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Scemblix (ASCIMINIB)
Scemblix works by blocking the ABL1 enzyme, which is involved in the growth and survival of cancer cells.
At a glance
| Generic name | ASCIMINIB |
|---|---|
| Sponsor | Novartis |
| Target | Tyrosine-protein kinase ABL1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 894 |
Mechanism of action
Asciminib is an 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 the kinase, including the T315I mutation.
Approved indications
- Newly diagnosed Ph+ CML in CP
- Previously treated Ph+ CML in CP
- Ph+ CML in CP with T315I mutation
Common side effects
- Upper respiratory tract infections
- Musculoskeletal pain
- Thrombocytopenia
- Neutropenia
- Fatigue
- Rash
- Hypertension
- Diarrhea
- Nausea
- Abdominal pain
- Pyrexia
- Cardiac failure congestive
Key clinical trials
- Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL (PHASE1)
- 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 (PHASE2)
- Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy (PHASE2)
- Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP (PHASE2)
- Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (PHASE2)
- Asciminib Treatment Optimization in ≥ 3rd Line CML-CP (PHASE3)
- Asciminib With or Without Sildenafil for Brain Tumors (EARLY_PHASE1)
- A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Scemblix CI brief — competitive landscape report
- Scemblix updates RSS · CI watch RSS
- Novartis portfolio CI