Lisaftoclax

Phase 3Small molecule

Lisaftoclax is one of 200 small molecule programs targeting Acute Promyelocytic Leukemia (APL). It is currently in Phase 3.

Indications

Total Trials

Active Trials

199

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Promyelocytic Leukemia (APL)Not yet recruiting

Mantle Cell Lymphoma (MCL)Recruiting

Cutaneous T-Cell Lymphoma/mycosis FungoidesNot yet recruiting

Acute Myeloid Leukemia (AML)Not yet recruiting

CLL/SLLRecruiting

Indolent LymphomaNot yet recruiting

AMLRecruiting

Acute Lymphoblastic LeukemiaNot yet recruiting

TreatmentRecruiting

T-Cell Acute Lymphoblastic LeukemiaNot yet recruiting

Acute Promyelocytic Leukemia (APL)Preclinical

Not yet recruiting

Mantle Cell Lymphoma (MCL)Phase 2

Recruiting

Cutaneous T-Cell Lymphoma/mycosis FungoidesPhase 2

Not yet recruiting

Acute Myeloid Leukemia (AML)Phase 3

Not yet recruiting

CLL/SLLPhase 3

Recruiting

Indolent LymphomaPhase 2

Not yet recruiting

AMLPreclinical

Recruiting

Acute Lymphoblastic LeukemiaPreclinical

Not yet recruiting

TreatmentPhase 2

Recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 1

Not yet recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Lisaftoclax

Ascentage Pharma Group Inc.

Phase 3

1 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Lotemax

PPharmos

Preclinical

1 8

Clomid

Ferring

Preclinical

1 9

Aurlumyn

BBTG International Inc.

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

CLL/SLL

NCT04215809

Q1 2028

Phase 2Not yet recruiting

Indolent Lymphoma

NCT07459608

Q2 2028

PreclinicalRecruiting

AML

NCT06265545

Q3 2028

Phase 3Recruiting

CLL/SLL

NCT06319456

Phase 2Recruiting

Mantle Cell Lymphoma (MCL)

NCT07272499

Clinical

Trials by Indication[1]

CLL/SLL2 trials

Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1·NCT04215809·144 enrolled

A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06319456·344 enrolled

Acute Myeloid Leukemia (AML)2 trials

A Multi-Center, Prospective, Open-Label, Single-Arm Study of Homoharringtonine Combined With Lisaftoclax and Azacitidine in Patients With Acute Myeloid Leukemia After Failure of Venetoclax-Based Therapy

Enrolling by invitation·GGuangdong Second Provincial General Hospital·Phase 2·NCT07813390·73 enrolled

Maintenance Therapy With Lisaftoclax Plus Azacitidine After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse: A Multicenter, Open-Label, Randomized Controlled Trial

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT07686965·191 enrolled

Mantle Cell Lymphoma (MCL)2 trials

A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib Plus Lisaftoclax and Rituximab in Treatment-Naive, High-Risk Mantle Cell Lymphoma (MCL)

Recruiting·RRuijin Hospital·Phase 2·NCT07272499·25 enrolled

A Prospective Phase 2 Study of Lisaftoclax Plus Pirtobrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma After Failure of BTK-Targeted Therapy

Not yet recruiting·HHenan Cancer Hospital·Phase 2·NCT07684950·45 enrolled

Relapsed/Refractory AML1 trial

Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1/2·NCT04501120·458 enrolled

Myelodysplastic Syndrome1 trial

Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06641414·490 enrolled

8 more indications

Treatment1 trial

Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT07255963·29 enrolled

T-cell acute lymphoblastic leukemia1 trial

A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07428486·24 enrolled

Phase IB1 trial

Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study

Not yet recruiting·SSun Yat-sen University·Phase 1/2·NCT07398638·122 enrolled

Acute Lymphoblastic Leukemia1 trial

A Single-Center, Prospective, Exploratory Clinical Study of the Lishatoclax Combination Regimen in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Not yet recruiting·LLanZhou University·Preclinical·NCT07795099·30 enrolled

AML1 trial

Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT06265545·458 enrolled

Indolent Lymphoma1 trial

Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphomas

Not yet recruiting·HHenan Cancer Hospital·Phase 2·NCT07459608·75 enrolled

Cutaneous T-Cell Lymphoma/Mycosis Fungoides1 trial

A Phase II, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in Patients With CD30-positive Cutaneous T-cell Lymphoma (CTCL)

Not yet recruiting·PPeking University First Hospital·Phase 2·NCT07717580·46 enrolled

Acute Promyelocytic Leukemia (APL)1 trial

Lisaftoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail

Not yet recruiting·TThe Affiliated People's Hospital of Ningbo University·Preclinical·NCT07597941·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Lisaftoclax. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lisaftoclax compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lisaftoclax. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Ascentage Pharma Group Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Ascentage Pharma Group Inc.

Lisaftoclax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q2 2028

Q3 2028

Trials by Indication[1]

CLL/SLL2 trials

Acute Myeloid Leukemia (AML)2 trials

Mantle Cell Lymphoma (MCL)2 trials

Relapsed/Refractory AML1 trial

Myelodysplastic Syndrome1 trial

Treatment1 trial

T-cell acute lymphoblastic leukemia1 trial

Phase IB1 trial

Acute Lymphoblastic Leukemia1 trial

AML1 trial

Indolent Lymphoma1 trial

Cutaneous T-Cell Lymphoma/Mycosis Fungoides1 trial

Acute Promyelocytic Leukemia (APL)1 trial

References

Drug Info

Quick Facts

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