Numerous clinical trials spanning Early Phase 1 through Phase 3 are evaluating APG-2575 (lisaftoclax) for hematologic malignancies—such as chronic lymphocytic leukemia, small lymphocytic lymphoma, acute lymphoblastic leukemia, T-prolymphocytic leukemia, and myelodysplastic syndrome—and autoimmune diseases like systemic lupus erythematosus. Conducted by biopharmaceutical developers like Ascentage Pharma Group alongside academic and hospital institutions, these studies encompass recruiting, active not recruiting, completed, and not yet recruiting protocols. This diverse portfolio underscores active global clinical investigation of the compound.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07686965 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML); Maintenance Treatment; Hematopoetic Stem Cell Transplantation |
Institute of Hematology & Blood Diseases Hospital, China |
2026-08-10 | PHASE3 |
| NCT07651176 | ENROLLING_BY_INVITATION | Acute Myeloid Leukemia; Lisaftoclax |
First Affiliated Hospital of Zhejiang University |
2026-03-01 | PHASE2; PHASE3 |
| NCT07651163 | ENROLLING_BY_INVITATION | Acute Myeloid Leukemia (AML); Lisaftoclax |
First Affiliated Hospital of Zhejiang University |
2026-03-01 | PHASE2; PHASE3 |
| NCT07795099 | NOT_YET_RECRUITING | Acute Lymphoblastic Leukemia |
LanZhou University |
2026-08 | |
| NCT06641414 | RECRUITING | Higher-risk Myelodysplastic Syndrome |
Ascentage Pharma Group Inc. |
2025-01-22 | PHASE3 |
| NCT07398638 | NOT_YET_RECRUITING | Diffuse Large B Cell Lymphoma (DLBCL) |
Sun Yat-sen University |
2026-02-28 | PHASE1; PHASE2 |
| NCT07717580 | NOT_YET_RECRUITING | Cutaneous T-Cell Lymphoma/Mycosis Fungoides; Primary Cutaneous Anaplastic Large Cell Lymphoma |
Peking University First Hospital |
2026-07-31 | PHASE2 |
| NCT07684950 | NOT_YET_RECRUITING | Mantle Cell Lymphoma (MCL) |
Henan Cancer Hospital |
2026-06-30 | PHASE2 |
| NCT07255963 | RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma |
The First Affiliated Hospital of Soochow University |
2025-11-30 | PHASE2 |
| NCT07272499 | RECRUITING | Mantle Cell Lymphoma (MCL) |
Ruijin Hospital |
2025-09-10 | PHASE2 |
| NCT04501120 | RECRUITING | Relapsed/Refractory Acute Myeloid Leukaemia; Myeloid Malignancy |
Ascentage Pharma Group Inc. |
2020-09-28 | PHASE1; PHASE2 |
| NCT07597941 | NOT_YET_RECRUITING | Acute Promyelocytic Leukemia (APL) |
The Affiliated People's Hospital of Ningbo University |
2026-07 | PHASE2; PHASE3 |
| NCT07601607 | NOT_YET_RECRUITING | Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) |
Sun Yat-sen University |
2026-05-30 | PHASE1; PHASE2 |
| NCT06389292 | RECRUITING | Acute Myeloid Leukemia |
Ascentage Pharma Group Inc. |
2024-06-11 | PHASE3 |
| NCT06265545 | RECRUITING | AML; Refractory; Relapsed |
Institute of Hematology & Blood Diseases Hospital, China |
2024-02-22 | |
| NCT06319456 | RECRUITING | CLL/SLL |
Ascentage Pharma Group Inc. |
2024-04-07 | PHASE3 |
| NCT07459608 | NOT_YET_RECRUITING | Indolent Lymphoma; WM; MZL; CLL / SLL |
Henan Cancer Hospital |
2026-07-10 | PHASE2 |
| NCT05701306 | RECRUITING | Neuroblastoma; Solid Tumor |
Ascentage Pharma Group Inc. |
2023-02-28 | PHASE1; PHASE2 |
| NCT07552324 | NOT_YET_RECRUITING | DHL; THL; DLBCL - Diffuse Large B Cell Lymphoma |
Ruijin Hospital |
2026-05-01 | 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 |
| NCT06104566 | RECRUITING | CLL/SLL |
Ascentage Pharma Group Inc. |
2023-12-20 | PHASE3 |
| NCT05147467 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Ascentage Pharma Group Inc. |
2021-12-28 | PHASE2 |
| NCT04496349 | RECRUITING | T-Prolymphocytic Leukemia; Non-Hodgkins Lymphoma |
Ascentage Pharma Group Inc. |
2021-07-12 | PHASE2 |
| NCT07428486 | WITHDRAWN | Phase I; FLAG Chemotherapy; Lisaftoclax; Pelcitoclax; Relapsed/Refractory; Lymphoblastic Leukemia Acute |
M.D. Anderson Cancer Center |
2026-04-27 | PHASE1 |
| NCT06182969 | RECRUITING | SLE |
Ascentage Pharma Group Inc. |
2024-08-09 | PHASE1; PHASE2 |
| NCT04215809 | RECRUITING | CLL/SLL |
Ascentage Pharma Group Inc. |
2020-03-02 | PHASE1 |
| NCT04494503 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Ascentage Pharma Group Inc. |
2020-08-31 | PHASE1; PHASE2 |
| NCT03913949 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma |
Ascentage Pharma Group Inc. |
2019-06-03 | PHASE1 |
| NCT03537482 | UNKNOWN | Hematologic Malignancies |
Ascentage Pharma Group Inc. |
2018-08-07 | EARLY_PHASE1 |
| NCT04942067 | UNKNOWN | Multiple Myeloma; Amyloidosis |
Ascentage Pharma Group Inc. |
2021-12-23 | PHASE1; PHASE2 |
| NCT04946864 | SUSPENDED | Breast Cancer; Solid Tumor, Adult |
Ascentage Pharma Group Inc. |
2021-08-13 | PHASE1; PHASE2 |
| NCT04964518 | UNKNOWN | AML, Adult |
Ascentage Pharma Group Inc. |
2021-07-30 | PHASE1; PHASE2 |
| NCT04260217 | COMPLETED | Waldenstrom Macroglobulinemia |
Ascentage Pharma Group Inc. |
2021-05-30 | PHASE1 |
| NCT04674514 | UNKNOWN | Multiple Myeloma |
Ascentage Pharma Group Inc. |
2021-04-13 | PHASE1; PHASE2 |
| NCT06182969 | Not yet recruiting | SLE |
Ascentage Pharma Group Inc.|Suzhou Yasheng Pharmaceutical Co. Ltd. |
2023-12 | Phase 1|Phase 2 |
| NCT05517616 | COMPLETED | Pharmacokinetics |
Ascentage Pharma Group Inc. |
2022-09-14 | 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 | Phase 1 |
| NCT04496349 | Recruiting | T-Prolymphocytic Leukemia |
Ascentage Pharma Group Inc. |
2021-07-12 | Phase 2 |
| NCT04494503 | Recruiting | Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma |
Ascentage Pharma Group Inc. |
2020-08-31 | Phase 1|Phase 2 |
| NCT03913949 | Active not recruiting | Chronic Lymphocytic Leukemia|Non Hodgkin Lymphoma |
Ascentage Pharma Group Inc.|Suzhou Yasheng Pharmaceutical Co. Ltd. |
2019-06-03 | Phase 1 |
| NCT03537482 | Recruiting | Hematologic Malignancies |
Ascentage Pharma Group Inc. |
2018-08-07 | Early Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-07-07)
Check the
APG-2575 (lisaftoclax)
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>).
- APG-2575 (lisaftoclax) Solubility in DMSO
- APG-2575 (lisaftoclax) Stock Solution
- APG-2575 (lisaftoclax) Storage
- APG-2575 (lisaftoclax) Stability
- APG-2575 (lisaftoclax) Molecular Weight
- APG-2575 (lisaftoclax) SMILES
- APG-2575 (lisaftoclax) CAS Number
- APG-2575 (lisaftoclax) Chemical Structure (2D and 3D)
- APG-2575 (lisaftoclax) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.