Product Description
APG-115 is an orally bioavailable and highly selective small molecule MDM2 inhibitor independently developed by Ascentage Pharma. APG-115 has high binding affinity for MDM2 and restores p53 tumor suppressor activity by blocking the MDM2-p53 interaction. (Sourced from: https://www.ascentagepharma.com/product-candidates/apoptosis-targeted-candidates/APG-115/?lang=zh-hant)
Mechanisms of Action: MDM2 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - MelanomaOrphan Drug - Acute Myeloid LeukemiaOrphan Drug - Gastrointestinal CancerOrphan Drug - Melanoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Ascentage Pharma Group
Company Location:
Company Founding Year: 2009
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Ascentage Pharma Group presented P1 Sarcoma results on 2026-05-30 for Alrizomadlin
- Clinical Outcomes Reported - Ascentage Pharma Group presented Unknown Rhabdomyosarcoma results on 2026-05-30 for Alrizomadlin
Highest Development Phases
Phase 2: Adenoid Cystic Carcinoma|Liposarcoma|Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Neurofibrosarcoma|Prolymphocytic Leukemia|Prolymphocytic T-Cell Leukemia|Salivary Gland Cancer|T-Cell Lymphoma|Uveal Melanoma
Phase 1: Acute Myeloid Leukemia|Myelodysplastic Syndrome|Neuroblastoma|Preleukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03781986 |
UMCC 2018.127 | P2 |
Active, not recruiting |
Adenoid Cystic Carcinoma|Salivary Gland Cancer |
2026-07-01 |
12% |
2026-03-04 |
Primary Endpoints |
NCT04275518 |
APG115AC101 | P1 |
Recruiting |
Myelodysplastic Syndrome|Preleukemia|Acute Myeloid Leukemia |
2025-12-31 |
34% |
2023-08-31 |
Primary Completion Date|Primary Endpoints |
NCT03611868 |
APG-115-US-002 | P2 |
Active, not recruiting |
Neurofibrosarcoma|Uveal Melanoma |
2025-12-30 |
12% |
2025-08-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05701306 |
APG115XC103 | P1 |
Recruiting |
Neuroblastoma |
2026-06-01 |
12% |
2024-01-24 |
Primary Endpoints|Start Date |
NCT04496349 |
APG115TU101 | P2 |
Recruiting |
Lymphoid Leukemia|T-Cell Lymphoma|Prolymphocytic T-Cell Leukemia|Prolymphocytic Leukemia|Lymphoma, Non-Hodgkin |
2026-05-31 |
39% |
2024-08-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04785196 |
APG115XC102 | P2 |
Recruiting |
Liposarcoma |
2026-04-01 |
12% |
2024-06-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
CTR20230193 |
CTR20230193 | P1 |
Recruiting |
Neuroblastoma |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |