Asciminib

Generic Name: Asciminib

Brand Names: Scemblix

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₁₈ClF_₂N_₅O_₃

CAS Number: 1492952-76-7

Unique Ingredient Identifier: L1F3R18W77

Background: Asciminib is a tyrosine kinase inhibitor (TKI) used in the treatment of chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). More specifically, it is an inhibitor of the ABL1 kinase activity of the BCR-ABL1 fusion protein which serves as a driver of CML proliferation in most patients with the disease. It has also shown benefit i...

Indication: Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with ≥2 tyrosine kinase inhibitors. It is also indicated in the treatment of Ph+ CML in adult patients with the T315I mutation.

Associated Conditions: Chronic Phase Chronic Myeloid Leukemia

Associated Therapies: -

Clinical Trials

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Phase 3

Active, not recruiting

Conditions: Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

Interventions: Drug: Imatinib
Drug: Asciminib
Drug: Nilotinib
Drug: Bosutinib
Drug: Dasatinib

First Posted Date: 2021-07-21

Last Posted Date: 2024-05-03

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 404

Registration Number: NCT04971226

Locations: 🇬🇧
Novartis Investigative Site, Oxford, United Kingdom
🇺🇸
Texas Oncology Austin, Dallas, Texas, United States
🇺🇸
Texas Oncology Texas Onc - Amarillo, Dallas, Texas, United States

and more 12 locations

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

Phase 2

Active, not recruiting

Conditions: Leukemia, Chronic Myelogenous

Interventions: Other: best available treatment
Drug: asciminib

First Posted Date: 2021-03-12

Last Posted Date: 2024-11-20

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 84

Registration Number: NCT04795427

Locations: 🇨🇳
Novartis Investigative Site, Tianjin, China

Managed Access Programs for ABL001, Asciminib

Conditions: Chronic Myeloid Leukemia in Chronic Phase

First Posted Date: 2020-04-24

Last Posted Date: 2024-10-28

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT04360005

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

Phase 2

Active, not recruiting

Conditions: Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia

Interventions: Drug: Asciminib

First Posted Date: 2020-01-02

Last Posted Date: 2024-10-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT04216563

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Frontline Asciminib Combination in Chronic Phase CML

Phase 2

Active, not recruiting

Conditions: Chronic Myeloid Leukemia

Interventions: Drug: Asciminib
Drug: Dasatinib
Drug: Nilotinib 300 mg
Drug: Imatinib

First Posted Date: 2019-04-08

Last Posted Date: 2023-05-10

Lead Sponsor: University of Jena

Target Recruit Count: 125

Registration Number: NCT03906292

Locations: 🇩🇪
Universitätsklinikum Aachen Medizinische Klinik IV, Aachen, Germany
🇩🇪
Klinikum Bremen Mitte, Bremen, Germany
🇩🇪
Charite Universitätsmeditin Berlin, Campus Virchow Klinikum, Berlin, Germany

and more 18 locations

De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination

Phase 2

Active, not recruiting

Conditions: Chronic Myeloid Leukemia

Interventions: Drug: Nilotinib
Drug: Asciminib

First Posted Date: 2019-03-14

Last Posted Date: 2024-11-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 124

Registration Number: NCT03874858

Locations: 🇮🇹
Novartis Investigative Site, Novara, Italy

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

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: Asciminib

First Posted Date: 2018-07-30

Last Posted Date: 2021-10-12

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 14

Registration Number: NCT03605277

Locations: 🇩🇪
Novartis Investigative Site, Berlin, Germany

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

Phase 3

Active, not recruiting

Conditions: Chronic Myelogenous Leukemia

Interventions: Drug: Asciminib
Drug: Bosutinib

First Posted Date: 2017-04-10

Last Posted Date: 2024-10-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 233

Registration Number: NCT03106779

Locations: 🇺🇸
University of Michigan Clinical Trials Office Main site., Ann Arbor, Michigan, United States
🇺🇸
Uni Of TX MD Anderson Cancer Cntr, Houston, Texas, United States
🇺🇸
University of Chicago Hospital, Chicago, Illinois, United States

and more 8 locations

Drug Development Updates

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