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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Kuvan Clear all
Completed Phase 3 Interventional Results available

Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006

NCT00332189
View directory record Official record
Conditions
Phenylketonuria
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
4 Years and older
Enrollment
111 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
14
States / cities
Los Angeles, California • Sacramento, California • San Jose, California + 11 more
Source: ClinicalTrials.gov public record
Updated Nov 15, 2012 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Not applicable Interventional Results available

Rhode Island Diastolic Dysfunction - Heart Failure

NCT02353312
View directory record Official record
Conditions
Heart Failure, Cardiovascular Disease
Interventions
Kuvan
Drug
Lead sponsor
Providence VA Medical Center
Federal
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Jul 2, 2025 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 4 Interventional Results available

Effects of Kuvan on Melatonin Secretion

NCT01617070
View directory record Official record
Conditions
Phenylketonuria (PKU)
Interventions
Kuvan, Large Neutral Amino Acid Therapy
Drug · Dietary Supplement
Lead sponsor
University of Southern California
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Nov 17, 2016 · Synced Sep 2, 2026, 1:42 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

The Brain and Neuropsychological Functioning in Adults With Sapropterin Dihydrochloride Treated Phenylketonuria

NCT02297347
View directory record Official record
Conditions
Phenylketonuria
Interventions
Not listed
Lead sponsor
Boston Children's Hospital
Other
Eligibility
18 Years to 55 Years
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 4, 2018 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 2 Interventional

Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria

NCT00104260
View directory record Official record
Conditions
Phenylketonurias
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
8 Years and older
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
13
States / cities
Los Angeles, California • Oakland, California • New Haven, Connecticut + 10 more
Source: ClinicalTrials.gov public record
Updated Apr 8, 2007 · Synced Sep 2, 2026, 1:42 AM EDT
Completed No phase listed Observational

PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

NCT00778206
View directory record Official record
Conditions
Phenylketonuria, Hyperphenylalaninaemia
Interventions
Kuvan
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
Not listed
Enrollment
1,887 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2021
U.S. locations
45
States / cities
Los Angeles, California • Orange, California • San Diego, California + 38 more
Source: ClinicalTrials.gov public record
Updated Oct 11, 2022 · Synced Sep 2, 2026, 1:42 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan Nonresponders

NCT01274026
View directory record Official record
Conditions
Phenylketonuria, Behavior and Behavior Mechanisms, PAH Gene Expression
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
Tulane University School of Medicine
Other
Eligibility
2 Years to 21 Years
Enrollment
21 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2013
U.S. locations
1
States / cities
New Orleans, Louisiana
Source: ClinicalTrials.gov public record
Updated Aug 13, 2023 · Synced Sep 2, 2026, 1:42 AM EDT
Withdrawn Phase 1 Interventional Accepts healthy volunteers

O2 Transport and Utilization in Health and Lung Disease

NCT04014712
View directory record Official record
Conditions
COPD, Tetrahydrobiopterin Deficiency, Oxidative Stress
Interventions
Tetrahydrobiopterin, Placebo oral tablet
Drug
Lead sponsor
University of Massachusetts, Amherst
Other
Eligibility
18 Years to 85 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Amherst, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 18, 2023 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of Kuvan Treatment in Adults With GTPCH Deficiency

NCT01425528
View directory record Official record
Conditions
GTP Cyclohydrolase Deficiency
Interventions
Sapropterin
Drug
Lead sponsor
University of Utah
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Mar 31, 2025 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment

NCT02530996
View directory record Official record
Conditions
Rheumatologic Disease
Interventions
BH4, Vasculopathy assessment, Placebo
Drug · Diagnostic Test
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years to 95 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2019
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 4, 2021 · Synced Sep 2, 2026, 1:42 AM EDT
Recruiting Phase 1 Interventional

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

NCT06312748
View directory record Official record
Conditions
Heart Failure With Preserved Ejection Fraction, Inflammation
Interventions
L-Citrulline, Placebo for L-Citrulline, BH4, Placebo for BH4, Atorvastatin, Placebo for Atorvastatin
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 22, 2026 · Synced Sep 2, 2026, 1:42 AM EDT
Terminated Not applicable Interventional Accepts healthy volunteers Results available

A Pilot Study on Diurnal Variation

NCT01806051
View directory record Official record
Conditions
Phenylketonuria (PKU)
Interventions
Kuvan
Drug
Lead sponsor
Dr. Linda Randolph
Other
Eligibility
4 Years and older
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Apr 19, 2016 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 2 Interventional Results available

Endothelial Facilitation in Alzheimer's Disease

NCT01439555
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
Simvastatin, L-Arginine, Tetrahydrobiopterin
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
55 Years to 85 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 29, 2019 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Cystic Fibrosis and Endothelial Function: At Rest and During Exercise

NCT01772758
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
BH4 5mg, BH4 20mg, Antioxidant Cocktail
Drug · Dietary Supplement
Lead sponsor
Augusta University
Other
Eligibility
7 Years and older
Enrollment
64 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2016
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jun 19, 2019 · Synced Sep 2, 2026, 1:42 AM EDT
Terminated Phase 2 Interventional Results available

Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction

NCT00802893
View directory record Official record
Conditions
Isolated Systolic Hypertension, Endothelial Dysfunction
Interventions
6R-BH4, Placebo
Drug · Other
Lead sponsor
Johns Hopkins University
Other
Eligibility
40 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 20, 2017 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Kuvan in People With Schizophrenia and Schizoaffective Disorder

NCT01706965
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Kuvan, Multivitamin
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 64 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 12, 2017 · Synced Sep 2, 2026, 1:42 AM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

Response to Phenylketonuria to Tetrahydrobiopterin (BH4)

NCT00244218
View directory record Official record
Conditions
Phenylketonuria
Interventions
tetrahydrobiopterin (BH4)
Drug
Lead sponsor
The University of Texas Medical Branch, Galveston
Other
Eligibility
10 Years and older
Enrollment
57 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2015
U.S. locations
1
States / cities
Galveston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 20, 2021 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 3 Interventional Results available

Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU

NCT00838435
View directory record Official record
Conditions
Phenylketonuria
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
Up to 6 Years
Enrollment
95 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
12
States / cities
La Jolla, California • Orange, California • Tampa, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 21, 2020 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

NCT00104247
View directory record Official record
Conditions
Phenylketonurias
Interventions
sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
8 Years and older
Enrollment
89 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
13
States / cities
Los Angeles, California • Oakland, California • New Haven, Connecticut + 10 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2014 · Synced Sep 2, 2026, 1:42 AM EDT
Recruiting Phase 2 Interventional

Neurovascular Transduction During Exercise in Chronic Kidney Disease

NCT02947750
View directory record Official record
Conditions
Renal Insufficiency, Chronic
Interventions
6R-BH4, 6R-BH4 placebo, Folic acid, Exercise training, Stretching, Histidine and beta-alanine supplementation, Histidine and beta-alanine placebo
Drug · Other · Dietary Supplement
Lead sponsor
Emory University
Other
Eligibility
18 Years to 75 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
3
States / cities
Atlanta, Georgia • Decatur, Georgia
Source: ClinicalTrials.gov public record
Updated May 17, 2026 · Synced Sep 2, 2026, 1:42 AM EDT
Terminated No phase listed Observational

Behavioral Effects of Kuvan in Children With Mild Phenylketonuria

NCT00827762
View directory record Official record
Conditions
Phenylketonuria
Interventions
Kuvan
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
6 Years to 18 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
4
States / cities
Chicago, Illinois • Columbia, Missouri • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 4, 2013 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency

NCT00355264
View directory record Official record
Conditions
Tetrahydrobiopterin Deficiencies, Hyperphenylalaninemia, Non-Phenylketonuric
Interventions
Phenoptin
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
Not listed
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
9
States / cities
Los Angeles, California • Chicago, Illinois • Minneapolis, Minnesota + 6 more
Source: ClinicalTrials.gov public record
Updated Sep 24, 2020 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Phase 2 Interventional Results available

Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response

NCT00841100
View directory record Official record
Conditions
Phenylketonuria
Interventions
Kuvan, Diet
Drug · Other
Lead sponsor
University of Miami
Other
Eligibility
4 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Dec 2, 2019 · Synced Sep 2, 2026, 1:42 AM EDT
Completed Not applicable Interventional Results available

Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.

NCT01135186
View directory record Official record
Conditions
Gastroparesis
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Sep 9, 2019 · Synced Sep 2, 2026, 1:42 AM EDT