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 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SCEMBLIX (asciminib) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA on October 29, 2021, for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), and blastic transformation of CML. The drug represents a newer generation TKI option in the leukemia treatment landscape, offering an alternative mechanism to established agents like imatinib and ponatinib. It is administered as an oral tablet and is currently in peak lifecycle stage.
$0.1BPart D
14.0 years to LOEMechanism 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)
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 May 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
A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany
Started Apr 2026
380 enrolled
Leukemia, Chronic Myeloid
Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML
Started Mar 2026
45 enrolled
Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Blastic Transformation of Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)+1 more
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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.