Pegargiminase
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | localized pleural mesothelioma | 2023-11-17 | “今(11/17)日宣布已向美國食品藥品監督管理局（FDA）正式啟動ADI-PEG 20生物製劑許可證（BLA）送件，以治療罕見而侵略性的癌症──惡性肺間皮癌。” polarispharma.com ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT05813327 | Mar 2024 → Apr 2026 | soft tissue sarcoma | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05001828 | Apr 2022 → May 2026 overdue | acute myeloid leukemia | Polaris Group | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03922880 | Apr 2019 → Jan 2023 | uveal melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03498222 | Jun 2018 → Jan 2020 | non-small cell lung carcinoma | Queen Mary University of London | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03254732 | Jul 2017 → May 2019 | high grade malignant neoplasm | Polaris Group | Terminated | No outcome recorded |
| Phase 1 | NCT02875093 | Jan 2017 → Jul 2019 | acute myeloid leukemia | Polaris Group | Terminated | No outcome recorded |
| Phase 1 | NCT02101580 | Nov 2014 → May 2017 | pancreatic neoplasm | Polaris Group | Completed | No outcome recorded |
| Phase 1 | NCT02101593 | Nov 2014 → Feb 2016 | hepatocellular carcinoma | Polaris Group | Completed | No outcome recorded |
| Phase 1 | NCT02029690 | Apr 2014 → Aug 2018 | glioma, hepatocellular carcinoma, malignant peritoneal mesothelioma, malignant pleural mesothelioma +3 | Polaris Group | Terminated | No outcome recorded |
| Phase 1 | NCT01948843 | Apr 2014 → Apr 2016 | Her2-receptor negative breast cancer | Polaris Group | Completed | No outcome recorded |
| Phase 1 | NCT01665183 | Sep 2012 → Feb 2016 | melanoma | Polaris Group | Completed | No outcome recorded |
| Phase 1 | NCT01528384 | Dec 2011 → Mar 2014 | argininosuccinic aciduria | Polaris Group | Completed | No outcome recorded |
| Phase 1 | NCT01497925 | Sep 2011 → Mar 2016 | prostate cancer | Polaris Group | Completed | No outcome recorded |
| Phase 1/26 trials · 1 missed | ||||||
| Phase 1/2 | NCT07389278 | Jun 2027 → Jun 2032 expected | diffuse glioma, H3 G34 mutant, diffuse midline glioma, H3 K27M-mutant, glioblastoma | Sabine Mueller, MD, PhD | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06085729 | Feb 2024 → Sep 2027 expected | prostate cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06006286 | Aug → Nov 2023 | hepatocellular carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05616624 | Apr 2023 → Jul 2026 overdue | non-small cell lung carcinoma, small cell lung carcinoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02102022 | Nov 2014 → Feb 2020 | colorectal cancer, gastric cancer, hepatocellular carcinoma | Polaris Group | Terminated | No outcome recorded |
| Phase 1/2 | NCT00520299 | Jul 2007 → Mar 2010 | metastatic melanoma, skin cancer | Ludwig Institute for Cancer Research | Completed | Missed primary |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT05829239 | Apr 2024 | obesity disorder, prediabetes syndrome | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT06034977 | Dec 2023 → Jul 2026 overdue | hepatocellular carcinoma | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05842512 | Sep 2023 → Dec 2027 expected | metabolic dysfunction-associated steatohepatitis | Polaris Group | Recruiting | No outcome recorded |
| Phase 2 | NCT04965714 | Apr 2022 → Feb 2023 | hepatocellular carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04587830 | Sep 2020 → Feb 2027 expected | glioblastoma | Polaris Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03449901 | May 2018 → Jul 2022 | soft tissue sarcoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01910012 | Jan 2015 → Sep 2016 | acute myeloid leukemia | Polaris Group | Completed | No outcome recorded |
| Phase 2 | NCT02006030 | Oct 2014 → Jul 2016 | hepatocellular carcinoma | Polaris Group | Completed | No outcome recorded |
| Phase 2 | NCT01910025 | Dec 2013 → Aug 2016 | non-Hodgkin lymphoma | Polaris Group | Completed | No outcome recorded |
| Phase 2 | NCT01279967 | Jan 2011 → Jan 2015 | malignant pleural mesothelioma | Barts & The London NHS Trust | Unknown | Met primary |
| Phase 2 | NCT01266018 | Jan 2011 → Jan 2014 | small cell lung carcinoma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00450372 | Jun 2004 → Jan 2011 | cutaneous melanoma | University of Miami | Completed | No outcome recorded |
| Phase 2 | NCT00056992 | Sep 2002 → Oct 2003 | hepatocellular carcinoma | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT03970447 | Jul 2019 → Jun 2028 expected | glioblastoma | Global Coalition for Adaptive Research | Recruiting | Missed primary |
| Phase 2/3 | NCT02709512 | Aug 2017 → Aug 2022 | mesothelioma | Polaris Group | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05712694 | Nov 2023 → May 2026 | soft tissue sarcoma | Polaris Group | Terminated | No outcome recorded |
| Phase 3 | NCT05317819 | Mar 2022 → Sep 2028 expected | hepatocellular carcinoma | Polaris Group | Recruiting | No outcome recorded |
| Phase 3 | NCT01287585 | Jul 2011 → Jul 2015 | hepatocellular carcinoma | Polaris Group | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Polaris Group | Results 北極星藥業集團使用ADI-PEG 20於急性骨髓性白血病的一期臨床試驗結果 polarispharma.com ↗
於 23 名可評估的患者中，16 名（69.6%）達到完全緩解；總體客觀反應率 為 21/23（91.3%），且反應持久。 |
| 2025-08-18 | Polaris Group | Regulatory 北極星藥業集團使用於治療惡性肺間皮癌生物製劑Pegargiminase (ADI-PEG 20) 之上市查驗登記申請（BLA）已獲通知正式進入美國FDA藥證實質審查階段 polarispharma.com ↗
我們已完成送件之受理審查，並認定申請案內容足夠完整，可進入實質審查階段。 |
| 2025-06-09 | Polaris Group | Regulatory 北極星藥業集團完成向美國FDA呈送Pegargiminase(ADI-PEG 20)生物製劑用於治療惡性肺間皮癌的上市許可證申請案(BLA) polarispharma.com ↗
並於美國時間2025年6月9日完成提交BLA的最終部分。 |
| 2024-02-19 | Polaris Group | Results 北極星藥業肺間皮癌新藥三年存活率增加四倍，於國際知名醫學期刊JAMA Oncology發表 polarispharma.com ↗
該研究顯示，將傳統化療與新藥ADI-PEG20結合治療，使參與者的中位數生存期增加了1.6個月，並且相較於安慰劑-化療組，36個月的存活率增加了四倍。 |
| 2023-11-17 | Polaris Group | Regulatory 北極星藥業啟動向FDA呈送ADI-PEG 20用於治療肺間皮癌的上市許可證申請案（BLA） polarispharma.com ↗
北極星藥業集團（TWSE：6550），今(11/17)日宣布已向美國食品藥品監督管理局（FDA）正式啟動ADI-PEG 20生物製劑許可證（BLA）送件，以治療罕見而侵略性的癌症──惡性肺間皮癌。 |
| 2023-04-17 | Polaris Group | Results 北極星癌症新藥眾所矚目特別於AACR全體會員大會獲邀發表臨床成果，揭開代謝療法治療實體腫瘤的新篇章 polarispharma.com ↗
研究顯示，隨機分配至ADI-PEG 20與Pemetrexed和Cisplatin聯合使用的患者中，中位數總生存期為9.3個月，而對照組為7.66個月，兩組差異在總生存期之療效終點上達到統計顯著意義（p value=0.0234）。 |
| 2021-03-02 | Polaris Group | Results 北極星肺癌臨床三期期中分析達最高標，獲得藥證指日可待 polarispharma.com ↗
北極星-KY（6550）在美國進行的肺間皮癌(肺癌的一種)臨床試驗三期期中分析報告於美國時間2月25日出爐，以現有期中的數據來分析，預估最後整體試驗的成功機率在80%以上（80～100%之間）。 |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Polaris Group | 北極星藥業集團使用ADI-PEG 20於急性骨髓性白血病的一期臨床試驗結果 polarispharma.com ↗ |
| 2025-08-18 | Polaris Group | 北極星藥業集團使用於治療惡性肺間皮癌生物製劑Pegargiminase (ADI-PEG 20) 之上市查驗登記申請（BLA）已獲通知正式進入美國FDA藥證實質審查階段 polarispharma.com ↗ |
| 2025-06-09 | Polaris Group | 北極星藥業集團完成向美國FDA呈送Pegargiminase(ADI-PEG 20)生物製劑用於治療惡性肺間皮癌的上市許可證申請案(BLA) polarispharma.com ↗ |
| 2024-02-19 | Polaris Group | 北極星藥業肺間皮癌新藥三年存活率增加四倍，於國際知名醫學期刊JAMA Oncology發表 polarispharma.com ↗ |
| 2023-11-17 | Polaris Group | 北極星藥業啟動向FDA呈送ADI-PEG 20用於治療肺間皮癌的上市許可證申請案（BLA） polarispharma.com ↗ |
| 2023-04-17 | Polaris Group | 北極星癌症新藥眾所矚目特別於AACR全體會員大會獲邀發表臨床成果，揭開代謝療法治療實體腫瘤的新篇章 polarispharma.com ↗ |
| 2021-03-02 | Polaris Group | 北極星肺癌臨床三期期中分析達最高標，獲得藥證指日可待 polarispharma.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pegargiminase | “Pegargiminase (ADI-PEG 20; ADI) degrades arginine and potentiates pemetrexed (Pem) cytotoxicity in argininosuccinate synthetase 1 (ASS1)-deficient malignant pleural mesothelioma (MPM).” PMID 34589965 ↗ Sep 2020 |
| Known as | 0B7PYQ9YRT | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137346 ↗ |
| Known as | ADI | “Pegargiminase (ADI-PEG 20; ADI) degrades arginine and potentiates pemetrexed (Pem) cytotoxicity in argininosuccinate synthetase 1 (ASS1)-deficient malignant pleural mesothelioma (MPM).” PMID 34589965 ↗ Sep 2020 |
| Known as | ADI-PEG | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137346 ↗ |
| Known as | ADI-PEG20 | “This study is measuring the safety of the study drug, ADI-PEG 20, combined with immunotherapy drugs nivolumab and ipilimumab in treating patients with advanced uveal melanoma.” NCT03922880 ↗43“The role of the arginine-lowering agent pegylated arginine deiminase (ADI-PEG20) has not been evaluated in a randomized and biomarker-driven study among patients with cancer.” PMID 27584578 ↗ Jan 2017 “The efficacy of pegylated ADI (ADI-PEG20) in relapsed/refractory/poor-risk acute myeloid leukemia (AML) was evaluated in 43 patients in a prospective, phase II trial” PMID 28900115 ↗ Sep 2017 “Arginine-depleting therapy with pegylated arginine deiminase (ADI-PEG20) was reported to have activity in advanced melanoma in early phase I-II trial” PMID 22472884 ↗ Apr 2012 “Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)” NCT06085729 ↗ “ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m\^2 via intramuscular injection into either the deltoid or gluteal muscle.” NCT05813327 ↗ “Pegylated arginine deiminase (ADI-PEG20) monotherapy depletes circulating arginine, thereby selectively inducing tumor cell death.” PMID 33787078 ↗ Mar 2021 “Phase I/II study of pegylated arginine deiminase (ADI-PEG 20) in patients with advanced melanoma.” PMID 22864522 ↗ Aug 2012 “Phase I/II study of pegylated arginine deiminase (ADI-PEG 20) in patients with advanced melanoma.” PMID 22864522 ↗ Aug 2012 “Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.” NCT03254732 ↗ “Drug: ADI PEG20” NCT03254732 ↗ |
| Known as | Adi-peg20 arginine deiminase | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137346 ↗ |
| Known as | ADI-SS | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137346 ↗ |
| Known as | Arginine deiminase pegylated | “ADI-PEG 20 (Arginine deiminase pegylated)” NCT07389278 ↗ |
| Known as | Pegargiminasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137346 ↗ |
| Known as | PEGylated arginine deiminase | “This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior...” NCT01287585 ↗7“ADI-PEG20 (PEGylated arginine deiminase) is an arginine catabolizing enzyme preparation that improves insulin sensitivity, mitochondrial respiration, and energy utilization in...” NCT05829239 ↗ “The role of the arginine-lowering agent pegylated arginine deiminase (ADI-PEG20) has not been evaluated in a randomized and biomarker-driven study among patients with cancer.” PMID 27584578 ↗ Jan 2017 “Arginine-depleting therapy with pegylated arginine deiminase (ADI-PEG20) was reported to have activity in advanced melanoma in early phase I-II trial” PMID 22472884 ↗ Apr 2012 “Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)” NCT06085729 ↗ “Pegylated arginine deiminase (ADI-PEG20) monotherapy depletes circulating arginine, thereby selectively inducing tumor cell death.” PMID 33787078 ↗ Mar 2021 “Phase I/II study of pegylated arginine deiminase (ADI-PEG 20) in patients with advanced melanoma.” PMID 22864522 ↗ Aug 2012 |
| Action | Inhibit | “arginine-lowering agent” PMID 27584578 ↗ Jan 2017 |
| Modality | Protein / enzyme biologic | “Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)” NCT00450372 ↗ |
| Route | Other | “a once a week injection of 160 IU/m2 of ADI-PEG 20” NCT00056992 ↗ |