Drug
Sapropterin clinical trials
Also written Kuvan, Tetrahydrobiopterin and Phenoptin.
- studies test it
- 63
- open now
- 5
- in phase 3
- 12
- first study started
- 2004
Keep track of what changes. Save the sapropterin studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Name
Other names
- BH4
- 9
Studies by the year they started
62 studies that test it; most in 2011 (9)
| Year | Studies |
|---|---|
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 6 |
| 2009 | 4 |
| 2010 | 6 |
| 2011 | 9 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
By phase
A phase 1/2 study counts in both.
- Early Phase 1
- 2
- Phase 1
- 15
- Phase 2
- 27
- Phase 3
- 12
- Phase 4
- 5
- No phase
- 9
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 18 · Other 45
BioMarin Pharmaceutical (15) · Emory University (4) · VA Office of Research and Development (3) · Augusta University (3) · The Children's Health Council (2) · Merck KGaA, Darmstadt, Germany (2) · The University of Texas Health Science Center, Houston (2) · West China Second University Hospital (2)
Often tested with
Tested in the same studies.
Ascorbic Acid (5) · Vitamin E (4) · Thioctic Acid (4) · Antioxidants (1) · Simvastatin (1) · Arginine (1) · Acetovanillone (1) · Allopurinol (1)
Studies
Open first, then newest update. How each study uses sapropterin is read from its arms, and is right about nine times in ten.
Testing it · 63
- : Vascular Function in Health and DiseaseRecruitingPhase 1D. Walter WrayNCT02966665Written as BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate
- Neurovascular Transduction During Exercise in Chronic Kidney DiseaseRecruitingPhase 2Emory UniversityNCT02947750Written as 6R-BH4
- A Single Patient Study of Sapropterin for Multisystem Smooth Muscle Dysfunction SyndromeNot yet recruitingNot applicableGregor AndelfingerNCT07574034Written as Kuvan (Sapropterine)
- Novel Approaches for Improving Vascular Function in Veterans With HFpEFRecruitingPhase 1VA Office of Research and DevelopmentNCT06312748Written as BH4
- PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDACRecruitingPhase 2Sun Yat-sen UniversityNCT06396637Written as Sapropterin Dihydrochloride
- The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent ClaudicationActive, not recruitingPhase 1Louis MessinaNCT04800692Written as Tetrahydrobiopterin 10 mg/kg
- Evaluation of BH4 Responsiveness in Our PKU PatientsActive, not recruitingPhase 1Sohag UniversityNCT07255599Written as Sapropterin Dihydrochloride (BH4, tetrahydrobiopterin)
- Exercise and NO in HFrEFCompletedEarly Phase 1VA Office of Research and DevelopmentNCT03136029Written as Tetrahydrobiopterin (BH4)
- Rhode Island Diastolic Dysfunction - Heart FailureCompletedNot applicableProvidence VA Medical CenterNCT02353312Written as Kuvan
- Study on Sapropterin Dihydrochloride Oral Suspension in Healthy SubjectsCompletedPhase 1APR Applied Pharma Research s.a.NCT06481709Written as RLF-OD032
- Study of Kuvan Treatment in Adults With GTPCH DeficiencyCompletedPhase 1/2University of UtahNCT01425528Written as Sapropterin
- Effects of Tetrahydrobiopterin (BH4) on Leg Blood Flow and Exercise Capacity in Patients With Peripheral Artery DiseaseWithdrawnPhase 4University of NebraskaNCT03493412Written as Sapropterin Dihydrochloride (BH4, tetrahydrobiopterin)
- O2 Transport and Utilization in Health and Lung DiseaseWithdrawnPhase 1University of Massachusetts, AmherstNCT04014712Written as Tetrahydrobiopterin
- Kuvan®'s Effect on the Cognition of Children With PhenylketonuriaCompletedPhase 4BioMarin PharmaceuticalNCT01965912Written as Kuvan®
- BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)Status unknownPhase 1West China HospitalNCT05299203Written as Sapropterin dihydrochloride tablets
- A Study for Assessing the Efficacy and Safety of BH4 in Radiation EnteritisStatus unknownPhase 2West China Second University HospitalNCT05138887Written as Tetrahydrobiopterin
- A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin InjuryStatus unknownPhase 1West China Second University HospitalNCT05114226Written as Tetrahydrobiopterin
- Response to Phenylketonuria to Tetrahydrobiopterin (BH4)TerminatedPhase 1The University of Texas Medical Branch, GalvestonNCT00244218Written as tetrahydrobiopterin (BH4)
- A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult SubjectsCompletedPhase 1BioMarin PharmaceuticalNCT00789568Written as sapropterin dihydrochloride
- A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial DysfunctionCompletedPhase 2BioMarin PharmaceuticalNCT00532844Written as Sapropterin Dihydrochloride
See all 63 studies that test sapropterin →
Given in every arm · 3 — sapropterin is usual care beside what is tested
- Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed ConditionsCompletedPhase 1APR Applied Pharma Research s.a.NCT06987773Written as Kuvan 100 MG Powder for Oral Solution
- L-arginine Study for Persistent Symptoms of SchizophreniaWithdrawnPhase 2University of Massachusetts, WorcesterNCT04054973Written as Sapropterin Dihydrochloride
- Sex Hormones and Atherosclerosis Prevention in Perimenopausal WomenCompletedEarly Phase 1University of Colorado, DenverNCT02042196Written as KUVAN
Codes
What other systems call sapropterin · ClinicalTrials.gg INT002274
- MeSH (NLM) C003402sapropterinOne source NLM
- UNII (FDA) EGX657432ISAPROPTERINConfirmed FDA, NLM, Wikidata
- RxNorm 753340One source FDA
- Wikidata Q419808sapropterinConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C78087SapropterinOne source FDA
- DrugBank DB00360One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C003402 | sapropterin | One source NLM |
| UNII (FDA) | EGX657432I | SAPROPTERIN | Confirmed FDA, NLM, Wikidata |
| RxNorm | 753340 | — | One source FDA |
| Wikidata | Q419808 | sapropterin | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C78087 | Sapropterin | One source FDA |
| DrugBank | DB00360 | — | One source Wikidata |
Also registered as 2,4,5-trihydroxybutyrophenone (UNII KN729W3LR0) and sapropterin dihydrochloride (UNII RG277LF5B3 · RxNorm 753341).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.