Drugs / Pegvaliase
Pegvaliase
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PALYNZIQ | — | 2020-10-06 – 2026-02-27 | fda.gov ↗ |
| Approved | EU (EMA) | Palynziq | — | 2019-05-03 | europa.eu ↗ |
| Approved | US (FDA) | PALYNZIQ | — | 2018-05-24 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT01560286 | May 2012 → Sep 2013 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT01212744 | Mar 2011 → Apr 2015 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00924703 | Jan 2010 → Jan 2019 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00925054 | Sep 2009 → Jun 2015 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05270837 | Jun 2022 → Jan 2025 overdue | phenylketonuria | BioMarin Pharmaceutical | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03694353 | Sep 2018 → Jan 2021 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06780332 | Feb 2025 → Aug 2026 overdue | phenylketonuria | BioMarin Pharmaceutical | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00634660 Comparator | May 2008 → Apr 2009 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01889862 Comparator | Jul 2013 → Jan 2016 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT01819727 Comparator | May 2013 → Nov 2015 | phenylketonuria | BioMarin Pharmaceutical | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07477691 Background | May 2026 → Sep 2027 expected | phenylketonuria | BioMarin Pharmaceutical | Recruiting | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegvaliase | “Pegvaliase is approved to reduce phenylalanine (Phe) levels for people with phenylketonuria (PKU).” PMID 34826353 ↗ Nov 2021 |
| Known as | BMN 165 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01560286 ↗ |
| Known as | Palynziq | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06780332 ↗ |
| Known as | Peg pal | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297802 ↗ |
| Known as | Pegvaliasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297802 ↗ |
| Known as | Pegvaliase pqpz | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297802 ↗ |
| Known as | Phenylase | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297802 ↗ |
| Known as | rAvPAL-PEG | “BMN 165 (rAvPAL-PEG)” NCT01560286 ↗ |
| Modality | Protein / enzyme biologic | “PEGylated recombinant Anabaena variabilis phenylalanine ammonia lyase” PMID 32593547 ↗ Jun 2020 |
| Route | Subcutaneous | “subcutaneous injection” NCT00634660 ↗ |