ADI-PEG 20

Phase 3Small molecule

PPolaris Group

ADI-PEG 20 is one of 152 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

151

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid LeukemiaCompleted

Glioblastoma MultiformeActive, not recruiting

GlioblastomaRecruiting

Acute Myeloid LeukemiaPhase 2

Completed

Glioblastoma MultiformePhase 2

Active, not recruiting

GlioblastomaPhase 3

Recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Xospata

Astellas

Phase 3

24 3

Fludara

Sanofi

Phase 3

17 4

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 5

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 6

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

30 7

Nexavar

Bayer

Phase 3

12 8

Cellcept

Roche

Phase 3

10 9

Busulfex

Peony

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Acute Myeloid Leukemia

NCT05001828

Q2 2027

Phase 2Active, not recruiting

Glioblastoma Multiforme

NCT04587830

Q4 2027

PreclinicalRecruiting

Prostate Cancer

NCT06085729

Q2 2030

PreclinicalRecruiting

Glioblastoma

NCT03970447

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma5 trials

Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy

Completed·PPolaris Group·Phase 3·NCT01287585·636 enrolled

Testing of ADI-PEG in Hepatocellular Carcinoma

Completed·FFDA Office of Orphan Products Development·Phase 2·NCT00056992·34 enrolled

Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma

Terminated·PPolaris Group·Phase 1/2·NCT02102022·140 enrolled

Show 2 more trials

Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

Completed·PPolaris Group·Phase 2·NCT02006030·30 enrolled

A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT06006286

Cisplatin2 trials

Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Terminated·PPolaris Group·Phase 1·NCT02029690·85 enrolled

Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Completed·PPolaris Group·Phase 2/3·NCT02709512·249 enrolled

Metastatic Melanoma2 trials

Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma

Completed·PPolaris Group·Phase 1·NCT01665183·8 enrolled

Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery

Completed·UUniversity of Miami·Phase 2·NCT00450372·38 enrolled

Non-Small Cell Lung Cancer2 trials

Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

Completed·PPolaris Group·Phase 1·NCT01497925·43 enrolled

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers

Terminated·WWashington University School of Medicine·Preclinical·NCT05616624·31 enrolled

Acute Myeloid Leukemia2 trials

PH 2 ADI-PEG 20 Acute Myeloid Leukemia

Completed·PPolaris Group·Phase 2·NCT01910012·43 enrolled

Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia

Active, not recruiting·PPolaris Group·Phase 1·NCT05001828·38 enrolled

12 more indications

Glioblastoma2 trials

A Phase 1/2 Study of Pegylated Arginine Deiminase (ADI-PEG 20) Plus Radiotherapy (RT) and Temozolomide (TMZ) in Children, Adolescents, and Young Adults With Newly Diagnosed High-grade Glioma (HGG)

Not yet recruiting·SSabine Mueller, MD, PhD·Preclinical·NCT07389278·97 enrolled

GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Recruiting·GGlobal Coalition for Adaptive Research·Preclinical·NCT03970447·2,250 enrolled

Small Cell Lung Cancer1 trial

Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer

Terminated·LLudwig Institute for Cancer Research·Phase 2·NCT01266018·22 enrolled

Pancreatic Cancer1 trial

Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer

Completed·PPolaris Group·Phase 1·NCT02101580·21 enrolled

Lymphoma1 trial

PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

Completed·PPolaris Group·Phase 2·NCT01910025·18 enrolled

Older Patients1 trial

Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML

Terminated·PPolaris Group·Phase 1·NCT02875093·23 enrolled

Malignant Pleural Mesothelioma1 trial

A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma

Unknown status·BBarts & The London NHS Trust·Phase 2·NCT01279967·70 enrolled

Melanoma1 trial

Study of ADI-PEG 20 in Patients With Advanced Melanoma

Completed·LLudwig Institute for Cancer Research·Phase 1/2·NCT00520299·31 enrolled

Liver Cancer1 trial

Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer

Completed·PPolaris Group·Phase 1·NCT02101593·8 enrolled

Glioblastoma Multiforme1 trial

ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme

Active, not recruiting·PPolaris Group·Phase 2·NCT04587830·100 enrolled

Breast Cancer1 trial

Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

Completed·PPolaris Group·Phase 1·NCT01948843·15 enrolled

Pediatric1 trial

Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient

Completed·PPolaris Group·Phase 1·NCT01528384·8 enrolled

Prostate Cancer1 trial

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06085729·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for ADI-PEG 20. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ADI-PEG 20 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ADI-PEG 20. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Polaris Group company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: PPolaris Group

ADI-PEG 20

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q2 2030

Trials by Indication[1]

Hepatocellular Carcinoma5 trials

Cisplatin2 trials

Metastatic Melanoma2 trials

Non-Small Cell Lung Cancer2 trials

Acute Myeloid Leukemia2 trials

Glioblastoma2 trials

Small Cell Lung Cancer1 trial

Pancreatic Cancer1 trial

Lymphoma1 trial

Older Patients1 trial

Malignant Pleural Mesothelioma1 trial

Melanoma1 trial

Liver Cancer1 trial

Glioblastoma Multiforme1 trial

Breast Cancer1 trial

Pediatric1 trial

Prostate Cancer1 trial

References

Drug Info

Quick Facts

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