Drugs / Alrizomadlin
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05701306 | Feb 2023 → Jun 2026 overdue | neuroblastoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04275518 | Jul 2020 → Dec 2025 overdue | acute myeloid leukemia, myelodysplastic syndrome | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT02935907 | Oct 2016 → Jun 2019 | — | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT06735820 | Oct 2025 → Oct 2027 expected | atypical neurofibroma, malignant peripheral nerve sheath tumor, neurofibromatosis type 1 | AeRang Kim | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04785196 | May 2021 → Apr 2026 overdue | liposarcoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04358393 | Dec 2020 → Dec 2024 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Ascentage Pharma Group Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT03781986 | Oct 2019 → Jan 2026 overdue | salivary gland cancer | University of Michigan Rogel Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03611868 | Aug 2018 → Dec 2025 overdue | CDK4 linked melanoma, cutaneous melanoma, malignant peripheral nerve sheath tumor, mucosal melanoma +1 | Ascentage Pharma Group Inc. | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06654050 | Mar 2026 | BAP1-related tumor predisposition syndrome, malignant mesothelioma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT04496349 | Jul 2021 → May 2026 overdue | T-cell prolymphocytic leukemia | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Its First Dataset on MDM2-p53 Inhibitor Alrizomadlin (APG-115) in Pediatric Solid Tumors at ASCO 2026 ascentage.com ↗
The data presented demonstrated preliminary antitumor activity and a manageable tolerability profile of alrizomadlin in pediatric solid tumors. |
| 2025-06-02 | Ascentage Pharma Group Inc. | Results Live from ASCO 2025 | Ascentage Pharma Releases Promising Clinical Data on Alrizomadlin Monotherapy and Combinations in Solid Tumors ascentage.com ↗
These clinical data on alrizomadlin in ACC and other solid tumors demonstrated the antitumor activity of alrizomadlin monotherapy in patients with advanced ACC or malignant peripheral nerve sheath tumor (MPNST). |
| 2025-05-22 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Clinical Data of Lisaftoclax, Which Shows Therapeutic Potential in Venetoclax-Refractory Patients, Selected for Oral Report at ASCO 2025 ascentage.com ↗
Both lisaftoclax and alrizomadlin demonstrated antitumor activity, and the data support their further clinical development. |
| 2024-04-07 | Ascentage Pharma Group Inc. | Results AACR 2024 | Ascentage Pharma Presents Results from Three Studies at 2024 American Association of Cancer Research Annual Meeting ascentage.com ↗
We are pleased to present the preclinical research data of four assets in our pipeline at the AACR 2024. |
| 2024-03-06 | Ascentage Pharma Group Inc. | Results AACR 2024 | Ascentage Pharma to Present Three Preclinical Studies at 2024 American Association of Cancer Research Annual Meeting ascentage.com ↗
Results from this preclinical study show that in preclinical models of PCa, targeting both EED and MDM2 can synergistically enhance antitumor activities by modulating pathways related to DNA methylation, cell cycle, and apoptosis. |
| 2023-06-05 | Ascentage Pharma Group Inc. | Results Live from ASCO 2023 | For the Third Consecutive Year, Ascentage Pharma Releases Promising Results of Alrizomadlin plus Pembrolizumab in Patients with Cutaneous Melanoma that Failed Immuno-Oncologic (IO) Therapies ascentage.com ↗
Ascentage Pharma (6855.HK) announced today that it has released updated results from a Phase II study of MDM2-P53 inhibitor, alrizomadlin (APG-115), in combination with pembrolizumab in patients with unresectable or metastatic cutaneous melanoma that had failed immuno-oncologic (IO) drugs in a Poster Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2023-04-18 | Ascentage Pharma Group Inc. | Results AACR 2023 | Ascentage Pharma Presents Results from Three Studies Underscoring Exploratory Efforts in Potential New Indications ascentage.com ↗ |
| 2023-03-15 | Ascentage Pharma Group Inc. | Results Ascentage to Present Three Preclinical Studies at AACR 2023 ascentage.com ↗
the MDM2-p53 inhibitor alrizomadlin (APG-115), have been selected for presentations at the 2023 American Association of Cancer Research Annual Meeting (AACR 2023). |
| 2022-06-06 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Releases Updated Results Demonstrating the Therapeutic Potential of Alrizomadlin (APG-115) plus Pembrolizumab in Patients with Solid Tumors who Progressed on Immunotherapies ascentage.com ↗
The updated results further validate the combination therapy’s efficacy in patients with immuno-oncologic- (I-O) drug-resistant or recurrent melanoma, including two complete responses (CRs), an objective response rate (ORR) of 11% and a disease control rate (DCR) of 57%. |
| 2022-05-27 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Presents Updated Results from Multiple Clinical Studies Demonstrating Rapid Progress in Global Clinical Development ascentage.com ↗ |
| 2022-04-14 | Ascentage Pharma Group Inc. | Results AACR 2022 | Ascentage Presents Six Preclinical Studies ascentage.com ↗
The results demonstrate that the combination of MDM2 inhibitor alrizomadlin and proteasome inhibitors have synergistic antitumor effects on MM tumors harboring WT TP53 in animal models. |
| 2022-03-22 | Ascentage Pharma Group Inc. | Regulatory Alrizomadlin(APG-115) Granted RPD by the US FDA in Neuroblastoma ascentage.com ↗
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a Rare Pediatric Disease (RPD) designation by the US Food and Drug Administration (FDA), for the treatment of neuroblastoma. |
| 2022-03-09 | Ascentage Pharma Group Inc. | Results Ascentage to Present Six Preclinical Studies at AACR 2022 ascentage.com ↗
This study shows that the MDM2-p53 inhibitor APG-115 in combination with proteasome inhibitor has synergistic antitumor activity in models of TP53 wild-type multiple myeloma. |
| 2021-09-23 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s MDM2-p53 Inhibitor Alrizomadlin (APG-115) Granted Fast Track Designation by the US FDA for the Treatment of Relapsed/Refractory Unresectable or Metastatic Melanoma ascentage.com ↗ |
| 2021-07-21 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s MDM2-p53 Inhibitor APG-115 (Alrizomadlin) Granted an Orphan Drug Designation by the FDA for the Treatment of Stage IIB-IV Melanoma, Marking the Twelfth Obtained by the Company ascentage.com ↗
Ascentage Pharma (6855.HK), a globally focused biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) recently granted an Orphan Drug Designation (ODD) to the company’s MDM2-p53 inhibitor, APG-115 (alrizomadlin), for the treatment of stage IIB-IV melanoma. |
| 2021-06-08 | Ascentage Pharma Group Inc. | Results Live from ASCO 2021 | Ascentage Pharma Presents Updated Results of MDM2-p53 Inhibitor Alrizomadlin (APG-115) Demonstrating an ORR of 24.1% Including Complete Response in Combination with Pembrolizumab in Patients with Advanced Melanoma Resistant or Refractory to Prior Immuno-Oncologic Drugs ascentage.com ↗
In addition, partial responses (PRs) were reported in enrolled patients with other tumor types. |
| 2021-05-20 | Ascentage Pharma Group Inc. | Results ASCO 2021 | Ascentage Pharma to Announce Updated Results Demonstrating Clinical Potential of Alrizomadlin (APG-115) Plus Pembrolizumab in Patients with Advanced Solid Tumors that Had Failed Immunotherapies in Oral Presentation ascentage.com ↗
Of these, the Phase II study of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs demonstrated favorable results, including a disease control rate (DCR) of 60.9% and an objective response rate (ORR) of 17.4% in the PD-1/PD-L1 inhibitor-resistant melanoma cohort. |
| 2021-02-02 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Released Preclinical Results of MDM2-p53 Inhibitor APG-115 in an Oral Presentation at WCLC 2020, Demonstrating Therapeutic Potential in STK11-Mutant Non-Small Cell Lung Cancer ascentage.com ↗
Results from this study showed that APG-115 has therapeutic potential in NSCLC harboring |
| 2020-12-02 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Clearances in China and the US for the Phase IIa Study of APG-115 Single Agent or in Combination with APG-2575 for the Treatment of Relapsed or Refractory T-cell Prolymphocytic Leukemia ascentage.com ↗ |
| 2020-10-27 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Study of MDM2-p53 Inhibitor APG-115 in Combination with Immunotherapy for the Treatment of Patients with Advanced Liposarcoma or other Advanced Solid Tumors in China ascentage.com ↗ |
| 2020-10-09 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Apoptosis-Targeting Drug Candidates Granted Two More Orphan Drug Designations by the US FDA ascentage.com ↗ |
| 2020-09-14 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s MDM2-p53 Inhibitor APG-115 Granted Orphan Drug Designation by the FDA for the Treatment of Gastric Cancer ascentage.com ↗
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted APG-115, a novel MDM2-p53 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of gastric cancer (GC). |
| 2020-05-15 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Six Abstracts at 2020 AACR Annual Meeting ascentage.com ↗
The activity was enhanced when HQP1351 was combined with APG-115. |
| 2019-06-04 | Ascentage Pharma Group Inc. | Results Ascentage Pharma presents new clinical data of apoptosis-targeted drug candidates APG-115 and APG-1387 at 2019 ASCO ascentage.com ↗
It is encouraging that in the study of APG-115 as a monotherapy, a confirmed PR was observed in 1 patient with liposarcoma (TP53-WT and MDM2Amp), with target lesion decreased 64%. |
| 2019-05-23 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present New Data at 2019 ASCO Annual Meeting from Clinical Trials of MDM2-p53 Antagonist and IAP Inhibitor in Cancers ascentage.com ↗
The MTD / RP2D of APG-115 monotherapy with oral administration, QOD for 21 days of a 28-day cycle for treatment of patients with advanced solid tumors was determined as 100 mg. |
| 2019-03-26 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Nine Abstracts To Be Presented at the 2019 American Association for Cancer Research Annual Meeting ascentage.com ↗
MDM2 Inhibitor APG-115 Synergizes With CDK4/6 Inhibitors In A Patient Derived Xenograft Model of Dedifferentiated Liposarcoma |
All press releases naming this drug 29 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alrizomadlin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06654050 ↗ |
| Known as | APG-115 | “Alrizomadlin (APG-115) oral tablets (150 mg) taken every other day on Days 1, 3, 5, 7, 9, 11, and 13 of every cycle (1 cycle=21 days) for 8 cycles (i.e., Course 1).” NCT06654050 ↗ |
| Action | Inhibit | “MDM2) inhibitor” NCT02935907 ↗ |
| Modality | Small molecule | “orally active small-molecule” NCT02935907 ↗ |
| Route | Oral | “Orally Administered APG-115” NCT02935907 ↗ |
| Target | MDM2 | “mouse double minute 2 homolog (MDM2) inhibitor” NCT02935907 ↗ |