Success Metrics

Clinical Success Rate
100.0%

Based on 13 completed trials

Completion Rate
100%(13/13)
Active Trials
1(6%)
Results Posted
69%(9 trials)

Phase Distribution

Ph not_applicable
3
18%
Ph phase_1
1
6%
Ph phase_2
6
35%
Ph phase_3
5
29%

Phase Distribution

1

Early Stage

6

Mid Stage

5

Late Stage

Phase Distribution15 total trials
Phase 1Safety & dosage
1(6.7%)
Phase 2Efficacy & side effects
6(40.0%)
Phase 3Large-scale testing
5(33.3%)
N/ANon-phased studies
3(20.0%)

Highest Phase Reached

Phase 3

Trial Status & Enrollment

Completion Rate

86.7%

13 of 15 finished

Non-Completion Rate

13.3%

2 ended early

Currently Active

1

trials recruiting

Total Trials

17

all time

Status Distribution
Active(1)
Completed(13)
Terminated(2)
Other(1)

Detailed Status

Completed13
Withdrawn2
Recruiting1
unknown1

Development Timeline

Analytics

Development Status

Total Trials
17
Active
1
Success Rate
100.0%
Most Advanced
Phase 3

Trials by Phase

Phase 11 (6.7%)
Phase 26 (40.0%)
Phase 35 (33.3%)
N/A3 (20.0%)

Trials by Status

recruiting16%
withdrawn212%
completed1376%
unknown16%

Recent Activity

Clinical Trials (17)

Showing 17 of 17 trials
NCT06396637Phase 2

PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

Recruiting
NCT01274026

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

Completed
NCT04054973Phase 2

L-arginine Study for Persistent Symptoms of Schizophrenia

Withdrawn
NCT00789568Phase 1

A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects

Completed
NCT00532844Phase 2

A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction

Completed
NCT00445978Phase 2

A Phase 2 Study of the Effects of 6R-BH4 in Subjects With Sickle Cell Disease

Completed
NCT00403494Phase 2

A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease

Completed
NCT00838435Phase 3

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

Completed
NCT01135186Not Applicable

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

Completed
NCT01114737Phase 3

Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients

Completed
NCT00272792Phase 3

Study of Phenoptin to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet

Completed
NCT01412437Not Applicable

Neuroimaging and Neurocognitive Assessment and Response to Sapropterin Dihydrochloride Treatment in Phenylketonuria

Withdrawn
NCT01141595Not Applicable

Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders

Completed
NCT00332189Phase 3

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

Completed
NCT00225615Phase 3

A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels

Completed
NCT00484991

Sapropterin Expanded Access Program

Unknown
NCT00104260Phase 2

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

Completed

All 17 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
17