4 completed, 1 approved for marketing. 2 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
Follow phenoptin: new trials by email Literature Review of phenoptin trials Research Report on phenoptin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients Sapropterin dihydrochloride, Placebo - Phenylketonuria | Phase 3 | Completed | BioMarin Pharmaceutical | 206 | 2010-08-01 | 2016-02-01 |
| Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU sapropterin dihydrochloride - Phenylketonuria | Phase 3 | Completed | BioMarin Pharmaceutical | 95 | 2009-02-01 | 2020-12-22 |
| Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria 6R BH4, Vitamin C - Kidney Disease, Albuminuria | Phase 2 | Completed | University of Michigan | 17 | 2008-05-01 | 2016-10-18 |
| Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency Phenoptin - Tetrahydrobiopterin Deficiencies, Hyperphenylalaninemia, Non-Phenylketonuric | Phase 2 | Completed | BioMarin Pharmaceutical | 12 | 2006-08-01 | 2020-09-25 |
| Sapropterin Expanded Access Program Sapropterin dihydrochloride - Phenylketonuria | Approved for marketing | BioMarin Pharmaceutical | 2008-04-15 |
Phenylketonurias (4) · Albuminuria (1) · Attention Deficit Disorder with Hyperactivity (1) · Kidney Diseases (1)
BioMarin Pharmaceutical (4) · University of Michigan (1)
United States (5) · Canada (2) · Germany (1)
Joshua Lilienstein, M.D. (1) · Rajiv Saran, MD (1) · Suyash Prasad, MD (1)