A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)
← catalyst calendarNCT05813678 · readout in 2,631 d
Sponsored by BioMarin Pharmaceutical (industry) · BMRN — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
450estimated
Sites
26
Countries
Germany, Italy, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-06 | actual | When the study began enrolling |
| Primary completion | 2033-11-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-11-01 | estimated | The whole study's end, after follow-up |
| First posted | 2023-04-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Phenylketonuria (PKU)
Intervention
- Drug: Pegvaliase
Primary outcome
what the primary-completion date above is the date OFTo quantify and characterize the risk of protocol-defined safety events in incident-users receiving pegvaliase for the treatment of PKU in a real¬ world setting.
measured A maximum of 10 years treatment duration.
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