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 14 indications[4].[1]

Scemblix is one of 221 small molecule programs targeting Myeloid Leukemia. It is currently in Approved.

Indications

Total Trials

Active Trials

220

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Myeloid LeukemiaRecruiting

Chronic Myeloid LeukemiaActive, not recruiting

Kidney DiseaseApproved

Childhood LeukemiaApproved

Acute Promyelocytic LeukemiaApproved

Chronic Phase Chronic Myelogenous LeukemiaRecruiting

Chronic Myeloid Leukemia (CML)Active, not recruiting

MyeloidRecruiting

TreatmentRecruiting

Chronic Myelogenous LeukemiaActive, not recruiting

Myeloid LeukemiaPhase 2

Recruiting

Chronic Myeloid LeukemiaPhase 2

Active, not recruiting

Kidney DiseaseApproved

Approved

Childhood LeukemiaApproved

Approved

Acute Promyelocytic LeukemiaApproved

Approved

Chronic Phase Chronic Myelogenous LeukemiaPhase 2

Recruiting

Chronic Myeloid Leukemia (CML)Phase 3

Active, not recruiting

MyeloidPreclinical

Recruiting

TreatmentPhase 2

Recruiting

Chronic Myelogenous LeukemiaPhase 3

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Scemblix

Novartis

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Clomid

Ferring

Preclinical

1 8

Aurlumyn

BBTG International Inc.

Preclinical

1 9

Lotemax

PPharmos

Preclinical

1 10

Norpramin

VValidus Pharmaceuticals

Preclinical

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

Chronic Myeloid Leukemia

NCT03906292

Q2 2028

Phase 1Not yet recruiting

Brain Tumor

NCT07039760

Phase 1Not yet recruiting

Acute Lymphoblastic Leukemia

NCT07040982

Q3 2028

Phase 2Not yet recruiting

Myeloid Leukemia

NCT06368414

Clinical

Trials by Indication[1]

Chronic Myelogenous Leukemia5 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 2 more trials

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

Completed· Novartis logo

Novartis·Phase 3·NCT03106779·233 enrolled

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

Myeloid Leukemia4 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

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

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

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

Show 1 more trial

Phase I/II of the Combination of Fludarabine, Cytarabine, Idarubicin, G-CSF (FLAG-Ida) With Venetoclax and Asciminib in Patients With Advanced Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07604233·30 enrolled

Acute Lymphoblastic Leukemia3 trials

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

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

Open-label, Phase I/II Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL

Recruiting· Novartis logo

Novartis·Preclinical·NCT07387926·50 enrolled

Chronic Myeloid Leukemia3 trials

Frontline Asciminib Combination in Chronic Phase CML

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

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

Chronic Myeloid Leukemia (CML)2 trials

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Active, not recruiting· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 3·NCT04971226·405 enrolled

Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations

Active, not recruiting·TThomas Ernst, PD Dr. med.·Phase 2·NCT07789574·50 enrolled

11 more indications

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

Aged1 trial

Managed Access Programs for ABL001, Asciminib

Available· Novartis logo

Novartis··NCT04360005

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

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

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

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

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

Chronic Phase Chronic Myelogenous Leukemia1 trial

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

Regulatory

FDA Approval Timeline[5]

Oct 29, 2021

SCEMBLIX

NDA NDA215358

Sources

References

[1]
ClinicalTrials.gov — 28 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

Q2 2028

Q3 2028

Trials by Indication[1]

Chronic Myelogenous Leukemia5 trials

Myeloid Leukemia4 trials

Acute Lymphoblastic Leukemia3 trials

Chronic Myeloid Leukemia3 trials

Chronic Myeloid Leukemia (CML)2 trials

Tyrosine Kinase Inhibitors1 trial

Aged1 trial

Impaired Renal Function1 trial

Maintenance Therapy1 trial

HIE1 trial

TED1 trial

Ph+ ALL1 trial

Treatment1 trial

Brain Tumor1 trial

Myeloid1 trial

Chronic Phase Chronic Myelogenous Leukemia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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