Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU (Prism-2)
A Four-Part, Phase 3, Randomized, Double-Blind, Placebo- Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self-Administered by Adults With Phenylketonuria (PKU)
Sponsor: BioMarin Pharmaceutical
This PHASE3 trial investigates Phenylketonuria (PKU) and is currently completed. BioMarin Pharmaceutical leads this study, which shows 12 recorded versions since 2013 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
12 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jun 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jun 2021 [monthly]
Completed PHASE3
▶ Show 7 earlier versions
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Sep 2019 — Jan 2021 [monthly]
Completed PHASE3
-
Aug 2019 — Sep 2019 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Jun 2018 — Aug 2019 [monthly]
Active Not Recruiting PHASE3
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Jan 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
-
Dec 2017 — Jan 2018 [monthly]
Active Not Recruiting PHASE3
-
Feb 2017 — Dec 2017 [monthly]
Active Not Recruiting PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Jul 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- BioMarin Pharmaceutical
For direct contact, visit the study record on ClinicalTrials.gov .