Last Updated: November 14, 2026

CLINICAL TRIALS PROFILE FOR SAPROPTERIN DIHYDROCHLORIDE

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All Clinical Trials for sapropterin dihydrochloride

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00104247 ↗	Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels	Completed	BioMarin Pharmaceutical	Phase 3	2005-03-01	The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria.
NCT00104260 ↗	Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria	Completed	BioMarin Pharmaceutical	Phase 2	2004-12-01	The primary objective is to evaluate the degree and frequency of response to Phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe) level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject population, and identify individuals in this subject population who respond to Phenoptin™ treatment with a reduction in blood Phe level.
NCT00325962 ↗	A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension	Completed	BioMarin Pharmaceutical	Phase 2	2006-05-01	The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for sapropterin dihydrochloride

Condition Name

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Condition Name for sapropterin dihydrochloride
Intervention	Trials
Phenylketonuria	17
Phenylketonurias	2
Autistic Disorder	2
[disabled in preview]	1
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Condition MeSH

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Condition MeSH for sapropterin dihydrochloride
Intervention	Trials
Phenylketonurias	20
Hypertension	3
Disease	2
[disabled in preview]	1
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Clinical Trial Locations for sapropterin dihydrochloride

Trials by Country

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Trials by Country for sapropterin dihydrochloride
Location	Trials
United States	119
Canada	7
China	3
Italy	3
Germany	3
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Trials by US State

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Trials by US State for sapropterin dihydrochloride
Location	Trials
California	10
Texas	8
Pennsylvania	7
Massachusetts	6
Georgia	6
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Clinical Trial Progress for sapropterin dihydrochloride

Clinical Trial Phase

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Clinical Trial Phase for sapropterin dihydrochloride
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	2
Phase 4	2
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Clinical Trial Status

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Clinical Trial Status for sapropterin dihydrochloride
Clinical Trial Phase	Trials
Completed	26
Terminated	4
Not yet recruiting	3
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Clinical Trial Sponsors for sapropterin dihydrochloride

Sponsor Name

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Sponsor Name for sapropterin dihydrochloride
Sponsor	Trials
BioMarin Pharmaceutical	24
Merck KGaA	3
University of Missouri-Columbia	3
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Sponsor Type

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Sponsor Type for sapropterin dihydrochloride
Sponsor	Trials
Other	39
Industry	31
NIH	2
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