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 15 indications[4].[1]

Scemblix is one of 234 small molecule programs targeting Kidney Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

233

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 LeukemiaRecruiting

Chronic Myeloid LeukemiaRecruiting

TreatmentRecruiting

HIEActive, not recruiting

Maintenance TherapyRecruiting

MyeloidRecruiting

Kidney DiseaseApproved

Approved

Chronic Myelogenous LeukemiaPhase 3

Active, not recruiting

Acute Promyelocytic LeukemiaApproved

Approved

Childhood LeukemiaApproved

Approved

Acute Lymphoblastic LeukemiaPhase 2

Recruiting

Chronic Myeloid LeukemiaPhase 2

Recruiting

TreatmentPhase 2

Recruiting

HIEPhase 3

Active, not recruiting

Maintenance TherapyPhase 1

Recruiting

MyeloidPreclinical

Recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Scemblix

Novartis

Approved

1 2

Theo-Dur

Pfizer

Preclinical

1 3

Lamprene

Novartis

Preclinical

1 4

Emtriva

Gilead

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Clomid

Ferring

Preclinical

1 8

Aurlumyn

BBTG International Inc.

Preclinical

1 9

Reminyl

WWim Janssens

Preclinical

1 10

Sirturo

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

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

Q3 2028

Phase 2Not yet recruiting

Myeloid Leukemia

NCT06368414

Q4 2028

Phase 1Not yet recruiting

B Acute Lymphoblastic Leukemia With T(9;22)(q34.1;q11.2); BCR-ABL1

NCT07914166

Phase 2Recruiting

Malignant Solid Tumors

NCT06629584

Clinical

Trials by Indication[1]

Chronic Myelogenous Leukemia5 trials

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

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 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 Leukemia3 trials

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

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

Chronic Myeloid Leukemia3 trials

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·NCT06236724·150 enrolled

Frontline Asciminib Combination in Chronic Phase CML

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

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL12 trials

Pilot Study of Asciminib as a Maintenance Treatment Post Cellular Therapies in Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Recruiting·CCity of Hope Medical Center·Phase 1·NCT07040982·30 enrolled

A Phase 1 Study of Asciminib-Based Induction Therapy in Newly Diagnosed Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Not yet recruiting·CCity of Hope Medical Center·Phase 1·NCT07914166·21 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

14 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

Completed· Novartis logo

Novartis·Phase 1·NCT03605277·14 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

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

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

Philadelphia Chromosome-Positive1 trial

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·Preclinical·NCT06308588·40 enrolled

Malignant Solid Tumors1 trial

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

Acute Lymphoblastic Leukemia1 trial

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

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

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

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 — 29 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 2027

Q2 2028

Q3 2028

Q4 2028

Trials by Indication[1]

Chronic Myelogenous Leukemia5 trials

Myeloid Leukemia3 trials

Chronic Myeloid Leukemia3 trials

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL12 trials

Chronic Myeloid Leukemia (CML)2 trials

Tyrosine Kinase Inhibitors1 trial

Treatment1 trial

Maintenance Therapy1 trial

Impaired Renal Function1 trial

TED1 trial

Aged1 trial

HIE1 trial

Ph+ ALL1 trial

Philadelphia Chromosome-Positive1 trial

Malignant Solid Tumors1 trial

Acute Lymphoblastic Leukemia1 trial

Myeloid1 trial

Brain Tumor1 trial

Chronic Phase Chronic Myelogenous Leukemia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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