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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Pegvaliase

Company
BioMarin Pharmaceutical
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
5 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

5 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Nov 11, 2026

Find a Clinical Trial Near Me

See recruiting studies for Pegvaliase and check eligibility with the study team.

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Treatment type

"Added to GLP-1" means the investigational treatment is being studied on top of an existing GLP-1-based therapy.

Your ZIP code is only used to calculate distance to trial sites — it isn't stored.

Trial details
  • Recruiting NCT NCT04404530

    Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU)

    Emory University 45 participants Est. completion 2028-12 2 sites
    Other conditions: Phenylketonurias
    View official trial listing →
  • Recruiting NCT NCT05579548

    A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

    BioMarin Pharmaceutical 50 participants Est. completion 2032-10-04 4 sites
    Other conditions: Phenylketonuria, Maternal
    View official trial listing →
  • Recruiting NCT NCT05813678

    A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)

    BioMarin Pharmaceutical 450 participants Est. completion 2033-11-01 26 sites
    Other conditions: Phenylketonuria (PKU)
    View official trial listing →
  • Recruiting NCT NCT06305234

    A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)

    BioMarin Pharmaceutical 200 participants Est. completion 2033-11-18 11 sites
    Other conditions: Phenylketonuria (PKU)
    View official trial listing →
  • Recruiting NCT NCT07477691

    Immune Modulation During Palynziq® Treatment in Adults (IMPALA)

    Not yet reported BioMarin Pharmaceutical 12 participants Est. completion 2027-09-30 12 sites Stand-alone
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT00634660

    Safety and Tolerability Study of rAvPAL-PEG to Treat Phenylketonuria

    Not yet reported BioMarin Pharmaceutical 25 participants Est. completion 2009-10 8 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT00924703

    Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)

    Not yet reported BioMarin Pharmaceutical 68 participants Est. completion 2019-01-31 14 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT00925054

    Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU

    Not yet reported BioMarin Pharmaceutical 40 participants Est. completion 2015-06 11 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT01212744

    Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)

    Not yet reported BioMarin Pharmaceutical 16 participants Est. completion 2015-04 9 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT01560286

    A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks

    Not yet reported BioMarin Pharmaceutical 24 participants Est. completion 2015-07 6 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT01819727

    An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165

    Not yet reported BioMarin Pharmaceutical 261 participants Est. completion 2015-11-25 31 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT01889862

    Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU

    Not yet reported BioMarin Pharmaceutical 215 participants Est. completion 2019-02-05 29 sites
    Other conditions: Phenylketonuria (PKU)
    View official trial listing →
  • Completed NCT NCT02468570

    A Phase 3 Substudy to Evaluate Executive Function in Adults With PKU Who Are Participating in the Phase 3 Study, 165-302

    BioMarin Pharmaceutical 9 participants Est. completion 2017-02-01 4 sites
    Other conditions: Phenylketonuria
    View official trial listing →
  • Completed NCT NCT03505125

    A Non-Interventional Interview Study of Phenylketonuria (PKU) Adults

    BioMarin Pharmaceutical 63 participants Est. completion 2019-07-31 14 sites
    Other conditions: Phenylketonuria (PKU)
    View official trial listing →
  • Completed NCT NCT03694353

    Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU

    Not yet reported BioMarin Pharmaceutical 37 participants Est. completion 2021-01-13 17 sites Stand-alone
    Other conditions: Phenylketonuria (PKU)
    View official trial listing →
  • Completed NCT NCT03792451

    Nutrition Status of Adults Treated With Pegvaliase

    Boston Children's Hospital 18 participants Est. completion 2020-12-31 1 site
    Other conditions: Phenylketonurias
    View official trial listing →
  • Completed NCT NCT03856203

    Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase

    Boston Children's Hospital 12 participants Est. completion 2023-10-20 1 site
    Other conditions: Phenylketonurias
    View official trial listing →
  • Active, not recruiting NCT NCT05270837

    Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria

    Not yet reported BioMarin Pharmaceutical 55 participants Est. completion 2027-10 16 sites Stand-alone
    Other conditions: Phenylketonuria (PKU)
    View official trial listing →
  • Completed NCT NCT05356377

    Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU

    University of Missouri-Columbia 6 participants Est. completion 2025-07-01 2 sites
    Other conditions: Phenylketonurias
    View official trial listing →
  • Completed NCT NCT06780332

    Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

    Not yet reported BioMarin Pharmaceutical 9 participants Est. completion 2026-08-17 1 site Stand-alone
    Other conditions: Phenylketonuria, PKU
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: Pegvaliase, Palynziq

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.