Product Description
Pegvaliase is a pegylated PAL enzyme that converts phenylalanine to ammonia and trans-cinnamic acid. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31258325/)
Mechanisms of Action: Phenylalanine Converter
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Poland | Portugal | Slovakia | Slovenia | Spain | Sweden | Taiwan | United States
Approved Indications: None
Known Adverse Events: None
Company: Biomarin
Company Location: NOVATO CA 94949
Company CEO: Jean-Jacques Bienaimé
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Germany, Japan, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Phenylketonuria, Maternal|Phenylketonurias
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 165-306 | P3 |
Unknown Status |
Phenylketonuria, Maternal |
2027-08-14 |
|
| PEGASUS | P3 |
Active, not recruiting |
Phenylketonurias |
2025-01-01 |
95% |
| jRCT2080224573 | P3 |
Completed |
Phenylketonuria, Maternal |
2024-01-31 |
|
| JapicCTI-194642 | P3 |
Active |
Phenylketonuria, Maternal |
2024-01-31 |