Drugs / Pegzilarginase
Pegzilarginase
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Loargys | — | 2023-12-15 | europa.eu ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03371979 | Dec 2017 → Jan 2021 | small cell lung carcinoma | Aeglea Biotherapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT02488044 | Jun 2016 → Feb 2019 | arginase deficiency | Aeglea Biotherapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT02561234 | Oct 2015 → May 2019 | — | Aeglea Biotherapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03378531 | Dec 2017 → Dec 2022 | arginase deficiency | Aeglea Biotherapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02732184 | Aug 2016 → Dec 2017 | acute myeloid leukemia, myelodysplastic syndrome | Aeglea Biotherapeutics | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06582524 | Aug 2024 → Jun 2025 | arginase deficiency | Immedica Pharma AB | Completed | No outcome recorded |
| Phase 3 | NCT05676853 | Apr 2023 | arginase deficiency | Aeglea Biotherapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03921541 | Apr 2019 → Jan 2023 | arginase deficiency | Aeglea Biotherapeutics | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegzilarginase | “Pegzilarginase (AEB1102) is an investigational enzyme therapy which is being developed as a novel arginine lowering approach.” PMID 33325055 ↗ Jan 2021 |
| Known as | AEB1102 | “Pegzilarginase (AEB1102) is an investigational enzyme therapy which is being developed as a novel arginine lowering approach.” PMID 33325055 ↗ Jan 20212“A Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients With Advanced Solid Tumors” NCT02561234 ↗ |
| Known as | Co-ArgI-PEG | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02561234 ↗ |
| Known as | Loargys | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297803 ↗ |
| Known as | Pegzilarginasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297803 ↗ |
| Modality | Protein / enzyme biologic | “an investigational enzyme therapy” PMID 33325055 ↗ Jan 2021 |
| Route | Intravenous | “intravenously (IV) administered pegzilarginase” PMID 33325055 ↗ Jan 2021 |