrolled
Chronic Myeloid Leukemia

Loss of Exclusivity

LOE Date
Oct 7, 2032
80 months away
Patent Expiry
Oct 7, 2032
Exclusivity Expiry
Mar 23, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
8501760
Jul 18, 2026
Product
8389537
Jul 18, 2026
U-1374
8415363
Jul 18, 2026
SubstanceProduct
U-1374
8415363*PED
Jan 18, 2027
8389537*PED
Jan 18, 2027