Pegvaliase Clinical Trials (2026): 8 Studies for Phenylketonuria (PKU) & Phenylketonurias
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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8 Pegvaliase clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 4 indications (including Phenylketonuria (PKU) & Phenylketonurias) and 828 total planned enrollment. 2 Phase 3 Pegvaliase trials, 1 Phase 4 are listed. 4 Pegvaliase clinical trials are actively recruiting at 24 U.S. sites across 13 states. Most recent activity: NCT06305234 (Nov 2033).
Where to Participate: All Pegvaliase Trial Sites in the U.S. (24 sites across 13 states)
Every actively recruiting Pegvaliasetrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CO | University of Colorado | Aurora80045 | NCT05813678 | Map |
| CO | University of Colorado | Aurora80045 | NCT06305234 | Map |
| GA | Emory University | Atlanta30322 | NCT05813678 | Map |
| GA | Emory University | Atlanta30322 | NCT06305234 | Map |
| IL | Northwestern University | Chicago60611 | NCT05813678 | Map |
| IL | Northwestern University | Chicago60611 | NCT06305234 | Map |
| IN | Indiana University School of Medicine | Indianapolis46202 | NCT05813678 | Map |
| IN | Riley Children's Hospital/ Indiana University Health | Indianapolis46202 | NCT06305234 | Map |
| LA | Tulane University Medical Center | New Orleans70118 | NCT05813678 | Map |
| LA | Tulane University School of Medicine | New Orleans70112 | NCT06305234 | Map |
| MA | Boston Children's Hospital | Boston02215 | NCT05813678 | Map |
| MA | Boston Children's Hospital | Boston02215 | NCT06305234 | Map |
| NC | Syneos Health | Wilmington28403 | NCT05579548 | Map |
| OR | Oregon Health & Science University | Portland97239 | NCT06305234 | Map |
| OR | Oregon Health and Science University | Portland97239 | NCT05813678 | Map |
| PA | University of Pittsburgh Medical Center | Pittsburgh15224 | NCT05813678 | Map |
| PA | University of Pittsburgh Medical Center | Pittsburgh15213 | NCT06305234 | Map |
| TN | Vanderbilt University Medical School | Nashville37235 | NCT05813678 | Map |
| TN | Vanderbilt University Medical School | Nashville37235 | NCT06305234 | Map |
| TX | University of Texas Southwestern Medical Center | Dallas75390 | NCT05813678 | Map |
| TX | UT Southwestern Medical Center | Dallas75390 | NCT06305234 | Map |
| UT | University of Utah | Salt Lake City84112 | NCT05813678 | Map |
| WI | Children's Wisconsin/Medical College of Wisconsin | Milwaukee53226 | NCT06305234 | Map |
| WI | Medical College of Wisconsin | Milwaukee53226 | NCT05813678 | Map |
Pegvaliase clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | Total |
|---|---|---|---|---|---|
| P3 | 1 | 1 | 2 | ||
| P4 | 1 | 1 | |||
| N/A | 3 | 2 | 5 |
Recruiting Pegvaliase clinical trials (4)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06305234 | A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) | — | Phenylketonuria (PKU) | 200 | Jan 2024 |
| NCT05813678 | PALaceA Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace) | — | Phenylketonuria (PKU) | 450 | Jun 2022 |
| NCT05579548 | PALominoA Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding | — | Phenylketonuria, Maternal | 50 | Nov 2022 |
| NCT07477691 | IMPALAImmune Modulation During Palynziq® Treatment in Adults (IMPALA) | P4 | Phenylketonuria | 12 | Mar 2026 |
Pegvaliase clinical trials by indication
Phenylketonuria (PKU) (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06305234 | — | N/A | recruiting | A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) |
| NCT05813678 | PALace | N/A | recruiting | A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace) |
| NCT05270837 | PEGASUS | P3 | active not recruiting | Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria |
| NCT03694353 | — | P3 | completed | Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU |
Phenylketonurias (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05356377 | — | N/A | completed | Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU |
| NCT03792451 | — | N/A | completed | Nutrition Status of Adults Treated With Pegvaliase |
Phenylketonuria (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07477691 | IMPALA | P4 | not yet recruiting | Immune Modulation During Palynziq® Treatment in Adults (IMPALA) |
Phenylketonuria, Maternal (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05579548 | PALomino | N/A | recruiting | A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding |
Pegvaliase pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| IMPALA | NCT07477691 | P4 | not yet recruiting | Phenylketonuria | 12 | — |
| PEGASUS | NCT05270837 | P3 | active not recruiting | Phenylketonuria (PKU) | 55 | — |
All Pegvaliase trials (8)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06305234 | A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) | — | recruiting | 200 | BioMarin Pharmaceutical | Jan 2024 | |
| NCT05813678 | PALace | A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace) | — | recruiting | 450 | BioMarin Pharmaceutical | Jun 2022 |
| NCT05579548 | PALomino | A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding | — | recruiting | 50 | BioMarin Pharmaceutical | Nov 2022 |
| NCT05270837 | PEGASUS | Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria | P3 | active not recruiting | 55 | BioMarin Pharmaceutical | Jun 2022 |
| NCT07477691 | IMPALA | Immune Modulation During Palynziq® Treatment in Adults (IMPALA) | P4 | not yet recruiting | 12 | BioMarin Pharmaceutical | Mar 2026 |
| NCT05356377 | Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU | — | completed | 6 | University of Missouri-Columbia | May 2022 | |
| NCT03694353 | Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU | P3 | completed | 37 | BioMarin Pharmaceutical | Sep 2018 | |
| NCT03792451 | Nutrition Status of Adults Treated With Pegvaliase | — | completed | 18 | Boston Children's Hospital | Jan 2019 |
Pegvaliase clinical trials: frequently asked questions
- How many Pegvaliase clinical trials are there?
- 8 Pegvaliase clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 3 are marked completed.
- Are Pegvaliase clinical trials recruiting in 2026?
- Yes — 3 Pegvaliase trials are actively recruiting in 2026, with 24 U.S. sites across 13 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Pegvaliase being studied for?
- Pegvaliase is being studied for Phenylketonuria (PKU), Phenylketonurias, Phenylketonuria, Phenylketonuria, Maternal. The trials are grouped by indication on this page.
- What phase is Pegvaliase in?
- Pegvaliase clinical trials span 1 Phase 4, 2 Phase 3. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Pegvaliase clinical trials?
- The lead sponsor across the most Pegvaliase trials is BioMarin Pharmaceutical, with 2 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Pegvaliaseas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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