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6R-BH4

Phase 2

Hypertension | Small molecule | Cardiovascular |BioMarin Pharmaceutical Inc.|Last Updated: Jul 21, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

6R-BH4 · 1 trial · 1 indication

Phase 2 1
NCT00325962A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic HypertensionHypertension
COMPLETED84 Analytics
PHASE2COMPLETED
A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
Hypertension
NCT0032596284
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Study Endpoints

Primary Endpoints

To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.

Secondary Endpoints

To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial diastolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in insulin sensitivity after 8 weeks of treatment in subjects with both type 2 diabetes and poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in eNOS activity and endothelial dysfunction after 8 weeks of treatment in subjects with poorly controlled hypertension
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
6R-BH4 (sapropterin dihydrochloride)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures. * At least 18 years of age. * Willing and able to comply with all study-related procedures. * History of documented essen...

Countries:United States
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Competitive Landscape -Hypertension 40 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS2PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN2 - Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Orchestra BioMed Holdings, Inc.OBIO3N/AUndisclosed
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
CVRx, Inc.CVRX1N/AMedical Management
Medtronic PlcMDT4N/AUndisclosed
IQVIA Holdings IncIQV1N/AUndisclosed
Verve Medical, IncVERV1N/AActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1N/ATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
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Frequently asked questions about 6R-BH4

What is 6R BH4 used for?

6R BH4 is an investigational small molecule being studied for hypertension and kidney disease, specifically chronic kidney disease with albuminuria. It is developed by BioMarin Pharmaceutical Inc. and is currently in Phase 2 clinical development, though the trials listed have been completed.

What does 6R BH4 target?

6R BH4 is a synthetic form of tetrahydrobiopterin, a cofactor for enzymes involved in nitric oxide synthesis. By potentially restoring nitric oxide production, it may improve blood pressure and kidney function. However, specific molecular targets have not been disclosed in the available information.

Who makes 6R BH4?

6R BH4 is developed by BioMarin Pharmaceutical Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BMRN. The company is conducting clinical research on this compound for hypertension and kidney disease indications.

What phase is 6R BH4 in?

6R BH4 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in hypertension and one in chronic kidney disease with albuminuria. It is not approved by the FDA and remains an investigational drug.

What clinical trials is 6R BH4 in?

6R BH4 has been studied in two completed Phase 2 trials. NCT00325962 evaluated its effects on blood pressure in 84 patients with poorly controlled hypertension. NCT00625820 assessed its use in 17 patients with chronic kidney disease and albuminuria. Both trials were conducted in the United States.

Is 6R BH4 the same as tetrahydrobiopterin?

6R BH4 is a synthetic form of tetrahydrobiopterin, also known as BH4. It is the 6R stereoisomer of the naturally occurring cofactor. This compound is being investigated for its potential role in treating hypertension and kidney disease.