Lisaftoclax
Also known as APG-2575
ASCENTAGE PHARMA GROUP INTERNATIONAL AAPG · Acute Myeloid Leukemia; CLL/SLL; Higher-risk Myelodysplastic Syndrome
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
3
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASCENTAGE PHARMA GROUP INTERNATIONAL AAPG Source: Company record for ASCENTAGE PHARMA GROUP INTERNATIONAL (opens in a new tab)
- Indications
- Acute Myeloid Leukemia; CLL/SLL; Higher-risk Myelodysplastic Syndrome Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 7 Apr 20243 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Lisaftoclax. Editors add each one with its source.
Filed application
No filed application is on record for Lisaftoclax. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Lisaftoclax.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06641414ClinicalTrials.gov record for NCT06641414 (opens in a new tab) | Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4). | Phase 3 | Recruiting | 490 (estimated) | Jun 2029 (estimated) | No |
| NCT06389292ClinicalTrials.gov record for NCT06389292 (opens in a new tab) | A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia | Phase 3 | Recruiting | 486 (estimated) | 25 May 2028 (estimated) | No |
| NCT06319456ClinicalTrials.gov record for NCT06319456 (opens in a new tab) | A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. | Phase 3 | Recruiting | 344 (estimated) | Aug 2027 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Lisaftoclax.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06641414 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06319456 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06389292 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.