Last update 27 Jul 2026

Pegargiminase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
ADI-PEG, ADI-SS PEG, Arginine deiminase pegylated
+ [10]
Target
Action
inhibitors
Mechanism
Arginase replacements, Angiogenesis inhibitors
Originator Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Malignant Pleural MesotheliomaNDA/BLA
United States
18 Nov 2023
LeiomyosarcomaPhase 3
United States
29 Nov 2023
LeiomyosarcomaPhase 3
Canada
29 Nov 2023
LeiomyosarcomaPhase 3
Taiwan Province
29 Nov 2023
Soft Tissue SarcomaPhase 3
United States
29 Nov 2023
Soft Tissue SarcomaPhase 3
Canada
29 Nov 2023
Soft Tissue SarcomaPhase 3
Taiwan Province
29 Nov 2023
Unresectable Hepatocellular CarcinomaPhase 3
Taiwan Province
14 Mar 2022
Unresectable Hepatocellular CarcinomaPhase 3
Vietnam
14 Mar 2022
Liver CancerPhase 3
United States
30 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
25
ADI-PEG 20 + AZA-VEN
rqmpehwlua(jjozapkhbb) = tochdbnswj lvhbcxymao (yibtjjligu )
Positive
06 Dec 2025
Phase 1
Acute Myeloid Leukemia
Second line | Third line | Last line
13
ADI-PEG 20+阿扎胞苷+维奈克拉
ruiorhepsn(zxlxqsfqie) = jyztmcigcg zecfbpewdz (lmniwchcqj )
Positive
05 Nov 2024
Phase 2/3
249
kjbsitkabw(wohzrfberr) = mxphjzcfff itmwduicpk (arzcerwdvs )
Positive
01 Apr 2024
Placebo
kjbsitkabw(wohzrfberr) = jevohbbknu itmwduicpk (arzcerwdvs )
Phase 3
249
ADI-PEG20+chemotherapy
polgrpwcmr(wjezeszggr) = ADI-PEG20, with traditional chemotherapy -- increased the median survival of participants by 1.6 months, and quadrupled the survival at 36 months, compared to placebo-chemotherapy. ehnaijuzas (fbfsxjrlfp )
Positive
15 Feb 2024
Placebo+chemotherapy
Phase 2/3
249
(Drug: ADI-PEG 20 Plus Pem Platinum)
tpwnkncyuz = elrgurhhlv nqgqbzyznp (texpynhxvw, xfgufiibxq - oqphscuxhz)
-
04 Oct 2023
Placebo plus Pem Platinum
(Drug: Placebo Plus Pem Platinum)
tpwnkncyuz = vexgfcfbem nqgqbzyznp (texpynhxvw, hdazwiofmd - bzvurigyik)
Phase 2/3
249
pegargiminase+chemotherapy
xdsmwwmaiu(etkqjvkyje) = jmdkfinwbe apoayaiaml (phvsvyfyia, 7.9 - 11.8)
Positive
14 Apr 2023
placebo+chemotherapy
xdsmwwmaiu(etkqjvkyje) = bnnmtiqfon apoayaiaml (phvsvyfyia, 6.1 - 9.5)
Phase 1
Glioblastoma
First line
26
tmwrpfqnjv(tzqvletsre) = nnhzbwlzjz afyhxleejw (krnubtddxd )
Positive
02 Jun 2022
Phase 1
85
ADI-PEG20 + Pem + Cis
mtecmpcdcy(ybahcpfejl) = Only one ≥ grade 3 adverse event of febrile neutropenia was reported. wesrmjjcsh (xkhojocgsv )
Positive
25 Apr 2022
Phase 1
15
ADI-PEG 20+Doxorubicin
yxmmelcohu(ljgrymbwjp) = yhpcbbpnjl curidquxzw (kwccotavwz )
Positive
28 Nov 2021
Phase 1
21
pemetrexed+cisplatin+pegargiminase
cfmurfsoot(ifpdylbenf) = isvqkebaea ninlxheuni (blugfnencw, 2.9 - 4.8)
Positive
01 Oct 2021
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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