SCEMBLIX (asciminib hydrochloride) · Novartis
Scemblix (asciminib) is a kinase inhibitor indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Its indications include: 1) Newly diagnosed Ph+ CML-CP (accelerated approval based on major molecular response rate); 2) Ph+ CML-CP previously treated with two or more tyrosine kinase inhibitors; and 3) Ph+ CML-CP harboring the T315I mutation.
How SCEMBLIX Works
Asciminib is a STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. Unlike traditional BCR::ABL1 tyrosine kinase inhibitors (TKIs) that compete for the ATP-binding site, asciminib binds to the ABL myristoyl pocket of the BCR::ABL1 fusion protein. This binding induces an inactive conformation of the kinase, effectively inhibiting its catalytic activity. Because of this distinct mechanism, asciminib maintains activity against most ATP-binding site mutations, including the T315I gatekeeper mutation.
Details
- Status
- Prescription
- First Approved
- 2021-10-29
- Patent Cliff
- 2040
- Revenue
- $391M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
SCEMBLIX Approval History
What SCEMBLIX Treats
1 indicationsSCEMBLIX is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
SCEMBLIX Target & Pathway
ProTarget
SCEMBLIX Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SCEMBLIX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SCEMBLIX treats. First-in-class if their pivotal trials read out positive.
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Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SCEMBLIX FDA Label Details
Indications & Usage
FDA Label (PDF)SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia c...
SCEMBLIX Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SCEMBLIX
Revenue Insights
- • Q4-2025: $391M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 36 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.