ADI PEG20

Phase 3Small molecule

PPolaris Group

ADI PEG20 is one of 31 small molecule programs targeting Hepatocellular Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Hepatocellular CarcinomaRecruiting

NASHRecruiting

Hepatocellular CarcinomaPhase 3

Recruiting

NASHPhase 2

Recruiting

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

ADI PEG20

PPolaris Group

Phase 3

2 2

Ibrance

Pfizer

Preclinical

1 3

Viread

Gilead

Preclinical

1 4

Sovaldi

Gilead

Preclinical

1 5

Cysteine Hydrochloride

Novartis

Preclinical

1 6

Hepsera

Coreg

2 8

Doptelet

AAkarx

Preclinical

1 9

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 10

Vermox

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q1 2028

Phase 2Recruiting

NASH

NCT05842512

Q4 2028

Phase 3Recruiting

Hepatocellular Carcinoma

NCT05317819

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma2 trials

Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma

Recruiting·PPolaris Group·Phase 3·NCT05317819·300 enrolled

Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma

Recruiting·—·Phase 2·NCT06034977·120 enrolled

Soft Tissue Sarcoma2 trials

A Phase I/II Trial of Neoadjuvant ADI-PEG 20 in Combination With Ifosfamide and Radiotherapy in Soft Tissue Sarcoma (STS)

Terminated·WWashington University School of Medicine·Phase 1·NCT05813327·6 enrolled

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

Terminated·PPolaris Group·Phase 3·NCT05712694·218 enrolled

NASH1 trial

Study of ADI-PEG 20 Versus Placebo in Subjects With NASH

Recruiting·PPolaris Group·Phase 2·NCT05842512·60 enrolled

Obesity1 trial

ADI-PEG20, Obesity and Prediabetes

Withdrawn·WWashington University School of Medicine·Phase 2·NCT05829239

Carboplatin1 trial

Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin

Withdrawn·QQueen Mary University of London·Phase 1·NCT03498222

2 more indications

Uveal Melanoma1 trial

Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03922880·9 enrolled

Advanced Solid Cancers1 trial

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Terminated·PPolaris Group·Phase 1·NCT03254732·33 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for ADI PEG20. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ADI PEG20 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ADI PEG20. 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 PEG20

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q4 2028

Trials by Indication[1]

Hepatocellular Carcinoma2 trials

Soft Tissue Sarcoma2 trials

NASH1 trial

Obesity1 trial

Carboplatin1 trial

Uveal Melanoma1 trial

Advanced Solid Cancers1 trial

References

Drug Info

Quick Facts

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