Pegargiminase

Summary

Pegargiminase (CHEMBL3137346) is a phase-3 clinical-stage enzyme; indicated across 16 conditions including hepatocellular carcinoma and soft tissue sarcoma; with CIViC clinical evidence for 1 variant-indication association (e.g. ASS1 Loss in sarcoma).

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Enzyme
• Indications: 16 conditions
• Clinical trials: 31
• Precision-oncology evidence (CIViC): 1 variant–indication association

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3137346
Name	Pegargiminase
Type	Enzyme
Max phase	3

Also known as: 0B7PYQ9YRT, ADI-PEG, ADI-PEG 20, ADI-PEG-20, ADI-PEG20, Adi-peg20 arginine deiminase, ADI-SS, ADIPEG20, PEG 20, Pegargiminasa, Pegargiminase, Pegylated arginine deiminase

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

16 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
hepatocellular carcinoma	3	MONDO:0007256	EFO:0000182
soft tissue sarcoma	3	MONDO:0018078	EFO:1001968
malignant pleural mesothelioma	2	MONDO:0005112	EFO:0000770
acute myeloid leukemia	2	MONDO:0018874	EFO:0000222
cutaneous melanoma	2	MONDO:0005012	EFO:0000389
mesothelioma	2	MONDO:0005065	EFO:0000588
non-Hodgkin lymphoma	2	MONDO:0018908	EFO:0005952
glioblastoma	2	MONDO:0018177	EFO:0000519
metabolic dysfunction-associated steatohepatitis	2	MONDO:0007027	EFO:1001249
small cell lung carcinoma	2	MONDO:0008433	EFO:0000702
breast neoplasm	1	MONDO:0021100	MONDO:0007254
malignant pancreatic neoplasm	1	MONDO:0009831	EFO:1000359
non-small cell lung carcinoma	1	MONDO:0005233	EFO:0003060
uveal melanoma	1	MONDO:0006486	EFO:1000616
neoplasm	1	MONDO:0005070	MONDO:0004992

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 31.

Phase distribution

Phase	Trials
PHASE2	13
PHASE1	9
PHASE1/PHASE2	5
PHASE3	2
PHASE2/PHASE3	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03970447	PHASE2/PHASE3	RECRUITING	A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
NCT05317819	PHASE3	RECRUITING	Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
NCT01287585	PHASE3	COMPLETED	Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy
NCT02709512	PHASE2/PHASE3	COMPLETED	Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
NCT04587830	PHASE2	ACTIVE_NOT_RECRUITING	ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme
NCT05616624	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
NCT05842512	PHASE2	RECRUITING	Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
NCT06034977	PHASE2	RECRUITING	Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma
NCT06085729	PHASE1/PHASE2	RECRUITING	Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
NCT07389278	PHASE1/PHASE2	NOT_YET_RECRUITING	Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
NCT00056992	PHASE2	COMPLETED	Testing of ADI-PEG in Hepatocellular Carcinoma
NCT00450372	PHASE2	COMPLETED	Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
NCT01266018	PHASE2	TERMINATED	Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
NCT01279967	PHASE2	UNKNOWN	A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma
NCT01910012	PHASE2	COMPLETED	PH 2 ADI-PEG 20 Acute Myeloid Leukemia
NCT01910025	PHASE2	COMPLETED	PH 2 ADI-PEG 20 Study in Non-Hodgkin’s Lymphoma Subjects Who Have Failed Prior Systemic Therapy
NCT02006030	PHASE2	COMPLETED	Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
NCT02102022	PHASE1/PHASE2	TERMINATED	Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma
NCT03449901	PHASE2	COMPLETED	ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing’s Sarcoma, and Small Cell Lung Cancer
NCT04965714	PHASE2	WITHDRAWN	Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer
NCT05829239	PHASE2	WITHDRAWN	ADI-PEG20, Obesity and Prediabetes
NCT06006286	PHASE1/PHASE2	WITHDRAWN	A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma
NCT05001828	PHASE1	ACTIVE_NOT_RECRUITING	Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia
NCT01497925	PHASE1	COMPLETED	Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
NCT01528384	PHASE1	COMPLETED	Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient
NCT01665183	PHASE1	COMPLETED	Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma
NCT01948843	PHASE1	COMPLETED	Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
NCT02029690	PHASE1	TERMINATED	Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
NCT02101580	PHASE1	COMPLETED	Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer
NCT02101593	PHASE1	COMPLETED	Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer
NCT02875093	PHASE1	TERMINATED	Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML

Clinical evidence (CIViC)

Variant × indication × effect (1 predictive associations from 1 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
ASS1 Loss	Sarcoma	Sensitivity/Response	Chloroquine + Pegargiminase	CIViC D	EID5988

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).