Numerous clinical trials evaluate asciminib (ABL001) primarily in chronic myeloid leukemia—specifically chronic phase, Philadelphia chromosome-positive, and T315I mutation-positive cases—alongside studies in advanced solid tumors and biliary tract cancer. Spanning Early Phase 1 through Phase 4, these trials are supported by pharmaceutical sponsors such as Novartis, clinical trial groups like GIMEMA, and academic research institutions. Current trial statuses across these studies include not yet recruiting, actively recruiting, active not recruiting, and completed stages.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07493408 | NOT_YET_RECRUITING | Ph+ Acute Lymphoblastic Leukemia (Ph+ALL); Blastic Transformation of Chronic Myeloid Leukemia; Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL); Haematopoietic Stem Cell Transplant, Allogeneic |
The University of Hong Kong |
2026-03-30 | PHASE2 |
| NCT07387926 | RECRUITING | Acute Lymphoblastic Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
Novartis Pharmaceuticals |
2026-07-05 | PHASE1; PHASE2 |
| NCT06236724 | RECRUITING | Chronic Myeloid Leukemia |
M.D. Anderson Cancer Center |
2024-01-31 | PHASE2 |
| NCT07354074 | RECRUITING | Chronic Myelogenous Leukemia; Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive |
Novartis Pharmaceuticals |
2026-04-28 | PHASE2 |
| NCT05143840 | ACTIVE_NOT_RECRUITING | Chronic Myeloid Leukemia, Chronic Phase; Adult CML; Leukemia, Myeloid; Leukemia,Myeloid, Chronic |
University of Alabama at Birmingham |
2022-04-22 | PHASE2 |
| NCT07604233 | NOT_YET_RECRUITING | Myeloid Leukemia |
M.D. Anderson Cancer Center |
2026-11-30 | PHASE1; PHASE2 |
| NCT07804901 | NOT_YET_RECRUITING | Chronic Myeloid Leukemia (CML) |
Prof. Dr. med. Andreas Hochhaus |
2027-01-01 | PHASE2 |
| NCT07136428 | RECRUITING | HER2+ Metastatic Breast Cancer |
Duke University |
2026-07-07 | PHASE1; PHASE2 |
| NCT04877522 | RECRUITING | Chronic Myelogenous Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Novartis Pharmaceuticals |
2022-08-30 | PHASE4 |
| NCT07789574 | ACTIVE_NOT_RECRUITING | Chronic Myeloid Leukemia (CML) |
Thomas Ernst, PD Dr. med. |
2026-06-22 | PHASE2 |
| NCT07250087 | RECRUITING | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
H. Lee Moffitt Cancer Center and Research Institute |
2026-01-21 | PHASE1 |
| NCT06409936 | RECRUITING | CML, Chronic Phase; Chronic Myeloid Leukemia, Chronic Phase; Chronic Myeloid Leukemia, BCR/ABL-Positive; Chronic Myeloid Leukemia |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
2025-06-26 | PHASE2 |
| NCT06773936 | ENROLLING_BY_INVITATION | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia; CD19+ Acute Leukemia |
SWOG Cancer Research Network |
2026-04-13 | PHASE2 |
| NCT06514534 | RECRUITING | Chronic Myeloid Leukemia (CML) |
Novartis Pharmaceuticals |
2025-02-18 | PHASE2 |
| NCT06368414 | RECRUITING | Chronic Myeloid Leukemia, Chronic Phase |
Korean Society of Hematology |
2024-03-11 | PHASE2 |
| NCT07040982 | RECRUITING | B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 |
City of Hope Medical Center |
2026-12-19 | PHASE1 |
| NCT04838041 | RECRUITING | Chronic Phase Chronic Myelogenous Leukemia |
Medical College of Wisconsin |
2021-11-11 | PHASE2 |
| NCT07538401 | NOT_YET_RECRUITING | Chronic Myeloid Leukemia (CML) in |
University Health Network, Toronto |
2026-04-25 | PHASE2 |
| NCT07039760 | NOT_YET_RECRUITING | Brain Tumor |
Washington University School of Medicine |
2026-08-31 | EARLY_PHASE1 |
| NCT04925479 | RECRUITING | Myeloid Leukemia, Philadelphia Positive |
Novartis Pharmaceuticals |
2021-12-27 | PHASE1; PHASE2 |
| NCT06308588 | RECRUITING | Philadelphia Chromosome-Positive; Acute Lymphoblastic Leukemia |
M.D. Anderson Cancer Center |
2024-08-05 | PHASE1; PHASE2 |
| NCT03906292 | ACTIVE_NOT_RECRUITING | Chronic Myeloid Leukemia |
University of Jena |
2019-08-19 | PHASE2 |
| NCT06629584 | RECRUITING | Malignant Solid Tumors |
M.D. Anderson Cancer Center |
2025-02-14 | PHASE2 |
| NCT03595917 | RECRUITING | B-cell Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL |
Marlise Luskin, MD |
2018-07-24 | PHASE1 |
| NCT06427811 | COMPLETED | Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase |
Novartis Pharmaceuticals |
2024-11-28 | PHASE4 |
| NCT03874858 | TERMINATED | Chronic Myeloid Leukemia |
Novartis Pharmaceuticals |
2019-03-22 | PHASE2 |
| NCT05384587 | ACTIVE_NOT_RECRUITING | Chronic Myelogenous Leukemia - Chronic Phase |
Novartis Pharmaceuticals |
2022-11-11 | PHASE2 |
| NCT05413915 | TERMINATED | Chronic Myeloid Leukemia; Chronic Myeloid Leukemia, BCR/ABL-Positive; Chronic Myeloid Leukemia in Remission |
Sarit Assouline |
2023-11-01 | PHASE3 |
| NCT05456191 | ACTIVE_NOT_RECRUITING | Philadelphia Chromosome-Positive Chronic Myeloid Leukemia |
Novartis Pharmaceuticals |
2022-11-21 | PHASE3 |
| NCT04216563 | TERMINATED | Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia |
M.D. Anderson Cancer Center |
2020-07-29 | PHASE2 |
| NCT06409936 | Not yet recruiting | CML Chronic Phase|Chronic Myeloid Leukemia Chronic Phase|Chronic Myeloid Leukemia BCR/ABL-Positive|Chronic Myeloid Leukemia |
Gruppo Italiano Malattie EMatologiche dell''Adulto|Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica |
2024-09 | Phase 2 |
| NCT04948333 | COMPLETED | Chronic Myelogenous Leukemia |
Novartis Pharmaceuticals |
2021-10-13 | PHASE3 |
| NCT06092879 | Recruiting | Chronic Myeloid Leukemia |
Novartis Pharmaceuticals|Novartis |
2024-03-06 | -- |
| NCT04492033 | TERMINATED | P1b: Advanced Solid Tumors; P2: Biliary Tract Cancer |
Handok Inc. |
2020-06-22 | PHASE1; PHASE2 |
| NCT04971226 | ACTIVE_NOT_RECRUITING | Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive |
Novartis Pharmaceuticals |
2021-10-06 | PHASE3 |
| NCT04666259 | COMPLETED | Chronic Myelogenous Leukemia - Chronic Phase |
Novartis Pharmaceuticals |
2021-05-25 | PHASE3 |
| NCT04795427 | COMPLETED | Leukemia, Chronic Myelogenous |
Novartis Pharmaceuticals |
2021-12-06 | PHASE2 |
| NCT06211153 | Completed | Chronic Myeloid Leukemia With T315I Mutation |
Novartis Pharmaceuticals|Novartis |
2021-12-31 | -- |
| NCT04795427 | Active not recruiting | Leukemia Chronic Myelogenous |
Novartis Pharmaceuticals|Novartis |
2021-12-06 | Phase 2 |
| NCT03578367 | COMPLETED | CML; Chronic Myelogenous Leukemia; Leukemia, Myeloid Chronic; Hematologic Diseases |
Novartis Pharmaceuticals |
2018-11-22 | PHASE2 |
| NCT02081378 | COMPLETED | Chronic Myelogenous Leukemia; Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia |
Novartis Pharmaceuticals |
2014-04-24 | PHASE1 |
| NCT03292783 | COMPLETED | Advanced Solid Tumors |
ABL Bio, Inc. |
2017-09-18 | PHASE1 |
| NCT04492033 | Active not recruiting | P1b: Advanced Solid Tumors|P2: Biliary Tract Cancer |
Handok Inc.|Compass Therapeutics|ABL Bio Inc. |
2020-06-22 | Phase 1|Phase 2 |
| NCT03106779 | COMPLETED | Chronic Myelogenous Leukemia |
Novartis Pharmaceuticals |
2017-10-26 | PHASE3 |
| NCT03605277 | COMPLETED | Renal Impairment |
Novartis Pharmaceuticals |
2018-11-16 | PHASE1 |
| NCT02857868 | COMPLETED | Hepatic Impairment |
Novartis Pharmaceuticals |
2016-05-03 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-03-25)
Check the
ABL001 (Asciminib)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- ABL001 (Asciminib) Mechanism of Action: BCR-ABL1 Inhibition in Myeloid Cells Research
- ABL001 (Asciminib): Selectivity & Specificity
- ABL001 (Asciminib) Working Concentration | Cell Culture | Treatment
- ABL001 (Asciminib) Solubility in DMSO
- ABL001 (Asciminib) Stock Solution
- ABL001 (Asciminib) Storage
- ABL001 (Asciminib) Stability
- ABL001 (Asciminib) Combination Database
- ABL001 (Asciminib) Molecular Weight
- ABL001 (Asciminib) SMILES
- ABL001 (Asciminib) CAS Number
- ABL001 (Asciminib) Chemical Structure (2D and 3D)
- ABL001 (Asciminib) IC50 for Cell-based and Cell-free Assays
- ABL001 (Asciminib) Sigma (BL3H160C4B14)? Try a better option.
- ABL001 (Asciminib) APExBIO (BA8800)? Try a better option.
- ABL001 (Asciminib) MedChemExpress (HY-104010)? Try a better option.
- ABL001 (Asciminib) Cayman (26126)? Try a better option.
- ABL001 (Asciminib) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.