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APG-2575(Lisaftoclax )
APG-2575(Lisaftoclax ) is a BCL-2/BCL-xL inhibitor Small molecule drug developed by Ascentage Pharma Group Inc.. It is currently in Phase 3 development for Relapsed or refractory acute myeloid leukemia (AML), Relapsed or refractory B-cell lymphomas.
APG-2575 (Lisaftoclax) is a BCL-2 family protein inhibitor that promotes apoptosis by blocking anti-apoptotic proteins in cancer cells.
APG-2575, also known as lisaftoclax, is a Bcl-2 inhibitor that has been studied in clinical trials for various conditions, including Systemic Lupus Erythematosus, CLL/SLL, T-Prolymphocytic Leukemia, Non-Hodgkins Lymphoma, and Mantle Cell Lymphoma. It has been investigated in combination with a BTK inhibitor and as a single agent in phase I/II clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | APG-2575(Lisaftoclax ) |
|---|---|
| Sponsor | Ascentage Pharma Group Inc. |
| Drug class | BCL-2/BCL-xL inhibitor |
| Target | BCL-2, BCL-xL |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lisaftoclax selectively inhibits BCL-2 and BCL-xL proteins, which are overexpressed in many hematologic and solid malignancies and prevent programmed cell death. By blocking these anti-apoptotic factors, the drug restores the intrinsic apoptotic pathway, allowing cancer cells to undergo programmed death. This mechanism is particularly relevant in cancers with high BCL-2 dependence.
Approved indications
- Relapsed or refractory acute myeloid leukemia (AML)
- Relapsed or refractory B-cell lymphomas
Common side effects
- Tumor lysis syndrome
- Cytopenias (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Diarrhea
- Fatigue
Key clinical trials
- Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL (PHASE2)
- Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma (PHASE2)
- A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus. (PHASE1, PHASE2)
- Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease (PHASE2)
- A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia (PHASE3)
- Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4). (PHASE3)
- A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL (PHASE2)
- Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- APG-2575(Lisaftoclax ) CI brief — competitive landscape report
- APG-2575(Lisaftoclax ) updates RSS · CI watch RSS
- Ascentage Pharma Group Inc. portfolio CI
Frequently asked questions about APG-2575(Lisaftoclax )
What is APG-2575(Lisaftoclax )?
How does APG-2575(Lisaftoclax ) work?
What is APG-2575(Lisaftoclax ) used for?
Who makes APG-2575(Lisaftoclax )?
What drug class is APG-2575(Lisaftoclax ) in?
What development phase is APG-2575(Lisaftoclax ) in?
What are the side effects of APG-2575(Lisaftoclax )?
What does APG-2575(Lisaftoclax ) target?
Related
- Drug class: All BCL-2/BCL-xL inhibitor drugs
- Target: All drugs targeting BCL-2, BCL-xL
- Manufacturer: Ascentage Pharma Group Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory acute myeloid leukemia (AML)
- Indication: Drugs for Relapsed or refractory B-cell lymphomas
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing