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Lisaftoclax
Lisaftoclax is a Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 2 development. Also known as: APG2575.
Lisaftoclax is an investigational new drug being developed by Ascentage Pharma for the treatment of hematological malignancies, including Diffuse Large B Cell Lymphoma (DLBCL), DHL, THL, and Neuroblastoma. It is a selective inhibitor of the B-cell lymphoma 2 (BCL-2) protein, designed to restore the normal process of programmed cell death (apoptosis) in cancer cells.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Lisaftoclax |
|---|---|
| Also known as | APG2575 |
| Sponsor | M.D. Anderson Cancer Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
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 Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia (PHASE1)
- A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (PHASE1)
- Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study (PHASE1, 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)
- Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL (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:
- Lisaftoclax CI brief — competitive landscape report
- Lisaftoclax updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about Lisaftoclax
What is Lisaftoclax?
Who makes Lisaftoclax?
Is Lisaftoclax also known as anything else?
What development phase is Lisaftoclax in?
Related
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: APG2575
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing