Scemblix

(Asciminib)

ApprovedProtein / enzyme

Asciminib is used to treat a type of blood cancer called chronic myeloid leukemia. It works by blocking an abnormal protein that tells cancer cells to multiply, helping to stop the cancer from growing.[2] Scemblix is currently approved and in use across 9 indications[4].[1]

Scemblix is one of 203 small molecule programs targeting Kidney Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

202

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Kidney DiseaseApproved

Chronic Myelogenous LeukemiaActive, not recruiting

Acute Promyelocytic LeukemiaApproved

Childhood LeukemiaApproved

Acute Lymphoblastic LeukemiaActive, not recruiting

GlioblastomaActive, not recruiting

Chronic Myeloid LeukemiaTerminated

Brain TumorNot yet recruiting

Myeloid LeukemiaActive, not recruiting

Kidney DiseaseApproved

Approved

Chronic Myelogenous LeukemiaPhase 3

Active, not recruiting

Acute Promyelocytic LeukemiaApproved

Approved

Childhood LeukemiaApproved

Approved

Acute Lymphoblastic LeukemiaPhase 1/Phase 2

Active, not recruiting

GlioblastomaPhase 3

Active, not recruiting

Chronic Myeloid LeukemiaPhase 2

Terminated

Brain TumorPhase 1

Not yet recruiting

Myeloid LeukemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

514 competitors in Glioblastoma

#DrugCompanyPhaseTrials

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Scemblix

1 3

Ceenu

AAzurity Pharmaceuticals

Phase 3

22 4

Gleevec

Novartis

Phase 3

2 5

Cymbalta

Alnylam Pharmaceuticals

Phase 3

1 6

Lexapro

AbbVie

Phase 3

1 7

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

4 8

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

4 9

Feraheme

AAzurity Pharmaceuticals

Phase 3

4 10

Droxia

TTheravia

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

TED

NCT06427811

Q4 2027

Phase 2Active, not recruiting

Chronic Myelogenous Leukemia

NCT05384587

Phase 2Active, not recruiting

Frontline

NCT03906292

Phase 3Recruiting

Glioblastoma

NCT04971226

Q1 2028

Phase 1Not yet recruiting

Brain Tumor

NCT07039760

Q2 2028

Phase 1Not yet recruiting

Acute Lymphoblastic Leukemia

NCT07040982

Clinical

Trials by Indication[1]

Myeloid Leukemia5 trials

Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06629584·40 enrolled

A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia

Not yet recruiting·KKorean Society of Hematology·Phase 2·NCT06368414·69 enrolled

ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04216563·7 enrolled

Show 2 more trials

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04838041·51 enrolled

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06236724·50 enrolled

Chronic Myelogenous Leukemia4 trials

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05384587·34 enrolled

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05456191·568 enrolled

A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation

Recruiting· Novartis logo

Novartis·Phase 2·NCT07354074·50 enrolled

Show 1 more trial

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

Recruiting· Novartis logo

Novartis·Approved·NCT04877522·347 enrolled

Acute Lymphoblastic Leukemia3 trials

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)

Not yet recruiting· Novartis logo

Novartis·Phase 1/2·NCT07387926·50 enrolled

Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06308588·40 enrolled

Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Not yet recruiting·—·Phase 1·NCT07040982·30 enrolled

Tyrosine Kinase Inhibitors1 trial

Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors

Completed· Novartis logo

Novartis·Phase 2·NCT04795427·84 enrolled

Treatment1 trial

PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

Recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT06409936·160 enrolled

12 more indications

Efficacy1 trial

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

Completed· Novartis logo

Novartis·Phase 3·NCT03106779·233 enrolled

Maintenance Therapy1 trial

Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT07250087·36 enrolled

Impaired Renal Function1 trial

Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers

Completed· Novartis logo

Novartis·Phase 1·NCT03605277·14 enrolled

Aged1 trial

Managed Access Programs for ABL001, Asciminib

Available· Novartis logo

Novartis··NCT04360005

HIE1 trial

Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML

Active, not recruiting·SSarit Assouline·Phase 3·NCT05413915·164 enrolled

TED1 trial

Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation

Active, not recruiting· Novartis logo

Novartis·Phase 4·NCT06427811·85 enrolled

Ph+ ALL1 trial

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

Completed· Novartis logo

Novartis·Phase 1·NCT02081378·326 enrolled

Frontline1 trial

Frontline Asciminib Combination in Chronic Phase CML

Active, not recruiting·UUniversity of Jena·Phase 2·NCT03906292·125 enrolled

Chronic Myeloid Leukemia1 trial

A Phase II, Single-arm Study of De-escalation and Treatment-free Remission in Patients With Chronic Myeloid Leukemia Treated With Nilotinib in First-line Therapy Followed by a Second Attempt After Nilotinib and Asciminib Combination: DANTE Study

Terminated· Novartis logo

Novartis·Phase 2·NCT03874858·135 enrolled

Brain Tumor1 trial

An Early Phase 1 Study of Asciminib With or Without Sildenafil for Brain Tumors

Not yet recruiting·WWashington University School of Medicine·Phase 1·NCT07039760·12 enrolled

Myeloid1 trial

A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors

Recruiting· Novartis logo

Novartis·Preclinical·NCT04925479·34 enrolled

Glioblastoma1 trial

FIREFLY-301: Tovorafenib in Pediatric LGG

Recruiting· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 3·NCT04971226·340 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 29, 2021

SCEMBLIX

NDA NDA215358

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Asciminib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Scemblix drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Asciminib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Asciminib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215358). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Scemblix. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bcr/abl Fusion Protein Inhibitor; Tyrosine-Protein Kinase ABL Inhibitor[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Oct 29, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8829195Oct 29, 2035

12252478May 14, 2040

11407735May 14, 2040

12252479May 17, 2040

Scemblix

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Myeloid Leukemia5 trials

Chronic Myelogenous Leukemia4 trials

Acute Lymphoblastic Leukemia3 trials

Tyrosine Kinase Inhibitors1 trial

Treatment1 trial

Efficacy1 trial

Maintenance Therapy1 trial

Impaired Renal Function1 trial

Aged1 trial

HIE1 trial

TED1 trial

Ph+ ALL1 trial

Frontline1 trial

Chronic Myeloid Leukemia1 trial

Brain Tumor1 trial

Myeloid1 trial

Glioblastoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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