SCEMBLIX

Peak

asciminib

NDAORALTABLETPriority Review
Approved
Oct 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

ABL/BCR-ABL1 tyrosine kinase inhibitor. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein, by binding to the ABL myristoyl pocket. In studies conducted in vitro or in animal models of CML, asciminib showed activity against wild-type BCR::ABL1 and several mutant forms of…

Clinical Trials (5)

NCT07354074Phase 2Not Yet Recruiting

Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP

Started Jun 2026
50 enrolled
Chronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
NCT06773936Phase 2Enrolling By Invitation

Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

Started May 2026
55 enrolled
Philadelphia Chromosome Positive Acute Lymphoblastic LeukemiaCD19+ Acute Leukemia
NCT07387926Phase 1/2Not Yet Recruiting

Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

Started Mar 2026
50 enrolled
Acute Lymphoblastic LeukemiaLeukemia, Lymphoblastic, Acute, Philadelphia-PositivePhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT07375355N/ANot Yet Recruiting

Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China

Started Feb 2026
200 enrolled
Chronic Myeloid Leukemia in Chronic Phase
NCT07136428Phase 1/2Not Yet Recruiting

Asciminib in HER2+ Breast Cancer Brain Metastases

Started Feb 2026
42 enrolled
HER2+ Metastatic Breast Cancer

Loss of Exclusivity

LOE Date
May 17, 2040
172 months away
Patent Expiry
May 17, 2040
Exclusivity Expiry
Oct 29, 2031

Patent Records (4)

Patent #ExpiryTypeUse Code
8829195
Oct 29, 2035
Substance
U-1374
11407735
May 14, 2040
Substance
12252478
May 14, 2040
Product
12252479
May 17, 2040
U-1374