Drugs / APG-2575
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APG-2575

also known as Lisaftoclax · [14C] APG-2575

Small molecule targets BCL2 via inhibition

Developed for
acute myeloid leukemia · chronic lymphocytic leukemia/small lymphocytic lymphoma · diffuse large B-cell lymphoma · mantle cell lymphoma · plasma cell myeloma · acute promyelocytic leukemia · amyloidosis · B-cell chronic lymphocytic leukemia
+14 more · B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) · breast cancer · childhood acute lymphoblastic leukemia · hematopoietic and lymphoid cell neoplasm · large B-cell lymphoma · marginal zone lymphoma · myelodysplastic syndrome · neuroblastoma · relapsed/refractory diffuse large B-cell lymphoma · systemic lupus erythematosus · T lymphoblastic leukemia/lymphoma · T-cell prolymphocytic leukemia · T-cell/histiocyte rich large B cell lymphoma · Waldenstrom macroglobulinemia
Investigated by
Ascentage Pharma Group Inc. · Suzhou Yasheng Pharmaceutical Co., Ltd. · First Affiliated Hospital of Zhejiang University · Ruijin Hospital · Henan Cancer Hospital · Institute of Hematology & Blood Diseases Hospital, China
+12 more · Sun Yat-sen University · First Affiliated Hospital of Wenzhou Medical University · Fujian Medical University Union Hospital · Huadong Hospital · M.D. Anderson Cancer Center · Qilu Hospital of Shandong University · Shanghai Minhang Central Hospital · The Affiliated People's Hospital of Ningbo University · The First Affiliated Hospital of Anhui Medical University · The First Affiliated Hospital of Soochow University · The Third Xiangya Hospital of Central South University · Yangpu District Central Hospital Affiliated to Tongji University

Trials 33 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03537482 Aug 2018 → Sep 2024 overdue hematopoietic and lymphoid cell neoplasm Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 17 trials
Phase 1 NCT07428486 Apr 2026 T lymphoblastic leukemia/lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT05701306 Feb 2023 → Jun 2026 overdue neuroblastoma Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1 NCT05517616 Sep → Nov 2022 Ascentage Pharma Group Inc. Completed No outcome recorded
Phase 1 NCT05495035 Sep 2022 → Aug 2024 B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), childhood acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Unknown No outcome recorded
Phase 1 NCT04260217 May 2021 → Feb 2024 Waldenstrom macroglobulinemia Ascentage Pharma Group Inc. Completed No outcome recorded
Phase 1 NCT04215809 Mar 2020 → Oct 2025 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1 NCT03913949 Jun 2019 → Oct 2024 overdue B-cell chronic lymphocytic leukemia Ascentage Pharma Group Inc. Active not recruiting No outcome recorded
Phase 1/210 trials
Phase 1/2 NCT07601607 May 2026 → May 2028 expected relapsed/refractory diffuse large B-cell lymphoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 1/2 NCT07398638 Feb 2026 → Feb 2029 expected diffuse large B-cell lymphoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 1/2 NCT07159906 Sep 2025 → Aug 2027 expected diffuse large B-cell lymphoma First Affiliated Hospital of Zhejiang University Not yet recruiting No outcome recorded
Phase 1/2 NCT06182969 Aug 2024 → Apr 2026 overdue systemic lupus erythematosus Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1/2 NCT04942067 Dec 2021 → Sep 2024 amyloidosis, plasma cell myeloma Ascentage Pharma Group Inc. Unknown No outcome recorded
Phase 1/2 NCT04946864 Aug 2021 → Aug 2024 breast cancer Ascentage Pharma Group Inc. Suspended No outcome recorded
Phase 1/2 NCT04964518 Jul 2021 → Jul 2024 acute myeloid leukemia Ascentage Pharma Group Inc. Unknown No outcome recorded
Phase 1/2 NCT04674514 Apr 2021 → Jan 2024 plasma cell myeloma Ascentage Pharma Group Inc. Unknown No outcome recorded
Phase 1/2 NCT04501120 Sep 2020 → Sep 2028 expected acute myeloid leukemia Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1/2 NCT04494503 Aug 2020 → Oct 2024 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 28 trials
Phase 2 NCT07684950 Jun 2026 → Oct 2028 expected mantle cell lymphoma Henan Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07602322 May 2026 → May 2028 expected large B-cell lymphoma Ruijin Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07552324 May 2026 → May 2027 expected T-cell/histiocyte rich large B cell lymphoma Ruijin Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07459608 Mar 2026 → Jan 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma Henan Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07255963 Nov 2025 → Sep 2028 expected diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 2 NCT07272499 Sep 2025 → Sep 2028 expected mantle cell lymphoma Ruijin Hospital Recruiting No outcome recorded
Phase 2 NCT05147467 Dec 2021 → Dec 2026 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 2 NCT04496349 Jul 2021 → May 2026 overdue T-cell prolymphocytic leukemia Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07597941 Jul 2026 → Jun 2028 expected acute promyelocytic leukemia The Affiliated People's Hospital of Ningbo University Not yet recruiting No outcome recorded
Phase 2/3 NCT07651163 Mar 2026 → Dec 2029 expected acute myeloid leukemia First Affiliated Hospital of Zhejiang University Enrolling by invitation No outcome recorded
Phase 2/3 NCT07651176 Mar 2026 → Dec 2029 expected acute myeloid leukemia First Affiliated Hospital of Zhejiang University Enrolling by invitation No outcome recorded
Phase 34 trials
Phase 3 NCT07686965 Aug 2026 → Aug 2030 expected acute myeloid leukemia Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 3 NCT06641414 Jan 2025 → Jun 2029 expected myelodysplastic syndrome Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 3 NCT06389292 Jun 2024 → May 2028 expected acute myeloid leukemia Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 3 NCT06319456 Apr 2024 → Aug 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Ascentage Pharma Group Inc. Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT06104566 Comparator Dec 2023 → Dec 2026 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Ascentage Pharma Group Inc. Recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 35 sources stand behind the page.

FieldValueCited text
Known as APG-2575 “A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small...” NCT06104566
23

“Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.” NCT04260217

“Safety, tolerability, and pharmacokinetics of lisaftoclax (APG-2575)-based therapy in patients with chronic lymphocytic leukemia: Phase 1b/2 study.” PMID 41109219 Oct 2025

“Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count \>2.0×10⁹/L or ≥24-hour 2-fold WBC elevation.” NCT07597941

“Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.” NCT04501120

“lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor” NCT07459608

“Drug: Lisaftoclax (APG-2575)” NCT07272499

“Lisaftoclax (APG-2575)” NCT06319456

“Lisaftoclax (APG-2575)” NCT06641414

NCT06182969

NCT06389292

NCT05495035

NCT04964518

NCT04674514

NCT04496349

NCT04494503

NCT03913949

NCT03537482

NCT04260217

NCT04946864

NCT05701306

NCT05517616

NCT05147467

NCT04942067

Known as [14C] APG-2575 “A Single-center, Open-label, Single-dose Phase 1 Clinical Study to Investigate the Absorption, Metabolism and Excretion of APG-2575 in Healthy Subjects After Oral...” NCT05517616
Known as Lisaftoclax “R 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21” NCT07552324
19

“Venetoclax (or Lisaftoclax, depending on study drug) is a selective oral BCL-2 inhibitor that restores apoptosis in tumor cells.” NCT07159906

“GC Type: Glofitamab + BCL-2 inhibitor (e.g., Lisaftoclax/Venetoclax)” NCT07602322

“APG-2575(Lisaftoclax )” NCT06389292

NCT07651176

NCT07272499

NCT06641414

NCT07686965

NCT07684950

NCT06319456

NCT07398638

NCT06104566

NCT07597941

NCT07601607

NCT07459608

NCT07255963

NCT04215809

NCT07428486

NCT07651163

NCT04501120

Action Inhibit “Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.” PMID 41109219 Oct 2025
Modality Small molecule “Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.” PMID 41109219 Oct 2025
Route Oral “APG-2575 will be administered as an oral tablet” NCT03537482
Target BCL2 “Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.” PMID 41109219 Oct 2025