Pegvaliase
ApprovedProtein / enzyme
BioMarin PharmaceuticalPegvaliase is a protein / enzyme that works as a PAL Enzyme Substitution.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]
Pegvaliase is one of 44 enzyme replacement programs targeting Phenylketonuria. It is currently in Approved.
3
Indications
7
Total Trials
5
Active Trials
43
Competitors
8
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
350 competitors in Treatment
#DrugCompanyPhaseTrials
1Pegvaliase
BioMarin PharmaceuticalApproved
Lamprene
NovartisPreclinical
Emtriva
GileadPreclinical
Niclocide
BayerPreclinical
Levulan
Sun Pharmaceutical Industries, Inc.Preclinical
Hivid
CConrado Roberto Hoffmann Filho
Preclinical
Foscavir
CClinigen, Inc.
Preclinical
Valium
Akero TherapeuticsPreclinical
Clomid
FerringPreclinical
Aurlumyn
BBTG International Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Immune Response1 trial
Pregnancy1 trial
Adult1 trial
Nutrition Status of Adults Treated With Pegvaliase
Completed·—··NCT03792451·18 enrolled
Safety and Efficacy1 trial
2 more indications
Phenylketonuria (PKU)1 trial
Regulatory
FDA Approval Timeline[4]
May 24, 2018
PALYNZIQ
NDA BLA761079
Oct 6, 2020
PALYNZIQ
NDA BLA761079
Oct 6, 2020
PALYNZIQ
NDA BLA761079
Oct 6, 2020
PALYNZIQ
NDA BLA761079
Nov 20, 2020
PALYNZIQ
NDA BLA761079
Dec 9, 2023
PALYNZIQ
NDA BLA761079
Nov 20, 2025
PALYNZIQ
NDA BLA761079
Feb 27, 2026
PALYNZIQ
NDA BLA761079
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Pegvaliase. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Mechanism of Action
- PAL Enzyme Substitution[2]
- Modality
- Protein / enzyme[2]
- Highest Phase
- Approved[1]
- Company