Multiple clinical trials evaluate the therapeutic efficacy and safety of olverembatinib across oncological indications, including Philadelphia chromosome-positive acute lymphoblastic leukemia, chronic myeloid leukemia in blast phase, and advanced gastrointestinal stromal tumors. Spanning early Phase 1 to pediatric Phase 3 protocols, these studies are sponsored by industry entities like Ascentage Pharma Group alongside academic institutions such as M.D. Anderson Cancer Center and the Institute of Hematology & Blood Diseases Hospital. Active protocols currently feature various recruitment statuses across early- and late-stage evaluations, including actively recruiting, available, and not yet recruiting cohorts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07178912 | NOT_YET_RECRUITING | Phase II Clinical Trial; Blinatumomab; Olverembatinib; Lymphoblastic Leukemia; Philadelphia Chromosome Positive |
M.D. Anderson Cancer Center |
2026-08-27 | PHASE2 |
| NCT07152041 | RECRUITING | Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+); Childhood Leukemia, Acute Lymphoblastic |
Institute of Hematology & Blood Diseases Hospital, China |
2025-03-28 | PHASE3 |
| NCT04501120 | RECRUITING | Relapsed/Refractory Acute Myeloid Leukaemia; Myeloid Malignancy |
Ascentage Pharma Group Inc. |
2020-09-28 | PHASE1; PHASE2 |
| NCT07493161 | RECRUITING | Ph+ ALL |
Institute of Hematology & Blood Diseases Hospital, China |
2026-04-10 | |
| NCT07454226 | RECRUITING | Ph-Like; Acute Lymphoblastic Leukemia |
Institute of Hematology & Blood Diseases Hospital, China |
2026-05-30 | |
| NCT06051409 | RECRUITING | Ph+ ALL; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
Ascentage Pharma Group Inc. |
2023-08-31 | PHASE3 |
| NCT07443488 | NOT_YET_RECRUITING | HSCT; Ph+ ALL |
Institute of Hematology & Blood Diseases Hospital, China |
2026-03-14 | PHASE2 |
| NCT06658925 | NOT_YET_RECRUITING | Ph+ Acute Lymphoblastic Leukemia (Ph+ALL); HSCT; Tyrosine Kinase Inhibitor |
Institute of Hematology & Blood Diseases Hospital, China |
2024-11-01 | PHASE2 |
| NCT06640361 | RECRUITING | GIST |
Ascentage Pharma Group Inc. |
2024-11-11 | PHASE3 |
| NCT06817720 | RECRUITING | Chronic Myeloid Leukemia |
M.D. Anderson Cancer Center |
2025-10-13 | PHASE2 |
| NCT06401603 | RECRUITING | Advanced Chronic Myeloid Leukemia; Philadelphia Chromosome-Positive Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2024-08-06 | PHASE1 |
| NCT05495035 | RECRUITING | Lymphoblastic Leukemia, Acute, Childhood; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive; Relapsed Leukemia; Refractory Leukemia |
Institute of Hematology & Blood Diseases Hospital, China |
2022-09-01 | PHASE1 |
| NCT06757855 | RECRUITING | CML,Blast Phase |
Institute of Hematology & Blood Diseases Hospital, China |
2025-01-26 | PHASE1; PHASE2 |
| NCT06082934 | RECRUITING | Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia |
Xijing Hospital |
2023-11-01 | PHASE1; PHASE2 |
| NCT07282093 | RECRUITING | Pharmacokinetic; Olverembatinib |
Ascentage Pharma Group Inc. |
2025-11-11 | PHASE1 |
| NCT06481228 | RECRUITING | Philadelphia Positive Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia, Adult |
Institute of Hematology & Blood Diseases Hospital, China |
2024-06-04 | |
| NCT06220487 | RECRUITING | Acute Lymphoblastic Leukemia; Philadelphia Chromosome; Philadelphia-Positive ALL; Adult ALL; IKZF1 Gene Mutation |
Nanfang Hospital, Southern Medical University |
2024-02-01 | PHASE2 |
| NCT06754267 | RECRUITING | Precursor B-Cell Acute Lymphoblastic Leukemia |
First Affiliated Hospital of Zhejiang University |
2024-12 | PHASE2 |
| NCT06423911 | RECRUITING | Chronic Myeloid Leukemia; CML; CML, Chronic Phase |
Ascentage Pharma Group Inc. |
2024-02-05 | PHASE3 |
| NCT07074496 | RECRUITING | Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
The First Affiliated Hospital of Soochow University |
2024-01-01 | EARLY_PHASE1 |
| NCT05931757 | NOT_YET_RECRUITING | Philadelphia-Positive ALL |
The First Affiliated Hospital of Soochow University |
2023-07-01 | PHASE2 |
| NCT05594784 | COMPLETED | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
Institute of Hematology & Blood Diseases Hospital, China |
2022-10-08 | PHASE2 |
| NCT05376852 | UNKNOWN | Chronic Myeloid Leukemia in Myeloid Blast Crisis; Chronic Myeloid Leukaemia Transformation; Chronic Myeloid Leukemia - Accelerated Phase; Chronic Myeloid Leukemia in Lymphoid Blast Crisis |
Nanfang Hospital, Southern Medical University |
2021-12-01 | PHASE2 |
| NCT05521204 | RECRUITING | Myeloproliferative Neoplasm; Acute Leukemia |
The First Affiliated Hospital of Soochow University |
2022-09-01 | PHASE2 |
| NCT05603156 | UNKNOWN | Ph+ ALL; Bone Marrow Transplant; Minimal Residual Disease |
Institute of Hematology & Blood Diseases Hospital, China |
2022-10-30 | |
| NCT05311943 | UNKNOWN | Olverembatinib; Chronic Myeloid Leukemia, Chronic Phase; Tyrosine Kinase Inhibitors |
Shenzhen Second People's Hospital |
2022-07-01 | PHASE3 |
| NCT05604755 | WITHDRAWN | Prophylactic HQP1351 Therapy; Third Generation TKI |
xuna |
2022-01-01 | PHASE2 |
| NCT05466175 | UNKNOWN | Philadelphia-Positive ALL |
Chen Suning |
2022-10-01 | PHASE2 |
| NCT03594422 | Recruiting | Gastrointestinal Stromal Tumor (GIST)|Solid Tumor Adult |
Ascentage Pharma Group Inc.|HealthQuest Pharma Inc. |
2018-07-11 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-08-12)
Check the
Olverembatinib dimesylate (GZD824)
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>).
- Olverembatinib dimesylate (GZD824) Solubility in DMSO
- Olverembatinib dimesylate (GZD824) Stock Solution
- Olverembatinib dimesylate (GZD824) Storage
- Olverembatinib dimesylate (GZD824) Stability
- Olverembatinib dimesylate (GZD824) Molecular Weight
- Olverembatinib dimesylate (GZD824) SMILES
- Olverembatinib dimesylate (GZD824) CAS Number
- Olverembatinib dimesylate (GZD824) Chemical Structure (2D and 3D)
- Olverembatinib dimesylate (GZD824) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.