Clinical Trial

A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria

Active, Not Recruiting Phase 3
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Record status
This record was last updated June 23, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2021-12-08; most recent amendment 2026-06-19.
Status change: Recruiting → Active, Not Recruiting 2026-02-05
Status change: Not Yet Recruiting → Recruiting 2022-02-23
Trial Details
NCT Number NCT05166161
Lead Sponsor PTC Therapeutics
Conditions Phenylketonuria
Enrollment 200 participants
Start Date 2022-02-14
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-23