NDAORALTABLETPriority Review
Approved
Oct 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SCEMBLIX (asciminib) is an oral small-molecule kinase inhibitor developed by Novartis for chronic myeloid leukemia (CML). It represents a next-generation BCR-ABL inhibitor designed to overcome resistance mechanisms in patients with prior tyrosine kinase inhibitor exposure. The drug addresses an unmet need in treatment-resistant CML populations.
$0.114BPart D
Peak13.9 years to LOEThe product is in peak commercial phase with $114M in 2023 Part D spending, suggesting a stable, mid-sized specialty oncology franchise with mature sales infrastructure.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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 Jul 2026
50 enrolled
Acute Lymphoblastic LeukemiaLeukemia, Lymphoblastic, Acute, Philadelphia-PositivePhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia
Asciminib in HER2+ Breast Cancer Brain Metastases
Started Jul 2026
42 enrolled
HER2+ Metastatic Breast Cancer
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
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Started Apr 2026
50 enrolled
Chronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment for Chronic Myelogenous Leukemia in Chronic Phase (ASC2ADVANCE)
Started Apr 2026
45 enrolled
Chronic Myeloid Leukemia (CML) in
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.